(151 days)
Vascette HP is intended for use as a temporary topical dressing for the management of bleeding from vascular access sites and percutaneous catheters.
Vascette HP is a 2 inch x 2 inch (50mm x 50mm) square, single use, multi-layer temporary topical wound dressing applied over vascular puncture sites and percutaneous catheter sites. There are two tissue contacting components in the device: 1) the polyethylene adhesive foam border and 2) the plant derived modified starch (carboxyl starch sodium (CMS)) hemostatic foam. The hemostatic foam is hydrophilic and dehydrates blood at the wound site, producing hemostasis. The device is non-invasive, and removal protocol is the same as other temporary topical hemostatic pads. Sterilization of the device is performed utilizing gamma irradiation to SAL 10-6.
Here is a summary of the acceptance criteria and the study details for the Vascette HP device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Achieved hemostasis | Achieved hemostasis within 5 minutes and 45 seconds in all test animals. |
| No clinically significant gross pathology findings related to the device | No clinically significant findings on gross pathology related to the subject device. |
| Non-cytotoxic | Non-cytotoxic (ISO 10993-5) |
| Non-toxic (Sensitization) | Non-toxic (ISO 10993-10) |
| Non-toxic (Intracutaneous Reactivity) | Non-toxic (ISO 10993-10) |
| Non-toxic (Acute Systemic Toxicity) | Non-toxic (ISO 10993-11) |
| Non-pyrogenic | Non-pyrogenic (ISO 10993-11) |
| Sterilization Assurance Level (SAL) 10-6 achieved | SAL 10-6 achieved (ISO 11137-2) |
| Bubble Leak Test Pass | Pass (ASTM F2096-11) |
| Seal Strength Test Pass | Pass (ASTM F88) |
| Distribution Simulation Pass | Pass (ASTM 4196-16) |
| Six Month Accelerated Aging Pass | Pass (ASTM 1980-16) |
| Two Year Accelerated Aging Pass | Pass (ASTM 1980-16) |
| Substantial equivalence to predicate device in safety and effectiveness | Confirmed substantial equivalence with respect to safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that hemostasis was achieved "in all test animals" in the porcine model study. However, the exact number of animals used in the GLP and non-GLP studies is not specified in the provided text.
- Data Provenance: The animal study was conducted using a porcine (pig) model. The country of origin for the data is not explicitly stated. The study type was pre-clinical animal evaluation, conducted according to GLP regulations (21 CFR Part 58), and would be considered prospective for the animal model.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
The document does not mention the use of human experts to establish ground truth for the test set. The outcome of hemostasis and gross pathology findings would have been evaluated by veterinary professionals involved in the animal study. Specific qualifications of these individuals are not provided.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. The assessment of hemostasis and gross pathology would have been part of the standard protocol for the animal study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The document explicitly states: "Evaluation in a clinical setting has not been performed." This implies no human-in-the-loop studies were conducted comparing AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study
The device is a topical hemostatic pad, not an algorithm. Therefore, the concept of an "algorithm only" or "standalone" performance study in the context of AI does not apply to this medical device. The performance was assessed through the animal study and bench testing.
7. Type of Ground Truth Used
The ground truth for the primary performance claim (hemostasis) was established by direct observation and measurement in a porcine animal model. For biocompatibility and sterilization, the ground truth was based on the outcomes of standardized laboratory tests. For the animal study, it included:
- Observation of hemostasis achievement.
- Gross pathology findings.
- Veterinary assessments (physical examination, body condition score, body weight, clinical monitoring, clinical pathology).
8. Sample Size for the Training Set
The document does not mention a training set in the context of an algorithm or AI. The Vascette HP is a physical medical device, not a software algorithm that would require training data.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an algorithm, this question is not applicable.
N/A