(133 days)
The Venowave VW5 series of devices are prescriptive and induce improved vascular and lymphatic flow of the lower limbs. Very similar to the predicate device, the Venowave V W5 series of devices are intended to treat the following:
- Management of the symptoms of post thrombotic syndrome (PTS) .
- Prevention of deep vein thrombosis, (DVT) .
- Prevention of primary thrombosis .
- . Treatment of lymphedema
- . Diminishing post-operative pain and swelling
- . Treatment of leg swelling due to vascular insufficiency
- . Treatment of varicose veins
- Treatment of chronic venous insufficiency t
- . Enhancing blood circulation
- Treatment of intermittent claudication .
The Venowave VW5 is a series of compact, battery-operated peristaltic pumps that generate a wave-form motion. and when worn below the knee strapped firmly to the calf, result in compression of the calf and consequently an increased upward volumetric displacement of venous and lymph fluid. Each of the models within the family (VW5-6; VW5-10; VW5-20; and VW5-30) is distinguished by the maximum number of times the wave plate cycles each minute (6, 10, 20 and 30 cycles/minute respectively). Each model is also capable of operating at two speeds. Clinical preference to choose a specific frequency of motion for each specific patient based upon that patient's clinical symptoms, severity of disease, and perceived compliance with treatment has been the motivation for creating each model within the series. The optimum choice of model for each patient is the slowest device that achieves the desired therapeutic objective. The slower the device is, the quieter the operation and the longer the battery and mechanical life of the unit. Each model, however, may in fact be used interchangeably to treat patients suffering from a class of diseases that result from chronic venous insufficiency.
The Venowave VW5 weighs about 260g, and has dimensions measuring roughly 190mm x 75mm x 30mm enabling one to wear it under loose clothing. It is designed to be packaged and sold as a prescription-only assembled device.
The Venowave generates a mechanical wave which starts at the lower pivot point and travels to the upper pivot point, a distance of 14cm (wavelength) traveled for each cycle of the crank. The swept volume of blood or lymph fluid displaced upwards for each cycle is the product of the wavelength (14cm), the width of the wave sheet (7,5cm) and the depth of the wave (0.95cm) or approximately 0.1 L/cycle. Operating by way of a single rechargeable 1.5 V NiMh AA battery, this single-patient use device enables the user to receive treatment anywhere, while remaining active.
The Venowave VW5 device did not undergo a study with specific acceptance criteria and reported device performance in the provided documentation. Instead, its substantial equivalence to a predicate device (ActiveCare++ System, K060146) was established through a comparison of technological characteristics, intended use, and a range of safety and performance tests.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria or quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the Venowave VW5 in the provided document. The demonstration of safety and effectiveness relies on substantial equivalence to the predicate device and the successful completion of a series of general safety and performance tests.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated as quantitative acceptance criteria) | Demonstrated substantial equivalence to predicate device (K060146) in performance characteristics, application, and indications of use. Completed various safety and performance tests. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Clinical evaluation with relevant patient populations," and specifically that the Venowave "has been clinically evaluated in patients with post thrombotic syndrome and has been found to be effective in the management of their symptoms (see Appendix 6)." However, the sample size for the test set and the data provenance (e.g., country of origin, retrospective or prospective nature) are not provided in the extracted text. The reference to "Appendix 6" suggests more detail might exist in other parts of the 510(k) submission, but this information is absent in the provided snippets.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the extracted text. The method for establishing "ground truth" for the clinical evaluation, if one were even explicitly defined beyond patient symptom management, is not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the extracted text.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported for the Venowave VW5. The evaluation focused on substantial equivalence to a predicate device and a clinical evaluation mentioned in passing, not a comparison of human readers with and without AI assistance. The Venowave VW5 is a mechanical device, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the Venowave VW5 is a mechanical medical device, not a software algorithm.
7. Type of Ground Truth Used
Based on the limited information available, the "effectiveness" in the clinical evaluation for post-thrombotic syndrome patients seems to be based on management of patient symptoms. The precise definition or measurement of this "ground truth" (e.g., specific clinical outcomes, physician assessments, patient-reported outcomes) is not detailed in the provided text subsections.
8. Sample Size for the Training Set
There is no mention of a training set as this is a medical device, not an AI/machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for an AI/machine learning algorithm.
Summary of the Study and its Evidence for Substantial Equivalence:
The Venowave VW5's acceptance for marketing was based on demonstrating substantial equivalence to a previously approved predicate device, the ActiveCare++ System (K060146). This approach is common for Class II medical devices in the 510(k) pathway.
The study that supports this, as described in the document, involved:
- Comparison of Device Characteristics: A detailed comparison of the Venowave VW5 with the predicate device, highlighting similarities in intended use, technological characteristics, mode of operation, source of power, and target populations. The key difference noted was the mechanical peristaltic pumping action of the Venowave versus the pneumatic cuff of the predicate.
- Safety and Performance Tests: A list of general safety and performance tests conducted:
- Electrical testing
- Gear motor tests
- Drop tests
- Labeling integrity testing
- Final assembly testing
- Random sample testing of each manufactured lot number
- Clinical Evaluation (Limited Information): A statement that the device has been "clinically evaluated with relevant patient populations" and specifically "in patients with post thrombotic syndrome and has been found to be effective in the management of their symptoms."
The core argument is that, despite the difference in mechanical action (peristaltic vs. pneumatic), the Venowave VW5 achieves the same therapeutic objective using similar principles and does not raise new questions of safety and effectiveness compared to the predicate device. The clinical evaluation mentioned is presented as supporting evidence for its effectiveness in managing symptoms of post-thrombotic syndrome.
§ 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).