← Product Code KGN · K233378 # ABCcolla® Collagen ADM Scaffold (K233378) _Acro Biomedical Co., Ltd. · KGN · Oct 18, 2024 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K233378 ## Device Facts - **Applicant:** Acro Biomedical Co., Ltd. - **Product Code:** KGN - **Decision Date:** Oct 18, 2024 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## 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. ## Device Story ABCcolla® Collagen ADM Scaffold is a decellularized porcine collagen biomaterial derived from porcine dermis; supplied in particle form (< 250um). Device applied to wounds by professional surgical surgeons in clinical settings. Principle of operation involves absorption of wound exudates to maintain a moist wound environment, facilitating healing. Device is sterile (gamma-irradiation, SAL ≤ 10^-6) and intended for single use. Clinical benefit derived from providing a scaffold for wound management. Healthcare providers apply the scaffold directly to the wound site; output is the physical presence of the collagen matrix within the wound bed to support management. ## Clinical Evidence Bench testing only. Biocompatibility testing performed per ISO 10993, including cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity, and genotoxicity. Performance evaluated in a full-thickness skin defect rat model, confirming safety in application. ## Technological Characteristics Decellularized porcine dermis-derived Type I collagen; particle form (< 250um). Sterilized via gamma-irradiation. Packaged in Tyvek pouch with glass bottle. No electronic components or software. ## Predicate Devices - ABCcolla® Collagen Matrix ([K162348](/device/K162348.md)) ## Reference Devices - Cook® ECM Powder ([K152033](/device/K152033.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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" {1}------------------------------------------------ (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. {2}------------------------------------------------ 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 {3}------------------------------------------------ ### 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)
| #### 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." {4}------------------------------------------------ # 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 | {5}------------------------------------------------ - 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 {6}------------------------------------------------ | 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. | {7}------------------------------------------------ | | 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®
Collagen ADM
Scaffold was same
as predicate device
and reference
device. | | | New device | Predicate device | Reference device | | | Item | ABCcolla® Collagen
ADM Scaffold | ABCcolla® Collagen
Matrix | Cook® ECM Powder | Same/ Difference
Interpretation | | | surgery, post-laser
surgery, podiatric, wound
dehiscence), trauma
wounds (abrasions,
lacerations, and skin
tears), first and second-
degree burns, draining
wounds. | post-laser surgery, podiatric,
wound dehiscence), trauma
wounds (abrasions,
lacerations, and skin tears),
first and second-degree
burns, draining wounds. | ulcers
tunneled/undermined
woundssurgical wounds
(donor sites/grafts,
post-Moh's surgery,
post-laser surgery
podiatric, wound
dehiscence)trauma wounds
(abrasions,
lacerations, second-
degree burns, and
skin tears)draining wounds | | | 5.
User | Professional surgical
surgeon | Professional surgical
surgeon | Professional surgical
surgeon | Same | | 6.
Material | Porcine dermis derived
collagen material | Porcine small intestinal
submucosa derived collagen
material | Porcine small intestinal
submucosa | The source of
material was the
same, from porcine
tissue. | | Item | New device | Predicate device | Reference device | | | | ABCcolla® Collagen
ADM Scaffold | ABCcolla® Collagen
Matrix | Cook® ECM Powder | Same/ Difference
Interpretation | | 7.
Material
Characterization | Type I collagen | Type I collagen | Type I collagen | Same | | 8.
Structure | Powder | Sheet form | Powder | ABCcolla®
Collagen ADM
Scaffold was same
as reference device.
But, different
compared to the
predicate, the
difference does not
raise different
questions of safety
and effectiveness. | | 9.
Dimensions | Particles < 250um | 1*2 cm to 5*10 cm
1*1 inch to 2*2 inch | Particles < 1000um | The appearance of
new device is
similar to reference
device; but different
compared to the
predicate, the
difference does not | | Item | New device
ABCcolla® Collagen
ADM Scaffold | Predicate device
ABCcolla® Collagen
Matrix | Reference device
Cook® ECM Powder | Same/ Difference
Interpretation | | | | | | raise different
questions of safety
and effectiveness. | | 10.
Packaging | peel packages with glass
bottle | Double peel-open Tyvek
pouch | n/a | Different compared
to the predicate but
the difference does
not raise different
questions of safety
and effectiveness. | | 11.
Sterilization
Method | Gamma-irradiation | Gamma-irradiation | Ethylene Oxide | The sterilization
method of
ABCcolla®
Collagen ADM
Scaffold is similar
with predicate
device. | | 12.
Sterility | SAL ≤ 10-6
single use | Sterile
single use | Sterile
single use | Same | | 13.
Biocompatibility | Biocompatibility
Assessments were
performed Cytotoxicity, | Biocompatibility assessment
conducted according to ISO
10993-1 | Biocompatibility
assessment conducted
according to ISO 10993-1 | ABCcolla®
Collagen ADM
Scaffold is | | | New device | Predicate device | Reference device | | | Item | ABCcolla® Collagen | ABCcolla® Collagen | Cook® ECM Powder | Same/ Difference | | | ADM Scaffold | Matrix | | Interpretation | | | 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. | | | compliance with ISO
10993, and the test
results confirmed
product safety. | ## Substantial Equivalence Comparison Table {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ --- **Source:** [https://fda.innolitics.com/device/K233378](https://fda.innolitics.com/device/K233378) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com