(478 days)
Sorbastace is indicated for use to absorb body fluid and to stop minor bleeding in fresh traumatic superficial lacerations or wounds. Once exudation and bleeding has stopped, it is irrigated from the wound and a protective dressing can be applied. It is intended to be distributed as an Over-The-Counter (OTC) device.
The device consists of fine granules of a biocompatible polymer which encapsulate micron-sized particles of an astringent product. The granular product is packaged in single-patient use packets for convenient sprinkling into fresh traumatic, superficial lacerations or wounds.
The device in intended to be applied to fresh, traumatic, superficial lacerations or wounds to absorb body fluid and stop minor bleeding. Once exudation and bleeding has stopped, it is irrigated from the wound and a protective dressing can be applied.
The polymeric granules absorb fluid into their interior spaces and adsorb fluid onto their surfaces, in volume approximately equal to the volume of the granules. The relatively large surface area of the granules fosters coagulation. Within the interior space of the granules, the astringent is dissolved by the fluid. The astringent released from the granules then acts within the wound site to have a local and limited protein coagulant effect to help arrest secretion and stop minor bleeding.
This document is a 510(k) summary for a medical device called Sorbastace. It describes the device, its intended use, and its comparison to predicate devices, and outlines the testing performed to demonstrate substantial equivalence.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific, quantifiable acceptance criteria or a dedicated table summarizing them. Instead, it relies on demonstrating substantial equivalence to predicate devices through various non-clinical tests.
However, based on the non-clinical testing performed, we can infer the performance aspects evaluated:
| Performance Aspect (Inferred Acceptance Criterion) | Reported Device Performance |
|---|---|
| Biocompatibility | Evaluated and found biocompatible (passed cytotoxicity, dermal sensitization, dermal irritation, acute systemic toxicity, and hemolysis tests). |
| Retention and Deposition | Evaluated through histopathological examination of treated animals. (Specific results not given, but implies acceptable levels). |
| Astringent Absorption Dose | Measured and compared to aluminum sulfate absorption from OTC styptic pencils subject to an FDA monograph. (Implies Sorbastace's absorption is within acceptable limits or less than the predicate). |
| Fluid Absorption Capacity | Measured in an in-vitro test. (Implies acceptable absorption capacity). |
| Ability to Stop Minor Bleeding | Evaluated in animal tests in comparison to predicate devices. (Implies comparable effectiveness). |
| Bacteriostatic/Bactericidal Activity | Evaluated for common wound pathogens. (Implies some level of effectiveness, though specifics are not given). |
2. Sample Sizes and Data Provenance for Test Set:
- The document describes non-clinical (in vitro and animal) testing.
- Sample sizes are NOT explicitly stated for any of the non-clinical tests. For example, it mentions "animals treated with the device" but doesn't quantify the number of animals.
- Data provenance is NOT explicitly stated (e.g., country of origin). Given the context of an FDA submission in the US, it's highly probable the studies were conducted in the US or in compliance with US regulatory standards, but this is an assumption.
- The tests are inherently prospective as they were designed and executed to evaluate the device.
3. Number of Experts and Qualifications for Ground Truth of Test Set:
- This question is not applicable in the traditional sense of a clinical or diagnostic device with a "ground truth" established by experts examining data like images.
- For non-clinical tests, the "ground truth" is typically defined by the test protocols and the scientific methods used for evaluation (e.g., cytotoxicity assays, histopathology, chemical analysis). The experts involved would be the scientists and technicians conducting and interpreting these specific laboratory and animal studies, but their number and specific qualifications are not detailed in this summary.
4. Adjudication Method for Test Set:
- Not applicable as there is no mention of human-reviewed data where adjudication would be necessary (e.g., discrepancies in expert opinions on medical images). The evaluations are based on laboratory measurements and observations in animal models.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not performed.
- The document explicitly states: "Clinical studies were not performed."
6. Standalone (Algorithm Only) Performance:
- Not applicable. Sorbastace is a physical medical device (granules) for topical application, not a software algorithm.
7. Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" was established through:
- In vitro assays: Measuring specific biological responses (e.g., cytotoxicity, hemolysis) and physical properties (fluid absorption).
- Animal models: Direct observation of physiological effects (stopping minor bleeding) and histopathological examination for retention/deposition.
- Chemical analysis: Measuring astringent absorption doses.
- Comparison to established standards: Such as the FDA monograph for OTC styptic pencils.
8. Sample Size for Training Set:
- Not applicable. The device is a physical product, not an AI/ML algorithm that requires a "training set."
9. How Ground Truth for Training Set was Established:
- Not applicable. As the device is not an AI/ML algorithm, there is no training set or ground truth established for one.
Summary of the Document's Scope:
The provided 510(k) summary focuses on demonstrating substantial equivalence for the Sorbastace device to existing legally marketed predicate devices. This demonstration is primarily based on shared intended use, similar technological characteristics, and non-clinical safety testing (biocompatibility, absorption, bleeding control in animals) rather than extensive clinical efficacy trials or AI/ML performance metrics. The lack of explicit acceptance criteria tables or clinical study details is common for 510(k) submissions of certain device types, especially those relying on predicate equivalence for safety and effectiveness.
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