Minor burns
Superficial lacerations, cuts and abrasions (partial thickness wounds) and skin tears
Under the direction of a healthcare professional, SoloSite® Gel Conformable Dressing is used to create a moist wound environment for the management of:
Venous ulcers (leg ulcers)
Surgical incisions
Diabetic foot ulcers
Pressure ulcers (including stage IV).
Additionally, SoloSite® Gel Conformable Dressing, creates a moist wound environment which assists in autolytic debridement of wounds covered with necrotic tissue.

Device Description

SoloSite® Gel Conformable Dressing is a non woven (70/30 rayon polyester blend) dressing impregnated with SoloSite® wound gel contained in a heat sealable, peal apart metalized/polyethylene pouch.
The product is applied in such a manner to completely cover the wound surface with the dressing and secured in place with an appropriate secondary dressing.
Gel conformable dressings are indicated to provide covering of the wound bed as well as creating a moist wound healing environment.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called SoloSite® Gel Conformable Dressing. It focuses on demonstrating substantial equivalence to previously marketed devices and biocompatibility testing, rather than a clinical study evaluating its performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for a comparative effectiveness study is not present in this document.

However, I can extract the information that is available and clarify what is not.

Acceptance Criteria and Study Information for SoloSite® Gel Conformable Dressing

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

No explicit acceptance criteria with numerical targets for clinical performance are presented in this 510(k) summary. The document primarily focuses on demonstrating the device's biocompatibility and substantial equivalence to predicate devices. The "performance" reported relates to the results of biocompatibility tests, indicating the device meets safety standards.

Acceptance Criteria (Implied from testing)	Reported Device Performance
Biocompatibility:
In vitro cytotoxicity (ISO 10993-5) – No significant cell lysis or toxicity.	"The test article showed no evidence of causing cell lysis or toxicity grater then a USP grade of 2 (mild reactivity). The test article was mildly cytotoxic and passed this ISO study."
Primary skin irritation (FHSA Regulations, 16 CFR 1500) – Not a primary irritant (Irritation Index < 5.00).	"Barely perceptible irritation was observed on the skin of the rabbits. The primary irritation index was calculated to be 0.88." "The test article would not be considered a primary irritant to the skin since the empirical score was less than 5.00."
Delayed dermal contact sensitization (ISO Part 10) – No evidence of sensitization.	"The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig."
Acute systemic toxicity (ISO Part 11) – No mortality or significant systemic toxicity.	"Under the conditions of this test there was no mortality or evidence of significant systemic toxicity."
Genotoxicity (Salmonella typhimurium Reverse Mutation Study) – Not mutagenic.	"SoloSite CWD was not considered to be mutagenic to Salmonella typhimurium tester strains."
Hemolysis (In Vitro Procedure - Extract Method) – Non-hemolytic.	"The mean hemolytic index for the test article extract was 0%. The test article extract was nonhemolytic."
Functional Equivalence:
Technologically the same as predicate devices (hydrogel impregnated dressing)	"The SoloSite® Gel Conformable Dressing is technologically the same as the substantially equivalent products... in that all products are hydrogel impregnated dressings indicated to provide covering of the wound bed as well as creating a moist wound healing environment."

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

Sample Size:
- Biocompatibility Tests: The document refers to standard in vitro and in vivo animal tests. Specific sample sizes for each test (e.g., number of cells for cytotoxicity, number of rabbits for irritation, number of guinea pigs for sensitization, number of mice for systemic toxicity) are not explicitly stated within the provided text. These are typically defined by the referenced ISO/FHSA standards.
- Clinical Performance: No clinical test set or human subject study designed to evaluate device performance against specific outcomes is described in this 510(k) summary. The submission relies on substantial equivalence to predicate devices for its intended use claims.
Data Provenance: The biocompatibility studies appear to be laboratory studies conducted as per international standards (ISO) and U.S. federal regulations (FSHC). The country of origin for the data generation (i.e., where the labs are located) is not specified, but the submission itself is to the U.S. FDA. The biocompatibility tests are prospective in nature, meaning they were conducted specifically for this device submission.

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)

This section is not applicable as the provided document describes biocompatibility testing and a substantial equivalence review, not a study requiring expert-established ground truth for clinical outcomes or diagnostic accuracy. The "ground truth" for the biocompatibility tests comes from the objective, quantifiable results of the laboratory assays and animal responses as interpreted by qualified professionals performing those tests.

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

This section is not applicable. No adjudication method for a test set is mentioned because there isn't a human-reader-dependent test set for clinical performance being described. The biocompatibility results are typically based on direct measurements and observations, not a consensus or adjudication process among multiple human readers.

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

No MRMC comparative effectiveness study was done. This document pertains to a medical dressing, not a diagnostic or AI-assisted device. Therefore, questions regarding human reader improvement with or without AI assistance are not relevant to this submission.

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

Not applicable. This device is a physical wound dressing, not an algorithm or AI system.

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

For the biocompatibility studies, the "ground truth" is established by:

For cytotoxicity, genotoxicity, and hemolysis: The results of in vitro laboratory assays with measurable endpoints (e.g., cell viability, mutation rates, hemolytic index).
For irritation and sensitization: Observable physiological responses in animal models, evaluated against established scoring systems.
For systemic toxicity: Observation of animal health and mortality.

There is no mention of expert consensus, pathology, or outcomes data in the context of clinical performance evaluation for this 510(k) submission.

8. The sample size for the training set

Not applicable. This document does not describe the development of an algorithm or AI model that would require a training set. The "device" is a physical product.

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

Not applicable. As there is no training set for an algorithm, there is no corresponding ground truth establishment mentioned.

Summary

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< 981150

JUN 22 1998

510(k) Summary

SoloSite® Gel Conformable Dressing

March 27, 1998 Preparation Date:

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

Packaging Company Identification /Establishment Registration Number

Tecnol Medical Products, Inc. 6316 Airport Freeway Fort Worth, TX 76117 Phone (817) 831-4700 (817) 838-7054 Fax

Establishment Registration Number: 1643958

Classification:

Smith & Nephew, Inc., Solo Site® Conformable Wound Trade Name: Dressing

Common Name: Conformable Wound Dressing

Classification Name: Unclassified

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Substantially Equivalent Products:

Product	Manufacturer
Biolex™ Impregnated Wound Dressing	Bard Patient Care DivisionMurray Hill, NJ (K935096)
CarraGauze® Carrasyn® Hydrogel woundDressing Saturated Pad	Carrington Laboratories, Inc.Irving, TX (K962218)
MPM GelPad™ Hydrogel Saturate Dressing	Marketing Professionals in Medicine, Inc.Arlington, TX (K933495)
Restore ™ Hydrogel Impregnated Sponge	By Renaissance Pharmaceutical for Hollister Inc.Libertyville IL

Device Description

SoloSite® Gel Conformable Dressing is a non woven (70/30 rayon polyester blend) dressing impregnated with SoloSite® wound gel contained in a heat sealable, peal apart metalized/polyethylene pouch.

The product is applied in such a manner to completely cover the wound surface with the dressing and secured in place with an appropriate secondary dressing.

Gel conformable dressings are indicated to provide covering of the wound bed as well as creating a moist wound healing environment.

SoloSite® Gel Conformable Dressing is used to create a moist wound environment for the treatment of minor conditions such as:

ન્ન્ Minor burns
Superficial lacerations, cuts and abrasions (partial thickness wounds) and skin tears *

Under the direction of a healthcare professional, SoloSite® Gel Conformable Dressing is used to create a moist wound environment for the management of:

- Venous ulcers (leg ulcers)
- Surgical incisions
Diabetic foot ulcers *
Pressure ulcers (including stage IV). *

Additionally, SoloSite® Gel Conformable Dressing, creates a moist wound environment which assists in autolytic debridement of wounds covered with necrotic tissue.

Technological Characteristics:

The SoloSite® Gel Conformable Dressing is technologically the same as the substantially equivalent products:

Biolex™ Impregnated Wound Dressing CarraGauze™ Carrasyn™ Hydrogel wound Dressing Saturated Pad MPM GelPad™ Hydrogel Saturate Dressing Restore™

in that all products are hydrogel impregnated dressings indicated to provide covering of the wound bed as well as creating a moist wound healing environment.

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Bio Compatibility

Cytotoxicity

An in vitro biocompatibility test, based on the International Organization for Standardization (ISO 10993-5) guidelines, was conducted on the test article, SoloSite® Gel Conformable Dressing, in order to determine the potential for in vitro cvtotoxicity.

Conclusion: Under the conditions of this study, the test article showed no evidence of causing cell lysis or toxicity grater then a USP grade of 2 (mild reactivity). The test article was mildly cytotoxic an passed this ISO study.

Animal Primary Irritation

The test article, SoloSite® Gel Conformable Dressing, was evaluated for primary skin irritation in accordance with the guidelines of the Federal Hazardous Substances Act (FHSA) Regulations, 16 CFR 1500.

Under conditions of this study, barely perceptible irritation was observed on the skin of the rabbits. The primary irritation index was calculated to be 0.88.

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

Delayed Contact Sensitization Study in the Guinea Pig (Repeated Patch Method)

A study was conducted in the guinea pig to evaluate the potential for delayed dermal contact sensitization of SoloSite® Gel Conformable Dressing. The study was conducted based on the requirements of the International Organization for Standardization Part 10: Tests for Irritation and Sensitization.

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

Acute Systemic Toxicity Study in The Mouse

The test article, SoloSite® Gel Conformable Dressing, was evaluated for systemic toxicity based on the requirements of the International Organization for Standardization: Biological Evaluation of Medical Devices, Part 11: Tests for Systemic Toxicity.

Conclusion: Under the conditions of this test there was no mortality or evidence of significant systemic toxicity.

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Genotoxicity: Salmonella typhimurium - Reverse Mutation Study

A Salmonella typhimurium reverse mutation standard plate incorporation study was conducted to determine whether SoloSite® Gel Conformable Dressing, would cause mutagenic changes in histidine-dependent Salmonella typhimurium strains in the presence and absence of S9 metabolic activation

Under the conditions of this assay, SoloSite CWD was not Conclusion: considered to be mutagenic to Salmonella typhimurium tester strains

Hemolysis Study - In Vitro Procedure (Extract Method)

The test article, SoloSite® Gel Conformable Dressing, was evaluated to determine whether the presence of any leachable chemicals from the test article would cause in vitro red blood cell hemolysis.

Conclusion: Under the conditions of this study, the mean hemolytic index for the test article extract was 0%. The test article extract was nonhemolytic.

Preservation

SoloSite® Gel Conformable Dressing is a preserved product and does not undergo sterilization.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged around a circular emblem. Inside the emblem is a stylized image of three human profiles facing right, overlaid to create a sense of depth and unity. Above the profiles is a graphic element consisting of three angled lines, resembling a stylized wing or a symbol of forward movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 1998

Mr. Jim G. Irvin Vice President Ouality Assurance & Regulatory Affairs Smith & Nephew, Incorporated 11775 Starkey Road P.O. Box 1970 Largo, Florida 33779-1970

Re: K981150 Trade Name: SoloSite® Conformable Wound Dressing Regulatory Class: Unclassified Product Code: MGQ Dated: March 27, 1998 Received: March 31, 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).

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Page 2 - Mr. Jim G. Irvin

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.

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,

fu 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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510(k) Number (if known):

Device Name: SoloSite® Gel Conformable Dressing

Indications for Use:

SoloSite® Gel Conformable Dressing is used to create a moist wound environment for the treatment of minor conditions such as:

务 Minor burns
Superficial lacerations, cuts and abrasions (partial thickness wounds) and skin tears 本

Under the direction of a healthcare professional, SoloSite® Gel Conformable Dressing is used to create a moist wound environment for the management of:

址 Venous ulcers (leg ulcers)
풀 Surgical incisions
曼 Diabetic foot ulcers

ిష

Pressure ulcers (including stage IV). 要
Additionally, SoloSite® Gel Conformable Dressing, creates a moist wound environment which assists in autolytic debridement of wounds covered with necrotic tissue.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------

Prescription Use
(Per 21CFR 801.109)

Over-The-Counter Use
----------------------

	(Optional Format 1-2-96)
--	--------------------------

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K981150

Regulation Number and Section

N/A