(29 days)
Not Found
Not Found
No
The summary describes a physical implant and its surgical use, with no mention of software, data processing, or AI/ML terms.
Yes
The device is used to restore or enhance a patient's facial appearance due to sagging skin, hollows, depressions, or severe facial trauma, which directly addresses a medical condition or aesthetic concern.
No
The device is described as an implant used to restore or enhance facial appearance, which is a therapeutic or reconstructive function, not a diagnostic one.
No
The device description and intended use clearly describe physical implants, not software.
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 restore or enhance facial appearance. This is a surgical procedure performed directly on the patient's body.
- Device Description: While the description is not found, the intended use clearly indicates a physical implant.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) outside of the body, which is the core function of an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Surgiform Anatomical Malar implants can be used by surgeons in a unique surgical procedure designed to restore or enhance a patients facial appearance. The implants can be used for aesthetic or reconstructive procedures. The implants can be inserted into a "pocket" created by means of a standard intraoral surgical incision. The implants can elevate and reposition sagging skin and can also fill the hollows and depressions caused by gravity and time. The implants can also be used by surgeons to restore a patients natural appearance as a result of severe facial trauma.
Product codes
LZK
Device Description
Surgiform Anatomical Malar Implant
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image contains the text 'Public Health Service'. The text is in a bold, sans-serif font. The words are arranged horizontally, with 'Public' and 'Health' on the first line and 'Service' on the second line.
Image /page/0/Picture/11 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
NOV 20 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard T. Nock Vice President Surgical Technology Laboratories, Inc. 1588 East 40th St. Cleveland, Ohio 44103
Re: K983756
Trade Name: Surgiform Anatomical Malar Regulatory Class: II Product Code: LZK Dated: October 16, 1998 Received: October 22, 1998
Dear Mr. Nock:
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 legally marketed predicate 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 (OS) 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. Richard T. Knock
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/dsma/dsmamain.html".
Sincerely yours,
Acooley
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
19 11:36 SURGIFORM
Image /page/2/Picture/1 description: The image shows the logo for Surgical Technology Laboratories, Inc. The logo is black and white and features the company name in a bold, sans-serif font. Below the company name is the address: 1588 East 40th St. Cleveland, Ohio 44103. The logo is simple and professional.
Image /page/2/Picture/2 description: The image shows a series of bold, black brushstrokes that appear to form characters or symbols. The strokes vary in thickness and direction, creating a dynamic and expressive composition. The characters are spaced irregularly, with some strokes connecting to form more complex shapes. The overall effect is abstract and calligraphic, suggesting a stylized or artistic representation of text.
(216) 431-5055
510(k) Number (if known): K 983756
Device Name: Surgiform Anatomical Malar Implant
Indications for Use:
Surgiform Anatomical Malar implants can be used by surgeons in a unique surgical procedure designed to restore or enhance a patients facial appearance. The implants can be used for aesthetic or reconstructive procedures. The implants can be inserted into a "pocket" created by means of a standard intraoral surgical incision. The implants can elevate and reposition sagging skin and can also fill the hollows and depressions caused by gravity and time. The implants can also be used by surgeons to restore a patients natural appearance as a result of severe facial trauma.
Acoole
Prescription Use
(Per 21 CFR 801.109)