(128 days)
CovaClearAg™ Collagen with Silver, Antimicrobial Gel Sheet Dressing is indicated for the management of full and partial thickness wounds including:
Pressure ulcers, Diabetic ulcers, Ulcers caused by mixed vascular etiologies, Venous ulcers, Donor and Graft sites, Abrasions and lacerations, Traumatic wounds healing by secondary intention, Dehisced surgical wounds, First & Second degree burns.
CovaClearAg™ Collagen with Silver, Antimicrobial, Gel Sheet Dressing is an advanced wound care dressing composed of collagen and silver lactate provided in a sterile sheet. CovaClearAg™ Collagen with Silver. Antimicrobial Dressings are pliable, hydrated collagen sheets that maintain a moist environment at the wound surface that aids in the formation of granulation tissue and epithelialization. Because of its significant water content (77.5%), the dressing provides hydration to the wound surface. The dressings act as an effective barrier to bacterial and fungal penetration. The silver content is intended to prevent colonization of the dressing. The dressings can be cut to fit specific wounds and can be layered for the management of deep wounds.
The provided 510(k) summary does not contain a typical acceptance criteria table with numerical performance goals for CovaClearAg™ Collagen with Silver, Antimicrobial Gel Sheet Dressing. This submission is for a wound dressing, and the evaluation focuses on demonstrating substantial equivalence to predicate devices through material composition, intended use, and biocompatibility, rather than a clinical performance study with specific quantitative acceptance criteria for a diagnostic or interventional device.
However, based on the document, we can infer the "acceptance criteria" were primarily demonstrating:
- Substantial Equivalence in composition and intended use to identified predicate devices: ColActiveAg™ Collagen with Silver Antimicrobial Dressing (K043296) and SilvaSorb® Silver Antimicrobial Dressing (K002599).
- Biocompatibility: The device is safe for its intended topical use.
- Antimicrobial Effect: The device functions as claimed with respect to its antimicrobial properties.
- Viral Inactivation: For the raw material (gelatin), demonstration of inactivation of Porcine Parvo Virus (PPV) and Swine Influenza Virus (SIV).
Here's a breakdown of the requested information based on the provided text, acknowledging the nature of this particular 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Conclusion |
|---|---|---|
| Substantial Equivalence | Device must be comparable in composition, materials, sterility, comparable sizes, biocompatibility testing (performed), antimicrobial effect (reported), and intended use to predicate devices (ColActiveAg™ and SilvaSorb®). | "It has been shown that CovaClearAg™ is comparable in composition with the predicate devices and shows substantial equivalence." The comparative table (pg 3/4) explicitly lists "Yes" for comparable sizes, biocompatibility testing (performed), and antimicrobial effect, and shows identical intended uses for CovaClearAg™ and its predicates. Materials are also compared. |
| Biocompatibility | Device must be biocompatible as outlined in G95-1 ("Biological Evaluations of Medical Devices Part 1: Evaluation and Testing") and consistent with the 'Draft Guidance for the Preparation of a Pre-market Notification for a Non-Interactive Wound and Burn Dressing'. Testing performed on the finished packaged device after validated sterilization. | "CovaClear Ag™ Collagen with Silver, Antimicrobial Gel Sheet Dressing has been tested for biocompatibility as outlined in the General Program Memorandum -#G95-1... Attachment 1 contains a testing schedule of all biocompatibility tests conducted that demonstrate that CovaClear Ag ™... is biocompatible, along with all test results." "The Biocompatibility testing shows safety of the product." |
| Antimicrobial Function | Device must demonstrate antimicrobial effect. | "Results of the Kirby-Bauer testing shows the product functions with respect to its antimicrobial claims." The comparative table also indicates "Yes" for "Antimicrobial Effect." |
| Viral Inactivation | For the gelatin raw material (same as predicate ColActiveAg™), demonstration of inactivation of Porcine Parvo Virus (PPV) and Swine Influenza Virus (SIV) during manufacturing or sterilization processes, supported by literature review. (This was a concern noted in the predicate's 510(k) filing and addressed for that device, which then applied to this one as it uses the same gelatin). | "For that 510(k) filing [ColActiveAg™], Covalon conducted a review of the manufacturing process of the raw material as well as the sterilization process and how it affects the PPV and SIV, and included an extensive literature review to support the inactivation of the two aforementioned viruses. The data provided demonstrated the inactivation of both viruses and consequently the safety of the raw material. (Attachment XII)" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) summary. The submission relies on laboratory (biocompatibility, antimicrobial) and literature data to demonstrate substantial equivalence to legally marketed predicate devices, rather than a prospective clinical trial with a "test set" of patients.
- Data Provenance: The biocompatibility and antimicrobial testing were performed by the manufacturer, Covalon Technologies Ltd., or contracted labs. The viral inactivation data was re-used from the predicate device's (ColActiveAg™) submission, involving a review of manufacturing processes and an extensive literature review. The country of origin for these specific tests is not explicitly stated but would likely be Canada (where the company is based) or a recognized contract lab. The review of manufacturing processes and literature is inherently retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as there was no "test set" of clinical cases requiring expert interpretation to establish ground truth. Substantial equivalence relies on technical, material, and performance comparisons to predicate devices, supported by laboratory testing.
4. Adjudication Method for the Test Set
- Not applicable as there was no "test set" or clinical data requiring adjudication.
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 applicable. This device is a wound dressing, not an imaging or diagnostic device involving human readers or AI.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a medical device (wound dressing), not an algorithm or AI.
7. The Type of Ground Truth Used
- Substantial Equivalence: The ground truth for this aspect is the established regulatory clearance of the predicate devices based on their safety and effectiveness.
- Biocompatibility: The ground truth is laboratory testing results conforming to ISO 10993 standards.
- Antimicrobial Effect: The ground truth is laboratory testing results from Kirby-Bauer diffusion tests.
- Viral Inactivation: The ground truth is data from validated manufacturing processes and scientific literature demonstrating the inactivation of specific viruses.
8. The Sample Size for the Training Set
- Not applicable. This is a medical device, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
N/A