(104 days)
The Vasculaire Compression System is indicated for use in:
- Preventing deep vein thrombosis (DVT) .
- . Enhancing blood circulation
- Diminishing post-operative pain and swelling .
- t Reducing wound healing time
- Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial . and diabetic leg ulcers
- Treatment of chronic venous insufficiency .
- . Reducing edema
The Vasculaire Compression System is an ambulatory, intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. The Vasculaire Compression System includes three components: the Patient Sleeve, the Controller, and the Charger.
The Patient Sleeve is a multiple-cell bladder intended to be attached directly to the patient's lower limb. It is intended to provide compression action to the tissue surrounding the venous vasculature in the foot and calf of a patient. The Controller is connected to the Patient Sleeve using two independent Flange Ports and can be mounted directly onto the Patient Sleeve for a completely ambulatory system. The Flange Ports allow the air from the Controller to control the compression action on the Calf go Foot Zones independently. The Controller is a lightweight (less than 1 Ib), battery-powered, electromechanical control unit intended to provide and monitor the inflation cycle for enhanced circulation therapy.
Here's an analysis of the provided 510(k) summary regarding the Vasculaire Compression System, focusing on the absence of acceptance criteria and a study proving their fulfillment:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| None specified | None specified |
Explanation: The provided 510(k) summary does not contain any explicit acceptance criteria for the Vasculaire Compression System, nor does it present specific performance metrics from a study against such criteria. The submission focuses on demonstrating substantial equivalence to a predicate device based on indications for use and technological characteristics, rather than meeting quantitative performance targets.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given 510(k) summary. The document mentions "clinical testing" but does not detail the nature of these tests, including sample sizes or data provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given 510(k) summary. Given the absence of detailed clinical study results, there's no mention of ground truth establishment by experts.
4. Adjudication Method for the Test Set
This information is not provided in the given 510(k) summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in the provided 510(k) summary. The device is a physical compression system, not an AI or imaging diagnostic tool that would typically involve human reader performance comparison with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable to the Vasculaire Compression System. This device is a physical, electromechanical system and does not involve an "algorithm only" component in the way a diagnostic AI would. Its performance is inherent in its mechanical operation and physiological effects, not in a standalone algorithmic assessment.
7. Type of Ground Truth Used
This information is not provided in the given 510(k) summary. As no specific clinical study data is presented, the type of ground truth used is not mentioned.
8. Sample Size for the Training Set
This information is not provided in the given 510(k) summary. The term "training set" is typically associated with AI algorithm development, which is not the primary focus or nature of this device's submission.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the given 510(k) summary. As mentioned above, the concept of a "training set" and its associated ground truth establishment is not relevant to the described device and its substantial equivalence submission.
Summary of the Document's Focus:
The provided 510(k) summary for the Vasculaire Compression System focuses on demonstrating substantial equivalence to an existing predicate device (Medical Compression Systems, ActiveCare + System - K060146). This type of submission relies on showing that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
Rather than providing detailed clinical study results with specific acceptance criteria and performance metrics, the document lists preclinical testing categories such as:
- Reliability testing of component interactions
- Physical bench testing (specification verification and transit testing)
- Software verification and validation
- Electrical safety and electromagnetic compatibility testing
- Cytotoxicity testing
These tests are typically conducted to ensure the device functions as intended and safely, but they are not presented as meeting specific, predefined acceptance criteria with reported performance values in the context of a clinical outcome study. The FDA's clearance is based on the determination of substantial equivalence, not necessarily on a comparative effectiveness study with quantitative acceptance criteria for clinical outcomes.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).