MARIGEN WOUND DRESSING

• K Number: K132343
• Device Name: MARIGEN WOUND DRESSING
• Manufacturer: KERECIS LIMITED
• Date Cleared: 2013-10-23 ( 85 days)
• Product Code: KGN
• Regulation Number: N/A
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K092096 , K092926 , K021792 , K082103 , K083440 , K071519 , K061711
• Predicate For: K153364 , K190528

Intended Use

MariGen Wound 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

Device Description

The Kerecis MariGen Wound Dressing is processed fish dermal matrix composed of fish collagen and is supplied as a sterile intact, or meshed sheet ranging in size from 3 x 3.5 cm (10.5 cm2), 3 x 7 cm (21 cm2) and 7 x 10 cm (70 cm2).
The device is intended for a single patient, one time use only.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the MariGen Wound Dressing:

Key Takeaway: The provided document is a 510(k) summary for a medical device seeking substantial equivalence, not a detailed clinical study report with specific acceptance criteria and performance metrics for a novel efficacy claim. It focuses on demonstrating equivalence to existing predicate devices through material composition, device characteristics, intended use, and non-clinical testing.

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Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary focused on substantial equivalence, specific "acceptance criteria" in terms of precise numerical performance targets (e.g., sensitivity, specificity, wound healing rate) as one might find in a clinical trial for a new drug or a de novo device are not explicitly stated or reported with quantitative results.

Instead, the acceptance criteria are implicitly met by:

1. Biocompatibility: Showing the device is "usable and biocompatible" as per ISO 10993-12.
2. Safety (from animal and limited human use): Demonstrating that animal studies support safety and that "no serious adverse events have been noted in limited clinical use."
3. Substantial Equivalence: Concluding that the device is "substantially equivalent to the predicate devices with respect to material composition, device characteristics and intended use," and that "The differences between these devices are limited to the animal source of collagen. This difference is minor and does not raise new issues of safety or effectiveness."

Therefore, a table of precise numerical acceptance criteria and reported performance metrics cannot be constructed from the provided text in the way one would for a diagnostic or AI-driven decision support system. The "performance" is primarily safety and biocompatibility validated against ISO standards and existing predicate devices.

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Study Details based on the provided text:

1. A table of acceptance criteria and the reported device performance

   Category	Acceptance Criteria (Implicit from text)	Reported Device Performance
   Biocompatibility	Meets requirements of ISO 10993-12 for biological evaluation.	"All biocompatibility tests that are required according to ISO 10993-12... were performed with favorable results." (Categories: cytotoxicity, sensitization, irritation, subchronic toxicity, genotoxicity). "The Kerecis MariGen Wound Dressing was shown to be usable and biocompatible."
   Safety (Animal)	Animal studies support the safety of the device.	"The results of the tests support the safety of the device."
   Safety (Clinical)	No serious adverse events in limited clinical use.	"No serious adverse events have been noted in limited clinical use."
   Functionality	Device functions to meet specified user requirements as per design validation.	"The design validation activities confirmed that the device as designed functions to meet specified user requirements."
   Substantial Equiv.	Same general intended use, principles of operation, and similar overall design to predicate devices. No new safety/effectiveness issues.	"The proposed and predicate devices have the same general intended use and principles of operation. The overall design... is similar... The differences... are minor and do not raise new issues of safety or effectiveness."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Test Set Sample Size:
     • Biocompatibility Tests: The specific number of samples for each test (cytotoxicity, sensitization, etc.) is not provided.
     • Animal Testing: "Several animal studies have been performed," but the number of animals or studies is not specified.
     • Clinical Testing: The product "has been studied on a limited number of subjects." The exact number is not provided.
   • Data Provenance: Not explicitly stated for any of the testing mentioned. The company is based in Iceland (Kerecis Itd., Isafjordur, Iceland), and the device is CE marked, suggesting European markets. The text does not specify where the limited clinical use took place.
   • Retrospective or Prospective: Not specified for any of the studies.

3. 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)

   • Not applicable/Not mentioned. The studies described are primarily non-clinical (biocompatibility, animal) and limited observational clinical experience, not studies requiring expert-adjudicated ground truth for a diagnostic performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable/Not mentioned. This type of adjudication is typically used for diagnostic performance studies involving human readers or AI algorithms for image interpretation, which is not the nature of the studies described here.

5. 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

   • No MRMC comparative effectiveness study was done. This device is a wound dressing, not an AI-powered diagnostic or decision support tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • No standalone algorithm performance study was done. This device is a wound dressing, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • For biocompatibility, the "ground truth" would be the established safety profiles and pass/fail criteria defined by the ISO 10993-12 standards.
   • For animal studies, the ground truth would be observations of tissue response, healing, inflammation, etc., as assessed by veterinary pathologists or researchers.
   • For limited clinical use, the "ground truth" for safety would be the absence of serious adverse events, likely collected from patient records and observational follow-ups. The document hints at "supports the safety of the device" rather than efficacy outcomes.

8. The sample size for the training set

   • Not applicable. The device is a physical wound dressing, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

   • Not applicable. No training set for an algorithm is involved.

Summary

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2 3 2013

510k Summary

SUBMITTER/510K HOLDER 1

Address:	Kerecis Itd.Eyrargata 2400 IsafjordurIceland
Contact Person:	Gudmundur Fertram SigurjonssonExecutive Chairman
Telephone:	011 354 562 2601
Date Prepared:	October 1, 2013

2 DEVICE NAME

Proprietary Name:	MariGen Wound Dressing
Common/Usual Name:	MariGen Wound
Classification Name:	Collagen Wound Dressing
510k Number:	K132343

PREDICATE DEVICES 3

• . Mesynthes Endoform™ Dermal Template (K092096)
• ACell MatriStem™ (K092926) .
• Integra™ Wound Matrix (Integra Life Sciences) (K021792) .
• . LifeCell Corporation's LTM Wound Dressing (K082103)
• . TEl Biosciences Inc. PriMatrix (K083440)
• . HemCon Chitoflex Surgical Dressing (K071519)
• Cook Biotech, Oasis (K061711) .

Traditional 510k, K132343

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DEVICE DESCRIPTION 4

The Kerecis MariGen Wound Dressing is processed fish dermal matrix composed of fish collagen and is supplied as a sterile intact, or meshed sheet ranging in size from 3 x 3.5 cm (10.5 cm2), 3 x 7 cm (21 cm2) and 7 x 10 cm (70 cm2).

The device is intended for a single patient, one time use only.

INTENDED USE 5

MariGen Wound 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

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL 6 EQUIVALENCE

The Kerecis MariGen Wound Dressing is substantially equivalent to the predicate devices with respect to material composition, device characteristics and intended use.

MECHANICAL TESTS AND BIOCOMPATIBILITY TESTS 7

The Kerecis MariGen Wound Dressing has been subjected to extensive testing to assess the biocompatibility and the performance of the device. The Kerecis MariGen Wound Dressing was shown to be usable and biocompatible.

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All biocompatibility tests that are required according to ISO 10993-12 "Biological Evaluation of Medical Devices" where performed with favorable results. Tests were done in the following categories; cytotoxicity, sensitization, irritation, subchronic toxicity and genotoxicity.

ANIMAL TESTING 8

Several animal studies have been performed on the device.

The results of the tests support the safety of the device.

CLINICAL TESTING ਰੇ

MariGen Wound is CE marked and has been in commercial use since 2011

The product has been studied on a limited number of subjects and this use supports the safety of the device. No serious adverse events have been noted in limited clinical use.

10 CONCLUSIONS

The proposed and predicate devices have the same general intended use and principles of operation. The overall design of the proposed and predicate devices is similar in that they are all comprised of collagen. The differences between these devices are limited to the animal source of collagen. This difference is minor and does not raise new issues of safety or effectiveness.

The MariGen Wound Dressing meets all defined acceptance criteria for the non-clinical testing required by the risk analysis. The design validation activities confirmed that the device as designed functions to meet specified user requirements. The information provided confirms that the MariGen Wound Dressing device is safe and effective for its intended use and performs as intended.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health and Human Services (USA). The seal features an eagle-like bird with three stylized wing feathers, representing health, services, and people. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" which is arranged in a circular fashion around the bird.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WOop-G609 Silver Spring MD 20993-0002

October 23, 2013

Kerecis LTD. Gudmundur F. Sigurjonsson Executive Chairman Eyrargata 2 400 Isafjordur Iceland

Re: K132343

Trade/Device Name: MeriGen Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: July 19. 2013 Received: August 7, 2013

Dear Sigurionsson:

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. The general controls provisions of the Act include requirements for annual registration. Ilisting 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 I that FDA has made a determination that your device complies with other requirements of the Act that 1197 has Intacted and regulations administered by other Federal agencies. You must or any with all the Act's requirements, including, but not limited to: registration and listing (2 l CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Gudmundur F. Sigurjonsson

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please. contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notilication" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.lda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours.

Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K132343

Device Name MariGen Wound Dressing

Indications for Use (Describe)

MariGen Wound Dressing 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), and

• 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Regulation Number and Section

N/A