Regulatory Open Forum

“The device A is intended for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The device A is intended for use with a compatible Camera Head and other accessory devices including an endoscope, optical coupler, and light cable. “

“The device B is intended for use in diagnostic and operative endoscopic procedures to provide illumination and visualization through either natural or surgical openings of interior cavities of the body, hollow body organs or joint spaces. The device B is intended to be used in a surgical setting by personnel trained in endoscopic procedures with a compatible camera head and other accessory devices including an endoscope, light cable, display and potentially image recording devices.”

“The device A is intended for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The device A is intended for use with a compatible Camera Head and other accessory devices including an endoscope, optical coupler, and light cable. “

“The device B is intended for use in diagnostic and operative endoscopic procedures to provide illumination and visualization through either natural or surgical openings of interior cavities of the body, hollow body organs or joint spaces. The device B is intended to be used in a surgical setting by personnel trained in endoscopic procedures with a compatible camera head and other accessory devices including an endoscope, light cable, display and potentially image recording devices.”

“The device A is intended for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The device A is intended for use with a compatible Camera Head and other accessory devices including an endoscope, optical coupler, and light cable. “

“The device B is intended for use in diagnostic and operative endoscopic procedures to provide illumination and visualization through either natural or surgical openings of interior cavities of the body, hollow body organs or joint spaces. The device B is intended to be used in a surgical setting by personnel trained in endoscopic procedures with a compatible camera head and other accessory devices including an endoscope, light cable, display and potentially image recording devices.”

“The device A is intended for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The device A is intended for use with a compatible Camera Head and other accessory devices including an endoscope, optical coupler, and light cable. “

“The device B is intended for use in diagnostic and operative endoscopic procedures to provide illumination and visualization through either natural or surgical openings of interior cavities of the body, hollow body organs or joint spaces. The device B is intended to be used in a surgical setting by personnel trained in endoscopic procedures with a compatible camera head and other accessory devices including an endoscope, light cable, display and potentially image recording devices.”

“The device A is intended for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The device A is intended for use with a compatible Camera Head and other accessory devices including an endoscope, optical coupler, and light cable. “

“The device B is intended for use in diagnostic and operative endoscopic procedures to provide illumination and visualization through either natural or surgical openings of interior cavities of the body, hollow body organs or joint spaces. The device B is intended to be used in a surgical setting by personnel trained in endoscopic procedures with a compatible camera head and other accessory devices including an endoscope, light cable, display and potentially image recording devices.”

Yes, it is from the official 510(k) clearance letter from the FDA website, the cleared indication for use statement is “The device A is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.  The device A is indicated for use with a compatible  <company> Camera Heard and other accessory devices including an endoscope, optical coupler, and light cable.”   Then on the 510(k) summary letter under the intended use section, the same verbiage was used for this device A’s intended use.  In this case the indication for use/intended use statement is the same.  Under intended use section of the 510(k) summary, it also spelled out that “the device A is intended for use n endoscopic procedures without limit to the decease or condition being treated by the treating physician.  The device A is intended for use with patients undergoing endoscopic procedures for which the treating surgeon desires external video display and/or illumination.”  I think it is general enough to cover endoscopic procedures without going into details.  In this case, the indication for use and intended use statements were used interchangeability.  I see that happen quiet often on cleared 510(k)s.  My take is that this device only really requires intended use statement, however since 510(k) requires an indication for use statement, some company just cut and paste the same verbiage into that FDA’s indication for use statement FORM. 

If I have a new device, “The device B is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization through either natural or surgical openings of interior cavities of the body, hollow body organs or joint spaces. The device B is intended to be used in a surgical setting by personnel trained in endoscopic procedures with a compatible camera head and other accessory devices including an endoscope, light cable, display and potentially image recording devices.”  

Even though the spell out of the verbiage tried to separate the indication for use and  intended use statements for device B, however in FDA’s 2014 SE Guidance, FDA had indicated the intended use encompass the indication for use, therefore I would say when submitting a 510(k), I would consider the the intended uses of the device B is the combination of indication for use and intended use in the above paragraph (see my original post for device B).

Julie, I am comparing the two intended uses (see my original post) and hope to understand if you consider device A&B are having the same intended use or not?  Like you said, clearly the two statements are not identical, if A & B are considered NOT having the same intended uses (or different enough), then using A as a predicate for B would not be sufficient as FDA requires predicate and subject devices must have the same intended uses.  I would think that the A&B are having the same intended uses in the context of “used in endoscopic procedure to provide illumination and visualization” whether it is through either natural or surgical openings of interior cavities of the body, hollow body organs or joint spaces.  I am wondering if anyone would recommend to remove these verbiage of hollow organs or joint spaces to be on the safe side of FDA's "intended uses must be the same" for SE determination?

“The device A is intended for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The device A is intended for use with a compatible Camera Head and other accessory devices including an endoscope, optical coupler, and light cable. “

“The device B is intended for use in diagnostic and operative endoscopic procedures to provide illumination and visualization through either natural or surgical openings of interior cavities of the body, hollow body organs or joint spaces. The device B is intended to be used in a surgical setting by personnel trained in endoscopic procedures with a compatible camera head and other accessory devices including an endoscope, light cable, display and potentially image recording devices.”

Yes, it is from the official 510(k) clearance letter from the FDA website, the cleared indication for use statement is “The device A is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.  The device A is indicated for use with a compatible  <company> Camera Heard and other accessory devices including an endoscope, optical coupler, and light cable.”   Then on the 510(k) summary letter under the intended use section, the same verbiage was used for this device A’s intended use.  In this case the indication for use/intended use statement is the same.  Under intended use section of the 510(k) summary, it also spelled out that “the device A is intended for use n endoscopic procedures without limit to the decease or condition being treated by the treating physician.  The device A is intended for use with patients undergoing endoscopic procedures for which the treating surgeon desires external video display and/or illumination.”  I think it is general enough to cover endoscopic procedures without going into details.  In this case, the indication for use and intended use statements were used interchangeability.  I see that happen quiet often on cleared 510(k)s.  My take is that this device only really requires intended use statement, however since 510(k) requires an indication for use statement, some company just cut and paste the same verbiage into that FDA’s indication for use statement FORM. 

If I have a new device, “The device B is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization through either natural or surgical openings of interior cavities of the body, hollow body organs or joint spaces. The device B is intended to be used in a surgical setting by personnel trained in endoscopic procedures with a compatible camera head and other accessory devices including an endoscope, light cable, display and potentially image recording devices.”  

Even though the spell out of the verbiage tried to separate the indication for use and  intended use statements for device B, however in FDA’s 2014 SE Guidance, FDA had indicated the intended use encompass the indication for use, therefore I would say when submitting a 510(k), I would consider the the intended uses of the device B is the combination of indication for use and intended use in the above paragraph (see my original post for device B).

Julie, I am comparing the two intended uses (see my original post) and hope to understand if you consider device A&B are having the same intended use or not?  Like you said, clearly the two statements are not identical, if A & B are considered NOT having the same intended uses (or different enough), then using A as a predicate for B would not be sufficient as FDA requires predicate and subject devices must have the same intended uses.  I would think that the A&B are having the same intended uses in the context of “used in endoscopic procedure to provide illumination and visualization” whether it is through either natural or surgical openings of interior cavities of the body, hollow body organs or joint spaces.  I am wondering if anyone would recommend to remove these verbiage of hollow organs or joint spaces to be on the safe side of FDA's "intended uses must be the same" for SE determination?

“The device A is intended for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The device A is intended for use with a compatible Camera Head and other accessory devices including an endoscope, optical coupler, and light cable. “

“The device B is intended for use in diagnostic and operative endoscopic procedures to provide illumination and visualization through either natural or surgical openings of interior cavities of the body, hollow body organs or joint spaces. The device B is intended to be used in a surgical setting by personnel trained in endoscopic procedures with a compatible camera head and other accessory devices including an endoscope, light cable, display and potentially image recording devices.”

Yes, it is from the official 510(k) clearance letter from the FDA website, the cleared indication for use statement is “The device A is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.  The device A is indicated for use with a compatible  <company> Camera Heard and other accessory devices including an endoscope, optical coupler, and light cable.”   Then on the 510(k) summary letter under the intended use section, the same verbiage was used for this device A’s intended use.  In this case the indication for use/intended use statement is the same.  Under intended use section of the 510(k) summary, it also spelled out that “the device A is intended for use n endoscopic procedures without limit to the decease or condition being treated by the treating physician.  The device A is intended for use with patients undergoing endoscopic procedures for which the treating surgeon desires external video display and/or illumination.”  I think it is general enough to cover endoscopic procedures without going into details.  In this case, the indication for use and intended use statements were used interchangeability.  I see that happen quiet often on cleared 510(k)s.  My take is that this device only really requires intended use statement, however since 510(k) requires an indication for use statement, some company just cut and paste the same verbiage into that FDA’s indication for use statement FORM. 

If I have a new device, “The device B is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization through either natural or surgical openings of interior cavities of the body, hollow body organs or joint spaces. The device B is intended to be used in a surgical setting by personnel trained in endoscopic procedures with a compatible camera head and other accessory devices including an endoscope, light cable, display and potentially image recording devices.”  

Even though the spell out of the verbiage tried to separate the indication for use and  intended use statements for device B, however in FDA’s 2014 SE Guidance, FDA had indicated the intended use encompass the indication for use, therefore I would say when submitting a 510(k), I would consider the the intended uses of the device B is the combination of indication for use and intended use in the above paragraph (see my original post for device B).

Julie, I am comparing the two intended uses (see my original post) and hope to understand if you consider device A&B are having the same intended use or not?  Like you said, clearly the two statements are not identical, if A & B are considered NOT having the same intended uses (or different enough), then using A as a predicate for B would not be sufficient as FDA requires predicate and subject devices must have the same intended uses.  I would think that the A&B are having the same intended uses in the context of “used in endoscopic procedure to provide illumination and visualization” whether it is through either natural or surgical openings of interior cavities of the body, hollow body organs or joint spaces.  I am wondering if anyone would recommend to remove these verbiage of hollow organs or joint spaces to be on the safe side of FDA's "intended uses must be the same" for SE determination?

“The device A is intended for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The device A is intended for use with a compatible Camera Head and other accessory devices including an endoscope, optical coupler, and light cable. “

“The device B is intended for use in diagnostic and operative endoscopic procedures to provide illumination and visualization through either natural or surgical openings of interior cavities of the body, hollow body organs or joint spaces. The device B is intended to be used in a surgical setting by personnel trained in endoscopic procedures with a compatible camera head and other accessory devices including an endoscope, light cable, display and potentially image recording devices.”