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Kerecis® Marigen Wound Extra Autologous Hydration, Kerecis Silicone Autologous Hydration and Kerecis Parvus Autologous Hydration

Management of wounds including:

• Partial thickness wounds
• Full thickness wounds
• Pressure ulcers
• Venous ulcers
• Chronic vascular ulcers
• Diabetic ulcers
• Trauma wounds (abrasions, lacerations, partial thickness burns, skin tears)
• Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence)
• Draining wounds

All three subject devices of this bundled submission are part of a family of devices manufactured by Kerecis Limited. The subject devices can be seen in Table 1. They are lyophilized, terminally sterilized, fish skin medical devices comprised of biocompatible, resorbable fish skin (Wild North Atlantic Cod) for wound management. The devices are intended for single use only. The devices are applied to the wound bed to maintain a moist wound environment. The primary predicate device is Marigen Wound Extra (K190528) and the additional predicate devices are Kerecis Silicone (K213231), and Kerecis Parvus (K241080). Marigen Wound Extra is commercially available under the names Kerecis MariGen, Kerecis GraftGuide, and Kerecis SurgiClose. Kerecis Silicone is commercially available under the names Kerecis Shield and Kerecis SurgiClose Silicone. For clarity, this submission will refer to the devices under their commercially available names, except when specifically referring to the primary predicate device. This information is also shown in Table 1.
Although the subject devices differ from each other in terms of device indications and dimensional specifications, each one remains physically identical to its primary predicate device, both in design and packaging, as well as for indications for use. The only difference between each subject device and its respective primary predicate device is in the device labeling, with the subject devices having additional rehydration fluid options included in their instructions for use (IFUs).

The provided FDA 510(k) clearance letter and summary describe the acceptance criteria and a study to prove the device meets these criteria. However, it's important to note that this submission is for a modification to an existing device (Kerecis Marigen Wound Extra, Kerecis Silicone, Kerecis Parvus) and not for an entirely novel device. The modification specifically addresses the inclusion of additional rehydration fluids. Therefore, the "study" is focused on verifying the device's performance with these new rehydration fluids, rather than establishing initial clinical effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the device's performance with the original rehydration fluid (saline) and the need for the device to perform comparably with the new rehydration fluids. The performance is assessed through specific bench tests.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for the rehydration and suture retention tests. It mentions "bench testing" was performed.

Data provenance: Not explicitly stated, but bench testing typically involves laboratory-controlled conditions. It is not patient data from a specific country, nor is it referred to as retrospective or prospective in a clinical trial sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This type of information (expert consensus for ground truth) is typically associated with clinical studies or diagnostic device clearances where a "truth" is established through expert review of patient data (e.g., radiologist opinions on images). Since this submission focuses on bench testing for a modification to rehydration fluids, this information is not relevant or provided. The "ground truth" here is the prior established performance of the predicate device under saline rehydration.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are relevant for studies involving human interpretation or clinical endpoints. As this submission describes bench testing for material and process compatibility, an adjudication method is not applicable and therefore not provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic devices where multiple readers evaluate cases to assess performance with and without AI assistance. This submission is for wound dressings and focuses on physical and biological compatibility with different rehydration fluids.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a wound dressing, not a software algorithm or an AI-based system. Therefore, there is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

For the specific tests conducted for this modification (rehydration and suture retention with new fluids), the ground truth is implicitly the established performance characteristics of the predicate device when rehydrated with saline. The goal of the new tests was to show that these characteristics are maintained or are comparable when using lactated Ringer's solution and autologous body fluids.

8. The Sample Size for the Training Set

This concept is not applicable as this is not a machine learning or AI device. The "training set" for a traditional medical device would refer to the data used to design and develop the device prior to its initial submission. The summary doesn't provide this detail for the original device development, only that performance testing was "leveraged from the Kerecis primary predicate devices."

9. How the Ground Truth for the Training Set was Established

Again, "training set" and its "ground truth" are terms typically used in AI/ML contexts. For a medical device like a wound dressing, the "ground truth" during initial development (analogous to a training phase) would involve extensive material testing, biocompatibility studies, mechanical property evaluations, and potentially pre-clinical and clinical studies to establish its safety and effectiveness for wound management. The summary indicates that for this modification, the ground truth is based on the previously established performance of the predicate devices.

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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.

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.

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.

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