(71 days)
The Zephyr™ Vascular Compression Devices are indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm or leg, including: radial, dorsalis pedis, or tibial blood vessels, arterial or venous line or sheath removal, hemodialysis, and in anticoagulation therapy.
The Zephyr™ Vascular Compression Devices are external compression devices deployed on a patient's arm or leg to promote hemostasis at a puncture site in a blood vessel. The Zephyr™ devices are single-use, sterile, individually pouched inflatable devices, deployed onto a skin surface by clinicians to help achieve hemostasis for vascular puncture sites in post-procedure patients. Zephyr is available in different lengths, with and without a separate cuff balloon. The strap measures approximately 1.5" x 8.25" (small) or 9.5" (large) and is composed of biocompatible multiple-layer PVC film and PVC tube, and a syringe and valve made of biocompatible thermoplastics. Hook and loop material is used to secure the strap in position. Only the PVC film comes into contact with broken skin.
The provided text describes a 510(k) summary for the Zephyr™ Vascular Compression Devices. However, the document focuses on establishing substantial equivalence to predicate devices and does not detail specific acceptance criteria or the comprehensive study design and results that would typically be associated with proving these criteria.
Based on the provided information, I can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "All testing passed acceptance criteria and demonstrated that the performance of the Zephyr™ Vascular Compression Devices is equivalent to the predicate devices." However, specific numerical acceptance criteria and corresponding reported device performance values are not provided in this document.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Performance Testing (Inflation and Compression) | Verified |
| Preclinical Testing (Compression, Deployment, Inflation/Deflation, Syringe Plunger Force, Syringe Airflow, Syringe Air Volume) | Passed acceptance criteria; demonstrated equivalence to predicate devices. |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation) | Non-cytotoxic, non-sensitizing, non-irritants. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Zephyr Vascular Compression devices were subjected to inspections and tests," but it does not specify the sample size of devices used for any of the performance or preclinical testing.
The data provenance is also not explicitly stated beyond being part of the manufacturer's internal testing processes. It does not mention country of origin, nor whether the tests were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This section is not applicable to the type of testing described. The tests are for device performance and biocompatibility, not for interpreting medical images or clinical outcomes that would require expert "ground truth."
4. Adjudication Method for the Test Set:
This section is not applicable as there is no mention of expert review or adjudication in the context of the device performance or preclinical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document describes preclinical and performance testing of the device itself, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable as the Zephyr™ Vascular Compression Device is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used:
For the performance and preclinical testing, the "ground truth" was established by engineering specifications and established testing protocols to confirm the device's functionality (e.g., inflation, compression, syringe function). For biocompatibility, the ground truth was based on ISO 10993 standards, which define acceptable levels of cytotoxicity, sensitization, and irritation.
8. The Sample Size for the Training Set:
This question is not applicable as the Zephyr™ Vascular Compression Device is a physical medical device, not an AI system that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as number 8.
§ 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).