ABCcolla® Collagen Matrix is intended to be used for management of wounds, including partial and full thickness wounds, venous ulcers, pressure ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor site/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, and skin tears), first and second-degree burns, draining wounds.

Device Description

ABCcolla® Collagen Matrix is a decellularized porous porcine collagen material which is biocompatible. ABCcolla® Collagen Matrix absorbs exudates, maintains a moist wound environment, and functions to protect the wound. Pre-wetting makes it supple, conforming to the contour of the wound site. ABCcolla® Collagen Matrix is supplied in double peel-open pouches that is terminally sterilized via gamma irradiation.

AI/ML Overview

This is not a medical device that relies on AI/ML. The provided text is a 510(k) premarket notification for a collagen matrix wound dressing (ABCcolla® Collagen Matrix), which is a biological product, not a software or AI-powered device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and AI-specific metrics is not applicable in this context.

The document discusses substantial equivalence to predicate devices based on:

Performance Data: Biocompatibility studies (ISO 10993), absorbency (EN 13726-1:2002), in vitro degradation, collagen content, and moisture content.
Animal Data: A wound healing study in animals.

The FDA's review confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Summary

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

May 10, 2017

Acro Biomedical Co., Ltd Dar-Jen Hsieh CEO 3f., No.57, Luke 2nd Rd, Lujhu Dist. Kaohsiung City, 82151 TW

Re: K162348

Trade/Device Name: ABCcolla Collagen Matrix Regulatory Class: Unclassified Product Code: KGN Dated: April 10, 2017 Received: April 10, 2017

Dear Dar-Jen Hsieh:

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 devicerelated 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.

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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

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Indications for Use

510(k) Number (if known) K162348

Device Name ABCcolla® Collagen Matrix

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)

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Image /page/3/Picture/0 description: The image contains the logo for ACRO Biomedical Co., Ltd. The logo features a stylized cross in red and gray with a green leaf element. The text "ACRO Biomedical Co., Ltd." is displayed in gray, with a line underneath each word.

510(k) Summary

This summary of 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act (SMDA) of 1990 and Title 21 CFR 807.92. The assigned 510(k) number is ________________________________________________________________________________________________________________________________________________

Applicant	ACRO Biomedical Co., Ltd.
	3F., No.57, Luke 2nd Rd., Lujhu Dist., Kaohsiung City 82151,Taiwan
	Telephone: +886-7-6955-569
	Fax: +886-7-6955-069
Contact Person	DAR-JEN HSIEH
	CEO
	E mail: dj@acrobiomedical.com
Date of Summary	July 31, 2016
Name of Device	ABCcolla® Collagen Matrix
Common Name	Wound dressing
Classification	Unclassified
Regulation Number	N/A
Product Code	KGN
Advisory Panel	General & Plastic Surgery
Predicate Device	• CollaWound wound dressing, K090894Collamatrix Inc.
Reference Device	• Matristem® Wound Matrix, K112409ACell, Inc.

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ABCcolla® Collagen Matrix is a decellularized porous porcine Device Description collagen material which is biocompatible. ABCcolla® Collagen Matrix absorbs exudates, maintains a moist wound environment, and functions to protect the wound. Pre-wetting makes it supple, conforming to the contour of the wound site. ABCcolla® Collagen Matrix is supplied in double peel-open pouches that is terminally sterilized via gamma irradiation.
ABCcolla® Collagen Matrix is intended to be used for management Intended Use of wounds, including partial and full thickness wounds, venous ulcers, pressure ulcers, chronic vascular ulcers, diabetic ulcers, tunneled/ undermined wounds, surgical wounds (donor site/ grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, and skin tears), first and second-degree burns, draining wounds.
Sterilization Gamma irradiation

Packaging Double peel-open Tyvek pouch

Technological ABCcolla® Collagen Matrix has been designed and manufactured to be substantially equivalent to predicate device and reference Characteristics device listed for safety and effectiveness. CollaWound wound dressing, K090894 Matristem® Wound Matrix, K112409

Biocompatibility Biocompatibility studies were performed in accordance with ISO 10993.
Absorbency was performed in accordance with EN 13726-1:2002. Performance Data In vitro degradation, collagen content, and moister content were also analyzed.

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Image /page/5/Picture/0 description: The image features the logo for ACRO Biomedical Co., Ltd. On the left is a stylized cross in gray and red, with a green leaf element integrated into the upper right quadrant of the cross. To the right of the logo is the company name, "ACRO Biomedical Co., Ltd.", in a simple, sans-serif font.

Animal Data	Wound healing study in animals was performed to evaluate thewound healing effect of ABCcolla® Collagen Matrix
Substantial	ABCcolla® Collagen Matrix is substantially equivalent to the
Equivalence	predicate device with respect to functionality, design, materials,
Summary	sterilized method, absorption, package material, intended use andperformance characteristics.
Conclusion	Based on the 510(k) summaries and the information providedherein, we conclude that ABCcolla® Collagen Matrix issubstantially equivalent to the predicate device under the FederalFood, Drug, and Cosmetic Act.

Regulation Number and Section

N/A