(382 days)
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.
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.
This document is a 510(k) premarket notification for the ABCcolla® Collagen ADM Scaffold, a medical device for wound management. The core of the submission is to demonstrate the substantial equivalence of the new device to a legally marketed predicate device, ABCcolla® Collagen Matrix (K162348), and a reference device, Cook® ECM Powder (K152033).
Based on the provided text, the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" are not related to an AI/ML-driven device's performance in terms of diagnostic accuracy or a clinical study in humans with a traditional statistical endpoint and acceptance criteria. Instead, the "acceptance criteria" for this specific device (a collagen scaffold for wound management) are primarily focused on benchmarking against a predicate device to demonstrate "substantial equivalence" as required by the FDA 510(k) pathway. The "study" here refers to the pre-clinical testing and characterization that demonstrates the new device has similar technological characteristics and performance to the predicate device, and any differences do not raise new questions of safety or effectiveness.
Here's an interpretation of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, "acceptance criteria" are not typically framed as specific performance metrics and thresholds like sensitivity/specificity for an AI device. Instead, the acceptance is based on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This is achieved by comparing various characteristics.
Here's a table based on the "Substantial Equivalence Comparison Table" in the document, interpreting "acceptance criteria" as demonstrating "sameness" or "differences that do not raise new questions of safety/effectiveness" compared to the predicate/reference devices:
| Characteristic | Predicate Device (ABCcolla® Collagen Matrix) Performance | Reference Device (Cook® ECM Powder) Performance | New Device (ABCcolla® Collagen ADM Scaffold) Performance | Acceptance Criteria (Implicit for 510(k)) | Interpretation/Result (From Document) |
|---|---|---|---|---|---|
| 1. 510(k) Number | K162348 | K152033 | N/A (New Submission) | Not Applicable (for comparison) | -- |
| 2. Product Code | KGN | KGN | KGN | Same | Same |
| 3. Classification | Unclassified | Unclassified | Unclassified | Same | Same |
| 4. Intended Use | 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, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, and skin tears), first and second-degree burns, draining wounds. | Similar wording for wound management categories | 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. | Substantially similar | ABCcolla® Collagen ADM Scaffold was same as predicate device and reference device. |
| 5. User | Professional surgical surgeon | Professional surgical surgeon | Professional surgical surgeon | Same | Same |
| 6. Material | Porcine small intestinal submucosa derived collagen material | Porcine small intestinal submucosa | Porcine dermis derived collagen material | Same source (porcine tissue) | The source of material was the same, from porcine tissue. |
| 7. Material Characterization | Type I collagen | Type I collagen | Type I collagen | Same | Same |
| 8. Structure | Sheet form | Powder | Powder | Differences do not raise new questions of safety/effectiveness | 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 | 12 cm to 510 cm, 11 inch to 22 inch | Particles < 1000um | Particles < 250um | Differences do not raise new questions of safety/effectiveness | The appearance of new device is similar to reference device; but different compared to the predicate, the difference does not raise different questions of safety and effectiveness. |
| 10. Packaging | Double peel-open Tyvek pouch | n/a | peel packages with glass bottle | Differences do not raise new questions of safety/effectiveness | Different compared to the predicate but the difference does not raise different questions of safety and effectiveness. |
| 11. Sterilization Method | Gamma-irradiation | Ethylene Oxide | Gamma-irradiation | Same as Predicate | The sterilization method of ABCcolla® Collagen ADM Scaffold is similar with predicate device. |
| 12. Sterility | Sterile, single use | Sterile, single use | SAL ≤ 10-6, single use | Same (in terms of sterility level and single use) | Same |
| 13. Biocompatibility | Assessment according to ISO 10993-1 | Assessment according to ISO 10993-1 | Comprehensive assessment per ISO 10993 | Compliance with ISO 10993; confirmed safety | ABCcolla® Collagen ADM Scaffold is compliance with ISO 10993, and the test results confirmed product safety. |
| Performance Data | N/A (implied clinical use) | N/A (implied clinical use) | Full thickness skin defect rat model results: safe | Safety shown in pre-clinical model | The results of the study show that device is safe in its application. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions one performance study: "A study was performed where the ABCcolla® Collagen ADM Performance Data Scaffold is performed in full thickness skin defect rat model."
- Sample size: Not specified. It only mentions "rat model," not the number of rats.
- Data provenance: Not specified regarding country of origin. This is a pre-clinical animal study, not human data.
- Retrospective or prospective: This would be a prospective animal study as it describes an experiment being "performed."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the provided document does not describe a clinical study in humans or an AI/ML device relying on expert-adjudicated ground truth. The "study" mentioned is an animal model for safety/performance, not human diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. There is no human expert adjudication involved for the "full thickness skin defect rat model."
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a collagen scaffold for wound management, not an AI/ML-driven diagnostic or assistive technology for human readers. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical device (collagen scaffold), not an algorithm or software. It does not have a "standalone" performance in the context of AI/ML.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the mentioned performance data (rat model):
- The "ground truth" would likely be based on histopathology and/or gross observation/measurements of wound healing in the rat model, as is typical for such pre-clinical studies. The document states "The results of the study show that device is safe in its application," implying direct observation and measurement of tissue response.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This is not applicable. There is no "training set."
In summary: The provided document is an FDA 510(k) clearance letter for a biological medical device (collagen scaffold), not an AI/ML device. Therefore, many of the requested points related to AI/ML evaluation (like expert ground truth, MRMC studies, training/test sets, etc.) are not relevant to this type of submission. The "acceptance criteria" are demonstrating substantial equivalence primarily through comparison of materials, design, intended use, and pre-clinical biocompatibility and safety testing against a predicate device.
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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,TaiwanTelephone: +886-7-6955-569Fax: +886-7-6955-069 |
|---|---|
| Contact Person | DAR-JEN HSIEHCEOE 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® CollagenADM Scaffold | ABCcolla® CollagenMatrix | Cook® ECM Powder | Same/ DifferenceInterpretation |
| 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® CollagenADM Scaffold is intendedto be used formanagement of wounds,including venous ulcers,pressure ulcers, chronicvascular ulcers, diabeticulcers, tunneled/undermined wounds,surgical wounds (donorsite/ grafts, post-Moh's | ABCcolla® Collagen Matrixis intended to be used formanagement of wounds,including partial and fullthickness wounds, venousulcers, 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 isintended for themanagement of woundsincluding:●partial and full-thickness wounds●pressure ulcers●venous ulcers●diabetic ulcers●chronic vascular | ABCcolla®Collagen ADMScaffold was sameas predicate deviceand referencedevice. |
| New device | Predicate device | Reference device | ||
| Item | ABCcolla® CollagenADM Scaffold | ABCcolla® CollagenMatrix | Cook® ECM Powder | Same/ DifferenceInterpretation |
| surgery, post-lasersurgery, podiatric, wounddehiscence), traumawounds (abrasions,lacerations, and skintears), first and second-degree burns, drainingwounds. | post-laser surgery, podiatric,wound dehiscence), traumawounds (abrasions,lacerations, and skin tears),first and second-degreeburns, draining wounds. | ulcerstunneled/underminedwoundssurgical wounds(donor sites/grafts,post-Moh's surgery,post-laser surgerypodiatric, wounddehiscence)trauma wounds(abrasions,lacerations, second-degree burns, andskin tears)draining wounds | ||
| 5.User | Professional surgicalsurgeon | Professional surgicalsurgeon | Professional surgicalsurgeon | Same |
| 6.Material | Porcine dermis derivedcollagen material | Porcine small intestinalsubmucosa derived collagenmaterial | Porcine small intestinalsubmucosa | The source ofmaterial was thesame, from porcinetissue. |
| Item | New device | Predicate device | Reference device | |
| ABCcolla® CollagenADM Scaffold | ABCcolla® CollagenMatrix | Cook® ECM Powder | Same/ DifferenceInterpretation | |
| 7.MaterialCharacterization | Type I collagen | Type I collagen | Type I collagen | Same |
| 8.Structure | Powder | Sheet form | Powder | ABCcolla®Collagen ADMScaffold was sameas reference device.But, differentcompared to thepredicate, thedifference does notraise differentquestions of safetyand effectiveness. |
| 9.Dimensions | Particles < 250um | 12 cm to 510 cm11 inch to 22 inch | Particles < 1000um | The appearance ofnew device issimilar to referencedevice; but differentcompared to thepredicate, thedifference does not |
| Item | New deviceABCcolla® CollagenADM Scaffold | Predicate deviceABCcolla® CollagenMatrix | Reference deviceCook® ECM Powder | Same/ DifferenceInterpretation |
| raise differentquestions of safetyand effectiveness. | ||||
| 10.Packaging | peel packages with glassbottle | Double peel-open Tyvekpouch | n/a | Different comparedto the predicate butthe difference doesnot raise differentquestions of safetyand effectiveness. |
| 11.SterilizationMethod | Gamma-irradiation | Gamma-irradiation | Ethylene Oxide | The sterilizationmethod ofABCcolla®Collagen ADMScaffold is similarwith predicatedevice. |
| 12.Sterility | SAL ≤ 10-6single use | Sterilesingle use | Sterilesingle use | Same |
| 13.Biocompatibility | BiocompatibilityAssessments wereperformed Cytotoxicity, | Biocompatibility assessmentconducted according to ISO10993-1 | Biocompatibilityassessment conductedaccording to ISO 10993-1 | ABCcolla®Collagen ADMScaffold 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, AcuteSystemic Toxicity Test,Pyrogen Test, SubacuteSystemic Toxicity Test,Subchronic SystemicToxicity Test, In vitroBacterial Gene MutationTest, In vitro MouseLymphoma Test, In vivoErythrocyte MicronucleusTest, Implantation test(Wound Healing Model)and Toxicological RiskAssessment, in accordancewith ISO 10993. | compliance with ISO10993, and the testresults confirmedproduct safety. |
Substantial Equivalence Comparison Table
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N/A