The modified SIS Fistula Plug is manufactured from porcine small intestinal submucosa (SIS) supplied in a tapered configuration with a flange to provide increased retention of the plug and improved blockage of the fistula. The device is packaged in a lyophilized (freeze-dried) state, and supplied sterile in a sealed double pouch system.

AI/ML Overview

This submission is for a Special 510(k) for a modified version of an existing device, the SURGISIS® Biodesign™ Enterocutaneous Fistula Plug. Special 510(k)s rely heavily on substantial equivalence to a predicate device, rather than new clinical studies with defined acceptance criteria and performance targets.

Here's a breakdown of the requested information based on the provided text, with notable absences for items not typically found in a Special 510(k) for a material modification:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Biocompatibility	Device is biocompatible.
Disinfection	Adequately disinfected.
Mechanical Properties	Appropriate mechanical characteristics.
Substantial Equivalence to Predicate	Similar to predicate device in intended use, materials, and technological characteristics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of a clinical performance study. The tests mentioned are bench testing and biocompatibility testing. Sample sizes for these types of tests are not provided in this summary. Data provenance (country of origin, retrospective/prospective) is also not specified, as this primarily relates to clinical data, which is not the focus of this Special 510(k).

3. 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. This Special 510(k) is based on bench and biocompatibility testing, not expert-adjudicated clinical data to establish ground truth for a diagnostic or therapeutic performance claim.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical test set requiring expert adjudication.

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 device is a surgical mesh, not an AI-powered diagnostic or decision support system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a surgical mesh, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the tests performed:

Biocompatibility: Likely evaluated against established biological safety standards.
Viral inactivation: Assessed against standards for viral clearance.
Mechanical testing: Compared to predetermined specifications for the device's physical properties.
Substantial Equivalence: Ground truth is the performance and characteristics of the legally marketed predicate device (SIS Fistula Plug, K050337).

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The "training" for such devices typically refers to the manufacturing process and quality controls.

9. How the ground truth for the training set was established

Not applicable, as there is no training set in the AI/ML context.

Summary

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Special 510(k) Submission, SURGISIS® Biodesign™ Enterocutaneous Fistula Plug September 8, 2008

Page 4

1872

FEB 2 7 2009

510(k) SUMMARY

Submitted By:

Perry Guinn, Vice President, Quality Assurance and Regulatory Affairs Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 (765) 412-6318 September 12, 2006

K082682

Name of Device:

SURGISIS® Biodesign™ Enterocutaneous Fistula Plug Trade Name: Common/Usual Name: Surgical Mesh Proposed classification name: Surgical Mesh

21 CFR 878.3300 (FTM) Class II

Predicate Device:

The predicate device is the original SIS Fistula Plug (510(k) No. K050337), cleared for marketing by the Food and Drug Administration on March 9, 2005.

Device Description:

Substantial Equivalence:

The modified SIS Fistula Plug is similar with respect to intended use, materials and technological characteristics to the original, unmodified SIS Fistula Plug as shown through an analysis of risk factors, bench testing and biocompatibility testing.

Discussion of Tests and Test Results:

The materials comprising the modified SIS Fistula Plug have been subjected to extensive biocompatibility testing, viral inactivation testing, and mechanical testing. Outcomes show the

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K082682 pg 2of2

device to be biocompatible, adequately disinfected, and with appropriate mechanical characteristics.

Conclusions Drawn from the Tests:

Outcomes from the evaluation of the modified SIS Fistula Plug provide evidence of its suitability for use in soft tissue reconstruction and substantial equivalency to the predicate device in terms of intended use and technological characteristics.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 27 2009

Cook Biotech. Inc. % Med Institute, Inc. Mr. Perry W. Guinn VP, QA/RA 1425 Innovation Place West Lafayette, Indiana 47906

Re: K082682

Trade/Device Name: SURGIS® Biodesign™ Enterocutaneous Fistula Plug Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: February 18, 2009 Received: February 19, 2009

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 Fed-ral 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

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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 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 Syrems 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 vours.

Milton R. Ogden

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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Indications for Use

82682

510(k) Number (if known):

Device Name:

SURGISIS® Biodesign™ Enterocutaneous Fistula Plug

Indications for Use:

The modified SIS Fistula Plug is indicated for implantation to reinforce soft tissue for repair of enterocutaneous fistulas.

Prescription Use XX

AND/OR

Over-the-Counter Use

(Per 21 CFR 801 Subpart D)

(21 CRF 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	DK for MYM 2/22/2009
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K082682

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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.