Regulatory Open Forum

Following the recent court case in Europe between Brain Products and BioSemi VOF concerning the use of a device that meets the definition of a medical device as per the MDD, but is not intended for a medical purpose, I would appreciate input from colleagues on a similar "scenario" opposite the FDA. By way of example, I will refer to a SPO2 (pulse oximeter) device. On the one hand, the FDA defines a pulse oximeter as a Class II device that requires a 510(k); while on the other hand SPO2 devices can be bought via Amazon as non-medical devices, without 510(k) clearance.

Question: can a device that is defined by FDA as falling within the category of a medical device due to its medical function, "become" a non-medical device by changing the labeling and intended use to that of non-medical?

Also, does it matter if the non-medical device is sold as stand-alone, or is part of a multi-function device that has an "overall" medical purpose, i.e. does a non-medical function "inherit" the medical intended use of a device that has both medical and non-medical functions?

Following the recent court case in Europe between Brain Products and BioSemi VOF concerning the use of a device that meets the definition of a medical device as per the MDD, but is not intended for a medical purpose, I would appreciate input from colleagues on a similar "scenario" opposite the FDA. By way of example, I will refer to a SPO2 (pulse oximeter) device. On the one hand, the FDA defines a pulse oximeter as a Class II device that requires a 510(k); while on the other hand SPO2 devices can be bought via Amazon as non-medical devices, without 510(k) clearance.

Question: can a device that is defined by FDA as falling within the category of a medical device due to its medical function, "become" a non-medical device by changing the labeling and intended use to that of non-medical?

Also, does it matter if the non-medical device is sold as stand-alone, or is part of a multi-function device that has an "overall" medical purpose, i.e. does a non-medical function "inherit" the medical intended use of a device that has both medical and non-medical functions?

Following the recent court case in Europe between Brain Products and BioSemi VOF concerning the use of a device that meets the definition of a medical device as per the MDD, but is not intended for a medical purpose, I would appreciate input from colleagues on a similar "scenario" opposite the FDA. By way of example, I will refer to a SPO2 (pulse oximeter) device. On the one hand, the FDA defines a pulse oximeter as a Class II device that requires a 510(k); while on the other hand SPO2 devices can be bought via Amazon as non-medical devices, without 510(k) clearance.

Question: can a device that is defined by FDA as falling within the category of a medical device due to its medical function, "become" a non-medical device by changing the labeling and intended use to that of non-medical?

Also, does it matter if the non-medical device is sold as stand-alone, or is part of a multi-function device that has an "overall" medical purpose, i.e. does a non-medical function "inherit" the medical intended use of a device that has both medical and non-medical functions?

Common Uses

Pulse Oximeters in Sports and Aviation

High Altitude Sport Participants

High elevation sports enthusiasts such as hikers and climbers may find the iSpO2 a useful tool to identify situations in which oxygen saturation is declining at higher elevations. Declining oxygen saturation is commonly associated with several conditions at high elevations, such as HAPE (high altitude pulmonary edema) and other forms of altitude sickness. For more information, visit:

• Altitude Sickness
• High Altitude Pulmonary Edema (HAPE)

Pilots

According to Pilotfriend:

"Unfortunately, the nature of hypoxia makes you, the pilot, the poorest judge of when you are its victim. The first symptoms of oxygen deficiency are misleadingly pleasant, resembling mild intoxication from alcohol. Because oxygen starvation strikes first at the brain, your higher faculties are dulled. Your normal self-critical ability is out of order. Your mind no longer functions properly; your hands and feet become clumsy without being aware of it; you may feel drowsy, languid, and nonchalant; you have a false sense of security; and, the last thing in the world you think you need is oxygen.¹"

Brent Blue, MD, of www.aeromedix.com, says the following about hypoxia:

"Lack of oxygen is the greatest single danger to man at high altitudes due to its immediate and critical effects. The shortage of oxygen in the human body is called hypoxia, which means that the body is not getting enough oxygen to maintain normal body functions. When a pilot inhales air at high altitudes, due to the decreased barometric pressure, the amount of oxygen inhaled with every breath is less than at sea level. Thus, the number of oxygen molecules that is available to be transported through the lung tissue into the blood stream is reduced. When the level of oxygen in the blood is low, the brain and other tissues are adversely affected.²

The Federal Aviation Regulations (FARs) require oxygen to be used if flying above 12,500 feet MSL (Mean Sea Level) for 30 or more minutes and at all times above 14,000 feet MSL. However, many pilots and passengers experience hypoxia at lower altitudes, especially at night."

Recommendations from Dr. Blue:

1. Always use oxygen if there is any sensation of hypoxia such as euphoria, visual changes, headache, dizziness, nausea, anxiety, panic, or confusion.
2. Pilots should use oxygen when their saturation drops five percentage points below their home field saturation, and must use oxygen if their saturation drops 10 points below their home field sat. For instance, if your home field saturation is 97%, you should use oxygen at 92% and must use oxygen at 87%. Refer to oxygen instructions for safe use.

The only practical way to know if you are hypoxic or in danger of becoming hypoxic is to use a pulse oximeter. Pulse oximeters measure the saturation of oxygen in the blood stream. Ninety-five to 100% is normal at sea level.

Following the recent court case in Europe between Brain Products and BioSemi VOF concerning the use of a device that meets the definition of a medical device as per the MDD, but is not intended for a medical purpose, I would appreciate input from colleagues on a similar "scenario" opposite the FDA. By way of example, I will refer to a SPO2 (pulse oximeter) device. On the one hand, the FDA defines a pulse oximeter as a Class II device that requires a 510(k); while on the other hand SPO2 devices can be bought via Amazon as non-medical devices, without 510(k) clearance.

Question: can a device that is defined by FDA as falling within the category of a medical device due to its medical function, "become" a non-medical device by changing the labeling and intended use to that of non-medical?

Also, does it matter if the non-medical device is sold as stand-alone, or is part of a multi-function device that has an "overall" medical purpose, i.e. does a non-medical function "inherit" the medical intended use of a device that has both medical and non-medical functions?

Common Uses

Pulse Oximeters in Sports and Aviation

High Altitude Sport Participants

High elevation sports enthusiasts such as hikers and climbers may find the iSpO2 a useful tool to identify situations in which oxygen saturation is declining at higher elevations. Declining oxygen saturation is commonly associated with several conditions at high elevations, such as HAPE (high altitude pulmonary edema) and other forms of altitude sickness. For more information, visit:

• Altitude Sickness
• High Altitude Pulmonary Edema (HAPE)

Pilots

According to Pilotfriend:

"Unfortunately, the nature of hypoxia makes you, the pilot, the poorest judge of when you are its victim. The first symptoms of oxygen deficiency are misleadingly pleasant, resembling mild intoxication from alcohol. Because oxygen starvation strikes first at the brain, your higher faculties are dulled. Your normal self-critical ability is out of order. Your mind no longer functions properly; your hands and feet become clumsy without being aware of it; you may feel drowsy, languid, and nonchalant; you have a false sense of security; and, the last thing in the world you think you need is oxygen.¹"

Brent Blue, MD, of www.aeromedix.com, says the following about hypoxia:

"Lack of oxygen is the greatest single danger to man at high altitudes due to its immediate and critical effects. The shortage of oxygen in the human body is called hypoxia, which means that the body is not getting enough oxygen to maintain normal body functions. When a pilot inhales air at high altitudes, due to the decreased barometric pressure, the amount of oxygen inhaled with every breath is less than at sea level. Thus, the number of oxygen molecules that is available to be transported through the lung tissue into the blood stream is reduced. When the level of oxygen in the blood is low, the brain and other tissues are adversely affected.²

The Federal Aviation Regulations (FARs) require oxygen to be used if flying above 12,500 feet MSL (Mean Sea Level) for 30 or more minutes and at all times above 14,000 feet MSL. However, many pilots and passengers experience hypoxia at lower altitudes, especially at night."

Recommendations from Dr. Blue:

1. Always use oxygen if there is any sensation of hypoxia such as euphoria, visual changes, headache, dizziness, nausea, anxiety, panic, or confusion.
2. Pilots should use oxygen when their saturation drops five percentage points below their home field saturation, and must use oxygen if their saturation drops 10 points below their home field sat. For instance, if your home field saturation is 97%, you should use oxygen at 92% and must use oxygen at 87%. Refer to oxygen instructions for safe use.

The only practical way to know if you are hypoxic or in danger of becoming hypoxic is to use a pulse oximeter. Pulse oximeters measure the saturation of oxygen in the blood stream. Ninety-five to 100% is normal at sea level.

Following the recent court case in Europe between Brain Products and BioSemi VOF concerning the use of a device that meets the definition of a medical device as per the MDD, but is not intended for a medical purpose, I would appreciate input from colleagues on a similar "scenario" opposite the FDA. By way of example, I will refer to a SPO2 (pulse oximeter) device. On the one hand, the FDA defines a pulse oximeter as a Class II device that requires a 510(k); while on the other hand SPO2 devices can be bought via Amazon as non-medical devices, without 510(k) clearance.

Question: can a device that is defined by FDA as falling within the category of a medical device due to its medical function, "become" a non-medical device by changing the labeling and intended use to that of non-medical?

Also, does it matter if the non-medical device is sold as stand-alone, or is part of a multi-function device that has an "overall" medical purpose, i.e. does a non-medical function "inherit" the medical intended use of a device that has both medical and non-medical functions?

Common Uses

Pulse Oximeters in Sports and Aviation

High Altitude Sport Participants

High elevation sports enthusiasts such as hikers and climbers may find the iSpO2 a useful tool to identify situations in which oxygen saturation is declining at higher elevations. Declining oxygen saturation is commonly associated with several conditions at high elevations, such as HAPE (high altitude pulmonary edema) and other forms of altitude sickness. For more information, visit:

• Altitude Sickness
• High Altitude Pulmonary Edema (HAPE)

Pilots

According to Pilotfriend:

"Unfortunately, the nature of hypoxia makes you, the pilot, the poorest judge of when you are its victim. The first symptoms of oxygen deficiency are misleadingly pleasant, resembling mild intoxication from alcohol. Because oxygen starvation strikes first at the brain, your higher faculties are dulled. Your normal self-critical ability is out of order. Your mind no longer functions properly; your hands and feet become clumsy without being aware of it; you may feel drowsy, languid, and nonchalant; you have a false sense of security; and, the last thing in the world you think you need is oxygen.¹"

Brent Blue, MD, of www.aeromedix.com, says the following about hypoxia:

"Lack of oxygen is the greatest single danger to man at high altitudes due to its immediate and critical effects. The shortage of oxygen in the human body is called hypoxia, which means that the body is not getting enough oxygen to maintain normal body functions. When a pilot inhales air at high altitudes, due to the decreased barometric pressure, the amount of oxygen inhaled with every breath is less than at sea level. Thus, the number of oxygen molecules that is available to be transported through the lung tissue into the blood stream is reduced. When the level of oxygen in the blood is low, the brain and other tissues are adversely affected.²

The Federal Aviation Regulations (FARs) require oxygen to be used if flying above 12,500 feet MSL (Mean Sea Level) for 30 or more minutes and at all times above 14,000 feet MSL. However, many pilots and passengers experience hypoxia at lower altitudes, especially at night."

Recommendations from Dr. Blue:

1. Always use oxygen if there is any sensation of hypoxia such as euphoria, visual changes, headache, dizziness, nausea, anxiety, panic, or confusion.
2. Pilots should use oxygen when their saturation drops five percentage points below their home field saturation, and must use oxygen if their saturation drops 10 points below their home field sat. For instance, if your home field saturation is 97%, you should use oxygen at 92% and must use oxygen at 87%. Refer to oxygen instructions for safe use.

The only practical way to know if you are hypoxic or in danger of becoming hypoxic is to use a pulse oximeter. Pulse oximeters measure the saturation of oxygen in the blood stream. Ninety-five to 100% is normal at sea level.

Following the recent court case in Europe between Brain Products and BioSemi VOF concerning the use of a device that meets the definition of a medical device as per the MDD, but is not intended for a medical purpose, I would appreciate input from colleagues on a similar "scenario" opposite the FDA. By way of example, I will refer to a SPO2 (pulse oximeter) device. On the one hand, the FDA defines a pulse oximeter as a Class II device that requires a 510(k); while on the other hand SPO2 devices can be bought via Amazon as non-medical devices, without 510(k) clearance.

Question: can a device that is defined by FDA as falling within the category of a medical device due to its medical function, "become" a non-medical device by changing the labeling and intended use to that of non-medical?

Also, does it matter if the non-medical device is sold as stand-alone, or is part of a multi-function device that has an "overall" medical purpose, i.e. does a non-medical function "inherit" the medical intended use of a device that has both medical and non-medical functions?

Common Uses

Pulse Oximeters in Sports and Aviation

High Altitude Sport Participants

High elevation sports enthusiasts such as hikers and climbers may find the iSpO2 a useful tool to identify situations in which oxygen saturation is declining at higher elevations. Declining oxygen saturation is commonly associated with several conditions at high elevations, such as HAPE (high altitude pulmonary edema) and other forms of altitude sickness. For more information, visit:

• Altitude Sickness
• High Altitude Pulmonary Edema (HAPE)

Pilots

According to Pilotfriend:

"Unfortunately, the nature of hypoxia makes you, the pilot, the poorest judge of when you are its victim. The first symptoms of oxygen deficiency are misleadingly pleasant, resembling mild intoxication from alcohol. Because oxygen starvation strikes first at the brain, your higher faculties are dulled. Your normal self-critical ability is out of order. Your mind no longer functions properly; your hands and feet become clumsy without being aware of it; you may feel drowsy, languid, and nonchalant; you have a false sense of security; and, the last thing in the world you think you need is oxygen.¹"

Brent Blue, MD, of www.aeromedix.com, says the following about hypoxia:

"Lack of oxygen is the greatest single danger to man at high altitudes due to its immediate and critical effects. The shortage of oxygen in the human body is called hypoxia, which means that the body is not getting enough oxygen to maintain normal body functions. When a pilot inhales air at high altitudes, due to the decreased barometric pressure, the amount of oxygen inhaled with every breath is less than at sea level. Thus, the number of oxygen molecules that is available to be transported through the lung tissue into the blood stream is reduced. When the level of oxygen in the blood is low, the brain and other tissues are adversely affected.²

The Federal Aviation Regulations (FARs) require oxygen to be used if flying above 12,500 feet MSL (Mean Sea Level) for 30 or more minutes and at all times above 14,000 feet MSL. However, many pilots and passengers experience hypoxia at lower altitudes, especially at night."

Recommendations from Dr. Blue:

1. Always use oxygen if there is any sensation of hypoxia such as euphoria, visual changes, headache, dizziness, nausea, anxiety, panic, or confusion.
2. Pilots should use oxygen when their saturation drops five percentage points below their home field saturation, and must use oxygen if their saturation drops 10 points below their home field sat. For instance, if your home field saturation is 97%, you should use oxygen at 92% and must use oxygen at 87%. Refer to oxygen instructions for safe use.

The only practical way to know if you are hypoxic or in danger of becoming hypoxic is to use a pulse oximeter. Pulse oximeters measure the saturation of oxygen in the blood stream. Ninety-five to 100% is normal at sea level.

Following the recent court case in Europe between Brain Products and BioSemi VOF concerning the use of a device that meets the definition of a medical device as per the MDD, but is not intended for a medical purpose, I would appreciate input from colleagues on a similar "scenario" opposite the FDA. By way of example, I will refer to a SPO2 (pulse oximeter) device. On the one hand, the FDA defines a pulse oximeter as a Class II device that requires a 510(k); while on the other hand SPO2 devices can be bought via Amazon as non-medical devices, without 510(k) clearance.

Question: can a device that is defined by FDA as falling within the category of a medical device due to its medical function, "become" a non-medical device by changing the labeling and intended use to that of non-medical?

Also, does it matter if the non-medical device is sold as stand-alone, or is part of a multi-function device that has an "overall" medical purpose, i.e. does a non-medical function "inherit" the medical intended use of a device that has both medical and non-medical functions?

Common Uses

Pulse Oximeters in Sports and Aviation

High Altitude Sport Participants

High elevation sports enthusiasts such as hikers and climbers may find the iSpO2 a useful tool to identify situations in which oxygen saturation is declining at higher elevations. Declining oxygen saturation is commonly associated with several conditions at high elevations, such as HAPE (high altitude pulmonary edema) and other forms of altitude sickness. For more information, visit:

• Altitude Sickness
• High Altitude Pulmonary Edema (HAPE)

Pilots

According to Pilotfriend:

"Unfortunately, the nature of hypoxia makes you, the pilot, the poorest judge of when you are its victim. The first symptoms of oxygen deficiency are misleadingly pleasant, resembling mild intoxication from alcohol. Because oxygen starvation strikes first at the brain, your higher faculties are dulled. Your normal self-critical ability is out of order. Your mind no longer functions properly; your hands and feet become clumsy without being aware of it; you may feel drowsy, languid, and nonchalant; you have a false sense of security; and, the last thing in the world you think you need is oxygen.¹"

Brent Blue, MD, of www.aeromedix.com, says the following about hypoxia:

"Lack of oxygen is the greatest single danger to man at high altitudes due to its immediate and critical effects. The shortage of oxygen in the human body is called hypoxia, which means that the body is not getting enough oxygen to maintain normal body functions. When a pilot inhales air at high altitudes, due to the decreased barometric pressure, the amount of oxygen inhaled with every breath is less than at sea level. Thus, the number of oxygen molecules that is available to be transported through the lung tissue into the blood stream is reduced. When the level of oxygen in the blood is low, the brain and other tissues are adversely affected.²

The Federal Aviation Regulations (FARs) require oxygen to be used if flying above 12,500 feet MSL (Mean Sea Level) for 30 or more minutes and at all times above 14,000 feet MSL. However, many pilots and passengers experience hypoxia at lower altitudes, especially at night."

Recommendations from Dr. Blue:

1. Always use oxygen if there is any sensation of hypoxia such as euphoria, visual changes, headache, dizziness, nausea, anxiety, panic, or confusion.
2. Pilots should use oxygen when their saturation drops five percentage points below their home field saturation, and must use oxygen if their saturation drops 10 points below their home field sat. For instance, if your home field saturation is 97%, you should use oxygen at 92% and must use oxygen at 87%. Refer to oxygen instructions for safe use.

The only practical way to know if you are hypoxic or in danger of becoming hypoxic is to use a pulse oximeter. Pulse oximeters measure the saturation of oxygen in the blood stream. Ninety-five to 100% is normal at sea level.

Following the recent court case in Europe between Brain Products and BioSemi VOF concerning the use of a device that meets the definition of a medical device as per the MDD, but is not intended for a medical purpose, I would appreciate input from colleagues on a similar "scenario" opposite the FDA. By way of example, I will refer to a SPO2 (pulse oximeter) device. On the one hand, the FDA defines a pulse oximeter as a Class II device that requires a 510(k); while on the other hand SPO2 devices can be bought via Amazon as non-medical devices, without 510(k) clearance.

Question: can a device that is defined by FDA as falling within the category of a medical device due to its medical function, "become" a non-medical device by changing the labeling and intended use to that of non-medical?

Also, does it matter if the non-medical device is sold as stand-alone, or is part of a multi-function device that has an "overall" medical purpose, i.e. does a non-medical function "inherit" the medical intended use of a device that has both medical and non-medical functions?

Common Uses

Pulse Oximeters in Sports and Aviation

High Altitude Sport Participants

High elevation sports enthusiasts such as hikers and climbers may find the iSpO2 a useful tool to identify situations in which oxygen saturation is declining at higher elevations. Declining oxygen saturation is commonly associated with several conditions at high elevations, such as HAPE (high altitude pulmonary edema) and other forms of altitude sickness. For more information, visit:

• Altitude Sickness
• High Altitude Pulmonary Edema (HAPE)

Pilots

According to Pilotfriend:

"Unfortunately, the nature of hypoxia makes you, the pilot, the poorest judge of when you are its victim. The first symptoms of oxygen deficiency are misleadingly pleasant, resembling mild intoxication from alcohol. Because oxygen starvation strikes first at the brain, your higher faculties are dulled. Your normal self-critical ability is out of order. Your mind no longer functions properly; your hands and feet become clumsy without being aware of it; you may feel drowsy, languid, and nonchalant; you have a false sense of security; and, the last thing in the world you think you need is oxygen.¹"

Brent Blue, MD, of www.aeromedix.com, says the following about hypoxia:

"Lack of oxygen is the greatest single danger to man at high altitudes due to its immediate and critical effects. The shortage of oxygen in the human body is called hypoxia, which means that the body is not getting enough oxygen to maintain normal body functions. When a pilot inhales air at high altitudes, due to the decreased barometric pressure, the amount of oxygen inhaled with every breath is less than at sea level. Thus, the number of oxygen molecules that is available to be transported through the lung tissue into the blood stream is reduced. When the level of oxygen in the blood is low, the brain and other tissues are adversely affected.²

The Federal Aviation Regulations (FARs) require oxygen to be used if flying above 12,500 feet MSL (Mean Sea Level) for 30 or more minutes and at all times above 14,000 feet MSL. However, many pilots and passengers experience hypoxia at lower altitudes, especially at night."

Recommendations from Dr. Blue:

1. Always use oxygen if there is any sensation of hypoxia such as euphoria, visual changes, headache, dizziness, nausea, anxiety, panic, or confusion.
2. Pilots should use oxygen when their saturation drops five percentage points below their home field saturation, and must use oxygen if their saturation drops 10 points below their home field sat. For instance, if your home field saturation is 97%, you should use oxygen at 92% and must use oxygen at 87%. Refer to oxygen instructions for safe use.

The only practical way to know if you are hypoxic or in danger of becoming hypoxic is to use a pulse oximeter. Pulse oximeters measure the saturation of oxygen in the blood stream. Ninety-five to 100% is normal at sea level.

Following the recent court case in Europe between Brain Products and BioSemi VOF concerning the use of a device that meets the definition of a medical device as per the MDD, but is not intended for a medical purpose, I would appreciate input from colleagues on a similar "scenario" opposite the FDA. By way of example, I will refer to a SPO2 (pulse oximeter) device. On the one hand, the FDA defines a pulse oximeter as a Class II device that requires a 510(k); while on the other hand SPO2 devices can be bought via Amazon as non-medical devices, without 510(k) clearance.

Question: can a device that is defined by FDA as falling within the category of a medical device due to its medical function, "become" a non-medical device by changing the labeling and intended use to that of non-medical?

Also, does it matter if the non-medical device is sold as stand-alone, or is part of a multi-function device that has an "overall" medical purpose, i.e. does a non-medical function "inherit" the medical intended use of a device that has both medical and non-medical functions?

Following the recent court case in Europe between Brain Products and BioSemi VOF concerning the use of a device that meets the definition of a medical device as per the MDD, but is not intended for a medical purpose, I would appreciate input from colleagues on a similar "scenario" opposite the FDA. By way of example, I will refer to a SPO2 (pulse oximeter) device. On the one hand, the FDA defines a pulse oximeter as a Class II device that requires a 510(k); while on the other hand SPO2 devices can be bought via Amazon as non-medical devices, without 510(k) clearance.

Question: can a device that is defined by FDA as falling within the category of a medical device due to its medical function, "become" a non-medical device by changing the labeling and intended use to that of non-medical?

Also, does it matter if the non-medical device is sold as stand-alone, or is part of a multi-function device that has an "overall" medical purpose, i.e. does a non-medical function "inherit" the medical intended use of a device that has both medical and non-medical functions?