Search Results

ColActive® Transfer is indicated for management of full and partial thickness wounds including: pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular etiologies, venous ulcers, second degree burns, donor and graft sites, abrasions, dehisced surgical wounds, traumatic wounds healing by secondary intention.

ColActive® Transfer is a modification to the existing ColActive® Collagen Wound Dressing previously cleared under K050177 on 27th April 2005. ColActive® Transfer is composed of the same base matrix material; collagen and sodium alginate and is made from substantially an equivalent manufacturing process as the predicate. The new product, ColActive® Transfer is a pliable, absorbent, perforated, and biocompatible dressing. ColActive® Transfer dressings absorb and transfer moisture such as wound fluid and maintains a moist environment at the wound surface. The dressings can be cut to fit specific wounds and can be layered for the management of deep wounds. ColActive® Transfer dressings contain multiple holes that are evenly distributed across the surface area in order to facilitate the movement of excess exudates through the dressing and away from the wound. The new product will be supplied sterile packaged in a single use heat sealed medical grade foil pouch. The single use primaries will be packed, with a product insert, into cartons for distribution.

This document is a 510(k) Summary of Safety and Effectiveness for a medical wound dressing, ColActive® Transfer. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics is not explicitly provided in this document.

Here's an analysis based on the provided text:

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

The document does not provide a table of acceptance criteria with specific quantitative targets. Instead, it relies on demonstrating substantial equivalence to a predicate device by comparing technological characteristics and performance through "bench testing."

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

The document mentions "bench testing," including "heat stability, crosslinking, fluid/water absorption, as well as visual testing (Defect Free surface and even dressing thickness)." However, it does not specify sample sizes for these tests or the data provenance. These are laboratory tests typically performed on manufactured batches of devices, not clinical data sets.

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)

This information is not applicable and therefore not provided. The study relies on bench testing of physical properties and comparison to a predicate device, not on expert interpretations or ground truth establishment in a clinical context.

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

This information is not applicable and therefore not provided. Adjudication methods are typically used in clinical studies with human assessors, not for bench testing of physical device properties.

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

An MRMC comparative effectiveness study was not performed. This is a wound dressing, not an AI-powered diagnostic device, so AI assistance is not relevant.

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

This is not applicable. The device is a physical wound dressing; it does not involve any algorithms or AI for standalone performance.

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

The concept of "ground truth" as typically used in AI/diagnostic studies is not applicable here. The "truth" for the performance tests (bench tests) would be the measured physical properties of the device (e.g., absorption capacity in ml/cm², stability at certain temperatures). These are objective measurements against predefined specifications or comparison to the predicate, not subjective expert consensus or clinical outcomes data.

8. The sample size for the training set

This is not applicable as there is no "training set" for this device. It is a physical medical device, not a machine learning model.

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

This is not applicable, as there is no training set or ground truth in that context.

Ask a specific question about this device

The Collagran wound dressing and Collagran Ag wound dressing are intended to be used for the following conditions: the management of full and partial thickness wounds including: pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular etiologies, venous ulcers, first and second degree burns, donor and graft sites, abrasions and lacerations, dehisced surgical wounds, traumatic wounds healing by secondary intention

Not Found

The provided text is a 510(k) premarket notification approval letter for the "Collagran wound dressing" and "Collagran Ag wound dressing." This type of document does not typically contain details about specific acceptance criteria or a study proving that a device meets those criteria in the way a clinical trial report or a performance study summary would.

The letter focuses on the FDA's determination of "substantial equivalence" to a legally marketed predicate device, allowing the devices to be marketed. It lists the intended indications for use (types of wounds the dressing can manage) but does not provide performance metrics or studies proving efficacy/safety beyond saying it is substantially equivalent to existing devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications from this document. This kind of information would typically be found in the 510(k) submission itself, a clinical study report, or a summary of safety and effectiveness, none of which are present here.

Ask a specific question about this device

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:

1. Substantial Equivalence in composition and intended use to identified predicate devices: ColActiveAg™ Collagen with Silver Antimicrobial Dressing (K043296) and SilvaSorb® Silver Antimicrobial Dressing (K002599).
2. Biocompatibility: The device is safe for its intended topical use.
3. Antimicrobial Effect: The device functions as claimed with respect to its antimicrobial properties.
4. 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

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.

Ask a specific question about this device