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K Number
K190528
Device Name
MariGen Wound Extra
Manufacturer
Kerecis Limited
Date Cleared
2019-07-10

(128 days)

Product Code
KGN
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K153364,K132343
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

MariGen Wound Extra is indicated for the management of wounds, including:

  • Partial and full-thickness wounds
  • Pressure ulcers
  • Venous ulcers
  • Chronic vascular ulcers
  • Diabetic ulcers
  • Trauma wounds (second degree burn, abrasions, lacerations, skin tears),
  • Surgical wounds (donor sites/grafts, post-Mohs surgery, post laser surgery, podiatric, wound dehiscence),
  • Draining wounds.
Device Description

The subject device is processed fish dermal matrix composed of fish collagen and is supplied as a sterile intact, or meshed sheet ranging in sizes up to 20 x 30 cm. The subject device is obtained from fish skin via standardized controlled GMP manufacturing process and supplied in terminally sterile packaging. The subject device is biocompatible, pliable, and non-cross linked.
The device is intended for single use only.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA, evaluating Kerecis Limited's MariGen Wound Extra device. The core of this document is to establish "substantial equivalence" to a predicate device, rather than to prove new performance criteria through a study involving AI. Therefore, the information requested about acceptance criteria and a study proving device performance, especially related to AI, is not present in the provided text.

The document states that "The subject device is identical to the predicate device apart from being offered in sizes up to 600cm²." This is a key statement explaining why extensive new performance studies (like those typically associated with AI devices) were not required. The approval is based on the device being a larger version of an already approved product made of the same material.

Here's how the requested information relates to the provided text:

  1. A table of acceptance criteria and the reported device performance:

    • Not Applicable. This document does not describe acceptance criteria for a new performance study like an AI model. Instead, it aims to show substantial equivalence to an existing cleared device. The "performance data" mentioned (elemental impurities and chemical residual analysis) are for basic safety and material characterization, not for clinical performance demonstration as would be expected for an AI device. The table provided is a "Summary Table of Substantial Equivalence," comparing features like product codes, intended use, indications, resource origin, tissue resource/scaffold base, nominal sizes, presentation, sterilization, and shelf life between the subject and predicate devices. The acceptance criteria for each of these features is "Equivalent," meaning the subject device needs to be essentially the same or functionally similar to the predicate.

  2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

    • Not Applicable. No test set or data provenance for a performance study (as would be done for an AI device) is described. The rationale for approval is similarity to an existing device.

  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. Ground truth establishment by experts for a test set is not described as part of this submission, as it is not an AI device or a device requiring a de novo clinical performance study against expert reads.

  4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

    • Not Applicable. No adjudication method is mentioned as there is no clinical performance test set described.

  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 device is a wound dressing, not an AI-assisted diagnostic or treatment device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this submission.

  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.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • Not Applicable. The "ground truth" here is the established safety and efficacy of the predicate device, which the subject device is deemed substantially equivalent to due to material and functional similarity. There's no new "ground truth" established for clinical performance via a new study.

  8. The sample size for the training set:

    • Not Applicable. There is no AI model or training set described.

  9. How the ground truth for the training set was established:

    • Not Applicable. There is no AI model or training set described.

In summary, the provided FDA 510(k) document for K190528, MariGen Wound Extra, is for a physical wound dressing and does not involve AI or new clinical performance studies to prove its efficacy. Its clearance is based on its substantial equivalence to a previously cleared predicate device (MariGen Wound) and a reference device (SecureMesh), primarily due to sharing the same material and functional design, with the only significant difference being larger available sizes.

N/A