The SIS Wound Dressing II is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

Device Description

The SIS Wound Dressing II is primarily composed of porcine collagen that is supplied in sheet form in sizes ranging from 2 x 4 cm to 20 x 40 cm.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SIS Wound Dressing II. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria and detailed performance metrics.

Therefore, the document does not contain information on acceptance criteria, a study proving device meeting acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth methodologies as one would expect for a novel device requiring extensive clinical validation.

Here's a breakdown of why this information is absent and what is provided:

A table of acceptance criteria and the reported device performance: This is not present. The 510(k) summary states, "The SIS Wound Dressing II was subjected to a panel of tests to assess biocompatibility. The SIS Wound Dressing II passed the requirements of all tests." It does not specify what those requirements (acceptance criteria) were, nor does it provide detailed performance results beyond a blanket "passed."
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No sample sizes for any clinical performance testing are mentioned because such testing was not the primary focus of this 510(k). The tests focused on biocompatibility, which typically involves in-vitro or animal studies, not human test sets for efficacy.
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. There was no "ground truth" establishment for a clinical test set in the context of this 510(k).
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication is described.
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 wound dressing, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical wound dressing, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the biocompatibility tests, the ground truth would typically be established by standardized pass/fail criteria for specific biological responses (e.g., cytotoxicity, irritation, sensitization). This type of "ground truth" is inherent to the specific biological test methods, rather than expert consensus on clinical findings.
The sample size for the training set: Not applicable. The device is a physical wound dressing and does not involve AI or machine learning that would require a training set.
How the ground truth for the training set was established: Not applicable, as no training set exists for this device.

What the document does state regarding "proof" and "acceptance criteria" (implicitly):

Acceptance Criteria Mentioned: "The SIS Wound Dressing II was subjected to a panel of tests to assess biocompatibility. The SIS Wound Dressing II passed the requirements of all tests." The specific requirements are not detailed, but the implicit acceptance criterion is "passing all biocompatibility tests."
Study Proving Acceptance: The "study" is the unnamed "panel of tests to assess biocompatibility."
Conclusion: "This device is, with respect to intended use and technological characteristics, substantially equivalent to the predicate devices." This is the ultimate "proof" sought in a 510(k) submission – that the device is as safe and effective as a legally marketed predicate. The biocompatibility tests are part of the data supporting this claim of substantial equivalence.

In summary, this 510(k) document is concerned with demonstrating substantial equivalence to predicate devices, primarily through materials analysis and biocompatibility testing, rather than detailed clinical performance studies with specific statistical acceptance criteria.

Summary

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510(K) SUMMARY 9.

Submitted By:

Neal E. Fearnot, Ph.D. President Cook Biotech. Incorporated 3055 Kent Avenue West Lafavette, IN 47906 (765) 497-3355

November 18, 1999

Device:

Trade Name: Common/Usual Name: Proposed Classification Name: SIS Wound Dressina II Topical Wound Dressing Unclassified (79KMF)

Intended Use:

Predicate Devices:

The SIS Wound Dressing II is similar to predicate collagen-based wound dressings that are currently marketed for the management of wounds including the SIS Wound Dressing (D.C. #K973170) manufactured by Cook Biotech, Incorporated, the FIBRACOL * Plus Collagen Wound Dressing with Alginate (D.C. #K982597) manufactured by Johnson and Johnson Medical, and the SkinTemp® Kollagen Wound Management Material (D.C. #K913023) and Medifil® Kollagen Particles (D.C. #K910944) manufactured by Biocore Medical Technologies.

Device Description:

The SIS Wound Dressing II is primarily composed of porcine collagen that is supplied in sheet form in sizes ranging from 2 x 4 cm to 20 x 40 cm.

Substantial Equivalence:

The SIS Wound Dressing II is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510(k) substantial equivalency.

Discussion of Tests and Test Results:

The SIS Wound Dressing II was subjected to a panel of tests to assess biocompatibility. The SIS Wound Dressing II passed the requirements of all tests.

Conclusions Drawn from Tests:

This device is, with respect to intended use and technological characteristics, substantially equivalent to the predicate devices.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized image of three human profiles facing right. The profiles are connected and appear to be emerging from a single form. The text is arranged in a circular fashion around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAH 1 9 200/

Neal E. Fearnot, Ph.D. President Cook Biotech, Inc. 3055 Kent Avenue West Lafayette, Indiana 47906

K993948 Re: Trade Name: SIS Wound Dressing II Regulatory Class: Unclassified Product Code: KGN Dated: November 18, 1999 Datod: November 22, 1999

Dear Dr. Fearnot:

This letter corrects our substantially equivalent letter of January 6, 2000.

We have reviewed your Section 510(k) premarket notification of intent to market the We have reviewed your Section 5 U(K) premailser in substantially equivalent (for the
device referenced above and have determined the devices marketed device referenced above and have determined the device is substantinate devices marketed
indications for use stated in the enclosure) to legally marketed predical Device indications for use stated in the enclosure) to legally that the Medical Device in
in interstate commerce prox to May 28, 1976, the enactment date of the provisions in interstate commerce prior to May 28, 1976, the enactment cate of the provisions of
Amendments or to devices that have been recuassified in accordance with the provisions o Amendments or to devices that have been technologic and the require approval of a
the Federal Food, Drug, and Cosme of the device, subject to the the Federal Food, Drug, and Cosmetic Act (Act) that do fict togule . pubject to the general
premarket approval (PMA). You may, therefore, market the device, subject to the g premarket approval (PMA). You may, merelore, mancovais as of the Act include
controls provisions of the Act. The general controls provisions of the Act include controls provisions of the Act. Ine general controls provides
requirements for annual registration, listing of devices, good manufacturing practice, requirements for anilual registration, noting

If your device is classified (see above) into either class II (Special Controls) or class III
ng your and the states and liveral controls. Fristing major regulations affect If your device is classified (see above) into either criass in (special ons affecting your
(PMA), it may be subject to additional controls. Existing major regulations affect (PMA), it may be subject to additional controls. Existing fille/ 1. Parts 800 to 898. In
device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 800 device can be found in the Code of Federal Regulations, THS 31, 2017
addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Neal E. Fearnot, Ph.D.

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 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 continue 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/dsma/dsmamain.html

Sincerely yours

Mark N. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): __ K 993948

Device Name: __ SIS Wound Dressing II

Indications For Use:

The SIS Wound Dressing II is intended for the management of wounds including:

·Partial and full-thickness wounds
·Pressure ulcers
·Venous ulcers
· Diabetic ulcers
•Chronic vascular ulcers
Tunneled/undermined wounds
· Surgical wounds (donor sites/grafts, post-moh's surgery, post-
laser surgery, podiatric, wound dehiscence)
· Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
•Draining wounds.

The device is intended for one-time use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Regulation Number and Section

N/A