(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 |
N/A