(79 days)
The proposed device is for use in the management of wounds which present moderate to heavy wound exudate such as dermal ulcers (i.e., venous stasis, pressure, arterial, diabetic); traumatic wounds (i.e., lacerations, punctures, abrasions or incisions); donor sites; and second-degree burns.
The Kendall CURASORB® Zn+Mg Alginate Wound Dressings are sterile, single-use, nonwoven, absorptive dressings. The off-white alginate fibers are composed of calcium, sodium, zinc and magnesium. As the dressing absorbs wound exudate it converts to a firm gel/fiber mat. This gel cushions the wound and forms a moist environment at the wound interface. The product is available in 2" x 2", 4" x 4", and 4" x 8" , 6" x 10", 12" x 24" pads, as well as 12", 24" and 36" long wound packing rope.
This submission for K973509 is a 510(k) for a wound dressing, which typically relies on demonstrating substantial equivalence to a predicate device rather than presenting specific performance metrics against pre-defined acceptance criteria in the same way a diagnostic or therapeutic device might. Therefore, the requested information in the prompt, particularly points 1, 5, 6, and details about sample sizes, experts, and ground truth for training/test sets, is not included in the provided 510(k) summary.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the 510(k) summary. For wound dressings in a 510(k), acceptance criteria are typically met by demonstrating substantial equivalence in composition, function, and intended use to a predicate device, along with biocompatibility and other regulatory requirements. Specific quantitative performance metrics (e.g., absorption rate, healing time improvement) against pre-defined acceptance criteria are generally not part of a 510(k) for this type of device unless specific claims are being made that necessitate such testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No specific test set or data provenance details are provided as this is not a study presenting clinical performance data from human subjects or a diagnostic algorithm. The "testing" mentioned refers to biocompatibility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is not a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving expert adjudication of a test set.
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 a wound dressing, not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a medical device (wound dressing), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No ground truth in this context is relevant for a wound dressing 510(k) submission.
8. The sample size for the training set:
Not applicable. There is no training set for a wound dressing.
9. How the ground truth for the training set was established:
Not applicable. There is no training set or ground truth in this context.
Summary of what is provided in the K973509 510(k) for the Kendall CURASORB® Zn+Mg Alginate Wound Dressing:
The device's acceptability is based on substantial equivalence to existing predicate devices (Kendall CURASORB® Calcium Alginate Dressing and Kendall CURASORB® Zn Alginate Wound Dressing).
Study/Evidence that proves the device meets the acceptance criteria (substantial equivalence):
- Product Comparison: The submission states that the Kendall CURASORB® Zn+Mg Alginate Wound Dressings are equivalent to the referenced predicate devices because "they are fabricated from similar materials, have a similar function and equivalent indications for use."
- Biocompatibility Testing: "Biocompatibility testing of the Kendall CURASORB® Zn+Mg Alginate Wound Dressing has demonstrated that it contains no bioactive components. Testing performed on the product was based upon guidelines presented in the 10993 ISO Standard, Part I, with the FDA modified matrix presented in memorandum G95-1." This demonstrates that the materials used are safe for their intended purpose in contact with the body.
The FDA's letter concurs with the finding of substantial equivalence, allowing the device to be marketed, with specific limitations on labeling claims related to third-degree burns, accelerated healing, long-term use, or explicit claims of treatment/cure.
§ 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.