(243 days)
The VasoStat™ Hemostasis Device is indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm, including radial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.
The VasoStat™ Hemostasis Device is an ergonomic, simple device that is adhered to the patient's skin directly over a percutaneous vascular puncture site and allows the application of adjustable compression to the puncture site to achieve hemostasis. The device is composed of a flexible thermoplastic base that has the ability to conform to the patient's anatomy (e.g. lower arm, upper arm, etc.) and is secured to the skin with biocompatible, hypoallergenic adhesive pads. A plunger component passes through the base, applies targeted pressure to the puncture site through a ratcheting mechanism, and can be adjusted with one hand to apply the appropriate pressure necessary to promote hemostasis. VasoStat has the ability to vary the amount of pressure applied to the puncture site to promote hemostasis while minimizing the risk of thrombosis. The device design and materials ensure that the product is comfortable for the patient to wear while their puncture site stops bleeding. Once hemostasis is achieved (in approximately 15 to 45 minutes), the device is easily removed and discarded.
Here's a breakdown of the acceptance criteria and study information for the VasoStat™ Hemostasis Device, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The 510(k) summary does not explicitly state numerical acceptance criteria in a pass/fail format. Instead, it demonstrates substantial equivalence by comparing the VasoStat™ Hemostasis Device's performance, particularly hemostasis time, to a legally marketed predicate device. The primary performance metric mentioned is time to hemostasis.
1. Table of Acceptance Criteria and Reported Device Performance
None explicitly stated as quantifiable acceptance criteria in the document. However, the study aimed to show performance comparable to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance (VasoStat™) | Predicate Device Performance (Terumo TR Band) |
|---|---|---|
| Achieve hemostasis | Achieved hemostasis | Achieved hemostasis |
| Time to hemostasis (comparable to predicate) | Approximately 5.8 minutes (average) | Approximately 5.8 minutes (average) |
| Biocompatibility | Non-cytotoxic, non-reactive, non-sensitizing | N/A (Established biocompatible materials for RaDAR, ISO 10993 for TR Band) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of animals. The study was conducted on a "domestic swine model."
- Data Provenance: Prospective (in vivo assessment), animal model (domestic swine). The country of origin is not specified but is implicitly assumed to be within the US, given the submission to the FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study involved a direct measurement of hemostasis time in an animal model, not expert evaluation of images or clinical outcomes that would require ground truth establishment by multiple experts.
4. Adjudication method for the test set
Not applicable. This was an in vivo animal study measuring the time to hemostasis, not a study requiring adjudication of expert interpretations.
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 device is a physical hemostasis device, not an AI-powered diagnostic or assistive tool, so an MRMC study is not relevant.
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
The "ground truth" for this study was the observed time to achieve hemostasis in the swine model, directly measured by the investigators of the study. This aligns with outcomes data (i.e., the clinical outcome of stopping bleeding).
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As noted in #8, there is no training set for a physical medical device.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).