(139 days)
Procoll may be used for the management of full and partial thickness wounds including:
- Diabetic ulcers .
- . Venous ulcers
- Pressure ulcers .
- Ulcers caused by mixed vascular etiologies
- Abrasions .
- . Traumatic wounds
- 1st and 2nd degree burns .
- Dehisced surgical wounds .
- Exuding wounds .
Procoll is a collagen matrix, conformable and resorbable, manufactured from purified type I collagen derived from bovine Achilles tendon. Procoll is supplied sterile and non-pyrogenic, in various sizes, and for single use only.
This document describes the 510(k) premarket notification for a device named "Procoll," a collagen matrix wound dressing. The submission asserts that Procoll is substantially equivalent to a predicate device, Collagen Sponge (K092805).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain any explicit acceptance criteria for device performance in terms of clinical outcomes or specific quantitative metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on material composition, manufacturing processes, and biocompatibility.
The "reported device performance" is essentially the evidence presented to support substantial equivalence:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Composition Equivalence | Procoll is produced using the same exact materials (purified type I collagen from bovine Achilles tendon) as Collagen Sponge (K092805). Biochemical characterization confirmed predominantly Type I collagen, not denatured during processing. |
| Manufacturing Process Equivalence | Procoll is produced using the same processes as Collagen Sponge. |
| Biocompatibility (per ISO 10993-1: 2009 requirements) | Evaluation completed in line with ISO 10993-1:2009. No new biocompatibility issues arising with the use of Procoll. |
| Sterility & Non-pyrogenicity | Procoll is supplied sterile and non-pyrogenic. |
| Viral Inactivation | Viral inactivation validation assessment on collagen demonstrates the material post-processing can be assumed not to contain any pathogenic organisms. |
| Intended Use Equivalence | Procoll's intended uses for full and partial thickness wounds (Diabetic ulcers, Venous ulcers, Pressure ulcers, Ulcers caused by mixed vascular etiologies, Abrasions, Traumatic wounds, 1st and 2nd degree burns, Dehisced surgical wounds, Exuding wounds) are implicitly considered equivalent to the predicate device, as this is a key component of substantial equivalence. |
| Mechanism of Action Equivalence (implied for collagen matrix) | Procoll is a collagen matrix, conformable and resorbable, consistent with the known mechanism of action for such wound dressings. |
2. Sample Size Used for the Test Set and Data Provenance
This submission is a 510(k) for substantial equivalence, not a clinical trial report. Therefore, there is no "test set" in the sense of a patient cohort evaluated for clinical outcomes. The "testing" referred to is for material characterization, biocompatibility, and viral inactivation.
- Sample Size: Not applicable in the context of a clinical test set. Material samples were tested for composition and safety.
- Data Provenance: The biocompatibility testing and biochemical characterization were conducted internally or by contracted labs. The viral inactivation validation was also conducted. The country of origin of the data is not explicitly stated beyond the submitter's location in Ireland. This is retrospective in the sense that it's laboratory testing and characterization, not prospective human clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as there was no clinical "test set" or "ground truth" derived from expert consensus on clinical outcomes. The "ground truth" for the material properties and safety aspects would be established by standard analytical and biological testing methodologies and interpretations by qualified laboratory personnel and regulatory affairs experts. Their specific number and qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
This is not applicable as there was no clinical "test set" requiring adjudication of outcomes.
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. This device is a wound dressing, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This device is a physical wound dressing, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" here refers to the verifiable properties of the device and its safety characteristics, not clinical outcomes.
- Material Composition: Established through biochemical characterization (e.g., spectroscopy, chromatography) confirming Type I collagen and its non-denatured state.
- Biocompatibility: Established through in-vitro and in-vivo testing according to ISO 10993-1:2009 standards, interpreted by toxicologists and biocompatibility experts.
- Viral Inactivation: Established through validated viral inactivation studies demonstrating the reduction or elimination of pathogenic organisms.
- Sterility and Non-pyrogenicity: Established through standard microbiological and pyrogenicity testing methods.
Essentially, the ground truth is based on recognized scientific and regulatory testing standards for medical device materials and safety.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of machine learning or AI for this device. The development of Procoll involved material science, manufacturing process development, and safety testing, not statistical model training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there was no training set.
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