(261 days)
No
The summary describes a collagen matrix wound dressing and its performance studies, with no mention of AI or ML technology.
Yes
The device is intended for the management and healing of various types of wounds, which are therapeutic actions.
No
The device description and intended use indicate it is a wound management product (collagen matrix wound dressing) designed to protect wounds, absorb exudates, and maintain a moist environment, not to diagnose a condition.
No
The device description clearly states it is a "decellularized porous porcine collagen material," indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "management 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 description details a material used to cover and protect wounds, absorb exudates, and maintain a moist environment. This aligns with a wound dressing or matrix, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility, absorbency, degradation, and wound healing effects in animals. These are relevant to the function of a wound care product, not an IVD.
Therefore, ABCcolla® Collagen Matrix is a medical device intended for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KGN
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.
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)
- 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.
- Wound healing study in animals was performed to evaluate the wound healing effect of ABCcolla® Collagen Matrix
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.
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.
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
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
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)
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.
| 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, K090894 |
| Collamatrix Inc. | |
| Reference Device | • Matristem® Wound Matrix, K112409 |
| ACell, 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 the
wound 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 and
performance characteristics. |
| Conclusion | Based on the 510(k) summaries and the information provided
herein, we conclude that ABCcolla® Collagen Matrix is
substantially equivalent to the predicate device under the Federal
Food, Drug, and Cosmetic Act. |