STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)

K973228 · Smith & Nephew, Inc. · KMF · Nov 25, 1997 · General Hospital

Device Facts

• Record ID: K973228
• Device Name: STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)
• Applicant: Smith & Nephew, Inc.
• Product Code: KMF · General Hospital
• Decision Date: Nov 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1

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. 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. - 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.

Device Story

No-Sting Skin Prep is a water-based, alcohol-free liquid applied via nonwoven wipe or tufted swab to intact skin. Solvent evaporates, leaving a protective polymeric film. Used by patients, family, or clinicians in home or clinical settings to prepare skin for adhesive devices (ostomy pouches, tubes, catheters, dressings). Film acts as a barrier against friction during adhesive removal and protects skin from irritation caused by urine, feces, or stomal secretions. Benefits include reduced skin trauma and improved adhesive adherence.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993-5 (cytotoxicity) and FHSA regulations (primary skin irritation in rabbits). Results showed no primary irritation (index 0.00). Delayed dermal contact sensitization study in guinea pigs showed no significant evidence of sensitization. Preservation efficacy confirmed per USP 23.

Technological Characteristics

Water-based, alcohol-free liquid formulation; nonwoven wipe or tufted swab applicator. Solvent carrier/polymer coating system. Non-sterile. No electronic or software components.

Indications for Use

Indicated for ostomates and individuals requiring skin protection at attachment sites for drainage tubes, external catheters, and adhesive dressings; serves as a protective interface to reduce friction during tape removal and irritation from body wastes/stoma fluid on intact skin. Not for use on open or deep puncture wounds.

Regulatory Classification

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.

Predicate Devices

• Bard Protective Barrier Film (K821271A)
• AllKare Protective Barrier Wipe
• 3M No Sting Barrier Film (K920794)

Submission Summary (Full Text)

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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 [phone] [phone]

# 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 [phone] [phone] 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

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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 Division<br>Murray Hill, NJ (K821271A) |
| AllKare Protective Barrier Wipe | Convatec, A Bristol Myers Squibb Co.<br>Princeton, NJ |
| 3M No Sting Barrier Film | Manufactured for 3M Health Care,<br>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.

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.

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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.

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.

- 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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.

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

Ela Will

Prescription Use

OR

Over-the Counter Use

(Per 21CFR 801.109)

(Optional Format 1-2-96)