Search Results

CollOvine™ Wound Dressing is indicated for the management of exuding wounds including:

• full-thickness & partial-thickness wounds
• pressure ulcers
• venous ulcers
• ulcers caused by mixed vascular etiologies
• diabetic ulcers
• superficial second-degree burns
• donor sites and other bleeding surface wounds
• abrasions
• traumatic wounds healing by secondary intention
• dehisced surgical incisions

CollOvine Wound Dressing is a sterile advanced wound care device composed of medical grade ovine collagen. CollOvine Wound Dressing is soft, absorbent, and readily conforms to the wound bed. CollOvine Wound Dressing is available in multiple sizes; 1"x1", 2"x2" and 4"x4". CollOvine wound dressing is intended to maintain the moist microenvironment. CollOvine Wound Dressing is a primary wound dressing that can be cut with sterile scissors to ensure good contact with the wound bed. CollOvine Wound Dressing should be used with suitable non-occlusive absorbent secondary dressing and secured with standard non-irritating fixations such as medical grade tape or semi-occlusive dressing as appropriate. CollOvine Wound Dressing is a primary dressing, to maintain the required moist wound bed environment. CollOvine Wound Dressing is soft and pliable. The ovine collagen for CollOvine Wound dressing is obtained from sheep in compliance with ISO22442, including controls of animal tissue sourcing, collection, storage and viral inactivation.

The provided FDA 510(k) clearance letter for the CollOvine™ Wound Dressing does not contain any information about acceptance criteria or a study that proves the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (Fibracol Plus Collagen wound dressing with Alginate) based on non-clinical testing in a side-by-side comparison.

Therefore, I cannot fulfill your request for the specific details you've asked for, as they are not present in the provided text.

Here is a breakdown of what is contained in the document related to testing, and why it doesn't align with your request for acceptance criteria and a study proving device performance:

1. A table of acceptance criteria and the reported device performance

• Not present. The document lists the Indications for Use for both the CollOvine Wound Dressing and the predicate device, showing they are identical. It also presents a "Technological Comparison" table that details attributes like classification, product code, regulatory class, indications for use, manufacturer, material, origin, device characteristics, biocompatibility, reusability, and sterilization method. This table focuses on comparing attributes rather than defining performance acceptance criteria or reporting specific performance metrics against those criteria. The “Device Characteristics” for both are simply listed as “Collagen” and “Collagen with 10% calcium alginate” respectively, which is a material description, not a performance metric.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not present. The document describes non-clinical biocompatibility testing (Acute systemic toxicity, Primary skin irritation, Dermal sensitization, Pyrogenicity, Subacute Systemic toxicity, Subcutaneous implant, In vitro Cytotoxicity, Chemical Characterization, Toxicological Risk assessment). For these tests, sample sizes and data provenance are not provided. These are generally standard biological safety tests, not clinical performance studies.

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)

• Not present. This information is typically relevant for studies involving human assessment or interpretation (e.g., radiology AI devices). This is not applicable to the non-clinical biocompatibility and physiochemical testing described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not present. Adjudication methods are typically used in clinical studies where expert consensus is needed. This is not mentioned for the non-clinical tests.

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

• Not present. An MRMC study is a type of clinical study, often used for diagnostic devices involving human interpretation (like AI in radiology). The document describes a wound dressing, and the testing conducted is non-clinical.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not present. This concept is specific to AI or software-as-a-medical-device (SaMD). The CollOvine Wound Dressing is a physical product, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not present. For the non-clinical biocompatibility tests, "ground truth" would be established by the results of standardized biological assays comparing the device's effects to known safety profiles or controls. For pH and absorbency tests, the "ground truth" is the measured physical property itself, compared to the predicate. No expert consensus or pathology is mentioned.

8. The sample size for the training set

• Not present. Training sets are relevant for AI/machine learning models. This is a physical wound dressing device.

9. How the ground truth for the training set was established

• Not present. As above, not relevant for this type of device.

Summary of what the document does provide regarding testing:

• Study Objective (Implied): To demonstrate substantial equivalence to the predicate device (Fibracol Plus Collagen wound dressing with Alginate, K982597) through non-clinical testing.
• Tests Performed:
  • Biocompatibility testing in compliance with ISO 10993 Part 1 Biological Evaluation of Medical Devices, including:
    • Acute systemic toxicity (in mice)
    • Primary skin irritation (in rabbits)
    • Dermal sensitization (in Guinea pigs)
    • Pyrogenicity (in rabbits)
    • Subacute Systemic toxicity (in rats; 30 days intraperitoneal route)
    • Subcutaneous implant (in rats, 1-week and 4-weeks)
    • In vitro Cytotoxicity (Direct cell contact)
    • Chemical Characterization
    • Toxicological Risk assessment
  • pH and absorbency testing (results stated as "found to be similar to that of the primary predicate Fibracol Plus wound dressing").
• Conclusion: Based on the non-clinical testing, CollOvine wound dressing is substantially equivalent to the predicate device.

In essence, the document serves as a regulatory clearance (510(k)) based on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical, benchtop, and biocompatibility studies, rather than a clinical performance study with predefined acceptance criteria for patient outcomes.

Ask a specific question about this device