(13 days)
Not Found
No
The 510(k) summary describes a physical implant made of ePTFE and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a permanent implant used for reconstructive surgery, which is typically considered a surgical instrument or prosthesis rather than a therapeutic device that actively treats disease or injury.
No
Explanation: The device is an implantable prosthesis used in reconstructive surgery, not a tool for diagnosing medical conditions. It is used to alter the physical structure of the face rather than to identify diseases or conditions.
No
The device description clearly states it is a "three-dimensional facial prosthesis" made from ePTFE, which is a physical implant, 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 use in facial plastic and reconstructive surgery." This describes a surgical procedure performed on a patient, not a test performed on a sample taken from a patient to diagnose or monitor a condition.
- Device Description: The device is described as a "three-dimensional facial prosthesis." This is an implantable device used to augment or reconstruct facial features.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
IVDs are used to perform tests in vitro (outside the body) on samples to provide information for diagnosis, monitoring, or screening. This device is an implantable medical device used in vivo (inside the body) for surgical purposes.
N/A
Intended Use / Indications for Use
PureForm ePTFE Facial Implants are indicated for use in facial plastic and reconstructive surgery.
Product codes (comma separated list FDA assigned to the subject device)
LZK, FWP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal, Chin, Malar (facial)
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): 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.
K933367, K021889, K983754, K983755, K983756, K002886
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
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 Road
Columbia, SC 29229
Tel: (803) 462-1714
Fax: (805) 462-1743 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Mathew Fairfax, President |
| Date Prepared | April 8, 2009 |
| Device Trade Name | PureForm ePTFE Facial Implants (Nasal, Chin, Malar) |
| Device Common
Name | Facial Implant (Prosthesis) |
| Classification
Name | 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)
1
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.
2
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.
3
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
4
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
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