Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a collagen scaffold for wound management and does not mention any AI or ML components or functionalities.

Therapeutic

Yes
The ABCcolla® Collagen ADM Scaffold is intended for the management of wounds, including various types of ulcers and burns, which are conditions requiring therapeutic intervention.

Diagnostic

No
The device is described as a scaffold used for wound management by absorbing exudates and maintaining a moist environment, which are therapeutic functions, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "decellularized porcine collagen biomaterial," indicating it is a physical material, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is for the management of wounds, which 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 collagen biomaterial applied to a wound to absorb exudates and maintain a moist environment. This is a physical interaction with the wound, not an analysis of biological samples.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information.

The device is a wound dressing/scaffold, which falls under the category of medical devices used for wound care.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

ABCcolla® Collagen ADM Scaffold is intended to be used for management of wounds, including 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.

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

KGN

Device Description

ABCcolla® Collagen ADM Scaffold is a decellularized porcine collagen biomaterial from porcine dermis. When applied on a wound, this product helps absorb wound exudates and maintain a moist wound environment.

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

Professional surgical surgeon

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)

A study was performed where the ABCcolla® Collagen ADM Scaffold is performed in full thickness skin defect rat model. The results of the study show that device is safe in its application.

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.

K162348

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.

K152033

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

Regulation Number and Section

N/A

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 18, 2024

ACRO Biomedical Co., Ltd. Dar-Jen Hsieh CEO 3F., No.57, Luke 2nd Rd., Lujhu Dist. Kaohsiung City, 82151 Taiwan

Re: K233378

Trade/Device Name: ABCcolla® Collagen ADM Scaffold Regulatory Class: Unclassified Product Code: KGN, Dated: September 29, 2023 Received: October 2, 2023

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 (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"

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(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).

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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.

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For comprehensive regulatory information about medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/2/Picture/3 description: The image shows the name "Mustafa A. Mazher" in a large, bold font. Below the name, there is a "-S". The background of the image is a light blue color. The text is black.

For Yu-Chieh Chiu, PhD 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

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Indications for Use

510(k) Number (if known) K233378

Device Name ABCcolla® Collagen ADM Scaffold

Indications for Use (Describe)

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

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510(k) Summary

| Applicant | ACRO Biomedical Co., Ltd.
3rd Fl., 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 | Oct.16.2024 |
| Name of Device | ABCcolla® Collagen ADM Scaffold |
| Common Name | Collagen Wound Dressing |
| Classification | Unclassified |
| Regulation Number | N/A |
| Product Code | KGN |
| Predicate Device | ABCcolla® Collagen Matrix, K162348 |

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Device Description ABCcolla® Collagen ADM Scaffold is a decellularized porcine collagen biomaterial from porcine dermis. When applied on a wound, this product helps absorb wound exudates and maintain a moist wound environment.
Intended Use ABCcolla® Collagen ADM Scaffold is intended to be used for management of wounds, including 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 Packaged in Tyvek pouch and each Tyvek pouch with one glass bottle.
Technological ABCcolla® Collagen ADM Scaffold is a decellularized porcine Characteristics collagen biomaterial and it is a particle form. When applied on a wound, this product helps absorb wound exudates and maintain a moist wound environment.
Biocompatibility Biocompatibility Assessments were performed Cytotoxicity, Intracutaneous Irritation, Skin Sensitization, Acute Systemic Toxicity Test, Pyrogen Test, Subacute Systemic Toxicity Test, Subchronic Systemic Toxicity Test, In vitro Bacterial Gene Mutation Test, In vitro Mouse Lymphoma Test, In vivo Erythrocyte Micronucleus Test, Implantation test (Wound Healing Model) and Toxicological Risk Assessment, in accordance with ISO 10993.
A study was performed where the ABCcolla® Collagen ADM Performance Data Scaffold is performed in full thickness skin defect rat model. The results of the study show that device is safe in its application. Substantial ABCcolla® Collagen ADM Scaffold is substantially equivalent to

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Equivalence Summary	the predicate device with respect to materials, physicochemical properties, biocompatibility and performance characteristics.
Conclusion	Based on the 510(k) summaries and the information provided herein, we conclude that ABCcolla® Collagen ADM Scaffold is substantially equivalent to the predicate device under the Federal Food, Drug, and Cosmetic Act.

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	New device	Predicate device	Reference device
Item	ABCcolla® Collagen
ADM Scaffold	ABCcolla® Collagen
Matrix	Cook® ECM Powder	Same/ Difference
Interpretation
1.
510(k) Number	N/A	K162348	K152033	--
2.
Product Code	KGN	KGN	KGN	Same
3.
Classification	Unclassified	Unclassified	Unclassified	Same
4.
Intended Use	ABCcolla® Collagen
ADM Scaffold is intended
to be used for
management of wounds,
including venous ulcers,
pressure ulcers, chronic
vascular ulcers, diabetic
ulcers, tunneled/
undermined wounds,
surgical wounds (donor
site/ grafts, post-Moh's	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,
diabetic ulcers, tunneled/
undermined wounds,
surgical wounds (donor site/
grafts, post-Moh's surgery,	Indications For Use:
Cook® ECM Powder is
intended for the
management of wounds
including:
●
partial and full-
thickness wounds
●
pressure ulcers
●
venous ulcers
●
diabetic ulcers
●
chronic vascular

            | ABCcolla®