(109 days)
Not Found
No
The summary describes a biological tissue graft and does not mention any computational or algorithmic components, including AI or ML.
No
The device is described as a tissue graft intended to reinforce soft tissues, specifically for hernia or body wall defect repair, which are structural repairs rather than therapeutic treatments.
No
The device is a tissue graft intended to reinforce soft tissues, not to diagnose a condition. Its function is to repair, not to detect or identify a disease or condition.
No
The device description clearly states it is a tissue graft manufactured from porcine small intestinal submucosa (SIS), which is a physical material, 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 to "reinforce soft tissues where weakness exists" and for "repair of a hernia or body wall defect." This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The device is a "tissue graft manufactured from porcine small intestinal submucosa (SIS)" and is "packaged in a dried state, and is supplied sterile." This further confirms it's a physical implant for surgical use.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition, monitor a treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device's function is purely structural and therapeutic, not diagnostic.
N/A
Intended Use / Indications for Use
The SURGISIS® Biodesign Tissue Graft is intended to be implanted to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect.
The SURGISIS® Biodesign Tissue Graft minimizes tissue attachment to the device in case of direct contact with viscera.
The device is intended for one-time use.
Product codes
FTM
Device Description
The SURGISIS® Biodesign Tissue Graft is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in a range of sizes. The device is packaged in a dried state, and is 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A number of animal studies from published and unpublished literature were conducted specific to the subject of this submission. All studies concluded that SURGISIS® Biodesign Tissue Graft demonstrates minimal tissue attachment to the viscera when compared to a named predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(k) Premarket Notification: SURGISIS® Biodesign Tissue Graft
Page 1 of 2
9 510(K) SUMMARY
Submitted by:
MAR 2 1 2008
Perry W. Guinn VP Regulatory Affairs and Quality Assurance Cook Biotech Incorporated 1425 Innovation Place West Lafavette. IN 47906 (765) 497-3355 November 30, 2007
Device:
Trade Names:
Common/Usual Name: Proposed Classification Name: SURGISIS® Biodesign Tissue Graft, SIS Hernia Repair Device Surgical Mesh Surgical Mesh 21 CFR §878.3300 (79FTM) Class II
Intended Use:
The SURGISIS® Biodesign Tissue Graft is intended to be implanted to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect.
The SURGISIS® Biodesign Tissue Graft minimizes tissue attachment to the device in case of direct contact with viscera.
The device is intended for one-time use.
Predicate Devices:
The SURGISTS® Biodesign Tissue Graft is substantially equivalent to itself (D.C. #K062697) acting as its own predicate and is substantially equivalent to Veritas® Collagen Matrix (D.C. #K062915) manufactured by Synovis Surgical Innovations.
Device Description:
The SURGISIS® Biodesign Tissue Graft is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in a range of sizes. The device is packaged in a dried state, and is supplied sterile in a sealed double pouch system.
Substantial Equivalence:
The SURGISIS® Biodesign Tissue Graft is similar with respect to intended use, rnaterials and technological characteristics to its predicate devices in terms of section 510(k) substantial equivalence, as shown through bench and biocompatibility testing submitted in previous cleared 510(k)s.
Company Confidential
1
Page ② of ②
Indication Testing:
A number of animal studies from published and unpublished literature were conducted specific to the subject of this submission. All studies concluded that SURGISIS® Biodesign Tissue Graft demonstrates minimal tissue attachment to the viscera when compared to a named predicate.
Conclusions Drawn from Tests:
The SURGISIS® Biodesign Tissue Graft is acting as its own predicate and is therefore substantially equivalent, having the same technological characteristics and intended use with the exception of the additional intended use, which is the subject of this submission.
Company Confidential
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2008
Cook Biotech, Inc. % Mr. Perry W. Guinn VP, Quality Assurance & Regulatory Affairs 1425 Innovation Place West Lafayette, Indiana 47906-1000
Re: K073391
Trade/Device Name: SURGISIS® Biodesign Tessue Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: February 26, 2008 Received: February 27, 2008
Dear Mr. Guinn:
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
3
Page 2 - Mr. Perry W. Guinn
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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.
Mark M Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: SURGISIS® Biodesign Tissue Graft
Indications For Use:
The SURGISIS® Biodesign Tissue Graft is intended to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect.
The SURGISIS® Biodesign Tissue Graft minimizes tissue attachment to the device in case of direct contact with viscera.
This device is intended for one-time use.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Mark A. Melhus
Division of General, Restorative, and Neurological Devices
510(k) Number K07339/