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This device is similar to the EZ Hold handle. The Compass device provides an alternative to the use of mechanical clamping systems or direct hand holding pressure to obtain hemostasis following femoral vascular catheterization procedures. A sterile SuperComfort disc is affixed to the handle. Then the disc is manually positioned at the femoral vascular access site. The medical practitioner then applies holding force sufficient to obtain hemostasis. 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 handle and disc provide a mechanical means for a medical practitioner to hold external pressure at or near the site of femoral vascular access. Direct pressure is used to obtain and maintain hemostasis on the access site or at a pressure point. Unlike the predicate device, the Compass handle mates with the SuperComfort™ Disc. The predicate device is made of stainless steel; the Compass handle is made of polycarbonate.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Compass™ Compression Assist Handle. The submission aims to demonstrate substantial equivalence to a predicate device, the EZ Hold Femoral Compression Device (K973731).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Mechanical fit to the CompressAR® SuperComfort™ Disc.	"Multiple assembly/extraction cycles verified proper fit and acceptable insertion/removal forces."
Ability to be used to apply pressure.	"Testing was conducted to determine that the Compass device... may be used to apply pressure." (Implied acceptance - the study confirmed its ability, suggesting this was the criterion).
Equivalence to the predicate device (EZ Hold Femoral Compression Device - K973731).	"It was concluded that the Compass Compression Assist Handle, used with the SuperComfort™ Disc, is equivalent to the predicate device." This equivalence is based on the mechanical fit and pressure application, and the fact that the device provides an alternative to mechanical clamping or direct hand pressure for hemostasis, similar to the predicate. The FDA's substantial equivalence determination also implies this criterion was met.
User comfort and reduced stress for caregivers (compared to direct digital compression).	"Market testing determined that use of a handle and disc for holding manual pressure, rather than use of fingers directly on the access site, was more comfortable and less stressful to the care giver." (While not an explicit "acceptance criterion," this was a stated benefit and a finding from market testing).

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "Multiple assembly/extraction cycles verified proper fit and acceptable insertion/removal forces." However, it does not specify the exact sample size (number of devices or cycles performed) for this test. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It appears to be part of internal testing done by Advanced Vascular Dynamics.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not mention any experts being used to establish ground truth for the mechanical fit or pressure application testing. The "market testing" about comfort and stress reduction for caregivers implies feedback from medical practitioners, but the number or qualifications of these practitioners are not specified.

4. Adjudication Method for the Test Set:

No adjudication method is described. The tests appear to be physical/mechanical evaluations with results based on observed performance (proper fit, acceptable forces).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC comparative effectiveness study was done or mentioned. The comparison is primarily against a predicate device based on functional similarity and intended use, not a clinical study comparing human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This question is not applicable as the device is a mechanical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used:

For the mechanical fit and pressure application, the "ground truth" was likely engineering specifications and observed performance against those specifications. For the market testing related to comfort and stress, the "ground truth" was subjective feedback from caregivers.

8. The Sample Size for the Training Set:

This question is not applicable as the device is a mechanical instrument and does not involve AI or algorithms that require a training set.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the same reason as point 8.

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K Number

K002767

Device Name

COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE

Manufacturer

SEMLER TECHNOLOGIES, INC.