(68 days)
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Not Found
No
The summary describes a physical implant and insertion tool, and there are no mentions of AI, ML, or related concepts.
Yes
The device is used for "Soft Tissue Augmentation" in "Plastic and Reconstructive Surgery," which implies a therapeutic purpose to improve or restore bodily function or appearance.
No
The device is described as an "Implant Soft Tissue Augmentation Tube with Insertion Tool," which is used for "Plastic and Reconstructive Surgery." Augmentation and implantation are therapeutic procedures, not diagnostic ones. Diagnostic devices are used to identify or detect a disease or condition.
No
The device description explicitly mentions an "Implant Soft Tissuc Augmentation Tube with Insertion Tool," which are physical hardware components.
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 the device is used in vivo (within the body) for surgical procedures.
- Device Description: The description is "Softform® Implant Soft Tissuc Augmentation Tube with Insertion Tool". This describes a physical implant and its delivery tool, not a test performed on biological samples in vitro.
- Lack of IVD Characteristics: The information 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 biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVDs are devices used to examine specimens from the human body to provide information for clinical purposes. This device is an implant used directly in the body during surgery.
N/A
Intended Use / Indications for Use
For Plastic and Reconstructive Surgery* * This product is available by prescription only.
Product codes
FTL
Device Description
Softform® Implant Soft Tissuc Augmentation Tube with Insertion Tool - Size Modifications
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use (Per 21 CFR 801.109)
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 1998
Jesse Kramer, Ph.D Tissue Technologies, Inc. 1370 Green Street San Francisco, California 94109
Re: K982475 Trade Name: Softform® Implant Regulatory Class: II Product Code: FTL Dated: July 14, 1998 Received: July 16, 1998
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 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 (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 yilry 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,
f. Joseph
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
TISSUE TECHNOLOGIES, INC.
1370 Green Street SAN FRANCISCO, CA 94109
PHONE 415/885-6269 FAX 415/885-6380
Image /page/2/Picture/4 description: The image shows the text "K982475" in a handwritten style at the top. Below this, the words "INDICATIONS FOR USE PAGE" are printed in a bold, sans-serif font. The text appears to be part of a document or label, possibly related to instructions or guidelines for using a product.
September 15, 1998
- PRODUCT: Softform® Implant
REFERENCE: 510(k)#: K982475 Soft Tissuc Augmentation Tube with Insertion Tool - Size Modifications
INDICATIONS: For Plastic and Reconstructive Surgery*
- This product is available by prescription only.
Prescription Use
(Per 21 CFR 801.109)
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