The SIS Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists. Indications for use include repair of a hernia or body wall defect. The graft is supplied sterile and intended for one time only use.

Device Description

The SIS Hernia Graft is composed of multiple layers of a bioabsorbable, extracellular collagen membrane matrix (Small Intestinal Submucosa, SIS) that are held together with a biodegradable suture to improve the device handling characteristics at time of implant. The SIS Hernia Graft is identical in its base material to its predicate SIS Hernia Repair Device (K974540/K062697), also manufactured by Cook Biotech Incorporated. The SIS Hernia Graft is substantially equivalent to its predicate in its technology in that it has the ability to be incorporated into the body. The device is substantially equivalent to its predicate in its intended use for reinforcement and repair of hernias or a body wall defect. The device is packaged in a dried state and supplied sterile in a sealed double pouch system.

AI/ML Overview

The provided document describes the 510(k) premarket notification for the "SIS Hernia Graft." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way one might find for a novel diagnostic or AI-driven device.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert consensus, and reader studies are not applicable or not provided in this type of regulatory submission.

However, I can extract the relevant information and structure it as much as possible according to your request categories, noting where information is not available from the provided text.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria for this 510(k) submission are fundamentally based on demonstrating substantial equivalence to a previously legally marketed device (the predicate device). This means the device must meet similar performance standards and safety profiles as the predicate. The "performance" is demonstrated through various tests and comparisons rather than numerical thresholds for a specific diagnostic accuracy.

Table 1: Acceptance Criteria (Demonstration of Substantial Equivalence) and Reported Device Performance

Category	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Device must meet biocompatibility requirements of ISO 10993-1 standard.	Demonstrated through various tests on sterilized SIS devices (genotoxicity, hemolysis, cytotoxicity, muscle implantation, acute intracutaneous reactivity, skin irritation, ISO sensitization, acute systemic toxicity, pyrogenicity, LAL endotoxins, subchronic systemic toxicity). Results provided evidence that the SIS Hernia Graft meets biocompatibility requirements.
Mechanical Strength	Device must provide adequate mechanical strength for its intended application.	Tested for Suture retention strength, Burst strength, Ultimate tensile strength, Tear strength, Stiffness. Results provided evidence that the SIS Hernia Graft provided adequate mechanical strength for its application.
Animal Testing (Safety & Biocompatibility)	Device should be well-tolerated, show minimal tissue response, and satisfactory remodeling characteristics.	Study 1 (Pig Hernia Model, 27 days): Device was well tolerated with minimal localized tissue response. Study 2 (Pig Hernia Model, 1 & 6 months): Satisfactory remodeling characteristics with minimal inflammation (used as a control article). Study 3 (Mouse, Angiogenesis): Sutured SIS performed as well as sutureless control SIS with robust vascular penetration. Results show the device is safe and biocompatible in its application.
Material Composition	Identical to predicate device.	Porcine small intestinal submucosa (porcine), primarily Types I, III, IV, and VI collagen (constituents of the extracellular matrix). (Identical to predicates K974540 and K062697).
Intended Use	Identical to predicate device.	Intended for implantation to reinforce soft tissues where weakness exists, including repair of a hernia or body wall defect. (Identical to predicates K974540 and K062697).
Dimensions	Comparable to predicate device.	New Device: 5 x 8 cm to 30 x 30 cm. Predicate K974540: 5 x 8 cm to 20 x 30 cm. Predicate K062697: 1 x 3 to 20 x 30 cm. (Variations noted but deemed substantially equivalent).
Thickness	Comparable to predicate device.	0.1 - 1.5 mm. (Identical to predicates K974540 and K062697).
Layers	Identical to predicate device.	8 layers. (Identical to predicates K974540 and K062697).
Drying Method	Acceptable for the material, maintaining similar incorporation and resorption characteristics.	New Device: Lyophilized. Predicates: Vacuum pressed. (Difference noted, but the SIS material is the same and exhibits similar characteristics when implanted).
Stitching	Addition of biodegradable suture to improve handling, without affecting the SIS material or its characteristics post-resorption.	New Device: Yes (resorbable suture). Predicates: No. (Addition for handling, suture is resorbed without effect on SIS material).

Additional Information on Studies (Not Directly Applicable/Provided for 510(k))

This 510(k) submission is for a medical device (surgical graft), not a diagnostic algorithm or AI system. Therefore, many of the requested items related to AI/diagnostic study design are not relevant to this type of submission.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Biocompatibility Tests: Performed on sterilized SIS devices (base material). No specific "test set" size is given beyond "SIS devices."
- Mechanical Testing: Performed on "SIS Hernia Graft material." No specific "test set" size or data provenance is detailed.
- Animal Testing:
  - Pig hernia model: Two separate studies mentioned. No specific number of animals provided for each study.
  - Mouse study: One study mentioned. No specific number of animals provided.
- Data Provenance: Not specified, but likely proprietary internal testing given the nature of the device and testing. All tests are prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth for biocompatibility and mechanical tests is determined by standardized laboratory methods and observations (e.g., cell viability, tensile strength, histopathology readings). For animal studies, expert pathologists would have interpreted the findings, but their number and qualifications are not specified in this summary.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to consensus among human readers for diagnostic interpretation, which is not part of this device's submission.
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 or diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical surgical graft, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Biocompatibility: In vitro and in vivo test results against ISO 10993-1 standards (e.g., cell viability, systemic toxicity markers, inflammation scores).
- Mechanical Testing: Objective measurements from testing equipment (e.g., force required for tear, ultimate tensile strength).
- Animal Testing: Gross and histopathological findings from implanted tissue, angiogenesis assessments. Considered direct evidence of tissue response and material integration.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of this physical medical device. This term is primarily relevant for machine learning or AI algorithm development.
How the ground truth for the training set was established:
- Not applicable.

Summary

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JUL 2 3 2014

510(k) Summary

July 18, 2014

Cook Biotech Incorporated

SIS Hernia Graft

Manufacturer Name:

Cook Biotech Incorporated 1425 Innovation Place West Lafayette, Indiana 47906 Telephone: +1 (765) 497-3355 FAX: +1 (765) 807-7709

Official Contact:

Perry W. Guinn

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulations:

SIS Hernia Graft Surgical graft Class II, 21 CFR §878.3300 (FTM and OXK)

INDICATIONS FOR USE:

DEVICE DESCRIPTION:

The SIS Hernia Graft is substantially equivalent to its predicate in its technology in that it has the ability to be incorporated into the body. The device is substantially equivalent to its predicate in its intended use for reinforcement and repair of hernias or a body wall defect. The device is packaged in a dried state and supplied sterile in a sealed double pouch system.

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EQUIVALENCE TO MARKETED DEVICES

The SIS Hernia Graft is substantially equivalent with respect to intended use, materials and technological characteristics to its predicate device in terms of section 510(k) substantial equivalence, as shown in biocompatibility testing (conducted in accordance to ISO 10993-1 standards), mechanical and pre-clinical testing.

Biocompatibility testing

The following biocompatibility tests were performed on sterilized SIS devices, which are identical in base material composition to the SIS Hernia Graft (according to the ISO 10993-1 standard):

Genotoxicity .
Direct contact in vitro hemolysis .
Cytotoxicity �
Muscle implantation .
Acute intracutaneous reactivity .
Skin irritation ●
ISO Sensitization .
Acute systemic toxicity .
Pyrogenicity ●
LAL endotoxins .
. Subchronic systemic toxicity

The results of these tests provided evidence that the SIS Hernia Graft meets biocompatibility requirements of the ISO standard.

Mechanical Testing

The SIS Hernia Graft material was tested for the following:

Suture retention strength .
. Burst strength
Ultimate tensile strength .
Tear strength .
Stiffness test .

The results of the mechanical testing provided evidence that the SIS Hernia Graft provided adequate mechanical strength for its application.

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Animal Testing

A study was performed where the SIS Hernia Graft was implanted in a pig hernia model and examined for gross and histopathological results after 27 days. The results show that the device is well tolerated with minimal localized tissue response. A second pig hernia study used the SIS Hernia Graft as a control article and examined one and 6-months post-implant showed satisfactory remodeling characteristics with minimal inflammation. Another animal study in the mouse examined the angiogenesis of the SIS Hernia Graft showed that the sutured SIS performed as well as its sutureless control SIS with robust vascular penetration. The results of the studies show that the device is safe and biocompatible in its application.

Substantial Equivalence

See Table 1 for a comparison of the subject device and its predicate.

Device	SIS Hernia Graft	SIS Hernia Repair Device	SIS Hernia Repair Device
Manufacturer	Cook Biotech Incorporated	Cook Biotech Incorporated	Cook Biotech Incorporated
510(k) Number	K133306	K974540	K062697
Intended Use	Intended for implantation toreinforce soft tissues whereweakness exists. Indicationsfor use include the repair of ahernia or body wall defect.	Intended to be implanted toreinforce soft tissues whereweakness exists. Indicationsfor use include the repair of ahernia or body wall defect.	Intended to be implanted toreinforce soft tissues whereweakness exists. Indicationsfor use include the repair of ahernia or body wall defect.
Material	Porcine small intestinalsubmucosa (porcine)Primarily Types I, III, IV andVI collagen (constituents ofthe extracellular matrix)	Porcine small intestinalsubmucosa (porcine)Primarily Types I, III, IV andVI collagen (constituents of theextracellular matrix)	Porcine small intestinalsubmucosa (porcine)Primarily Types I, III, IV andVI collagen (constituents of theextracellular matrix)
Dimensions	5 x 8 cm to 30 x 30 cm	5 x 8 cm to 20 x 30 cm	1 x 3 to 20 x 30 cm
Thickness	0.1 - 1.5mm	0.1 - 1.5 mm	0.1 - 1.5 mm
Type of drying	Lyophilized	Vacuum pressed	Vacuum pressed
Layers	8 layers	8 layers	8 layers
Stitched(resorbablesuture)	Yes	No	No
Biocompatible	Yes	Yes	Yes

Table 1 - Substantial Equivalence Comparison
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While the SIS Hernia Graft is dried differently than the predicate SIS Hernia Repair Device, the SIS material is the same and exhibits similar incorporation and resorption characteristics when implanted. The suture stitching of the SIS Hernia Graft is intended to hold the layers of the device together during the implantation period and is resorbed without any effect on the SIS material.

CONCLUSION: The biocompatibility, mechanical, and animal tests performed on the SIS Hernia Graft show that the device is substantially equivalent to its predicate.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three flowing lines representing support and care.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 23, 2014

Cook Biotech Incorporated Mr. Perry W. Guinn Vice President. Quality Assurance and Regulatory Affairs 1425 Innovation Place West Lafayette, Indiana 47906

Re: K133306

Trade/Device Name: SIS Hernia Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM. OXK Dated: June 10, 2014 Received: June 11, 2014

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither 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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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S.

Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133306

Device Name SIS Hernia Graft

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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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.