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The AeroDVx ™ System is comprised of a gradient compression sleeve, portable intermittent pneumatic pump, and hand pump designed to provide static or intermittent pneumatic compression to the calf and foot, in both the hospital and outpatient setting. It is intended to provide treatment for:

1. DVT Prophylaxis
2. Enhancement of blood circulation
3. Reduction of post-operative pain and swelling
4. Reduction of wound-healing time
5. Stasis dermatitis
6. Treatment and assistance of healing cutaneous ulceration
7. Venous stasis ulcers
8. Leg ulcers
9. Chronic venous insufficiency
10. Reduction of edema
11. Lymphedema

The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pneumatic pump and hand pump to provide static and/or intermittent pneumatic compression for compression therapy or DVT Prophylaxis. The AeroDVx™ gradient compression sleeve is composed of a family of non-sterile single patient use medical devices.

The AeroDVx ™ Gradient Compression Sleeve contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient's leg. The AeroDVx TM Gradient Compression Sleeve is available in four sizes and two different lengths (standard and short). The wrap is composed of two polyurethane laminates that are sealed together creating an internal bladder system. The bladder system contains circular and bar welds that were engineered with their spacing and location to provide gradient compression profile when worn and inflated.

An inflation source is attached to the inflation valve on the sleeve. The insertion of the inflation source onto the check valve of pressure opens the leur valve so that the bladder can be inflated or deflated based on the direction of airflow.

There will be two inflation sources provided: a portable, battery-operated intermittent pneumatic pump, the AeroDVx™ Pump, to provide intermittent pneumatic compression and a hand pump to provide static compression.

The system is intended for hospital and outpatient use.

The provided text is a 510(k) premarket notification for the AeroDVx System. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not contain specific details about acceptance criteria, a study proving the device meets those criteria, or the methodology of such a study.

The "Performance Data" section merely states: "The critical functions of the device have been tested for verification and have met the design inputs." without providing any quantitative data, study design, or results.

Therefore,Based on the provided text, I cannot complete a table of acceptance criteria and reported device performance or describe a study that proves the device meets the acceptance criteria. The document states:

"Performance Data [21 CFR 807.92(b) (1)]: The critical functions of the device have been tested for verification and have met the design inputs."

This statement confirms that testing was done and that design inputs were met, but it does not provide:

• A table of specific acceptance criteria.
• The reported device performance metrics against those criteria.
• Details of the study (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) that yielded these results.

Without this specific information, the requested table and study description cannot be generated from the given document.

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