(54 days)
The SURGISIS® Peyronie's Repair Graft is intended for implantation to reinforce soft tissue where weakness exists in the urological anatomy, including but not limited to the repair of tunica albuginea defects, and reinforcement in the repair of Peyronie's disease. This device is supplied sterile and is intended for one-time use only.
The SURGISIS® Peyronie's Repair Graft is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in an oval configuration. The device is packaged in a lyophilized (dried) state, and is supplied sterile in a sealed double pouch system.
The applicant, Cook Biotech Incorporated, sought to market the SURGISIS® Peyronie's Repair Graft, a surgical mesh made from porcine small intestinal submucosa (SIS), intended for reinforcing soft tissue in the urological anatomy, specifically for tunica albuginea defects and Peyronie's disease repair.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility Testing Requirements (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation tests) | Met the requirements of extensive biocompatibility testing. |
| Viral Inactivation Testing Requirements | Met the requirements of viral inactivation testing. |
| Mechanical Testing Requirements (e.g., tensile strength, burst strength, suture retention) | Met the requirements of mechanical testing. |
| Suitability for Use in Soft Tissue Repair | Demonstrated suitability for use in soft tissue repair. |
| Substantial Equivalence to Predicate Devices | Demonstrated substantial equivalence to predicate devices (SURGISIS® Sling (K992159), SURGISIS® Mesh (K980431), and AMS Collagen Dermal Matrix (K050445)) in terms of intended use, materials, and technological characteristics. |
2. Sample Size Used for the Test Set and the Data Provenance:
The provided documentation does not specify a distinct "test set" in the context of an AI/ML device. The "tests" discussed are bench and biocompatibility tests conducted on the physical device itself. Therefore, specific sample sizes for a test set (e.g., number of patient cases) and data provenance (country of origin, retrospective/prospective) are not applicable or provided here. The testing was performed on the manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. This device is a physical surgical mesh, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth on a test set of data. The ground truth for its performance is established through laboratory and animal testing, evaluated against predetermined scientific standards and regulatory guidelines.
4. Adjudication Method for the Test Set:
Not applicable. The evaluation of test results (biocompatibility, viral inactivation, mechanical properties) for a physical device is based on objective measurements and established scientific protocols, not on an adjudication method involving human interpretation of data in the way one would for a diagnostic study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
Not applicable. This is not an AI/ML device, and therefore no MRMC study looking at human reader performance with or without AI assistance was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used:
The ground truth for this device's performance is based on:
- Scientific Standards and Regulatory Guidelines: For biocompatibility (e.g., ISO 10993 series), viral inactivation (established methods to ensure safety), and mechanical properties (biomechanical testing standards).
- Bench and Biocompatibility Testing Results: Objective measurements derived from laboratory tests the device underwent.
- Comparison to Predicate Device Performance: Establishing equivalence based on the known safety and effectiveness profiles of already marketed, substantially equivalent devices.
8. The Sample Size for the Training Set:
Not applicable. This device does not involve a "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This device does not involve a "training set." The development and testing of this device relied on established scientific principles, engineering design, and regulatory compliance for medical device manufacturing.
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9 510(K) SUMMARY
Submitted by:
Perry W. Guinn VP Regulatory Affairs and Quality Assurance Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 (765) 497-3355 August 8, 2006
OCT - 2 2006
Device: Trade Name: Common/Usual Name: Proposed Classification Name:
SURGISIS® Peyronie's Repair Graft Surgical Mesh Surgical Mesh 21 CFR §878.3300 (79FTM) Class II
Intended Use:
The SURGISIS® Peyronie's Repair Graft is intended for implantation to reinforce soft tissue where weakness exists in the urological anatomy, including but not limited to the repair of tunica albuginea defects, and reinforcement in the repair of Peyronie's disease. This device is supplied sterile and is intended for one-time use only.
Predicate Devices:
The SURGISIS® Peyronie's Repair Graft is similar in terms of substantial equivalence to the following predicate devices: SuRGISIS® Sling (K992159) and SURGIS/S® Mesh (K980431) devices, both manufactured by Cook Biotech Incorporated, and AMS Collagen Dermal Matrix (K050445) manufactured by American Medical Systems.
Device Description:
The SURGISIS® Peyronie's Repair Graft is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in an oval configuration. The device is packaged in a lyophilized (dried) state, and is supplied sterile in a sealed double pouch system.
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510(k) Premarket Notification: SURGIS® Peyronie's Repair Graft
ft 17
K06330
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Substantial Equivalence:
The SURGISIS® Peyronie's Repair Graft is similar with respect to intended use, materials and technological characteristics to the above predicate devices in terms of section 510(k) substantial equivalence, as shown through bench and biocompatibility testing.
Discussion of Tests and Test Results:
The SURGIS® Peyronie's Repair Graft met the requirements of extensive biocompatibility testing, viral inactivation testing, and mechanical testing, demonstrating suitability for use.
Conclusions Drawn from Tests:
Outcomes from the evaluation of the SURGISIS® Peyronie's Repair Graft provide evidence of its suitability for use in soft tissue repair and substantial equivalency to predicate devices in terms of intended use and technological characteristics.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
000 - 2 2006
Cook Biotech Incorporated % Mr. Perry W. Guinn Vice President. Regulatory Affairs & Quality Assurance 1425 Innovation Place West Lafayette. IN 47906
Re: K062320
Trade/Device Name: Surgisis" Peyronie's Repair Graft Regulation Number: 21 CFR 878.3300 Regulation Name Surgical mesh Regulatory Class: II Product Code: FTM Dated: August 8. 2006 Received: August 9, 2006
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 iegally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the snactment 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 ail 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
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Page 2 – Mr. Perry W. Guinn
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.
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Pa
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K06)30
Indications for Use
510(k) Number (if known):
Device Name: SURGISIS® Peyronie's Repair Graft
Indications For Use:
The SURGIS® Peyronie's Repair Graft is intended for implantation to reinforce soft tissue where weakness exists in the urological anatomy, including but not limited to the repair of tunica albuginea defects, and reinforcement in the repair of Peyronie's disease. The device is supplied sterile and 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)
Concerrence of CDRH, Office of Device Evaluation (ODE)
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Division Sign-Or Division of General, Restes .. and Neurological Devices
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510(k) Number: K062320
§ 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.