(46 days)
This device is indicated for use to provide hemostasis of the femoral vascular access site during and following catheterization or cannulation procedures.
The PressureMate™ Compression Assist Handle mates with the SuperComfort™ Discs (K040615) to provide an alternative to the use of mechanical clamping systems or direct hand holding pressure to obtain hemostasis following fernoral vascular catheterization procedures.
The PressureMate™ handle itself is an aluminum handle with stainless steel stem. The stem ends in a female connection which mates to the male connector located on the SuperComfort Discs. The handle can not be used without a Disc.
The PressureMate™ comes in two designs: i) symmetrical, with both ends symmetrically tapering down at each end and centrally located stem or ii) asymmetrical, with one end tapered smaller than the other end and the stem slightly off center. The handle designs, round with tapered ends, enable better fit to an operator's hand.
Use of the handle and disc by a medical practitioner avoids prolonged direct contact with bodily fluids, and alleviates bio-mechanical stress which may occur during traditional direct digital compression of the femoral artery post-cardiac catheterization.
The provided text describes the PressureMate™ Compression Assist Handle, a device designed to assist with hemostasis following femoral vascular catheterization procedures. Here's an analysis of the acceptance criteria and the study information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Withstand holding force of 35 pounds | The device is designed and has been tested to withstand a holding force of 35 pounds. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical or performance testing on subjects/patients. The reported performance refers to a device design and material strength test.
- Test Set Description: The test involved evaluating the device's ability to withstand a specific mechanical force.
- Sample Size: Not explicitly stated for this mechanical test, but implies multiple units were tested to ensure consistency.
- Data Provenance: Not applicable as it's a mechanical test, not clinical data from patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The "ground truth" for the mechanical test is the physical capacity of the device to withstand 35 pounds, which is a manufacturing specification, not an expert assessment.
4. Adjudication Method for the Test Set
Not applicable. This was a mechanical engineering test, not a clinical study requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physical handle for manual compression, not an AI-assisted diagnostic tool or an imaging device that would typically involve MRMC studies.
6. Standalone (i.e. algorithm only without human-in-the loop performance) Study
No, a standalone study focusing on an algorithm's performance was not done. This device is a manual assist tool, not an algorithm or software.
7. Type of Ground Truth Used
The "ground truth" for the reported performance criterion (withstanding 35 pounds) is a physical/mechanical specification and measurement. It's a measure of the device's structural integrity and strength, rather than a clinical outcome or expert judgment.
8. Sample Size for the Training Set
Not applicable. As this device is a physical, manual compression assist handle and not an AI/software product, there is no "training set" in the context of machine learning or algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as above. There is no training set for this type of 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).