Hi Rashmi,
As Julie mentioned, your predicate device should have the same intended use, but it is possible to have different indications for use. The following are a couple of references which may be of interested to you:
What is Substantial Equivalence
A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is at least as safe and effective as the predicate.
A device is substantially equivalent if, in comparison to a predicate it:
- has the same intended use as the predicate; and
- has the same technological characteristics as the predicate;
or
- has the same intended use as the predicate; and
- has different technological characteristics and the information submitted to FDA;
- does not raise new questions of safety and effectiveness; and
- demonstrates that the device is at least as safe and effective as the legally marketed device.
A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm2005718.htm#se
A1Does the change affect the indications for use? The general statement of the "Indications for Use" identifies the target population in a significant portion of which sufficient scientific evidence has demonstrated that the device as labeled will provide clinically significant results and at the same time does not present an unreasonable risk of illness or injury associated with the use of the device.
12 Changes in the indications for use section of labeling raise more agency concern than any other aspect of labeling. In fact, most changes in this part of the labeling will require the submission of a 510(k). Any change in the indications for use that limits use to within the currently cleared indication may occur without the submission of a 510(k). For example, the device was cleared for use with three specific indications and the firm decides to market the device for only two of those indications, would not require submission of a new 510(k). Another example would be further limiting the patient population by age or weight e.g., if your device was indicated for use in adults, you could revise the indication to adults 60 years and older but it does not mean you could indicate it for pediatrics. A more difficult case is where the change expands use to closely related populations. In determining whether a change to the indications for use raises issues of safety or effectiveness, the manufacturer should ask whether the change poses any additional risks, expands the use to a new and distinguishable patient population, etc. If the expansion is to a population with similar demographics, diagnosis, prognosis, comorbidity and potential for complications as the original, then a new 510(k) is not ordinarily expected.
Confusion often results when discussing the distinction between "indications for use" and the "intended use" of the device. The regulatory term, "intended use," refers to the objective intent of the persons legally responsible for the labeling of the device. Intent may be determined by written expressions or may be shown by the circumstances surrounding the distribution of the device. The concept of intended use has particular relevance in determining whether a device can be cleared for marketing through the premarket notification (510(k)) process or must be evaluated in a premarket approval application (PMA). Manufacturers should recognize that if a particular labeling change results in a "new" intended use for the device, the agency will find the device to be not substantially equivalent and require premarket approval.
Rather than referring to "intended use" as a determinant in deciding when to submit a 510(k), this guidance identifies several specific labeling changes or modifications that have a major impact on intended use and thus would require the submission of a 510(k).
13 Two common labeling changes that impact intended use and would usually require submission of a 510(k) are:
- reuse of devices previously labeled "single use only;" and
- changes from prescription to over the counter (OTC).14
One exception to (2) above is providing home-use instructions for devices that remain prescription and whose use in the home is accepted medical practice in the United States. Many prescription devices are used in the home with increasing frequency and the Agency believes that 510(k)s are not necessary to add home-use labeling. The reader is referred, however, to the FDA publication, "Write It Right,"
15for techniques to provide clear and understandable home use instructions.
https://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080235.htmHopefully this is more on track to what you are looking for..!
Thanks,
Liz
------------------------------
Elizabeth Goldstein RAC
Regulatory Affairs Specialist
Medtronic Vascular
Santa Rosa CA
United States
------------------------------
Original Message:
Sent: 22-Aug-2017 02:20
From: Rashmi Pillay
Subject: 510k and indications for use
Hi Elizabeth,
My query was whether the new device qualifies for a 510 k clearance in the absence of a predicate with the same indications.
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
T + 61 8 7074 8105
E rpillay@ellex.com
W ellex.com
.............................................................................
One Powerful Vision.
Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document.
Original Message------
Hi Rashmi,
I'm not sure that I fully understand your question, however a change in indications does require a new 510k. Have a look at the FDA guidance on assessing changes to a cleared device: https://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080235.htm / http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM514771.pdf (draft).
If there is a change to the indications, you cannot submit a special 510k - you will likely pursue the traditional pathway.
Hope this helps,
Liz
------------------------------
Elizabeth Goldstein RAC
Regulatory Affairs Specialist
Medtronic Vascular
Santa Rosa CA
United States
------------------------------