FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

FIBRACOL* PLUS Collagen Wound Dressing with Alginate is an advanced wound care device composed of collagen and calcium alginate fibers. FIBRACOL PLUS is twice as absorbent as our traditional FIBRACOL* Dressing. Its unique combination of natural biopolymers created by a patented process combines the structural support of collagen and the gel forming properties of alginates into a sterile, soft, absorbent, conformable topical wound dressing. The dressing is manufactured from bovine collagen and medical grade alginate.

The source of collagen is from bovine hide splits from Australia. The hides are from healthy cattle slaughtered under the supervision of a Government appointed Veterinary Officer and subsequently processed further in a controlled clean room in order to avoid the possibility of boyine spongiform encephalpathy (BSE) contamination. The collagen is linked with the calcium alginate using a patented process.

AI/ML Overview

The provided text is a 510(k) summary for the FIBRACOL* PLUS Collagen Wound Dressing with Alginate, a medical device. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study proving performance against defined acceptance criteria.

Therefore, many of the requested sections regarding the study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness are not applicable or cannot be determined from this submission.

Here's an analysis based on the information available:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Comments
Biocompatibility: Device demonstrates acceptable biological response.	Pass. Tests conducted in accordance with ISO 10993 Part 1 Biological Evaluation of Medical Devices (e.g., Agar Overlay Assay, Hemolysis, MEM Elution Test, Muscle Implantation, Systemic Injection, Rabbit Pyrogen Assay, Primary Skin Irritation, Guinea Pig Maximization).	The document states, "FIBRACOL PLUS has been demonstrated to be an acceptable topical wound dressing" and "FIBRACOL PLUS has been demonstrated to be a safe topical wound dressing in accordance with ISO 10993-1." The specific quantitative acceptance criteria for each test (e.g., cytotoxicity levels, irritation scores) are not provided, but the overall conclusion is positive.
Substantial Equivalence: Device is substantially equivalent and identical in function to predicate devices.	Pass. The device is determined to be substantially equivalent to FIBRACOL* Collagen-Alginate Dressing (K925548) and SORBSAN Topical Wound Dressing (K881854, K914575).	This is the primary "acceptance criterion" for a 510(k) submission. The FDA's letter explicitly states, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have found the device is substantially equivalent...".
Absorbency: Twice as absorbent as traditional FIBRACOL* Dressing.	Stated as a physical characteristic: "FIBRACOL PLUS is twice as absorbent as our traditional FIBRACOL* Dressing."	This is a claim of improved performance over a predecessor, but not explicitly stated as an "acceptance criterion" with a defined quantitative threshold for this specific 510(k). The methodology for determining this absorbency difference is not detailed.
Indications for Use: Safe and effective for specified wound types.	Listed indications for use (e.g., Full thickness & partial thickness wounds, Pressure Ulcers, Venous ulcers, Diabetic ulcers, Second-degree burns, Donor sites).	The FDA concurs with the stated indications, with specific labeling limitations (e.g., not for third-degree burns, no claims of accelerating healing). The clinical evidence to support these indications is implicitly covered by substantial equivalence to predicate devices that have these indications.

Study Details (As applicable to a 510(k) for a basic wound dressing)

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Biocompatibility Tests: The 510(k) does not specify the sample sizes for the in vitro and in vivo biocompatibility tests (e.g., number of cells in agar overlay, number of rabbits/mice for animal studies). Data provenance is internal (Johnson & Johnson Medical).
- Substantial Equivalence: No "test set" in the sense of a clinical performance study. Substantial equivalence relies on comparison to predicate devices already on the market.
- Clinical Data: The 510(k) summary does not include explicit clinical study data with a test set of human patients. Typically, for wound dressings of this type, extensive clinical studies are often not required for 510(k) clearance if substantial equivalence can be demonstrated through material characterization, performance testing, and comparison of indications to a predicate.
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 applicable. For biocompatibility, "ground truth" is established by standard biological testing protocols and expert interpretation of those results by certified labs and regulatory bodies. For substantial equivalence, the "ground truth" is the performance and safety profile of the predicate devices. There's no mention of a ground truth panel of experts for a specific performance test set for this device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication is described in this submission. Biocompatibility test results are typically objective and follow pre-defined criteria, not requiring adjudication in the sense of a clinical expert panel.
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 AI-powered diagnostic or assistive technology.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical wound dressing, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Biocompatibility: Standardized biological test results (e.g., absence of cytotoxicity, irritation, pyrogenicity) as defined by ISO 10993.
- Substantial Equivalence: The safety and efficacy profile of the predicate devices based on their prior clearances and marketing history.
The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set in that context. The "development" of the device involves material selection, manufacturing process optimization, and testing, not algorithmic training.
How the ground truth for the training set was established:
- Not applicable. As above, no training set in the AI sense. The "ground truth" for the device's design and manufacturing is established through material science, engineering principles, and quality control.

Summary of 510(k) Approach:

This 510(k) submission primarily relies on demonstrating substantial equivalence to legally marketed predicate devices. The "study" that proves the device meets the (implied) acceptance criteria is the comprehensive documentation of its composition, physical properties, indications for use, and a battery of biocompatibility tests (in accordance with ISO 10993). The FDA's clearance letter confirms that, based on this information, the device is substantially equivalent to predicates and can be marketed for the stated indications, subject to specific labeling limitations. The document does not describe a clinical trial with a defined "test set" of patients in the way an AI diagnostic device submission would.

Summary

Regulation Number and Section

N/A