(389 days)
For use as a wound dressing to manage pressure ulcers (stages I-IV), stasis ulcers, diabetic skin ulcers, skin irritations, cuts, and abrasions.
Epi-Max is a cellulose acetate mesh wound dressing (initially in a 2 x 3 in2 size but later with smaller or larger sizes as per market demand) impregnated with 20mg of a petrolatum (polyethylene glycol-based) ointment. This ointment is a blend of PEG 400, PEG 4000, citric acid, a mild proprietary saline solution, and benzoic acid. The ointment is formulated to melt at skin temperature, helping to keep the wound moist and prevent wound-bandage adherence in order to make removal of the wound dressing less painful. Dressings are gamma irradiated for sterility.
This document describes a 510(k) premarket notification for the Epi-Max® wound dressing. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Epi-Max Performance |
|---|---|---|
| Biocompatibility | Non-cytotoxic | Met |
| Non-dermal irritant | Met | |
| 0% sensitization rating | Met | |
| Functionality | Promote a moist wound environment | Yes, due to ointment melting at skin temperature |
| Easier/less painful dressing removal | Yes, due to ointment melting at skin temperature | |
| Sterility | Gamma irradiated for sterility | Met |
| Indications for Use | Identical to Kendall Xeroform Petrolatum Gauze (Predicate) | Met |
Note: The document explicitly states that the Epi-Max's indications for use are "identical to the indications for use made by Kendall Healthcare Products, inc. for their Kendall Xeroform Petrolatum Gauze dressings." This serves as a key acceptance criterion for equivalence in claimed therapeutic application. The listed predicate devices in the 510(k) summary also indicate that the device is intended to be substantially equivalent in its fundamental properties and performance to these established products.
The Study Proving the Device Meets Acceptance Criteria:
The study described is a non-clinical performance study.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document refers to "GLP studies" using guidelines from the "10993 ISO Standard." ISO 10993 standards typically require specific sample sizes for various biocompatibility tests, but the exact numbers used for each test are not provided in this summary.
- Data Provenance: The studies were GLP (Good Laboratory Practice) studies, indicating they were conducted under controlled laboratory conditions to ensure data quality and integrity. The country of origin is not specified, but GLP is an internationally recognized standard. These were prospective studies, as they were conducted specifically to evaluate the Epi-Max device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This was a non-clinical, laboratory-based study for biocompatibility. The "ground truth" here is established by the methods and endpoints defined by the ISO 10993 standard for cytotoxicity, irritation, and sensitization, rather than expert consensus on a clinical outcome.
4. Adjudication Method for the Test Set:
Not applicable. Biocompatibility tests have pre-defined endpoints and acceptance criteria (e.g., cell viability for cytotoxicity, dermal reaction scores for irritation, lack of sensitization reactions). Result interpretation is typically based on objective measurements and comparison to these criteria, not subjective expert adjudication in the same way clinical image interpretation might be.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This device is a wound dressing, and the assessment presented is primarily for its safety (biocompatibility) and functional equivalence to predicate devices, not for its interpretive performance by human readers.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone performance study was not done. This is a physical wound dressing, not a software algorithm.
7. Type of Ground Truth Used:
The ground truth used for the non-clinical performance data was based on standardized test methods and acceptance criteria defined by the ISO 10993 standard for biocompatibility (cytotoxicity, dermal irritation, and sensitization).
8. Sample Size for the Training Set:
Not applicable. Clinical performance data was not provided ("N/A"). The non-clinical biocompatibility studies do not typically involve a "training set" in the context of machine learning or diagnostic algorithm development.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As noted above, there was no training set in this context.
N/A