(51 days)
Not Found
No
The 510(k) summary describes a biological matrix derived from porcine tissue for soft tissue repair. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies focus on material properties and biocompatibility.
No.
The device is described as a matrix for implantation to reinforce soft tissue, indicating a structural and supportive role rather than directly treating a disease or condition in a therapeutic manner.
No
Explanation: The device is a matrix for soft tissue reinforcement during plastic and reconstructive surgery and does not collect or analyze data for diagnostic purposes.
No
The device description clearly states it is manufactured from porcine small intestinal submucosa (SIS) and is supplied in a physical, sterile, lyophilized state, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery." This describes a device used in vivo (within the body) for structural support and repair.
- Device Description: The device is a "Plastic Surgery Matrix" made from porcine small intestinal submucosa (SIS) and is "implanted." This further confirms its use within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such examination of specimens.
The information provided clearly indicates this is a surgical implant used for tissue reinforcement, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The SIS Plastic Surgery Matrix is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
Product codes
FTM
Device Description
The SIS Plastic Surgery Matrix is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in a strand configuration. The device is packaged in a lyophilized (dried) state, and supplied sterile in a sealed double pouch system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
The material comprising the SIS Plastic Surgery Matrix was subjected to extensive biocompatibility testing, viral inactivation testing, and mechanical testing. Outcomes show the device to be biocompatible, manufacturing processes to adequately disinfect the material, and tensile strength and suture retention strength to be sufficient.
Outcomes from the evaluation of the SIS Plastic Surgery Matrix provide evidence of its suitability for use in soft tissue reconstruction and substantial equivalency to predicate devices in terms of intended use and technological characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SURGISIS® Soft Tissue Graft (K980431), Permacol (K013625), Advanta PTFE Facial Implant (K992991)
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
9. 510(K) SUMMARY
Mark Bleyer, President Submitted By: Cook Biotech Incorporated 3055 Kent Avenue West Lafayette, IN 47906 (765) 497-3355 February 04, 2004
Names of Device:
SIS Plastic Surgery Matrix Trade Name: Surgical Mesh Common/Usual Name: Proposed classification name: Surgical Mesh 21 CFR 878.3300 (FTM) Class II
Intended Use:
The SIS Plastic Surgery Matrix is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
Predicate Devices:
The SIS Plastic Surgery Matrix is similar to predicate devices, including the SURGISIS® Soft Tissue Graft (K980431) manufactured by Cook Biotech Incorporated, Permacol (K013625) manufactured by Tissue Science Laboratories, PLC, and Advanta PTFE Facial Implant (K992991) manufactured by Atrium Medical Corporation.
Device Description:
The SIS Plastic Surgery Matrix is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in a strand configuration. The device is packaged in a lyophilized (dried) state, and supplied sterile in a sealed double pouch system.
Substantial Equivalence:
The SIS Plastic Surgery Matrix is similar with respect to intended use, materials and technological characteristics to the above predicate devices in terms of 510(k) substantial equivalence as shown through in vitro and biocompatibility testing.
Discussion of Tests and Test Results:
The material comprising the SIS Plastic Surgery Matrix was subjected to extensive biocompatibility testing, viral inactivation testing, and mechanical testing. Outcomes show the device to be biocompatible, manufacturing processes to adequately disinfect the material, and tensile strength and suture retention strength to be sufficient.
Conclusions Drawn from the Tests:
Outcomes from the evaluation of the SIS Plastic Surgery Matrix provide evidence of its suitability for use in soft tissue reconstruction and substantial equivalency to predicate devices in terms of intended use and technological characteristics.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 2004
Mr. Mark Bleyer President Cook Biotech Incorporated 3055 Kent Avenue West Lafayette, Indiana 47906
Re: K034039
Trade/Device Name: SIS Plastic Surgery Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: December 24, 2003 Received: December 29, 2003
Dear Mr. Blever:
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.
2
Page 2 - Mr. Mark Bleyer
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). please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
iriam C. Provost
(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
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The SIS Plastic Surgery Matrix is for implantation to relnforce soft THS CO T laste Cargory mists in patients requiring soft tissue repair or relnforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
uriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K034039