SOCKIT! AND MCMERLIN DERMAL WOUND GEL

• K Number: K090092
• Device Name: SOCKIT! AND MCMERLIN DERMAL WOUND GEL
• Manufacturer: MCMERLIN DENTAL PRODUCTS LP
• Date Cleared: 2009-05-11 ( 117 days)
• Product Code: FRO
• Regulation Number: N/A
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K902345 , K915002 , K944427 , K951417 , K961758

Intended Use

This product provides for the management of and relieves the pain associated with all types of dermal wounds, skin sores, injuries and ulcers of the skin. Examples include:

• · All types of dermal wounds, skin sores, injuries and ulcers of the skin
• · First & Second degree burns
• · Pressure ulcers, stages I IV
• · Stasis ulcers
• · Diabetic ulcers
• · Radiation dermatitis
• Post-surgical incision
• · Surgical sites, including soft tissue graft sites
• · Foot ulcers
• Venous stasis ulcers
• Cuts & Abrasions
• · Partial thickness wounds
• · Irritation of the skin
• · Itching
• · Sunbum
• · Skin condition associated periostomy care
• · Chemical peel
• · Tattooing procedures
• · Irritation and pain following skin Laser resurfacing treatment
• · Irritation and pain following dermabrasion therapy

This product provides for the management of and relieves the pain associated with all minor dermal wounds, minor skin sores, minor injuries and minor irritations of the skin. Examples include:

• Minor burns
• Minor Cuts & Abrasions
• · Superficial itching
• · Sunburn
• · Minor burns from a chemical peel treatment
• · Minor irritation and pain following tattooing procedures
• · Minor irritation and pain following skin laser resurfacing treatment
• · Minor irritation and pain following dermabrasion therapy

Device Description

Socklt!® Dermal Wound Gel/McMerlin® Dermal Wound Gel is a clear, viscous hydrogel wound dressing composed entirely of all-natural, food-grade, safe ingredients, including an all-natural preservative system. It is safe if swallowed, is designed to be physiologically compatible with both intact and compromised tissues of the skin, and will manage the pain associated with all types of injuries to the skin.

The gel's primary mode of action for pain relief is that it adheres to the wound surface, conforms to the contours of the wound, and protects the wound from contamination and irritation by forming a profective barrier that is similar to dermal tissues. It also creates and maintains a moist wound environment, which is necessary for optimal healing. Socklt.10 Dermal Wound Gel/McMerlin® Dermal Wound Gel has been designed to be physiologically compatible with both intact and compromised tissues of the skin: the pH and osmotic pressure of the gel have been adjusted to be compatible with injured tissues.

Socklt!® Dermal Wound Gel and McMerlin® Dermal Wound Get are exactly the same in every aspect, the same device has two different trade names.

AI/ML Overview

Based on the provided text, the device in question is the "SockIt!® Dermal Wound Gel/McMerlin® Dermal Wound Gel," which is a hydrogel wound dressing. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results with specific acceptance criteria and performance metrics for the new device.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not available in this document. This document primarily describes the device, its intended use, and its technological characteristics in comparison to predicate devices for the purpose of regulatory clearance.

Here's a breakdown of what can and cannot be determined from the provided text:

1. Table of acceptance criteria and reported device performance:

• Not available. The document does not specify quantitative acceptance criteria or report specific performance metrics from a study for this device. The regulatory submission path chosen (510(k)) relies on demonstrating substantial equivalence to predicate devices, implying that if the device is substantially equivalent, it meets the performance expectations of those predicate devices.

2. Sample size used for the test set and data provenance:

• Not available. The document does not describe a clinical study or a test set with a specific sample size. It's a regulatory submission for a device, not a report of a clinical trial.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

• Not available. As there's no described test set or clinical study, there is no mention of experts establishing ground truth.

4. Adjudication method for the test set:

• Not available. No test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size:

• Not available. The document does not mention any MRMC study or any study comparing human readers with and without AI assistance (the device is a hydrogel wound dressing, not an AI diagnostic tool).

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

• Not applicable/Not available. This device is a wound dressing, not an algorithm.

7. The type of ground truth used:

• Not available. No specific ground truth establishment is described for performance evaluation of this device. The basis for clearance is substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable/Not available. This device is a physical product (wound dressing), not a machine learning model, so there is no concept of a "training set" in this context.

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

• Not applicable/Not available. As above, no training set concept applies.

Summary of available information from the document:

• Device Name: Socklt!® Dermal Wound Gel/McMerlin® Dermal Wound Gel (Hydrogel Wound Dressing)
• Intended Use: "This product provides management of and relief of the pain associated with all types of wounds, sores, injuries and ulcers of the dermal tissue." Examples include burn wounds (First & Second degree), diabetic ulcers, pressure ulcers (stages I - IV), venous stasis ulcers, radiation dermatitis, partial thickness wounds, irritation of the skin, itching, foot ulcers, post-surgical incision, surgical sites, cuts and abrasions, sunburn, skin conditions associated with periostomy care, irritation and pain following laser resurfacing treatment and dermabrasion therapy, chemical peel, and tattooing procedures. (Note: A later section clarifies the indications as "minor" for OTC use).
• Technological Characteristics: Clear, viscous hydrogel wound dressing, all-natural, food-grade, safe ingredients, all-natural preservative system. Physiologically compatible (pH and osmotic pressure adjusted). Adheres to wound surface, conforms to contours, protects from contamination/irritation, forms a protective barrier, creates and maintains a moist wound environment for optimal healing.
• Predicate Devices: K902345, K915002, K944427, K951417, K961758 (all Carrington Laboratories hydrogel wound dressings).
• Performance Standards: "No performance standards are established for this product under Section 514 of the Act." This indicates that the device operates under general controls and does not have specific FDA-mandated performance standards that would require a dedicated study to meet them for 510(k) clearance.

In conclusion, this 510(k) document establishes substantial equivalence based on a comparison of intended use, technological characteristics, and safety/effectiveness profiles with legally marketed predicate devices, rather than through a new, specific clinical study with predefined acceptance criteria and performance data for the subject device.

Regulation Number and Section

N/A