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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
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
More Information

K092096, K092926, K021792, K082103, K083440, K071519, K061711

Not Found

No
The device description and intended use focus on a biological wound dressing material (fish dermal matrix). There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies described are animal and limited human studies focused on safety, not algorithmic performance.

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 treatment and healing.

No

Explanation: The device description states that the Kerecis MariGen Wound Dressing is "processed fish dermal matrix composed of fish collagen" and is "indicated for the management of wounds." This indicates it is a therapeutic or wound healing device, not a device used to diagnose a medical condition.

No

The device description explicitly states it is a "processed fish dermal matrix composed of fish collagen" and is supplied as a physical sheet, indicating it is a hardware-based medical device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the management of various types of wounds. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
  • Device Description: The device is a wound dressing made of fish dermal matrix. This is a physical material applied to a wound, not a reagent or instrument used to analyze biological samples.
  • No mention of in vitro testing: There is no indication that this device is used to test samples outside of the body.

Therefore, the Kerecis MariGen Wound Dressing is a medical device intended for wound management, not an in vitro diagnostic device.

N/A

Intended Use / Indications for 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

Product codes (comma separated list FDA assigned to the subject device)

KGN

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.

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

Not Found

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 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 biocompatibility.
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.
Several animal studies have been performed on the device. The results of the tests support the safety of the device.
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

N/A

0

2 3 2013

510k Summary

SUBMITTER/510K HOLDER 1

| Address: | Kerecis Itd.
Eyrargata 2
400 Isafjordur
Iceland |
|-----------------|----------------------------------------------------------|
| Contact Person: | Gudmundur Fertram Sigurjonsson
Executive 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

1

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.

2

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.

3

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

4

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

5

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)