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510(k) Data Aggregation
(269 days)
DALIM TISSEN CO., LTD.
Collagen Wound Dressing is intended use for management of partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, tunneled / undermined wounds, surgical wound (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.
Collagen Wound Dressing (Absorbable Collagen Membrane) is a sterile, pliable porous and dense wound dressing made of highly purified collagen derived from porcine skin. It is crosslinked using 1-ethyl-3-(3-dimethyl aminopropyl) carbodiimide (EDC) for the resistance to enzymatic degradation. Collagen Wound Dressing is completely absorbable and highly biocompatible. Collagen Wound Dressing is composed of porous sponge layer for the wound surface and dense film layer for protecting wound from outside.
1. Acceptance Criteria and Reported Device Performance
This submission is for a Collagen Wound Dressing and does not involve an AI/ML device. The "acceptance criteria" and "reported device performance" are framed in terms of biocompatibility and substantial equivalence to a predicate device, rather than diagnostic accuracy metrics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Composition and Design: Pliable porous and dense scaffold agent made of highly purified porcine-derived collagen. | Substantially Equivalent: Collagen Wound Dressing (Absorbable Collagen Membrane) is a sterile, pliable porous and dense wound dressing made of highly purified collagen derived from porcine skin. It is crosslinked to resist enzymatic degradation, completely absorbable, and highly biocompatible. It is composed of a porous sponge layer and a dense film layer. This composition is considered substantially equivalent to the predicate device, which is also a sterile, pliable porous wound dressing made of highly purified porcine-derived collagen. |
| Intended Use: Management of partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, tunneled/undermined wounds, surgical wounds, trauma wounds, and draining wounds. | Same as Predicate Device: The intended use is stated as "Same as predicate device" and explicitly lists: pressure ulcers, venous ulcers, diabetic ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. |
| Biocompatibility: Meet requirements of ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing. | Passed: Collagen Wound Dressing was subjected to a panel of tests to assess biocompatibility in accordance with ISO 10993-1 and passed the requirements of all tests. |
| Purity and Identity: Confirmation of purity and identity of Type I collagen. | Confirmed: The purity and identity of Type I collagen have been confirmed by SDS-PAGE analysis. |
| Viral Inactivation and Removal: Confirmation of viral inactivation and removal. | Confirmed: Viral inactivation and removal have been confirmed. |
| Safety and Effectiveness: Demonstrate substantial equivalence to a legally marketed predicate device. | Substantially Equivalent: The Collagen Wound Dressing is found to be substantially equivalent to the predicate device (TheraForm™ Standard / Sheet, K090812) in design, material, and its intended use, and meets the requirements for premarket notification, thus deemed as safe and effective. |
Note: This device is a medical wound dressing and not an AI/ML diagnostic or assistive device. Therefore, several of the requested categories related to AI/ML studies are not applicable to this submission.
2. Sample Size Used for the Test Set and Data Provenance:
No clinical testing was performed for this submission. The evaluation was based on non-clinical testing for biocompatibility and comparison to a predicate device. Therefore, there is no "test set" in the context of an AI/ML algorithm evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable, as no test set requiring expert ground truth for an AI/ML algorithm was used.
4. Adjudication Method for the Test Set:
Not applicable, as no test set requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted. This device is a wound dressing, not an AI assistance tool for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable, as this is a physical medical device and not an algorithm.
7. Type of Ground Truth Used:
For the non-clinical testing, the "ground truth" was established by adherence to recognized international standards and analytical methods:
- Biocompatibility: Adherence to ISO 10993-1 requirements.
- Purity and Identity: Confirmed by SDS-PAGE analysis.
- Viral Inactivation and Removal: Confirmed by specific testing for these properties.
For substantial equivalence, the "ground truth" was the characteristics and performance of the legally marketed predicate device, TheraForm™ Standard / Sheet (K090812).
8. Sample Size for the Training Set:
Not applicable, as this is not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device submission.
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