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510(k) Data Aggregation
(105 days)
Indications for Use (Describe)
Prescription Use
Collagen Wound Dressing is indicated for the management of exuding wounds including:
- Full thickness and partial thickness wounds
- Pressure and venous ulcers
- Ulcers caused by mixed vascular etiologies
- Diabetic ulcers
- Partial thickness burns
- Donor sites and other bleeding surface wounds
- Abrasions
- Traumatic wound healing by secondary intention
- Dehisced surgical incisions
Over-The-Counter Use
Intended for the management of minor cuts, minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns.
Collagen Wound Dressing is a wound care device composed of pure freeze-dried cross-linked bovine collagen. It is a sterile, absorbent, white, porous, topical wound dressing. As a primary wound dressing that can be cut to any size or be used in multi-layers to fit wound. It can also be used in combination with either occlusive or semi-occlusive secondary dressing. The product is biodegradable. Please reapply the dressing as needed based on the patient's wound healing situation.
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(171 days)
The Collagen Wound Dressing is indicated for the management of exuding wounds including: Full thickness and partial thickness wounds Pressure and venous ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers Partial thickness burns Donor sites and other bleeding surface wounds Abrasions Traumatic wound healing by secondary intention Dehisced surgical incisions
Collagen Wound Dressing is an advanced wound care device composed of pure freezedried cross-linked bovine collagen. It is a sterile, absorbent, white, porous, topical wound dressing. As a primary wound dressing, it can be cut to any size or be used in multi-layers to fit wound. It can also be used in combination with either occlusive or semi-occlusive secondary dressing. The product is biodegradable.
The provided text does not describe a study that proves a device meets acceptance criteria for an AI/ML medical device. Instead, it is an FDA 510(k) clearance letter for a Collagen Wound Dressing, which is a physical medical device, not an AI/ML software.
The document discusses non-clinical data, performance tests (e.g., appearance, weight, absorption, pH, heavy metals, sterility, SEM, DSC, FTIR), biocompatibility, sterilization, and shelf-life studies. It explicitly states, "No clinical study is included in this submission."
Therefore, I cannot extract the information for an AI/ML medical device as requested, because the provided text is about a physical wound dressing and does not contain any details related to:
- Acceptance criteria for an AI/ML algorithm's performance (e.g., sensitivity, specificity, AUC)
- Sample sizes for test sets used in AI/ML validation
- Number/qualifications of experts for ground truth establishmen
- Adjudication methods
- MRMC studies
- Standalone algorithm performance
- Type of ground truth (e.g., pathology, outcomes data) in the context of an AI/ML model
- Training set details for an AI/ML model
The request's template is specifically designed for AI/ML device evaluations, which is not applicable to the content of this FDA clearance letter.
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(269 days)
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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(83 days)
Collagen Wound Dressing - Oral is indicated for the management of oral wounds and sores, including:
- Denture sores
- Oral ulcers (non-infected or viral)
- Periodontal surgical wounds
- Suture sites
- Burns
- Extraction sites
- Surgical wounds
- Traumatic wounds
Collagen Wound Dressing - Oral is a white to off-white, absorbent, microfibrillar collagen matrix. The product is supplied sterile and for single use only.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary for a Collagen Wound Dressing-Oral, which is a regulatory document from the FDA. It discusses the device's classification, indications for use, and substantial equivalence to predicate devices, but it does not include details on performance studies with acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies.
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(70 days)
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