(272 days)
Kerecis Silicone is indicated for the 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
The subject device is a bilayer of processed resorbable acellular fish dermal matrix adhered to a thin, transparent, porous, soft silicone layer.
The subject device is obtained from fish skin via standardized controlled GMP manufacturing process. The fish dermal matrix layer is approximately 1 mm in thickness and is porous.
The silicone layer is a transparent polyurethane film single-coated with soft, medical grade silicone that is attached to the scaly side of the fish dermal matrix. The silicone layer is porous, soft and conformable to the wound surface.
The subject device is supplied as a sterile intact sheet offered in two configurations: a) with the silicone layer extending beyond the borders of the fish dermal matrix and b) the silicone layer having the same dimension as the fish dermal matrix with no silicone layer extending beyond the fish dermal matrix.
The silicone acts as: protection for the fish dermal matrix layer, as additional wound coverage, and in configuration (a), as an adhesive contact layer to the skin surrounding the wound.
The silicone layer can be peeled off as the fish dermal matrix is resorbed.
The device is intended for single use only.
The provided document is a 510(k) summary for a medical device (Kerecis Silicone) and does not describe a study involving an AI/Machine Learning device or a human-in-the-loop study.
This document describes a medical device, Kerecis Silicone, which is a bilayer wound dressing. The substantial equivalence determination is based on the technological characteristics and performance testing of the device itself (biocompatibility, physical properties, etc.), not on the performance of a software algorithm or AI.
Therefore, most of the requested information regarding AI/ML acceptance criteria, ground truth establishment, sample sizes for AI training/testing, expert adjudication, or MRMC studies for AI assistance is not applicable to this document.
However, I can extract the relevant information regarding the device's acceptance criteria (in terms of performance testing) and the study proving it meets these criteria based on the provided text.
Device: Kerecis Silicone (a bilayer wound dressing)
Regulatory Status: 510(k) clearance (K213231)
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this medical device are based on demonstrating biocompatibility and physical/chemical characteristics that are comparable to or safe for its intended use, typically by meeting the requirements of established ISO and ASTM standards. The reported device performance is indicated by a "Pass" for each test.
| Test | Standard / Method | Acceptance Criteria (Implied: Meeting Standard Requirements) | Reported Device Performance |
|---|---|---|---|
| Cytotoxicity | ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity | Non-cytotoxic | Pass |
| Sensitization | ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization | Non-sensitizing | Pass |
| Intracutaneous Irritation | ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization | Non-irritating | Pass |
| Acute Systemic Toxicity | ISO 10993-11:2017, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | Non-systemically toxic | Pass |
| Material Mediated Pyrogenicity | ISO 10993-11:2017, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | Non-pyrogenic | Pass |
| Subacute Systemic Toxicity and Implantation Effects | ISO 10993-6, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation and ISO 10993-11:2017, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | Acceptable local and systemic effects | Pass |
| Endotoxin Validation and Analysis | ANSI/AAMI ST72 Bacterial Endotoxins - Test Methods, Routine Monitoring, And Alternatives To Batch Testing | Acceptable endotoxin levels | Pass |
| Hydration | N/A (Internal method implied) | Adequate hydration properties (implied) | Pass |
| Shelf Life and Stability | N/A (Internal method implied) | Stable for 36 months | Pass |
| Tensile strength | ASTM D638-14 Tensile Properties of Plastics | Adequate tensile strength (implied) | Pass |
| Implantation (for fish dermal matrix alone) | ISO 10993-6, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation | Acceptable local effects post-implantation | Pass |
| Genotoxicity (for fish dermal matrix alone) | ISO 10993-3, Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | Non-genotoxic | Pass |
| Genotoxicity – Chromosomal Aberration (for fish dermal matrix alone) | ISO 10993-3, Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | No chromosomal aberrations | Pass |
| Subchronic Toxicity (for fish dermal matrix alone) | ISO 10993-11:2017, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | Non-systemically toxic (subchronic) | Pass |
| Cellular Ingrowth (for fish dermal matrix alone) | N/A (Internal method implied) | Evidence of cellular ingrowth (implied) | Pass |
| Cell Remains and Collagen Structure (for fish dermal matrix alone) | N/A (Internal method implied) | Intact collagen structure, minimal cell remains (implied) | Pass |
| Hemostatic Properties (for fish dermal matrix alone) | N/A (Internal method implied) | Acceptable hemostatic properties (implied) | Pass |
| Resorption in Sprague-Dawley Rats (for fish dermal matrix alone) | N/A (Internal method implied) | Acceptable resorption profile (implied) | Pass |
| Collagen Induced Arthritis Mouse Modal (for fish dermal matrix alone) | N/A (Internal method implied) | No adverse inflammatory response in model (implied) | Pass |
Study Proving Device Meets Acceptance Criteria
The study proving the device meets the acceptance criteria is detailed under "7. PERFORMANCE TESTING" in the 510(k) summary. These are pre-clinical (biocompatibility, physical, and chemical) tests.
-
Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes for each specific biological or physical test. These tests generally use a small number of samples (e.g., typically n=3 or n=5 for physical tests, or a defined number of animals for in-vivo biocompatibility tests) as per the specific ISO/ASTM standards referenced.
- The data provenance is not specified in terms of country of origin, but it is implied to be from laboratory testing supporting the device's manufacturing and regulatory submission. The tests are retrospective to the submission date.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as this document does not describe a study involving image interpretation by experts or a clinical diagnostic AI. The "ground truth" here is established by validated laboratory testing methods governed by the cited ISO/ASTM standards, and the results are interpreted by qualified laboratory personnel.
-
Adjudication method for the test set:
- Not applicable. There is no "adjudication" in the sense of expert consensus for laboratory tests. The results are typically quantitative or qualitative (e.g., cytotoxic/non-cytotoxic) based on direct measurement and predefined criteria within the respective standards.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is not an AI/ML diagnostic device, so an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not a software algorithm.
-
The type of ground truth used:
- The ground truth for this device's performance is established through adherence to recognized international standards (ISO, ASTM, ANSI/AAMI) for biological safety and physical properties. This involves direct laboratory measurements and observations under controlled conditions to determine if the device elicits specific biological responses or possesses particular physical characteristics as defined by these standards.
-
The sample size for the training set:
- Not applicable. This concept applies to machine learning models, not to the pre-clinical performance testing of a physical medical device. The "training" for such a device involves product development and manufacturing process controls, not data-driven algorithm training.
-
How the ground truth for the training set was established:
- Not applicable. As above, this pertains to AI/ML context.
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June 29, 2022
Kerecis Limited Gudmundur Sigurjonsson President & CEO Eyrargata 2 Isafjordur, 400 Iceland
Re: K213231 Trade/Device Name: Kerecis Silicone Regulatory Class: Unclassified
Product Code: KGN Dated: September 24, 2021 Received: September 30, 2021
Dear Gudmundur Sigurjonsson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213231
Device Name Kerecis Silicone
Indications for Use (Describe)
Kerecis Silicone is indicated for the 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
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY - K213231
1. SUBMITTER/510(K) HOLDER
Kerecis Limited Eyrargata 2 400 Isafjordur Iceland Contact Person: G. Fertram Sigurjonsson Telephone: 011 354 562 2601
Date Prepared: June 27, 2022
2. DEVICE NAME
Proprietary Name: Kerecis Silicone Common/Usual Name: Dressing Wound Collagen Classification Name: Unclassified Product code: KGN
3. PREDICATE DEVICES
| • | Kerecis Marigen Wound Extra | K190528 | Predicate Device |
|---|---|---|---|
| --- | ----------------------------- | --------- | ------------------ |
- PELNAC™ Bilayer Wound Matrix ● K191992 Reference Device
4. DEVICE DESCRIPTION
The subject device is a bilayer of processed resorbable acellular fish dermal matrix adhered to a thin, transparent, porous, soft silicone layer.
The subject device is obtained from fish skin via standardized controlled GMP manufacturing process. The fish dermal matrix layer is approximately 1 mm in thickness and is porous.
The silicone layer is a transparent polyurethane film single-coated with soft, medical grade silicone that is attached to the scaly side of the fish dermal matrix. The silicone layer is porous, soft and conformable to the wound surface.
The subject device is supplied as a sterile intact sheet offered in two configurations: a) with the silicone layer extending beyond the borders of the fish dermal matrix and b) the silicone
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layer having the same dimension as the fish dermal matrix with no silicone layer extending beyond the fish dermal matrix.
The silicone acts as: protection for the fish dermal matrix layer, as additional wound coverage, and in configuration (a), as an adhesive contact layer to the skin surrounding the wound.
The silicone layer can be peeled off as the fish dermal matrix is resorbed.
The device is intended for single use only.
న. INTENDED USE
The subject device is indicated for the 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 ●
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The subject device and its predicate, Kerecis Marigen Wound Extra (K190528), are both composed of identical, resorbable, acellular fish skin dermal matrix. The fish skin layer is made from wild-caught Atlantic Cod that is minimally processed in order to preserve the natural proteins and structure of the fish skin.
The subject device differs from the predicate device in that it contains a second layer consisting of a porous silicone acts to protect the fish dermal matrix layer and is intended to ease the application of the device. The bilayer configuration of the subject device is similar to the reference device PELNAC Bilayer Wound Matrix (K191992) that includes a silicone layer and a porcine-derived collagen matrix layer.
The subject device is substantially equivalent to the predicate device, Kerecis Marigen Wound Extra (K190528).
The following table compares the proposed subject device side-by-side with the predicate device, Kerecis Marigen Wound Extra.
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| Device name | Kerecis Silicone (SubjectDevice- K213231) | Kerecis Marigen WoundExtra (Primary Predicate-K190528) | Comparison |
|---|---|---|---|
| Manufacturer | Kerecis Limited | Kerecis Limited | N/A |
| 510(k) | K213231 | K190528 | N/A |
| Intended forprescription andsingle useonly | Yes | Yes | Same |
| Product Code | KGN | KGN | Same |
| DeviceClassificationName | Dressing, Wound, Collagen | Dressing, Wound, Collagen | Same |
| Intended use | Kerecis Silicone is intended forthe management of woundsincluding:• Partial and full-thicknesswounds• Pressure ulcers• Venous ulcers• Chronic vascular ulcers• Diabetic ulcers• Trauma wounds(abrasions, lacerations,partial-thickness burns,skin tears)• Surgical wounds (donorsites/grafts, post-Mohssurgery, post-laser surgery,podiatric, wounddehiscence)• Draining wounds. | Marigen Wound Extra isindicated for the management ofwounds including:• Partial and full-thicknesswounds• Pressure ulcers• Venous ulcers• Chronic vascular ulcers• Diabetic ulcers• Trauma wounds (abrasions,lacerations, second-degreeburns, skin tears)• Surgical wounds (donorsites/grafts, post-Mohssurgery, post-laser surgery,podiatric, wounddehiscence)• Draining wounds | Same |
| Materials | Atlantic Cod fish skin +Silicone Film Layer | Atlantic Cod fish skin | Similar |
| Shape | Sheet (circular andrectangular) | Sheet (circular and rectangular) | Same |
| Suppliedsterile? | Yes | Yes | Same |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Same |
| SAL 10-6 | SAL 10-6 | ||
| Intended forsingle use? | Yes | Yes | Same |
| Biocompatibility | Yes | Yes | Same |
| Dimensions | Circular (diameter):15mm fish/25mm silicon20mm25mm30mm35mmRectangular:3x7 cm7x7 cm7x10cm7x20cm | Circular (diameter):15mm20mm25mm30mm35mmRectangular:3x7 cm7x7 cm7x10cm7x20cm | Same |
| PackagingConfiguration | Double Terminal SterileTyvek®Pouch | Double Terminal Sterile Tyvek®Pouch | Same |
| Shelf life | 36 months | 36 Months | Same |
Summary Table of substantial equivalence
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7. PERFORMANCE TESTING
The following table summarizes the tests that have been performed. The tests are either performed on the fish dermal matrix alone (predicate device, MariGen Wound Extra), or on the subject device. The fish dermal matrix is identical in both devices.
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| Test | Standard | |
|---|---|---|
| Cytotoxicity | Pass | ISO 10993-5, Biologicalevaluation of medicaldevices — Part 5: Tests forin vitro cytotoxicity |
| Sensitization | Pass | ISO 10993-10, Biologicalevaluation of medicaldevices — Part 10: Testsfor irritation and skinsensitization |
| Intracutaneous Irritation | Pass | ISO 10993-10, Biologicalevaluation of medicaldevices — Part 10: Testsfor irritation and skinsensitization |
| Acute Systemic Toxicity | Pass | ISO 10993-11:2017,Biological evaluation ofmedical devices — Part11: Tests for systemictoxicity |
| Material MediatedPyrogenicity | Pass | ISO 10993-11:2017,Biological evaluation ofmedical devices — Part11: Tests for systemictoxicity |
| Subacute Systemic Toxicityand Implantation Effects | Pass | ISO 10993-6, Biologicalevaluation of medicaldevices — Part 6: Tests forlocal effects afterimplantation and ISO10993-11:2017, Biologicalevaluation of medicaldevices — Part 11: Testsfor systemic toxicity |
| Endotoxin Validation andAnalysis | Pass | ANSI/AAMI ST72Bacterial Endotoxins - TestMethods, RoutineMonitoring, AndAlternatives To BatchTesting |
| Hydration | Pass | N/A |
| Shelf Life and Stability | Pass | N/A |
| Tensile strength | Pass | ASTM D638-14 TensileProperties of Plastics |
| Additional Performance tests on the Kerecis fish dermal matrix layer alone (leveraged from the predicate device) | ||
| Test | Standard | |
| Implantation | Pass | ISO 10993-6, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation |
| Genotoxicity | Pass | ISO 10993-3, Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| Genotoxicity – Chromosomal Aberration | Pass | ISO 10993-3, Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| Subchronic Toxicity | Pass | ISO 10993-11:2017, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| Cellular Ingrowth | Pass | N/A |
| Cell Remains and Collagen Structure | Pass | N/A |
| Hemostatic Properties | Pass | N/A |
| Resorption in Sprague-Dawley Rats | Pass | N/A |
| Collagen Induced Arthritis Mouse Modal | Pass | N/A |
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8. CONCLUSION
Based on the data provided within this submission, the subject device is substantially equivalent to the predicate device in regard to intended use and indication for use, technological characteristics including principles of operation, performance characteristics and device safety.
It is concluded that the subject device is substantially equivalent to the predicate device.
N/A