(83 days)
The Comfeel® Seasorb Dressing is indicated for use (under the guidance of a health care professional) in management of moderate to heavily exudating wounds, partial and full thickness wounds, including leg ulcers and pressure sores.
The revised Comfeel® Seasorb Dressing consists of an absorbent calcium sodium alginate/sodium carboxymethy/ceilulose xerogel cast onto a high density polyethylene net. The dressing is supplied in three sizes: 4 x 6 cm (3705), and 10 x 10 cm (3710) and 15 x 15 cm (3715). The dressings are packaged in individual pouches and sterilized by ethylene oxlde.
Here's an analysis of the provided text regarding the Comfeel® Seasorb Dressing, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category/Metric | Acceptance Criterion (for NEW device) | Reported Device Performance (NEW device) |
|---|---|---|
| Biocompatibility | Non-irritating | Shown no accumulative irritation effects |
| Non-sensitizing | No evidence of delayed hypersensitivity | |
| Non-cytotoxic | Non-cytotoxic (cytotoxicity grade ≤ 2) | |
| Physical Performance | Improved softness (compared to K953497) | Improved softness |
| Improved absorption capacity (compared to K953497) | Improved absorption capacity | |
| Sterility | Sterile | Sterile (by ethylene oxide) |
| Packaging Integrity | Maintained sterility and protection | Polyester pouches laminated with peelable polyethylene prior to sterilization |
Note: This submission primarily focuses on demonstrating substantial equivalence to a predicate device (K953497). The acceptance criteria are largely inferred from the statement that the modified device "has been tested and shown" to meet certain safety and performance characteristics, and that its performance has been "improved" compared to the predicate. There are no explicit numerical acceptance criteria stated for these tests in the provided text.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample sizes used for any of the tests. It simply mentions that the device "has been tested."
Regarding data provenance:
- The information provided is a 510(k) summary, which typically summarizes the results of various tests. It does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of biocompatibility and physical performance tests for a medical device, these would typically be conducted prospectively in a controlled laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a ground truth for testing, nor does it refer to any clinical studies where expert consensus would be required. The tests mentioned (biocompatibility, softness, absorption) are laboratory-based performance tests, not clinical evaluations requiring expert interpretation of outcomes.
4. Adjudication Method for the Test Set
As there's no mention of a clinical study or expert-adjudicated data, an adjudication method is not applicable or not specified in this document. The assessment for the reported performance metrics (biocompatibility, physical properties) would have been based on established laboratory protocols and measurements, not subjective expert agreement.
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
No MRMC study was performed. This device is a topical wound dressing, not an imaging or diagnostic device that would typically involve human readers or AI assistance in interpretation. Therefore, there's no information on an effect size for human readers improving with or without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm performance study was done. This device is a passive wound dressing and does not involve any algorithms or AI components.
7. The Type of Ground Truth Used
The "ground truth" for the tests described is based on:
- Established laboratory standards and methods: For biocompatibility (irritation, sensitization, cytotoxicity), the "ground truth" would be determined by the results of standardized assays that demonstrate compliance with predefined safety thresholds.
- Physical measurement techniques: For properties like softness and absorption capacity, the "ground truth" would be derived from quantifiable physical measurements following specific testing protocols.
There is no mention of pathology, outcomes data, or expert consensus in establishing the ground truth for these specific performance metrics.
8. The Sample Size for the Training Set
Not Applicable. This device does not use machine learning or AI, and therefore, there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set, 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.