(124 days)
Management of wounds including:
- Partial and 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
Kerecis "Parvus™ is a lyophilized, terminally sterilized, acellular, particulate fish skin medical device comprised of biocompatible, non-crosslinked, resorbable, acellular fish skin (North Atlantic Cod) for wound management. The device is intended for single use only.
The subject device is packaged in the following weights:
100mg (4 cm2) 200mg (8 cm2) 500mg (19 cm²) 1000mg (38 cm²) 2,500mg (95 cm2 ) 3,000mg (114 cm2)
This document is a 510(k) Premarket Notification summary for Kerecis® Parvus™, a wound dressing. It is not an AI/ML device, and therefore does not contain acceptance criteria for device performance related to AI/ML or a study proving those criteria are met. The document states that the Kerecis® Parvus™ is substantially equivalent to a predicate device, Kerecis MariGen Wound Extra (K190528), in terms of indications for use, intended use, raw material origin and composition, device performance, packaging material, and sterilization methods. The primary difference is an additional cutting and sieving step in the manufacturing process to convert the fish skin from intact sheets to fragmented pieces ≤2.0mm.
Here's a breakdown of the requested information based on the provided document, noting that many items are not applicable (N/A) due to the nature of the device:
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A table of acceptance criteria and the reported device performance
This document does not provide specific performance acceptance criteria or reported performance data in the traditional sense of a clinical or analytical study with defined metrics (e.g., accuracy, sensitivity, specificity). Instead, it asserts substantial equivalence to a predicate device based on material properties and manufacturing processes. The "Performance Characteristics" section for the subject device largely mirrors the predicate device, with differences primarily in the physical form (fragmented vs. sheets) and nominal sizes.
Characteristic Acceptance Criteria (Implied by Substantial Equivalence Goal) Reported Device Performance (as described) Source Origin Wild Caught Atlantic Cod Fish Wild Caught Atlantic Cod Fish (Same as predicate) Tissue source Fish Skin Fish Skin (Same as predicate) Nominal Sizes Fragmented, size controlled to ≤2.00mm Irregular shaped 3D fragmented fish skin, size controlled to ≤2.00mm and packaged in various weights (100mg to 3,000mg). (Differs from predicate's sheet sizes, but subject device is cut from predicate device sizes). Presentation Lyophilized, sterilized, fragmented fish skin Lyophilized, sterilized, Fragmented, fish skin in a Tyvek peel pouch. (Differs from predicate's sheet presentation due to cutting and sieving). Packaging Tyvek Single and Double Peel Pouch Tyvek Single and Double Peel Pouch (Same as predicate) Sterilization Ethylene Oxide Ethylene Oxide (Same as predicate) Sterility Assurance Level (SAL) SAL 10^-6^ SAL 10^-6^ (Same as predicate) Endotoxin limit ≤20 EU/device ≤20 EU/device (Same as predicate) Shelf Life At least 1 year (matching current reported) 1 year (Real-time shelf life testing in progress for the subject device; predicate has 3 years). Biocompatibility Demonstrated Additional testing for biocompatibility completed (for the subject device). Fragmented size characterization Demonstrated Additional testing for fragmented size characterization completed (for the subject device). Ethylene oxide residuals Demonstrated Additional testing for ethylene oxide residuals completed (for the subject device). Metal contamination Demonstrated Additional testing for metal contamination completed (for the subject device). Protein analysis Demonstrated Additional testing for protein analysis completed (for the subject device). Bioburden Demonstrated Additional testing for bioburden completed (for the subject device). Residual limits Demonstrated Additional testing for residual limits completed (for the subject device). -
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
N/A. This is a 510(k) submission for a non-AI/ML medical device establishing substantial equivalence through material and manufacturing process comparisons, not a clinical study involving a test set for performance evaluation. The "additional testing" mentioned is likely laboratory bench testing on the device materials.
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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)
N/A. Not an AI/ML device requiring expert-established ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Not an AI/ML device requiring adjudication of a test set.
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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
N/A. This device is not an AI/ML product and does not involve human readers or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. This device is not an AI/ML product.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
N/A. Not an AI/ML device requiring ground truth for performance evaluation. The substantial equivalence argument relies on material characteristics and manufacturing processes.
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The sample size for the training set
N/A. This is not an AI/ML device with a training set.
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How the ground truth for the training set was established
N/A. This is not an AI/ML device with a training set.
N/A