CoMatryx Collagen Wound Dressing may be used in the management of partial and full thickness wounds, pressure (stage I-IV) and venous ulcers, ulcers caused by mixed vascular etiologies, venous stasis and diabetic ulcers, 1st and 2nd degree burns, cuts, abrasions, and surgical wounds.

Device Description

Collagen Wound Dressing, a native bovine Type I Collagen which, when applied to a wound surface, absorbs wound fluid and maintains a moist wound environment in the management of wound healing. The CoMatryx Collagen Wound Dressing is provided sterile in the following patient ready configurations:

10 gram Bottle
1 gram Vial
1 gram pouch

AI/ML Overview

Acceptance Criteria and Device Performance Study for CoMatryx Collagen Wound Dressing

This document analyzes the acceptance criteria and the study performed to demonstrate the substantial equivalence of the CoMatryx Collagen Wound Dressing, as described in the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The device's acceptance criteria are based on demonstrating substantial equivalence to the predicate device, CollaTek Powder (now Medifil II Particles). The performance data primarily relies on direct comparison of characteristics and functional testing against specified parameters.

Parameter	Acceptance Criteria (Predicate Reference / Specific Value)	Reported Device Performance (CoMatryx Collagen Wound Dressing)	Test Methods (Standards)
Indications for Use	Same as predicate	Same as predicate	510k Comparison
Product Code	KGN	KGN	510K
Rx Status	Yes	Yes	510K
Physical Shape	Powder	Powder	510K
Color	White to off-white	White to off-white	Visual
Single Use	Single use only	Single use only	510K
Package Sizes	1 gram vial, 1 gram pouch, 10 grams bottle	1 gram vial, 1 gram pouch, 10 grams bottle	510K
Water Absorption Capacity	NLT 20 times its weight in USP Purified Water	NLT 20 times its weight in USP Purified Water	Strukmyer Procedure #HOMA-AFTP5R
Particle Size	Powder	Powder	Strukmyer Procedure #HOMA-AFTPRK
Product Type	Collagen	Collagen	510K
Product Description	Type I Bovine Collagen	Type I Bovine Collagen	510K
Animal Tissue	Dermis	Dermis	510K
Sterile	Yes	Yes	510K
Sterilization Method	E-Beam	E-Beam	510K
Product Classification	Unclassified	Unclassified	FDA
Moisture Content	≤ 17%	≤ 17%	Strukmyer Procedure #HOMA-9YQRG8
pH	≥ 2.5	≥ 2.5	Strukmyer Procedure #HOMA-9Z9HUM
InfraRed Spectroscopy Scan	Characteristic of Material, comparable to predicate	Characteristic of Material, comparable to predicate	Strukmyer Procedure #HOMA-A2CJEJ
SDS-PAGE Analysis	Characteristic of Material, comparable to predicate	Characteristic of Material, comparable to predicate	Alamo Labs, Inc. Report#3480-01
Biocompatibility	Meets ISO 10993 standards (excluding cytotoxicity for in-vitro)	Initial cytotoxicity indicated effect, but wound healing study found no impairment.	Cytotoxicity, Sensitization Guinea Pig, Intracutaneous Irritation Test, Acute Systemic Toxicity, Wound Healing Study ( porcine model)

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state a specific "test set" in the context of a dataset for an AI device. Instead, the "testing" involves a series of laboratory and animal studies to demonstrate the device's characteristics and safety.

Sample Size for Biocompatibility Tests: The document does not specify the exact number of samples used for each in vitro biocompatibility test (Cytotoxicity, Sensitization Guinea Pig, Intracutaneous Irritation Test, Acute Systemic Toxicity).
Sample Size for Physical/Chemical Characterization: The number of samples for each physical and chemical characteristic (e.g., Water Absorption Capacity, Moisture Content, pH, IR Spectroscopy, SDS-PAGE) is not explicitly stated. These are typically performed on a statistically relevant number of production lots.
Sample Size for Wound Healing Study: The document refers to "a Wound Healing Study" conducted on "porcine wounds." However, the exact number of porcine subjects or wounds used in this study is not provided.
Data Provenance: The studies appear to be prospective in nature, conducted specifically for the 510(k) submission. The location of the studies is not explicitly mentioned, but "Alamo Labs, Inc." is named for the SDS-PAGE analysis, suggesting a US-based laboratory.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable as the device is a wound dressing, not an AI/diagnostic device that requires expert-established ground truth for a test set. The "ground truth" for this type of device is established through laboratory test methods and animal studies demonstrating physical, chemical, and biological properties.

4. Adjudication Method

This section is not applicable as there is no mention of a human-read diagnostic test set requiring adjudication in this 510(k) submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This section is not applicable. The device is a wound dressing, not a diagnostic AI system, so an MRMC comparative effectiveness study is not relevant to its regulatory approval.

6. Standalone (Algorithm Only) Performance Study

This section is not applicable. The device is a physical wound dressing and does not involve an algorithm or AI component.

7. Type of Ground Truth Used

The "ground truth" for the CoMatryx Collagen Wound Dressing is established through:

Comparative Analysis: Direct comparison of the device's physical, chemical, and functional characteristics against a legally marketed predicate device (CollaTek Powder/Medifil II Particles).
Laboratory Testing: Adherence to established scientific and regulatory standards for material characterization (e.g., IR Spectroscopy, SDS-PAGE, pH, moisture content, water absorption).
Biocompatibility Testing: Adherence to ISO 10993 standards.
Animal Outcomes Data: The "Wound Healing Study" on porcine wounds provides outcomes data for the cellular response to the dressing and its impact on the healing process, particularly in addressing initial in vitro cytotoxicity concerns.

8. Sample Size for the Training Set

This section is not applicable as the device is a physical wound dressing and does not involve a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reason as point 8.

Summary

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

Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 25, 2017

Strukmyer Medical Pamela Liberto Director of OA 1801 Big Town Blvd Suite #100 Mesquite, Texas 75149

Re: K171645

Trade/Device Name: CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle

Regulatory Class: Unclassified Product Code: KGN Dated: June 2, 2017 Received: June 5, 2017

Dear Pamela Liberto:

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, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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

related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Industry and Consumer Education at its toll-free 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 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K171645

Device Name

CoMatryx Collagen Wound Dressing

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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."

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

510(k) SUMMARY

I. ADMINISTRATIVE

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

Strukmver Medical 1801 Big Town Blvd, Suite 100 Mesquite, Texas 75149

Telephone No.: 214-275-9595 Facsimile No.: 214-275-6748

Contact Person: Pamela Liberto E-Mail: pliberto@strukmyer.com

July 20, 2017 Date Prepared:

II. DEVICE NAME

Proprietary Name: CoMatryx Collagen Wound Dressing

Common or Usual Name: Collagen Wound Dressing

Classification: Dressing, Wound, Collagen

Regulatory Class: Unclassified

Product Code: KGN

III. PREDICATE DEVICE:

CollaTek Powder K012990, Biocore Medical Technologies, Inc. (Now sold under the name Medifil II Particles by Human BioSciences, Inc., Gaithersburg, MD 20878).

IV. DEVICE DESCRIPTION:

Collagen Wound Dressing, a native bovine Type I Collagen which, when applied to a wound surface, absorbs wound fluid and maintains a moist wound

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

environment in the management of wound healing. The CoMatryx Collagen Wound Dressing is provided sterile in the following patient ready configurations:

10 gram Bottle
1 gram Vial ●
1 gram pouch ●

V. INTENDED USE

VI. COMPARISON TO PREDICATE DEVICE

CoMatryx Collagen Wound Dressing is Type 1 bovine collagen which absorbs wound fluid, maintains a moist wound environment and is equivalent to predicate products currently in commercial distribution.

Both Predicate and Strukmyer CoMatryx Collagen Wound dressings are derived from Type 1 bovine collagen. Infrared Spectroscopy (IR) Scan provided as attachment of predicate and Strukmyer Collagen Wound dressings match identically proving that material composition of both products are same.

Both predicate and Strukmyer collagen dressings are ground to powder.

This formulation does not affect the intended use or alter the fundamental scientific technology of the device.

By comparing product characteristics such as physical shape, IR Spectrum, pH, color, absorbency and moisture content of both predicate and Strukmyer Collagen Wound dressings, it can be concluded that Strukmyer Collagen Wound dressings is substantially equivalent to the predicate device.

The CoMatryx Collagen Wound Dressing is as safe and effective as the predicate devices referenced herein. CoMatryx Collagen Wound Dressing has similar intended uses, technological characteristics, and basic principles of operation as the aforementioned predicate device and raises no new issues of safety or effectiveness. CoMatryx Collagen Wound Dressing is substantially equivalent to the predicate device. See below for a comparison table.

{5}------------------------------------------------

Parameters	CoMatryx Collagen WoundDressing	CollaTek* Powder(aka Medifil II Particles)BioCore K012990	Test Methods(standards)
Indications foruse	May be used in themanagement of:• Partial and full thicknesswounds• Pressure (stage I-IV) andvenous ulcers• Ulcers caused by mixedvascular etiologies• Venous stasis anddiabetic ulcers• 1st and 2nd degree burns• Cuts, abrasions, andsurgical wounds	May be used in themanagement of:• Partial and full thicknesswounds• Pressure (stage I-IV) andvenous ulcers• Ulcers caused by mixedvascular etiologies• Venous stasis anddiabetic ulcers• 1st and 2nd degree burns• Cuts, abrasions, andsurgical wounds	510k Comparison
Product Code	KGN	KGN	510K
Rx	Yes	Yes	510K
Physical Shape	Powder	Powder	510K
Color	White to off-white	White to off-white	Visual
Single Use	Single use only	Single use only	510K
Package Sizes	1 gram in vial1 gram in pouch10 grams in bottles	1 gram in vial1 gram in pouch10 grams in bottles	510K
WaterAbsorptionCapacity	NLT 20 times its weight inUSP Purified Water	NLT 20 times its weight inUSP Purified Water	Strukmyer Procedure#HOMA-AFTP5R
Particle Size	Powder	Powder	Strukmyer Procedure#HOMA-AFTPRK
Product Type	Collagen	Collagen	510K
ProductDescription	Type I Bovine Collagen	Type I Bovine Collagen	510K
Animal Tissue	Dermis	Dermis	510K
Sterile	Yes	Yes	510K
SterilizationMethod	E-Beam	E-Beam	510K
ProductClassification	unclassified	unclassified	FDA
Moisture content	≤ 17%	≤ 17%	Strukmyer Procedure#HOMA-9YQRG8
pH	≥ 2.5	≥ 2.5	Strukmyer Procedure# HOMA-9Z9HUM
InfraRedSpectroscopyScan	Characteristic of Material,comparable	Characteristic of Material,comparable	Strukmyer Procedure# HOMA-A2CJEJ
SDS-PAGEAnalysis	Characteristic of Material,comparable	Characteristic of Material,comparable	Alamo Labs, Inc.Report#3480-01

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

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility

Biocompatibility testing of CoMatryx Collagen Wound Dressing has been conducted in accordance with the testing standards of ISO 10993: "Biological Evaluation of Medical Devices." Biocompatibility testing included the following tests:

. Cytotoxicity
Sensitization Guinea Pig ●
. Intracutaneous Irritation Test
. Acute Systemic Toxicity

Animal Study

Since the MEM Endpoint Dilution Test (in-vitro) indicated cytotoxic effect for CoMattyx Collagen Wound Dressing, a Wound Healing Study as requested by FDA was conducted to analyze the effect of CoMatryx Collagen on porcine wounds. The Wound Healing study shows no evidence of impairment of wound healing with the use of CoMatryx Collagen wound dressing.

VIII. CONCLUSION

Based on a comparison of composition, technological characteristics, intended use and biocompatibility test results, we conclude that the CoMatryx Collagen Wound Dressing performs at least as well as the predicate device. The CoMatryx Collagen Wound Dressing is therefore considered to be substantially equivalent to the above-mentioned predicate device.

End of Summary

Regulation Number and Section

N/A