Kerecis Parvus (50207)

K241080 · Kerecis Limited · KGN · Aug 21, 2024 · SU

Device Facts

• Record ID: K241080
• Device Name: Kerecis Parvus (50207)
• Applicant: Kerecis Limited
• Product Code: KGN · SU
• Decision Date: Aug 21, 2024
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for 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

Device Story

Kerecis Parvus is a lyophilized, acellular, particulate fish skin (North Atlantic Cod) wound dressing. Device consists of biocompatible, non-crosslinked, resorbable fish skin fragments (≤2.0mm). Intended for single-use management of various wound types including chronic, surgical, and trauma wounds. Device is applied topically to the wound site. It acts as a scaffold for tissue regeneration. Manufacturing involves cutting and sieving fish skin into fragments. Terminally sterilized via ethylene oxide. Supplied in various weights (100mg to 3,000mg) in Tyvek pouches. Used in clinical settings by healthcare providers to facilitate wound healing.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included biocompatibility, fragmented size characterization, endotoxin levels, shelf life, sterilization validation, ethylene oxide residuals, metal contamination, protein analysis, and bioburden.

Technological Characteristics

Material: Acellular North Atlantic Cod fish skin. Form: Lyophilized, fragmented particles (≤2.0mm). Sterilization: Ethylene Oxide (SAL 10^-6). Packaging: Tyvek peel pouch. Endotoxin limit: ≤20EU/device. Shelf life: 1 year.

Indications for Use

Indicated for management of partial/full-thickness wounds, pressure ulcers, venous/chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), surgical wounds (donor sites/grafts, post-Mohs, post-laser, podiatric, dehiscence), and draining wounds in patients requiring wound management.

Predicate Devices

• Kerecis MariGen Wound Extra (K190528)

Submission Summary (Full Text)

{0}------------------------------------------------

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).

{1}------------------------------------------------

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.

{2}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{3}------------------------------------------------

# 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

# 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: | [phone] |

| Primary Contact Person: | Skuli Magnusson |
|-------------------------|-----------------------------------|
| Contact Title: | VP Quality and Regulatory Affairs |
| Email Direct: | [e-mail] |

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

{6}------------------------------------------------

| | podiatric, wound<br>dehiscence)<br>● Draining wounds | podiatric, wound<br>dehiscence)<br>● 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 fragmented<br>fish skin, size controlled to<br>≤2.00mm and packaged in the<br>following weights:<br>100mg (4 cm2)<br>200mg (8 cm2)<br>500mg (19 cm2)<br>1000mg (38 cm2)<br>2,500mg (95 cm2)<br>3,000mg (114 cm2) | 1.75 x 1.75cm (3.01 cm2)<br>3 x 3.5 cm (10.5 cm2)<br>3 x 7 cm (21 cm2)<br>7 x 7 cm (49 cm2)<br>7 x 10 cm (70 cm2)<br>7 x 20 cm (140 cm2)<br>10 x 20 cm (200 cm2)<br>20 x 20 cm (400 cm2)<br>20 x 25 cm (500 cm2)<br>20 x 30 cm (600 cm2) | The subject device<br>is cut from various<br>predicate device<br>sizes. |
| Presentation | Lyophilized, sterilized,<br>Fragmented, fish skin in a Tyvek<br>peel pouch. | Lyophilized, sterilized, fish skin<br>sheets in a Tyvek peel pouch. | The predicate and<br>the subject device<br>differ only in the<br>manufacturing steps<br>for cutting and<br>sieving to achieve<br>the finished size of<br>≤2.00mm. |
| Packaging | Tyvek Single and Double Peel<br>Pouch | Tyvek Single and Double Peel<br>Pouch | Same as predicate |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same as predicate |
| Sterility Assurance<br>Level | 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 life<br>testing 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.