OSMOCYTE ISLAND WOUND DRESSING

• K Number: K972150
• Device Name: OSMOCYTE ISLAND WOUND DRESSING
• Manufacturer: PROCYTE CORP.
• Date Cleared: 1997-12-10 ( 184 days)
• Product Code: KMF
• Regulation Number: 880.5090
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

A self adhesive highly absorptive island dressing for the management of exudating wounds, infected and non-infected, including pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions, cuts, abrasions and general first aid.

Device Description

OsmoCyte® Island Wound Dressing utilizes a powdered polymer absorbent pad contained in a non-woven mesh pillow attached to a sheet of foam polyurethane and coated with a medical grade acrylic emulsion adhesive.

AI/ML Overview

The provided text is a 510(k) summary for the OsmoCyte® Island Wound Dressing. This type of regulatory submission in the U.S. demonstrates substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria in the same way a new device would.

Therefore, the document does not contain information about acceptance criteria or a study designed to prove the device meets those criteria in terms of performance metrics like sensitivity, specificity, or reader improvement with AI.

Instead, the "Assessment of Performance Data" section states:

• Biocompatibility testing has been performed as recommended in the "International Standard for the Biological Evaluation of Medical Devices, ISO 10993-1." These tests support the safe use of OsmoCyte® Island Wound Dressing as a wound dressing temporary in contact with breached or compromised skin.

This indicates that the primary "acceptance criteria" for this type of device (a wound dressing) in this regulatory context are related to biocompatibility and substantial equivalence to existing devices, rather than a quantitative performance metric.

Given the nature of the document, the following sections from your request cannot be fully answered as they pertain to clinical or algorithm performance studies not described within this 510(k) submission:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. The "performance" aspect discussed is biocompatibility and comparability to predicates in terms of absorption.
• 2. Sample sized used for the test set and the data provenance: Not applicable, no test set for performance described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, this is not an AI device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is not an AI device.
• 7. The type of ground truth used: Not applicable for performance metrics. For biocompatibility, the "ground truth" would be the ISO standard's pass/fail criteria.
• 8. The sample size for the training set: Not applicable (no algorithm).
• 9. How the ground truth for the training set was established: Not applicable (no algorithm or training set).

Summary of available information:

• Device: OsmoCyte® Island Wound Dressing
• Type of "Study" to meet acceptance criteria: Biocompatibility testing as per ISO 10993-1.
• Implicit Acceptance Criteria: The device must demonstrate biocompatibility according to ISO 10993-1 standards and be substantially equivalent to predicate wound dressings in function (e.g., absorption) and intended use.
• Reported Device Performance (for biocompatibility): "These tests support the safe use of OsmoCyte® Island Wound Dressing as a wound dressing temporary in contact with breached or compromised skin."

Limitations on Labeling (from FDA's response letter):

The FDA's clearance letter also specifies important limitations on labeling, which act as "acceptance criteria" for claims and intended use:

• May not be labeled for use on third-degree burns.
• May not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
• May not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
• May not be labeled as a treatment or a cure for any type of wound.

The core of this submission relies on demonstrating substantial equivalence to predicate devices already on the market, rather than conducting de novo performance studies with quantitative acceptance criteria typically seen for novel devices or AI/software.

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.