Under the care of a healthcare professional, CicaNet* Wound Contact Layer Dressing may be used in the management of partial and full thickness wounds including:

Leg ulcers
Pressure ulcers
Second degree burns
Surgical wounds
Diabetic foot ulcers

Device Description

CieaNet+ Wound Contact Layer Dressing is an air permeable, transparent, bi-axially stretched net constructed of high density polyethylene. This product is used in moist wound management of partial and full thickness wounds.

AI/ML Overview

The provided text describes a 510(k) submission for the CicaNet* Wound Contact Layer Dressing and does not include information about a study based on acceptance criteria or device performance in the context of AI/machine learning. The submission focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and biocompatibility testing. Therefore, I cannot provide the requested information.

Here's why each point cannot be answered from the provided text:

A table of acceptance criteria and the reported device performance: This document does not establish specific quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy) that would be relevant to an AI/ML device, nor does it report such performance metrics. The "performance" described relates to biocompatibility.
Sample size used for the test set and the data provenance: No test set in the context of an AI/ML model is mentioned. The biocompatibility tests used animal and cell models.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no AI/ML test set or ground truth establishment mentioned.
Adjudication method: Not applicable.
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 document is for a wound dressing, not an AI-powered diagnostic or assistive tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For the biocompatibility studies, the "ground truth" was the observed biological response to the material (e.g., cell viability, skin irritation, hemolytic index, systemic toxicity, mortality). This is not equivalent to ground truth in the context of AI/ML performance evaluation.
The sample size for the training set: Not applicable. There is no AI/ML model or training set mentioned.
How the ground truth for the training set was established: Not applicable.

Summary

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K981713

JUL 3 | 1998

510(k) Summary

CicaNet* Wound Contact Layer Dressing

Preparation Date:A A C A C A C C C C . C . C . CCommons of the first desires of the contraction of the contraction of the contraction of the contribution	Mav		15.1998
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Jim G. Irvin Submitter: Smith & Nephew Inc. Address: Wound Management Division 11775 Starkey Road Largo, FL 33773-4727 (813) 392-1261 Phone: (813) 399-3468 Fax:

Registration Official / Contact Person:

Jim Irvin, Vice President Quality Assurance and Regulatory Affairs Smith & Nephew, Inc. Wound Management Division

Manufacturer Identification/Establishment Registration Number

Smith & Nephew Inc. Wound Management Division 11775 Starkey Road Largo, FL 33773-4727 Phone (813) 392-1261 Fax (813) 399-3468

Establishment Registration Number: 1017593

Classification:

Trade Name: CicaNet*

Common Name: Wound Dressing

Classification Name: (Unclassified)

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Substantially Equivalent Products

Product	Manufacturer
3M Tegapore™ Wound Contact Material	3M Health CareSt. Paul, MN
DERMANET™ Wound Contact Layer	DeRoyal Wound CarePowell, TN
Conformant 2™ Transparent, Non-Adherent, WoundVeil	EXU-DRY Wound Care Products, Inc.Bronx, NY
TELFA CLEAR™ Nonadherent Wound Dressing	Kendall Healthcare ProductsMansfield, MA
N-TERFACE® Interpositional Surfacing Material	Winfield LaboratoriesDallas, TX (K973538)

Device Description

Wound contact layer dressings are indicated to provide covering for the wound bed.

Indications for Use

For OTC applications, CicaNet* Wound Contact Layer Dressing may be used for the management of minor wounds including

Abrasions サ
t Skin tears
용 Minor burns and scalds

Under the care of a healthcare professional, CicaNet* Wound Coutact Layer Dressing may be used in the management of partial and full thickness wounds including:

. Leg ulcers
Pressure ulcers 4
� Second degree burns
Surgical wounds .
t Diabetic foot ulcers

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Technological Characteristics:

The CicaNet* Wound Contact Layer Dressing is technologically the same as the substantially equivalent products:

3M Tegapore ™ Wound Contact Material DERMANET™ Wound Contact Layer Conformant 2 ™ Transparent, Non-Adherent, Wound Veil TELFA CLEAR ™ Nonadherent Wound Dressing N-TERFACE @ Interpositional Surfaceing Material

in that all products are an air permeable, transparent, non-adherent wound contact layer.

Bio Compatibility

Cytotoxicity

A study was conducted using mouse fibroblast cells as the substrate in order to determine the cytotoxicity of CicaNet* Wound Contact Layer Dressing.

Conclusion: Under the conditions of the study, the test article was found to be nontoxic.

Contact Sensitization

A study was conducted in the guinea pig to evaluate the potential for delayed dermal contact sensitization of CicaNet* Wound Contact Layer Dressing.

Conclusion: Under the conditions of this study, the test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig.

Animal Primary Irritation

CicaNet* Wound Contact Layer Dressing was evaluated for primary skin irritation in accordance with the guidelines of the Federal Hazardous Substances Act (FHSA) Regulations, 16 CFR 1500.

Conclusion: The test article would not be considered a primary irritant to the skin since the empirical score was less than 5.00.

Hemolysis Study - In Vitro Procedure (Extraction Method)

CicaNet* Wound Contact Layer Dressing was evaluated to determine whether the presence of any leachable chemicals would cause in vitro red blood cell hemolysis.

Conclusion: The mean hemolytic index for CicaNet* Wound Contact Layer Dressing extract was 0%. CicaNet* Wound Contact Layer Dressing is nonhemolytic.

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USP Systemic Toxicity Study in the Mouse (Extracts)

CicaNet* Wound Contact Layer Dressing was evaluated for systemic toxicity in accordance with the guidelines of the current USP.

Conclusion: There was no mortality or evidence of systemic toxicity from CicaNet* Wound Contact Layer Dressing

Sterilization

The method of sterilization will be Ethylene Oxide. An SAL of 10% will be achieved. Ethylene Oxide residuals will conform to FDA guidelines as originally published (Federal Register, Friday, June 23, 1978, Part V, "Proposed Maximum Residue Limits and Maximum Levels of Exposure").

Packaging

The product is packaged in a cold seal, peel apart, white, Kraft, ETO sterilizable Detectable Prior Opening (DPO) system, paper pouch. The individual dressings are protected by a parchment inner-wrap.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 31 1998

Mr. Jim G. Irvin Vice President, Quality Assurance & Regulatory Affairs Wound Management Division Smith & Nephew, Inc. 11775 Starkey Road Largo, Florida 33773

Re: K981713

Trade Name: Cicanet Wound Contact Layer Dressing Regulatory Class: Unclassified Product Code: MGP Dated: May 15, 1998 Received: May 15, 1998

Dear Mr. Irvin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

1. This device may not be labeled for use on third degree burns.
1. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
1. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
1. This device may not be labeled as a treatment or a cure for any type of wound.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

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Page 2 - Mr. Jim G. Irvin

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

Celia M.- Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K981713

510 (k) Number (if known)

CicaNet* Wound Contact Layer Dressing Device Name:

Wound contact layer dressings are indicated to provide covering for the wound bed.

For OTC applications, CicaNet* Wound Contact Layer Dressing may be used for the management of minor wounds including

Abrasions .
Skin tears キ
t Minor burns and scalds

Under the care of a healthcare professional, CicaNet* Wound Contact Layer Dressing may be used in the management of partial and full thickness wounds including:

t Leg ulcers
Pressure ulcers ◆
Second degree burns .
Surgical wounds �
♥ Diabetic foot ulcers

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K981713
Prescription Use	OR Over-The-Counter Use
(Per 21CFR 801 109)

(Per 21CFR 801.109)

(Options) Format 1-2-96)

Regulation Number and Section

N/A