(90 days)
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.
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.
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.
§ 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.