The Surgisis Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The device may be used for buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The device can be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding. The device can also be used for abdominal and thoracic wall repair, muscle flap reinforcement, trans-abdominal rectal and vaginal prolapse repair, trans-abdominal reconstruction of the pelvic floor, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical). The Surgisis Staple Line Reinforcement may be used with anastomotic staplers or with non-anastomotic staplers. The device is supplied sterile and is intended for one-time use.

Device Description

The Surgisis Stable Line Reinforcement is manufactured from porcine small intestinal submucosa and supplied in nominal strip sizes (unfolded) of 1 x 10.7 cm, 1.2 x 13.2 cm, and 1.2 x 17.3 cm. The device is packaged sterile, sealed double pouches.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text for the Cook Biotech Incorporated Surgisis® Staple Line Reinforcement:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Meet ISO 10993-1 standards	Met test requirements, supporting substantial equivalence.
Disinfection	Effectively disinfected	Met test requirements, supporting substantial equivalence.
Performance Characteristics	Provide reasonable assurance of device performance for intended use.	Met test requirements, supporting substantial equivalence.
Substantial Equivalence	Similar to predicate devices in intended use, materials, and technological characteristics.	Determined to be substantially equivalent to predicate devices.

Note: The document does not explicitly state numerical acceptance criteria. Instead, it refers to meeting test requirements and demonstrating substantial equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify a sample size for a test set or data provenance for any clinical or performance study that would resemble a "test set" in the context of an AI/ML device. The document describes tests conducted on the material itself ("The material comprising the Surgisis Staple Line Reinforcement was subjected to a panel of tests...").

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this 510(k) submission. This device is a surgical mesh, not an AI/ML device that generates diagnoses or interpretations requiring expert-established ground truth. The "ground truth" for this medical device would relate to its physical and biological properties.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a test set requiring adjudication in the context of expert review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not applicable to this type of medical device (surgical mesh). This type of study is relevant for diagnostic devices, particularly those involving human interpretation, often with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study in the context of an algorithm or AI system was not done and is not applicable. This document describes a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

Biocompatibility testing: Conforming to ISO 10993-1 standards.
Disinfection efficacy: Demonstrating effective disinfection.
Performance characteristics: Meeting mechanical and functional requirements relevant to its intended use as a surgical mesh.
Comparison to predicate devices: Demonstrating similar intended use, materials, and technological characteristics to legally marketed devices.

These are established through laboratory testing and validated regulatory standards, rather than expert consensus, pathology, or outcomes data in the way an AI diagnostic device would use those terms.

8. The Sample Size for the Training Set

The provided text does not mention a training set sample size. A "training set" is typically associated with AI/ML model development, which is not relevant to this device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no mention of a training set or AI/ML model development.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The study proving the Surgisis® Staple Line Reinforcement meets its (implied) acceptance criteria is described as a panel of tests conducted on the material itself. These tests assessed:

Biocompatibility: In accordance with ISO 10993-1 standards.
Disinfection: To ensure effective sterilization.
Performance Characteristics: Likely including mechanical properties and structural integrity relevant for its use as a soft tissue reinforcement.

The document states that the "material met the test requirements," providing "reasonable assurance of device performance for its intended use and supporting substantial equivalence." The overall conclusion drawn from these tests was that the device is "substantially equivalent" to existing predicate devices (Surgisis® Soft Tissue Graft, Surgisis® Peripheral Vascular Patch, Peri-Strips® Staple Line Reinforcement-Strip, and Seamguard® Staple Line Reinforcement Material) with respect to intended use and technological characteristics. This substantial equivalence is the primary basis for its 510(k) clearance.

Summary

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510(k) Summary

July 13, 2012

Cook Biotech Incorporated

Surgisis® Staple Line Reinforcement

Manufacturer Name:	Cook Biotech Incorporated1425 Innovation PlaceWest Lafayette, Indiana 47906Telephone: +1 (765) 497-3355FAX: +1 (765) 807-7709
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Official Contact: Perry W. Guinn

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	Surgisis® Staple Line Reinforcement
Common Name:	Surgical mesh, collagen, staple line reinforcementMesh, surgical, non-synthetic, urogynecologic, forapical vaginal and uterine prolapse, transabdominallyplaced
Classification Regulations:	Class II, 21 CFR §878.3300 (OXE, PAJ)

INTENDED USE:

PREDICATE DEVICES:

The Surgisis Staple Line Reinforcement is similar to predicate devices, including the Surgisis® Soft Tissue Graft (K980431) and Surgisis® Peripheral Vascular Patch (K001785) manufactured by Cook Biotech Incorporated, the Peri-Strips® Staple Line Reinforcement-Strip (K983162) manufactured by Biovascular Incorporated, and the Seamguard® Staple Line Reinforcement Material (K010936) manufactured by W.L. Gore & Associates.

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DEVICE DESCRIPTION:

SUBSTANTIAL EQUIVALENCE TO MARKETED DEVICES

The Surgisis Staple Line Reinforcement is similar with respect to intended use, materials and technological characteristics to the predicate device in terms of section 510(k) substantial equivalence, as shown biocompatibility testing (conducted in accordance to ISO 10993-1 standards), mechanical and clinical testing.

DISCUSSION OF TESTS AND TEST RESULTS:

The material comprising the Surgisis Staple Line Reinforcement was subjected to a panel of tests to assess biocompatibility, disinfection, and performance characteristics. The material met the test requirements, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence.

CONCLUSIONS DRAWN FROM THE TESTS:

The Surgisis Staple Line Reinforcement is, with respect to intended use and technological characteristics, substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name written around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure. The image is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Cook Biotech, Incorporated % Mr. Mark Blever President 3055 Kent Avenue West Lafayette, Indiana 47906-1076

AUG 30 2012

Re: K022044

Trade/Device Name: Surgisis® Staple Line Reinforcement Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OXE, FTM, PAJ Dated: June 20, 2002 Received: June 24, 2002

Dear Mr. Bleyer:

This letter corrects our substantially equivalent letter of August 23, 2002.

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 (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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Millman

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Surgisis Staple Line Reinforcement Device Name:

Indications For Use:

The Surgisis Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The device may be used for buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy/pneumectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The device can be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding. The device can also be used for abdominal and thoracic wall repair, muscle flap reinforcement, transabdominal rectal and vaginal prolapse repair, trans-abdominal reconstruction of the pelvic floor, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical). The Surgisis® Staple Line Reinforcement may be used with anastomotic staplers or with non-anastomotic staplers.

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 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dainl Krone for MM
Division Sign Off

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K022044

Page 1 of

Regulation Number and Section

§ 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.