(30 days)
gel-e Flex+ gel OTC is indicated for the local management of bleeding wounds such as minor lacerations and minor abrasions.
gel-e Flex+ gel OTC is a laboratory tested non-irritating topical chitosan-based gel designed to rapidly (within 30 to 60 seconds) promote hemostasis when in contact with a bleeding wound. Gel-e Flex+ gel OTC is a clear, convenient, and easy to apply gel that can be used with commercially available gauze.
The provided text describes a 510(k) submission for the gel-e Flex+ gel OTC device, which is indicated for the local management of bleeding wounds such as minor lacerations and minor abrasions. The submission primarily focuses on establishing substantial equivalence to a predicate device (gel-e Flex+, K182811), rather than proving the device meets a specific set of acceptance criteria through a standalone clinical study with human data or an AI algorithm.
Therefore, many of the requested details regarding acceptance criteria, AI algorithm performance, multi-reader multi-case studies, and detailed ground truth establishment for large datasets are not applicable to this 510(k) summary. This submission relies heavily on comparisons to the predicate device and in vitro/in vivo (animal) studies to demonstrate performance and safety.
However, I can extract information related to the performance data provided and present it in a structured way that addresses the applicable questions.
Device Studied: gel-e Flex+ gel OTC (K192667)
Indication for Use: Local management of bleeding wounds such as minor lacerations and minor abrasions.
Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" in this 510(k) context refers to demonstrating that the modified device performs comparably to or as expected, given its intended use and the performance of the predicate device. It's not presented as a set of quantified thresholds for, for example, diagnostic accuracy of an AI algorithm.
| Acceptance Criteria Category (Implied by FDA Review) | Reported Device Performance (Summary from 510(k)) |
|---|---|
| Hemostasis Efficacy | In vivo preclinical studies in a controlled acute swine model of skin laceration showed that "gel-e Flex+ gel OTC functioned as intended and the control of bleeding observed was as expected." Both the predicate and subject devices operate by the same mechanism of action and use the same materials, implying similar efficacy. |
| Preservation Effectiveness | Established in accordance with USP (Preservative Effectiveness Testing). The device met the acceptance criteria for 5 strains of microbial challenge organisms, demonstrating effective preservation for a period of 2 years. |
| Biocompatibility | Representative samples underwent testing per ISO 10993-1, covering cytotoxicity, irritation, sensitization, systemic toxicity, and pyrogenicity. The results demonstrate biocompatibility. |
| Bench Testing (Physical/Chemical Properties) | Representative samples underwent bench testing for pH and viscosity. The performance of gel-e Flex+ gel OTC was "substantially equivalent to the predicate device, gel-e Flex+." |
| Packaging Integrity | Packaging underwent testing including burst pressure and dye penetration testing. |
| Shelf-life and Use-life Stability | Shelf-life and use-life stability testing was conducted. Most notably, the "use life" (life after initially opening the product) was extended from 28 days for the predicate to 2 years for gel-e Flex+ gel OTC. This indicates that the device maintains its properties and effectiveness over this extended period. This was a key modification addressed in the submission, supported by the preservative effectiveness testing and other stability data. The device stability was demonstrated to support the 2-year use life claim. |
| Sterility Status | The device is "Not provided sterile." This is a change from the predicate which was terminally sterilized with gamma radiation. The acceptance for this change is implied by the FDA's acceptance of the 510(k) without requiring sterility for an OTC topical wound dressing. This is likely supported by the preservative effectiveness testing which addresses microbial load within the product. |
Study Details for Demonstrating Performance
Given that this is a 510(k) for a topical wound gel, not an AI/software device, the following points are addressed based on the provided information. Many questions are Not Applicable (N/A) in this context.
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Sample size used for the test set and the data provenance:
- Animal Studies: Mentioned as "preclinical studies... in a controlled acute swine model of skin laceration." No specific number of animals ("sample size") is given. The data provenance is pre-clinical animal study.
- Preservative Effectiveness Testing: In accordance with USP , which involves challenging the product with 5 specific microbial strains (e.g., S. aureus, P. aeruginosa, E. coli, C. albicans, A. brasiliensis). The "test set" here refers to the product samples subjected to microbial challenge. No specific sample size (N) of product units tested is provided, but it would align with standard laboratory testing protocols for USP.
- Biocompatibility/Bench/Packaging/Stability: These involve laboratory testing on a sufficient number of representative device samples to meet the requirements of the standards (ISO 10993-1, internal stability protocols, etc.). Specific sample sizes (N) are not detailed in the summary but performed according to established protocols.
- Data Provenance: All data appears to be from laboratory and pre-clinical animal studies, likely conducted by or for the manufacturer. No indication of retrospective or prospective human clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This device is a wound gel, and the "ground truth" for its performance (hemostasis, stability, biocompatibility) is established through standardized laboratory tests and observation in animal models, not through expert human interpretation of images or clinical outcomes in the same way an AI diagnostic device would be evaluated. Results are objective measurements (e.g., pH, viscosity, time to hemostasis, microbial counts) or adherence to pass/fail criteria of specific standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not relevant for laboratory or animal efficacy studies.
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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:
- N/A. This is not an AI/software device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This is not an AI/software device.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For Hemostasis: The "ground truth" was the observed time to hemostasis/bleeding control in a controlled acute swine model of skin laceration, compared to expected performance and the predicate device. This is an objective physiological outcome in an animal model.
- For Preservative Effectiveness: Meeting the quantitative acceptance criteria for reduction/maintenance of microbial challenge organisms as defined by USP .
- For Biocompatibility: Adherence to the pass/fail criteria of ISO 10993-1 standards for various biological endpoints.
- For Bench Testing/Stability: Measured physical and chemical properties (e.g., pH, viscosity) falling within pre-defined specifications and maintaining stability over time.
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The sample size for the training set:
- N/A. This refers to a manufactured medical device, not an AI model that requires a training set. The "training" in this context would be the R&D and formulation process to develop the gel, which is not quantified by a "training set size."
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How the ground truth for the training set was established:
- N/A. See point 7.
N/A