(272 days)
No
The device description focuses on the material composition and physical properties of a wound dressing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for the management of various types of wounds, including partial and full-thickness wounds, pressure ulcers, diabetic ulcers, and surgical wounds, which are conditions that require medical treatment.
No
The device description and intended use indicate that it is a wound dressing material, not a device used to diagnose a medical condition. It is designed for the "management of wounds."
No
The device description clearly describes a physical medical device composed of fish dermal matrix and a silicone layer, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a wound dressing composed of fish dermal matrix and silicone. It is applied directly to the wound for healing purposes.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue) to provide information about a person's health status, disease, or condition.
- Performance Studies: The performance studies focus on the biological and physical properties of the material and its interaction with the wound environment (cytotoxicity, implantation effects, resorption, etc.), not on diagnostic accuracy or analytical performance.
IVD devices are specifically designed to perform tests in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions. This device is applied in vivo (on the body) for wound management.
N/A
Intended Use / Indications for Use
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
Product codes
KGN
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- Cytotoxicity: Pass (ISO 10993-5)
- Sensitization: Pass (ISO 10993-10)
- Intracutaneous Irritation: Pass (ISO 10993-10)
- Acute Systemic Toxicity: Pass (ISO 10993-11:2017)
- Material Mediated Pyrogenicity: Pass (ISO 10993-11:2017)
- Subacute Systemic Toxicity and Implantation Effects: Pass (ISO 10993-6, ISO 10993-11:2017)
- Endotoxin Validation and Analysis: Pass (ANSI/AAMI ST72)
- Hydration: Pass (N/A)
- Shelf Life and Stability: Pass (N/A)
- Tensile strength: Pass (ASTM D638-14)
Additional Performance tests on the Kerecis fish dermal matrix layer alone (leveraged from the predicate device):
- Implantation: Pass (ISO 10993-6)
- Genotoxicity: Pass (ISO 10993-3)
- Genotoxicity – Chromosomal Aberration: Pass (ISO 10993-3)
- Subchronic Toxicity: Pass (ISO 10993-11:2017)
- 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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The words "U.S. FOOD & DRUG" are stacked on top of the word "ADMINISTRATION".
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
1
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
2
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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3
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
4
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.
5
| Device name | Kerecis Silicone (Subject
Device- K213231) | Kerecis Marigen Wound
Extra (Primary Predicate-
K190528) | Comparison |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | Kerecis Limited | Kerecis Limited | N/A |
| 510(k) | K213231 | K190528 | N/A |
| Intended for
prescription and
single use
only | Yes | Yes | Same |
| Product Code | KGN | KGN | Same |
| Device
ClassificationName | Dressing, Wound, Collagen | Dressing, Wound, Collagen | Same |
| Intended use | Kerecis Silicone is intended 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. | 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 (abrasions,
lacerations, second-degree
burns, skin tears)
• Surgical wounds (donor
sites/grafts, post-Mohs
surgery, post-laser surgery,
podiatric, wound
dehiscence)
• Draining wounds | Same |
| Materials | Atlantic Cod fish skin +
Silicone Film Layer | Atlantic Cod fish skin | Similar |
| Shape | Sheet (circular and
rectangular) | Sheet (circular and rectangular) | Same |
| Supplied
sterile? | Yes | Yes | Same |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Same |
| | SAL 10-6 | SAL 10-6 | |
| Intended for
single use? | Yes | Yes | Same |
| Biocompatibility | Yes | Yes | Same |
| Dimensions | Circular (diameter):
15mm fish/25mm silicon
20mm
25mm
30mm
35mm
Rectangular:
3x7 cm
7x7 cm
7x10cm
7x20cm | Circular (diameter):
15mm
20mm
25mm
30mm
35mm
Rectangular:
3x7 cm
7x7 cm
7x10cm
7x20cm | Same |
| Packaging
Configuration | Double Terminal Sterile
Tyvek®Pouch | Double Terminal Sterile Tyvek®
Pouch | Same |
| Shelf life | 36 months | 36 Months | Same |
Summary Table of substantial equivalence
6
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.
7
| Test | Standard | |
|---|---|---|
| Cytotoxicity | Pass | ISO 10993-5, Biological |
| evaluation of medical | ||
| devices — Part 5: Tests for | ||
| in vitro cytotoxicity | ||
| Sensitization | Pass | ISO 10993-10, Biological |
| evaluation of medical | ||
| devices — Part 10: Tests | ||
| for irritation and skin | ||
| sensitization | ||
| Intracutaneous Irritation | Pass | ISO 10993-10, Biological |
| evaluation of medical | ||
| devices — Part 10: Tests | ||
| for irritation and skin | ||
| sensitization | ||
| Acute Systemic Toxicity | Pass | ISO 10993-11:2017, |
| Biological evaluation of | ||
| medical devices — Part | ||
| 11: Tests for systemic | ||
| toxicity | ||
| Material Mediated | ||
| Pyrogenicity | Pass | ISO 10993-11:2017, |
| Biological evaluation of | ||
| medical devices — Part | ||
| 11: Tests for systemic | ||
| toxicity | ||
| Subacute Systemic Toxicity | ||
| and Implantation Effects | Pass | 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 | ||
| Endotoxin Validation and | ||
| Analysis | Pass | ANSI/AAMI ST72 |
| Bacterial Endotoxins - Test | ||
| Methods, Routine | ||
| Monitoring, And | ||
| Alternatives To Batch | ||
| Testing | ||
| Hydration | Pass | N/A |
| Shelf Life and Stability | Pass | N/A |
| Tensile strength | Pass | ASTM D638-14 Tensile |
| Properties 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 |
8
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.