(47 days)
The ThrombiGe1® thrombin/gelatin foam hemostat is applied topically and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds.and for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
The ThrombiGel® thrombin/gelatin foam hemostat consists of a lyophilized absorbable gelatin sponge, USP containing thrombin, sodium carboxymethylcellulose (CMC), and calcium chloride.
The ThrombiGel® thrombin/gelatin foam hemostat is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical barrier to bleeding.
The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin.
The ThrombiGel® thrombin/gelatin foam hemostat is wetted before use with sterile water for injection or saline (not provided.) There are three versions of the pad which differ in their dimensions. The ThrombiGel® 10 thrombin/gelatin foam hemostat is approximately 10 cm³, the ThrombiGel® 40 thrombin/gelatin foam hemostat is approximately 40 cm² and the ThrombiGel® 100 thrombin/gelatin foam hemostat is approximately 100 cm . A desiccant is added to the package to maintain the moisture content.
This document is a 510(k) premarket notification for the ThrombiGel® thrombin/gelatin foam hemostat. The information provided outlines non-clinical testing performed to demonstrate the device's substantial equivalence to a predicate device, rather than defining specific acceptance criteria for performance metrics or presenting a study that proves it meets those criteria.
Therefore, the requested information elements cannot be fully populated as they pertain to clinical performance studies and specific acceptance thresholds, which are not detailed in this submission for this type of device and regulatory pathway.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for device performance in the manner requested (e.g., sensitivity, specificity for diagnostic devices, or specific clinical endpoints for therapeutic devices). It lists physical and biocompatibility tests whose results confirmed the suitability of the device for its intended use, but not explicit numerical targets.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Properties | |
| Moisture Content Testing | Confirmed suitability for intended use |
| Thrombin Activity Testing | Confirmed suitability for intended use |
| Thrombin Activity Testing post 4 hours pot-life | Confirmed suitability for intended use |
| Wetting Time | Confirmed suitability for intended use |
| pH | Confirmed suitability for intended use |
| Biocompatibility | |
| MEM Elution | Biocompatible |
| Intracutaneous Injection Test | Biocompatible |
| Systemic Injection Test | Biocompatible |
| Rabbit Pyrogen Test | Biocompatible |
| Kligman Skin Sensitization | Biocompatible |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for non-clinical tests.
- Data Provenance: The tests are described as "Bench testing" and "biocompatibility assessment," implying laboratory-based testing, not human-related data. No country of origin for the data is mentioned, but the submitter is Minneapolis, Minnesota, USA. The tests are non-clinical and would be considered prospective for the purposes of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood for diagnostic/clinical studies (e.g., expert reads, pathology) is not relevant for the non-clinical physical and biocompatibility testing described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are for reconciling differing expert opinions in clinical studies, which were not performed here.
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 is a medical device (hemostat), not an AI/diagnostic software. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" would be established by the standardized protocols and acceptance criteria of the respective physical and biocompatibility tests themselves (e.g., ISO standards, pharmacopeial methods).
8. The sample size for the training set
Not applicable. This submission describes non-clinical testing for a medical device's substantial equivalence, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. No training set for a machine learning model was involved.
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