(52 days)
The Implantech Conform™ Combined Submalar® Implant is indicated for implantation to augment or reconstruct the underdeveloped or traumatized malar region of the face. The soft, flexible Conform Combined Submalar Implant is designed to easily conform to the facial skeleton in the malar area.
The soft, flexible Conform Combined Submalar Implant is designed to easily conform to the facial skeleton in the malar area.
This document does not contain information about acceptance criteria or a study proving that a device meets those criteria. The provided text is a 510(k) clearance letter from the FDA for a medical device (Implantech Conform™ Binder Submalar® Implant), indicating that the device has been found substantially equivalent to a legally marketed predicate device. This letter allows the device to be marketed, subject to general controls and other regulations.
The letter explicitly states that the FDA "reviewed your Section 510(k) notification of intent to market the device ... and we have determined the device is substantially equivalent..." This is a regulatory clearance based on equivalence, not a performance study demonstrating specific acceptance criteria.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 199
Implantech Associates, Inc. ·c/o Mr. Edward M. Basile, Esq. King & Spalding 1730 Pennsylvania Avenue, NW Washington, District of Columbia 20006
Re: K973502
Trade Name: Implantech Conform™ Binder Submalar® Implant Regulatory Class: II Product Code: LZK Dated: September 16, 1997 Received: September 16, 1997
Dear Mr. Basile:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Edward M. Basile, Esq.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Acoella
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K99502
Include the following "Indications For Use" page that contains the applicant's name, name of the device and the intended use of the device. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the "indications for use" statement.
*For a new submission, do NOT fill in the 510(k) number blank.
INDICATIONS FOR USE
Applicant: Implantech Associates, Inc.
510(k) Number (if known): N/A*
Device Name: Implantech Conform™ Combined Submalar® Implant
Indications For Use:
The Implantech Conform™ Combined Submalar® Implant is indicated for implantation to augment or reconstruct the underdeveloped or traumatized malar region of the face. The soft, flexible Conform Combined Submalar Implant is designed to easily conform to the facial skeleton in the malar area.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K973502 |
| Prescription UsePer 21 CFR 801.109 | OR | Over-the-Counter |
|---|---|---|
| ---------------------------------------- | ------------------------------------------- | ------------------ |
§ 878.3550 Chin prosthesis.
(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.