(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:
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
The sample size for the training set
N/A. This is not an AI/ML device with a training set.
-
How the ground truth for the training set was established
N/A. This is not an AI/ML device with a training set.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 21, 2024
Kerecis Limited William Kabitz Senior Regulatory Specialist Sundstraeti 38, 400 Isafjordur P.O. Box 151, 400 Isafjordur Isafjordur. Iceland
Re: K241080
Trade/Device Name: Kerecis Parvus (50207) Regulatory Class: Unclassified Product Code: KGN Dated: July 16, 2024 Received: July 22, 2024
Dear William Kabitz:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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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, Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive 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) K241080
Device Name Kerecis® Parvus™
Indications for Use (Describe)
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
Premarket Notification Submission (510(k) Summary) prepared in accordance with 21 CFR § 807.92
Submitter Information
| Sponsor Name: | Kerecis Limited |
|---|---|
| Sponsor Address: | Eyrargata 2 – PO Box 151, 400 Isafjordur, Iceland |
| Sponsor Telephone: | +354-419-8000 |
| Primary Contact Person: | Skuli Magnusson |
|---|---|
| Contact Title: | VP Quality and Regulatory Affairs |
| Email Direct: | sm@kerecis.com |
Date Summary Prepared: March 30, 2024
Device Information
| Trade Name/Proprietary Name | Kerecis® Parvus™ |
|---|---|
| Regulation Number | Unclassified |
| Regulation Name: | Wound Dressing With Animal-Derived Material(s) |
| Product Code: | KGN |
| Classification | Unclassified |
| Panel | General & Plastic Surgery |
Predicate Device
| Company Name: | Kerecis Limited |
|---|---|
| Device Name (Proprietary): | Kerecis MariGen Wound Extra |
| Device 510(k): | K190528 |
Device Description
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)
{5}------------------------------------------------
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
Technological Characteristics & Substantial Equivalence
Comparison with the predicate device (K190528) demonstrates that the subject device is substantially equivalent with regard to indications for use, intended use, raw material origin and composition, device performance, packaging material, and sterilization methods. The manufacturing process adds an additional cutting and sieving step to convert fish skin from intact sheets to fragmented pieces ≤2.0mm.
The subject device is identical to the predicate device with respect to raw material, terminal sterilization, intended use, and indications for use.
| DEVICE | Subject Device: | Predicate Device: | Discussion |
|---|---|---|---|
| Device Name | Kerecis® Parvus™ | MariGen Wound Extra | N/A |
| Manufacturer | Kerecis Limited, Iceland | Kerecis Limited, Iceland | Same as predicate |
| Product Codes | KGN | KGN | Same as predicate |
| Intended Use | Management of wounds | Management of wounds | Same as predicate |
| Indications For Use | Partial and full-thickness wounds Pressure ulcers Venous ulcers Chronic vascular ulcers Diabetic ulcers Trauma wounds (abrasions, lacerations, superficial second-degree burns, skin tears) Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, | Partial and full-thickness wounds Pressure ulcers Venous ulcers Chronic vascular ulcers Diabetic ulcers Trauma wounds (abrasions, lacerations, superficial second-degree burns, skin tears) Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, | Same as predicate |
Performance Characteristics
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| podiatric, wounddehiscence)● Draining wounds | podiatric, wounddehiscence)● Draining wounds | ||
|---|---|---|---|
| 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 | Irregular shaped 3D fragmentedfish skin, size controlled to≤2.00mm and packaged in thefollowing weights:100mg (4 cm2)200mg (8 cm2)500mg (19 cm2)1000mg (38 cm2)2,500mg (95 cm2)3,000mg (114 cm2) | 1.75 x 1.75cm (3.01 cm2)3 x 3.5 cm (10.5 cm2)3 x 7 cm (21 cm2)7 x 7 cm (49 cm2)7 x 10 cm (70 cm2)7 x 20 cm (140 cm2)10 x 20 cm (200 cm2)20 x 20 cm (400 cm2)20 x 25 cm (500 cm2)20 x 30 cm (600 cm2) | The subject deviceis cut from variouspredicate devicesizes. |
| Presentation | Lyophilized, sterilized,Fragmented, fish skin in a Tyvekpeel pouch. | Lyophilized, sterilized, fish skinsheets in a Tyvek peel pouch. | The predicate andthe subject devicediffer only in themanufacturing stepsfor cutting andsieving to achievethe finished size of≤2.00mm. |
| Packaging | Tyvek Single and Double PeelPouch | Tyvek Single and Double PeelPouch | Same as predicate |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same as predicate |
| Sterility AssuranceLevel | SAL 106 | SAL 106 | Same as predicate |
| Endotoxin limit | ≤20EU/device | ≤20EU/device | Same as predicate. |
| Shelf Life | 1 year | 3 years | Real-time shelf lifetesting in progress |
Performance Data
The subject device is identical to the predicate device with respect to raw material, terminal sterilization, intended use, and indications for use. Additional testing for biocompatibility, fragmented size characterization, endotoxin, shelf life, sterilization, ethylene oxide residuals, metal contamination, protein analysis, bioburden, and residual limits were completed for the subject device.
Conclusion
Taken together the data provided confirms that the subject device (Kerecis "Parvus™) meets all requirements and is substantially equivalent to the predicate device.
N/A