Search Results

The Vena Pro Vascular Therapy System, model VP-3111, is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to:

• Aid in the prevention of DVT; .
• Enhance blood circulation; .
• Diminish post-operative pain and swelling; .
• Reduce wound healing time; .
• Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and . diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.

The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

The Vena Pro Vascular Therapy System is a lightweight, portable, rechargeable battery powered prescriptive device that is intended to be used in the home or clinical setting by or under the direction of a medical professional to help stimulate blood flow as an aid in the prevention of deep vein thrombosis (DVT).

The system utilizes pneumatically controlled, single chamber cuffs actuated by an electronically controlled air pump unit and solenoid valve. All pump, battery and control components are protectively housed in a plastic case that is permanently attached to a single use inflatable cuff. A single tactile touch control switch, tri-color LED for ON, LOW BATTERY, CHARGING and CHARGE COMPLETED indication, and a blue LED (for indicating a leak or low pressure alarm) provides for user interface. There is also a port for connecting the battery charger/AC adapter plug, and a currently unused port for future use in usage data reportung.

The leg wrap (cuff) component consists of a Polyvinyl Chloride (PVC) air bladder encased inside a soft, non-woven medical fabric made from Dupont Softesse (a Polyester blended medical fabric) or equal , which is adhered to the PVC air bladder. The units are supplied clean, non-sterile, packaged in pairs ( 1 left and 1 right side).

In operation, the user simply turns the power ON via the single button I/O control switch. A single user "cuff" containing air bladders is permanently connected to the unit. The control unit then fills the cuff to a pre-determined pressure (50 mmHg). Cuff pressure is monitored by an internal pressure switch and system software. Once the pressure reaches the proper level, the pump is turned OFF for an approximately 50 second "rest" period, and the cuff deflates to ambient pressure through a valve inside the plastic case. After the "rest" period, the cycle repeats until the unit is turned off.

Here's an analysis of the acceptance criteria and supporting studies for the Vena Pro Vascular Therapy System, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the Vena Pro Vascular Therapy System (VP-3111) and its substantial equivalence to predicate devices, rather than establishing new, explicit acceptance criteria with specific numerical thresholds for its own performance. Instead, the "acceptance criteria" are implicitly met by demonstrating that the Vena Pro system has performance characteristics substantially equivalent to or surpassing those of the listed predicate devices.

The core performance claims relate to:

• Pressure Delivery: Approximately 50 mmHg.
• Cuff Fill Time: Similar to predicate devices (e.g., 11.6 seconds for Venodyne).
• Cycle Time: Approximately 60 seconds per leg.
• Overall System Performance: Including electrical safety, EMC, mechanical integrity, environmental, and life cycle testing.

Table of Implicit Acceptance Criteria and Reported Performance:

Study Details

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

• Test Set: No specific test set for the Vena Pro device itself is mentioned for clinical evaluation. The document states, "No clinical testing was performed on the Vena Pro system."
• Data Provenance: The justification for clinical effectiveness is based on retrospective analysis of published clinical studies conducted on predicate devices. These studies are:
  • "Evaluation of Intermittent Pneumatic Compression Devices" (Orthopedics 24(3):257-261, 2001)
  • "Venous hemodynamics after total knee arthroplasty: Evaluation of active dorsal to planar flexion and several mechanical compression devices" (Journal of Bone and Joint Surgery, November 1998)
    The provenance of the data within these external studies (e.g., country of origin) is not provided in this 510(k) summary.

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

• This information is not applicable (N/A) as no clinical test set for the Vena Pro device itself was conducted. The ground truth for the predicate device studies would have been established by the methods described within those original publications, which are not detailed here. The 510(k) summary cites the conclusions of these studies.

3. Adjudication Method for the Test Set:

• N/A, as no clinical test set for the Vena Pro device was performed.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not conducted as part of this 510(k) submission for the Vena Pro device. The submission relies on non-clinical bench testing and comparison to published clinical data on predicate devices. Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.

5. Standalone Performance Study:

• No standalone (algorithm only without human-in-the-loop performance) clinical study was performed for the Vena Pro device. "Non-clinical validation" and "in-house bench testing" were conducted for its technical features (pressure, cycle time, etc.), but this does not constitute a standalone clinical performance study in terms of patient outcomes or physiological effects.

6. Type of Ground Truth Used:

• For the Vena Pro device itself, the "ground truth" for technical specifications (e.g., pressure output, cycle time) was established through in-house bench testing.
• For clinical efficacy claims (e.g., aid in DVT prevention), the ground truth is derived from the published outcomes data of clinical studies conducted on predicate devices, which are cited as surrogate clinical data. These predicate studies would have used various clinical outcomes to establish their efficacy (e.g., DVT rates, blood flow velocity measurements).

7. Sample Size for the Training Set:

• N/A. This device is a mechanical/pneumatic system, not an AI or machine learning algorithm that requires a "training set" in the computational sense.

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

• N/A, as there is no training set for this type of device.

Ask a specific question about this device