(52 days)
None
Not Found
No
The summary describes a physical implant and does not mention any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
This device is intended for implantation to augment or reconstruct a part of the body, which is a therapeutic purpose.
No
Explanation: The device is an implant used for augmentation or reconstruction; it does not diagnose conditions.
No
The device description clearly states it is an "Implant," which is a physical, hardware component intended for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical implantation to augment or reconstruct the malar region of the face. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant designed to be placed within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The provided information does not mention any such use or interaction with biological specimens.
Therefore, the Implantech Conform™ Combined Submalar® Implant is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
LZK
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
malar region of the face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The logo is black and white.
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.
1
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
2
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 Use
| Per 21 CFR 801.109 | OR | Over-the-Counter |
|---|---|---|
| ---------------------------------------- | ------------------------------------------- | ------------------ |