PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) by SURGICAL TECHNOLOGY LABORATORIES, INC ("STL")

The PureForm ePTFE Facial Implants are threedimensional facial prosthesis (Nasal, Chin, and Malar) that are made from expanded Polytetraflouroethylene (ePTFE). The device is offered sterile in multiple sizes.

AI/ML Overview

I am sorry, but based on the provided text, there is no information available about acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) summary for a medical device (PureForm ePTFE Facial Implants). This type of submission focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than presenting a performance study with defined acceptance criteria.

The key points of the provided text are:

Identification of the device: PureForm ePTFE Facial Implants (Nasal, Chin, Malar)
Applicant: Surgical Technology Laboratories, Inc.
Date Prepared: April 8, 2009
Predicate Devices: Several existing facial implants.
Conclusion: The device is deemed substantially equivalent to the predicate devices based on indications, intended use, material, design, and biocompatibility. This is a regulatory finding, not a demonstration of performance against specific, quantitative acceptance criteria through a study.
FDA Letter: The FDA letter confirms the substantial equivalence determination but does not mention any performance studies or acceptance criteria met by the device.

Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert qualifications, ground truth, or study types because the provided text does not contain this information.

Summary

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K091011
Page 1 of 2

Section 2 - 510(k) Summary

APR 22 2009

Pursuant to Section 12, Part (a)(i)3A of the Safe Medical Devices Act of 1990, Surgical Technology Laboratories, Inc. is providing a summary of the substantial equivalence decision making process proposed by Surgical Technology Laboratories and the safety and effectiveness information available for the PureForm ePTFE Facial Implants.

Applicant Name	Surgical Technology Laboratories, Inc ("STL")610 Clemson RoadColumbia, SC 29229Tel: (803) 462-1714Fax: (805) 462-1743
Contact Person	Mathew Fairfax, President
Date Prepared	April 8, 2009
Device Trade Name	PureForm ePTFE Facial Implants (Nasal, Chin, Malar)
Device CommonName	Facial Implant (Prosthesis)
ClassificationName	Implant, Nasal (LZK)
Predicate Devices

Gore-Tex SAM Facial Implant, manufactured by W. L. Gore and Associates, Flagstaff, AZ (K933367)

Surgiform Augmentation Material (SFAM), manufactured by Surgical Technology Laboratories, Inc., Columbia, SC (K021889)

Surgiform Silicone Facial Implants (Chin, Malar, Nasal), Manufactured by Surgical Technology Laboratories, Inc., Columbia, SC (K983754, K983755, K983756)

Implantech Composite Facial Implants (Malar, Chin, and Nasal), Manufactured by Implantech Associates, Inc., Ventura, CA (K002886)

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Kogioll

Device Description The PureForm ePTFE Facial Implants are threedimensional facial prosthesis (Nasal, Chin, and Malar) that are made from expanded Polytetraflouroethylene (ePTFE). The device is offered sterile in multiple sizes.

The PureForm ePTFE Facial Implants are indicated for Intended Use use in plastic and reconstructive surgery.

Device The indications and intended use of the PureForm Technological ePTFE Facial Implants are identical to those of the predicate facial implants. The material of fabrication of Characteristics and Comparison to the PureForm Implants is the same as that of the Gore-Tex SAM, Surgiform Facial Augmentation Predicate Devices Material (SFAM) and the lining of the Implantech Composite Facial Implants. The Surgiform PureForm ePTFE Facial Implants do not use or introduce any new technological characteristics.

Conclusions Based on a comparison of indications and intended use, material of fabrication, similarity of design, and demonstrated biocompatibility the Surgiform PureForm ePTFE Facial Implants are substantially equivalent to the identified predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Surgical Technology Laboratories, Inc % Mr. Mathew Fairfax President 610 Clemson Road Columbia, South Carolina 29229

APR 2 2 2009

Re: K091011

Trade/Device Name: Surgiform's PureForm ePTFE Implants Regulation Number: 21 CFR 878.3550 Regulation Name: Chin prothesis Regulatory Class: II Product Code: LZK, FWP Dated: April 8, 2009 Received: April 9, 2009

Dear Mr. Fairfax:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Mathew Fairfax

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,

Mark A. Milken

Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 1 - Indications for Use

510(k) Number: K69 10 11

Device Name: Surgiform's PureForm ePTFE Implants

Indications for Use:

PureForm ePTFE Facial Implants are indicated for use in facial plastic and reconstructive surgery.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for niving

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K091011

Page 3 of 47

Regulation Number and Section

§ 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.