(35 days)
Non-woven Compress is indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers.
Non-woven Compress is a sterile wound dressing indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers. Non-woven Compress absorbs wound exudate. The absorbent material, on hydration, forms a gel which immobilizes absorbed fluid exudate and helps prevent migration. The wound contact layer is designed to facilitate easy removal from both wet and dry wounds.
The provided document is a 510(k) Premarket Notification for a Non-woven Compress wound dressing. It focuses on demonstrating substantial equivalence to a predicate device, not on clinical performance acceptance criteria based on specific metrics like sensitivity or specificity. Therefore, many of the requested items (e.g., expert ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|
| Intended Use Equivalence: | Both products are equivalent in intended use for managing acute and chronic wounds. |
| Design and Function Equivalence: | Both products are equivalent in design and function. |
| Bench Testing Equivalence: | Comparative bench testing conducted shows the two products (Non-woven Compress and Mirasorb Sponges) to be equivalent. Specific metrics of this bench testing are not detailed in this summary. |
| Biocompatibility: | Non-sensitizing, non-cytotoxic, non-hemolytic, and a negligible irritant. |
| Compliance with Good Laboratory Practices (GLP): | All biocompatibility tests were conducted in accordance with GLP. |
| Compliance with ISO 10993 Part I: | Biocompatibility testing utilized ISO 10993 Part I with FDA modified matrix. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The comparative bench testing and biocompatibility testing were performed, but details on the number of samples or specimens are not disclosed in this summary.
- Data Provenance: Not specified for the bench testing. Biocompatibility testing was conducted in accordance with ISO 10993 Part I and GLP, implying controlled laboratory settings. The document is a submission to the US FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This type of medical device (wound dressing) submission relies on bench testing and biocompatibility rather than expert clinical assessment of diagnostic accuracy. There is no "ground truth" in the sense of expert consensus on images or clinical outcomes for performance evaluation in this context.
4. Adjudication Method for the Test Set
- Not Applicable. As there are no expert assessments for ground truth, no adjudication method is relevant.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No. An MRMC study is not relevant for this type of device. The comparison is between the new device and a predicate device through bench tests and biocompatibility, not on human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a physical wound dressing, not a software algorithm or AI device.
7. The Type of Ground Truth Used
- For Bench Testing: The "ground truth" for bench testing would be the performance characteristics of the predicate device (Mirasorb Sponges) and predefined engineering specifications or performance standards for wound dressings. The document states "Test results show the two products to be equivalent," implying that the Non-woven Compress's performance characteristics matched those of the predicate device.
- For Biocompatibility: The "ground truth" is established by the pass/fail criteria defined in the ISO 10993 Part I standard and FDA guidance for biological evaluation.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of a physical wound dressing and its regulatory submission. This concept applies to machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. There is no training set for this device.
§ 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.