(90 days)
K821271A
Not Found
No
The device description and intended use clearly define a topical skin protectant product with no mention of any computational or analytical capabilities that would involve AI/ML.
No
This device is intended to form a film on the skin to prepare it for adhesive devices, reduce friction, and act as a skin protectant against bodily wastes. It is not designed to treat or diagnose a disease or condition.
No
The device is described as a liquid film-forming product used to prepare skin for adhesives and provide a protective interface, or as a skin protectant. Its function is to create a physical barrier or improve adhesion, not to diagnose a medical condition or ailment.
No
The device is a liquid film-forming product applied to the skin using a wipe or swab, which are physical components, not software.
Based on the provided information, Smith & Nephew's "No Sting Skin Prep™" is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the product is applied to intact skin to form a film for skin attachment sites. This is a topical application for preparing the skin surface.
- Device Description: The description confirms it's a liquid applied to the skin that dries to form a film.
- Lack of In Vitro Testing: The performance studies mentioned are related to biocompatibility (cytotoxicity, sensitization, irritation) and preservation, which are relevant for a topical skin product. There are no mentions of testing biological samples (blood, urine, tissue, etc.) or performing diagnostic tests in vitro (outside the body).
- Anatomical Site: The anatomical site is the skin, not internal biological samples.
- No Mention of Diagnostic Purpose: The intended use and description do not mention any diagnostic purpose, such as detecting a disease, condition, or physiological state.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. "No Sting Skin Prep™" does not fit this definition. It is a topical skin protectant and preparation product.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KMF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intact skin, skin attachment sites for drainage tubes, external catheters, surrounding ostomy sites, sensitive stoma areas.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Ostomates and other individuals, patient, family member or health care professional. Sold OTC at various locations including pharmacies and home health care centers.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Cytotoxicity: USP grade of 2 (mild reactivity).
Animal Primary Irritation: Primary irritation index calculated to be 0.00.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K821271A
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
・・. .. ..
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.
4
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.
5
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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.
6
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
7
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.
(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
OR
Over-the Counter Use
(Per 21CFR 801.109)
(Optional Format 1-2-96)