(131 days)
Not Found
The user did not provide any reference devices. Therefore, I cannot extract any K/DEN numbers. My response is "Not Found".
No
The summary describes a physical implant for soft tissue augmentation and repair, with no mention of software, algorithms, or any technology that would suggest AI/ML.
Yes.
The device description states its intended use is "for augmentation or repair of the soft tissues of the facial area," which falls under therapeutic purposes.
No
The device is described as an implant intended for augmentation or repair of soft tissues, which is a therapeutic or reconstructive function, not a diagnostic one.
No
The device description clearly states it is an "implant" available in "sheets or strands," which are physical hardware components, 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 Plastic and Reconstructive Surgery" and "augmentation or repair of the soft tissues of the facial area." This describes a surgical implant used directly on a patient's body.
- Device Description: The description details physical implants (sheets and strands) made of a material for surgical use.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVDs are devices used in vitro (outside the body) to analyze samples to provide diagnostic or other medical information. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
For Plastic and Reconstructive Surgery
Product codes
KKY
Device Description
The Surgiform Technology Ltd.'s S.F.A.M. implant is intended for augmentation or repair of the soft tissues of the facial area. The product is available in sheets or strands of the following sizes: Sheets (Length 5-100mm, Width 5-100mm, Thickness 0.2-0.4mm) and Strands (5-15cm, OD-1.0-4.0mm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues of the facial area
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
§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure in profile, with three faces overlapping each other. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2002
Mr. Cameron J. Fordyce President Surgical Technology Laboratories, Inc. 11476 Hawke Road, #C Columbia Station, OH 44028
Re: K021889
Trade/Device Name: Surgiform Augmentation Material Regulation Number: 878.3500 Regulation Name: Polytetrafluoroethylene with carbon fibers composite implant material Regulatory Class: II Product Code: KKY Dated: August 26, 2002 Received: September 20, 2002
Dear Mr. Fordyce:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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); 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.
1
Page 2 - Mr. Cameron J. Fordyce
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Styph Shrode
Z. Celia M. Witten, Ph.D., M.D.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
KO21B3:9/A'
| 510(k) Number (if known): | K021889 |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Device Name: | Surgiform Augmentation Material |
|---|---|
| Indications For Use: |
| Indications: | For Plastic and Reconstructive Surgery |
|---|---|
| -------------- | ---------------------------------------- |
Product Description:
The Surgiform Technology Ltd.'s S.F.A.M. implant
is intended for augmentation or repair of the soft tissues of the facial area. The product is available in sheets or strands of the following sizes:
| Sheets | Length | Width | Thickness |
|---|---|---|---|
| and and any and the program and the program and the provinces of the program and | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | www.alla.com/articles/arguint/deal/grams/production/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/artic |
| 5-100mm | 5-100mm | 0.2-0.4mm |
Strands
5-15cm
OD-1.0-4.0mm
Contraindictions:
-
Cardiovascular defects
-
Temporomandibular joint (TMJ) reconstructions
-Dermal Placement
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE I NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styt Ruveli
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________ OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Prescription Use_V (Per 21 CFR 801.109)
(Optional Formal 1-2-؛
SK 445