Smith & Nephew's "No Sting Skin Prep™" is intended for use as a liquid film - forming product that when applied to intact skin, forms a film for skin attachment sites for drainage tubes, external catheters, surrounding ostomy sites and adhesive dressings.

a) "No Sting Skin Prep™" applies a coating that prepares the skin for adhesives and provides a protective interface that may reduce friction during the removal of tap:. "No Sting Skin Prep™" is indicated for skin attachment sites for draining tubes, external cather.ers, surrounding ostomy sites and other adhesive dressings.
b) "No Sting Skin Prep™" can be used in sensitive stoma areas as a skin protectant and may reduce irritation from contact with body wastes and stoma fluid.
c) "No Sting Skin Prep™" forms a protective film on skin that serves a: a skin protectant which may reduce exposure to urine and feces.

Device Description

No-Sting Skin Prep™ is a water based alcohol free liquid impregnated on to a nonwoven wipe or tufted swab applicators.

This product is sold OTC for use by ostomates and other individuals who wish to reduce trauma to skin upon removing adhesive devices/products. The product is applied to the skin and allowed to dry. The solvent base evaporates leaving a polymeric film on the skin. After drying, the adhesive device, dressing, Ostomy device, tape, etc., is attached.

AI/ML Overview

This document describes the 510(k) submission for Smith & Nephew's "No-Sting Skin Prep" product. The acceptance criteria and supporting studies are focused on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance metrics beyond general safety and biocompatibility.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit, quantitative acceptance criteria in the typical sense (e.g., minimum sensitivity/specificity). Instead, the studies aim to demonstrate that the device is biocompatible and not a dermal irritant or sensitizer, which are key safety aspects for a medical device that contacts skin. The "performance" is therefore reported in terms of passing these safety tests.

Acceptance Criteria Category	Specific Test / Guideline	Reported Device Performance
Biocompatibility	Cytotoxicity (ISO 10993-5)	Showed evidence of causing cell lysis or toxicity greater than a USP grade of 2 (mild reactivity). Not considered significant as product does not contact open wounds.
Safety	Contact Sensitization	No significant evidence of causing delayed dermal contact sensitization in guinea pig.
Safety	Animal Primary Irritation (FHSA, 16 CFR 1500)	No irritation observed on rabbit skin. Primary irritation index: 0.00 (less than 5.00 threshold for irritant).
Product Stability	Preservation (USP 23)	Adequately preserved when inoculated and evaluated per USP 23.
Functional Equivalence	Comparison to predicate products	Technologically the same as predicate products (solvent carrier/polymer coating system, deposits thin polymeric film, assists in protecting sensitive skin).

2. Sample Sizes Used for the Test Set and Data Provenance

Cytotoxicity: Not specified, but involved cell cultures. This is an in vitro study.
Contact Sensitization: "the guinea pig" – implies a conventional number of guinea pigs for such a study, but not explicitly stated. This is an in vivo animal study.
Animal Primary Irritation: "the rabbits" – implies a conventional number of rabbits for such a study, but not explicitly stated. This is an in vivo animal study.
Preservation: Not specified, but involved inoculation of the product. This is an in vitro study.

Data Provenance: The studies are animal and in vitro laboratory tests conducted to evaluate safety and biocompatibility rather than clinical performance on human subjects for diagnostic accuracy. The original location of these tests (country) is not specified but would typically be in a certified lab. The studies are prospective in design for evaluating specific characteristics of the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to the provided document. The studies conducted are laboratory-based biocompatibility, irritation, and preservation tests. "Ground truth" in the context of expert consensus or pathological diagnosis is typically relevant for interpretative diagnostic devices or those involving subjective clinical assessment. For these safety tests, the "ground truth" is determined by standardized laboratory protocols and objective measurements/observations (e.g., cell lysis, irritation scores).

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple human readers/experts in diagnostic studies to establish a "ground truth" or reference standard. The studies described here (biocompatibility, irritation, preservation) involve objective laboratory assessments and observations, not subjective human reader interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a new diagnostic algorithm or tool on human reader performance for tasks like diagnosis or detection. The "No-Sting Skin Prep" is a skin preparation product, not a diagnostic device.

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

Not Applicable. The device is a physical product (skin prep solution), not an algorithm. Therefore, "standalone algorithm performance" is not relevant. The described studies assess the product's inherent properties (biocompatibility, safety, preservation).

7. The Type of Ground Truth Used

Cytotoxicity: Objective assessment of cell lysis/toxicity based on standardized in vitro biological assays (e.g., macroscopic and microscopic examination of cell cultures).
Contact Sensitization: Objective assessment of dermal reactions in guinea pigs based on standardized in vivo animal assays.
Animal Primary Irritation: Objective assessment of skin irritation in rabbits based on standardized in vivo animal assays with calculated Primary Irritation Index.
Preservation: Objective assessment of microbial growth based on standardized USP 23 protocols.
Functional Equivalence: Comparison of product composition and intended mechanism of action to legally marketed predicate devices, with the ground truth being the established characteristics and regulatory standing of those predicates.

8. The Sample Size for the Training Set

Not Applicable. The described studies are not machine learning or AI-based. Therefore, there is no "training set" in the context of data for model development. The product development would involve formulations and material science, not data training.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set (as described in point 8), there is no ground truth established for it.

Summary

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・・. .. ..

<973228

Wound Management Division

1775 Starkey Road, P.O. Box 1970 go. FI_33779-1970 U.S.A

Smith - Nephew

ith & Nephew, Inc.

NOV 2 5 1997

510(K) S U M M A R Y

No-Sting Skin Prep

Preparation Date: August 21, 1997

Submitter: Address:

Phone:

Fax:

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

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 (813) 399-3468 Fax

Establishment Registration No: 1017593

Classification:

...

Trade Name:	Smith & Nephew, Inc., No-Sting Skin Prep™
Common Name:	Skin Preparation
Classification Name:	(Undetermined)

While no clear category exists for this product, the ments of the product should be discussed relative to classification.

002

h:1510(k)\suinmary.doc

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The first portion discussed is product use as part of an Ostomy pouching process. In this situation it is our belief that No-Sting Skin Prep™ may be considered as an accessory to an Ostomy pouch per 876.5900. This in fact represents a large use segment for this product. The product is normally applied, allowed to dry and the pouch, tube or other adhesive device is then attached over the deposited film.

The other general position is the use of No-Sting Skin Prep™ under adhesive tapes, films, bandages, etc. The same manner of application of Skin Prep is applicable. After drying the patient, family member or health care professional will apply the adhesive device. In this case the product could be considered as a liquid bandage and be classified per 880.5090. The product becomes part of a total bandaging system since it is applied prior to the application of dressings and other bandaging products.

No-Sting Skin Prep™ is not used over open wounds, deep puncture wounds, etc.

Product	Manufacturer
Bard Protective Barrier Film	Bard Patient Care DivisionMurray Hill, NJ (K821271A)
AllKare Protective Barrier Wipe	Convatec, A Bristol Myers Squibb Co.Princeton, NJ
3M No Sting Barrier Film	Manufactured for 3M Health Care,Minneapolis, MN (K920794)

Substantially Equivalent Products:

Device Description:

No-Sting Skin Prep™ is a water based alcohol free liquid impregnated on to a nonwoven wipe or tufted swab applicators.

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Intended Use:

Smith & Nephew's "No Sting Skin Prep™" is intended for use as a liquid film forming product that when applied to intact skin, forms a film for skin attachment sites for drainage tubes, external catheters, surrounding ostomy sites and adhesive dressings.

a) "No Sting Skin Prep™" applies a coating that prepares the skin for adhesives and provides a protective interface that may reduce friction during the removal of tape. "No Sting Skin Prep™" is indicated for skin attachment sites for draining tubes, external catheters, surrounding ostomy sites and other adhesive dressings.
b) "No Sting Skin Prep™" can be used in sensitive stoma areas as a skin protectant and may reduce irritation from contact with body wastes and stoma fluid.
"No Sting Skin PrepTM" forms a protective film on skin that serves as a skin c) protectant which may reduce exposure to urine and feces.

These types of products are sold OTC at various locations including pharmacies and home health care centers.

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Technological Characteristics:

The No-Sting Skin Prep 4 is technologically the same as the substantially equivalent products -

Bard Protective Barrier Film AllKare Protective Barrier Wipe 3M No-Sting Barrier Film

in that all products incorporate a solvent carrier/polymer coating system. As the product is applied, the solvent evaporates and deposits a thin polymer coating to the skin. The technological function of the products after application are also equivalent. All products are intended to:

关 deposit a thin polymeric film
assist in protecting sensitive skin from urine, stomal secretions, etc. *

Bio Compatibility

Cytotoxicity

An in vitro biocompatability test, based on the International Organization for Standardization (IS) 10993-5) guidelines, was conducted on the test article, Skin Prep Wipes - No-Sting Formula. After incubating, the cell cultures were examined macroscopically for cell decolorization around the test article and controls to determine the zone of cell lysis (if any). The cultures were then examined microscopically *100X) to verify any decolorized zones and to determine cell morphology in proximity to and beneath the test article.

The negative controls and the positive controls performed as anticipated. Under the conditions of this study, the test article showed evidence of causing cell lysis or toxicity greater than a USP grade of 2 (mild reactivity).

This is not considered significant as the product does not come into contact with open wounds. Typically beladine, alcohol and other topicals would be cytotoxic. These products are widely used in the health care sector without adverse consequences.

Contact Sensitization

A study was conducted in the guinea pig to evaluate the potential for delayed dermal contact sensitization of Skin Prep Wipes - No Sting Formula.

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

Animal Primary Irritation

The test article, Skin Prep Wipes - No Sting Formula, was evaluated for primary skin irritation in accordance with the guidelines of the Federal Hazardous Substances Act (FHSA) Regulations, 16 CFR 1500.

Under the conditions of this study, no irritation was observed on the skin of the rabbits. The primary irritation index was calculated to be 0.00. The test article would not be considered a primary irritant to the skin since the empirical score was less than 5.00.

Preservation

The product is sold non-sterile. When innoculated and evaluated per USP 23, the product is adequately preserved.

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Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three abstract human profiles facing to the right, stacked one above the other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 25 1997

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

K973228 Re: No-Sting Skin Prep™ Regulatory Class: I Product Code: KMF Dated: August 21, 1997 Received: August 27, 1997

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 (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (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, Title 21, Parts 800 to 895. ਕਿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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.

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Page 2 - Mr. Jim Irvin

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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510(k) Number 973228:

Device Name: "No Sting Skin PrepTM"

Indications for Use:

a) "No Sting Skin Prep™" applies a coating that prepares the skin for adhesives and provides a protective interface that may reduce friction during the removal of tap:. "No Sting Skin Prep™" is indicated for skin attachment sites for draining tubes, external cather.ers, surrounding ostomy sites and other adhesive dressings.
b) "No Sting Skin Prep™" can be used in sensitive stoma areas as a skin protectant and may reduce irritation from contact with body wastes and stoma fluid.
c) "No Sting Skin Prep™" forms a protective film on skin that serves a: a skin protectant which may reduce exposure to urine and feces.

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

Concurrence of CDRH, Office of Device Evaluation (OI)E)

Ela Will

Prescription Use

Over-the Counter Use

(Per 21CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 880.5090 Liquid bandage.

(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.