(73 days)
None
None
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is a physical implant.
No.
The 'SoftForm™ Implant' is described for use in "Plastic and Reconstructive Surgery," which is a medical specialty, and it is for "Prescription Use." However, it is an implant, which generally serves as a replacement or support structure and does not inherently deliver a therapy (like medication, radiation, or electrical stimulation) to treat a disease or condition. While it aids in reconstruction, its primary function isn't therapeutic in the active sense.
No
The "Intended Use / Indications for Use" states "For Plastic and Reconstructive Surgery*", and the "Device Description" is "SoftForm™ Implant". These details indicate it is an implant used in surgery, not a device used to diagnose a condition.
No
The device description explicitly states "SoftForm™ Implant," which indicates a physical implant, not a software-only device.
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". This indicates a surgical implant used directly on a patient's body, not a test performed on samples taken from the body (which is the definition of an IVD).
- Device Description: "SoftForm™ Implant" further confirms it's a physical device implanted in the body.
- Lack of IVD Characteristics: The description lacks any mention of analyzing samples (blood, urine, tissue, etc.), diagnostic testing, or providing information about a patient's health status based on such analysis.
Therefore, the SoftForm™ Implant is a medical device used in surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For Plastic and Reconstructive Surgery*
Prescription Use (Per 21 CFR 801.109)
- This product is available by prescription only.
Product codes
FTL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
Image /page/0/Picture/1 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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that suggest feathers and movement. The overall design is simple and iconic, representing the department's role in protecting the health of Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jesse Kramer, Ph.D. Tissue Technologies, Inc. 1370 Green Street San Francisco, California 94109
NOV 2 4 1997
K973462 Re: Trade Name: SoftForm™ Implant Regulatory Class: II Product Code: FTL ......... . Dated: September 11, 1997 Received: September 12, 1997
Dear Dr. Kramer:
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 - Jesse Kramer, Ph.D.
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,
J. Collett
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
1370 Grupp 218881. SAN FRANCISCO, CA 94109 TISSUE TECHNOLOGIES, INC.
PHONE 41 5/885-6269 Fax 415/885-6380
INDICATIONS FOR USE PAGE
November 20, 1997
Softform™ Implant PRODUCT:
510(k)#: K973462 REFERENCE:
For Plastic and Reconstructive Surgery* INDICATIONS:
Prescription Use
(Per 21 CFR 801.109)
- This product is available by prescription only.
