(17 days)
The EZvein™ inflatable secondary tourniquet is used in conjunction with a nonpneumatic tourniquet, to enhance the presentation of veins for access (blood draw or IV administration.)
The EZ Vein inflatable secondary tourniquet is made with soft fabric and flexible plastic to form an inflatable bladder. The integral Velcro attachment strips secure the EZVein around an appendage in the same way as would a blood pressure cuff. Dimensions have been chosen to wrap around most anyone's arm, but an extension is included to allow the EZVein to work on lower limbs or with large arms. The Vein Access Window allows the health care professional to position the EZVein over the target vein for access for IV drip, blood draw or injection. The EZVein cuff is applied after the initial conventional non-inflatable tourniquet (such as latex tubing) is applied. The initial tourniquet, as is conventional, blocks the return of venous blood through the major veins to the heart, but the application of the EZVein inflatable cuff helps move the blood in deep tissues into the veins to help them to distend for easier visualization and access. This may aid the medic desiring venous access to more accurately and rapidly achieve the desired aim.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Self-release between 195 mmHg and 220 mmHg | Self-releases between 195 mmHg and 220 mmHg |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that the device "has been tested," but it does not provide details about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts or the establishment of ground truth for the performance testing. The test described appears to be a direct physical measurement of the device's self-release mechanism.
4. Adjudication Method for the Test Set
As no experts or specific ground truth establishment method is mentioned, there is no information provided on any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The described testing focuses solely on the device's mechanical self-release property.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device, the EZ Vein inflatable tourniquet, is a physical medical device, not a software algorithm. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply. The described testing is inherently a standalone performance test of the device's physical mechanism.
7. Type of Ground Truth Used
The "ground truth" for the test appears to be a direct physical measurement of the pressure at which the Velcro strip self-releases. There is no mention of expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
The document does not mention a training set, as this is a physical device with a mechanical function, not a system that relies on machine learning or algorithms requiring a training phase.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, this information is not applicable.
Summary of the Study:
The study referenced in the document is a performance test to ensure the safety of the EZ Vein inflatable tourniquet. The primary safety concern addressed is the potential for over-inflation. The acceptance criterion is that the device's Velcro strip must self-release within a specified pressure range (195 mmHg to 220 mmHg). The reported device performance confirms that it meets this critical safety threshold.
The details regarding the methodology, sample size, and rigorousness of this "testing" are very limited in the provided excerpts. It is presented as a straightforward verification of a mechanical safety feature.
§ 878.5910 Pneumatic tourniquet.
(a)
Identification. A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.