(53 days)
The Venclose Maven System (digiRF Generator and Maven Catheter) is intended for endovascular coagulation of blood vessels in patients with perforator and tributary vein reflux.
Venclose Maven System consists of two (2) main components:
-
- Maven Catheter with integrated cable connector and,
- digiRF Generator which delivers radiofrequency (RF) energy to the Maven catheter. 2)
The Maven catheter is a sterile single-use disposable medical device for endovenous radiofrequency ablation. The primary components of the catheter include the shaft, handle and integrated connector cable. The catheter shaft is 6 French (6F = 2.0 mm in diameter) in profile, with an insertable length of 40 cm and a 0.5 cm heating coil. The catheter is energized by the digiRF Generator which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter.
The Venclose Maven System (digiRF Generator and Maven Catheter) uses resistive radiofrequency ablation (via energy delivered to heat the wall of an incompetent vein) with temperature-controlled RF energy, and an already widely accepted procedure to cause irreversible luminal occlusion. This is followed by fibrosis and ultimately resorption of the vein.
The Venclose Maven System (digiRF Generator and Maven Catheter) supports an optional foot pedal.
The acceptance criteria and device performance are described below, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study Type |
|---|---|---|
| Safe and effective for treatment of incompetent perforator veins without significant adverse outcomes | Observed to be safe and effective for treatment of incompetent perforator veins. | Clinical Study |
| Occlusion rate at 30-day follow-up | 80% | Clinical Study |
| Reflux-free rate at 30-day follow-up | 93% | Clinical Study |
Note: The text does not explicitly state pre-defined acceptance thresholds for occlusion and reflux-free rates; it only reports the achieved performance.
Study Information
The information provided relates to a clinical study.
2. Sample size used for the test set and the data provenance:
- Sample Size: 27 subjects
- Data Provenance: Prospective, single-investigator study. The country of origin is not explicitly stated, but the submission is to the U.S. FDA by a company based in San Jose, California, suggesting a U.S. study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. The study is described as a "single-investigator study," but it does not specify how ground truth (e.g., incompetence of perforator veins, occlusion, reflux status) was established or adjudicated, nor does it detail the qualifications of any experts involved in assessing these outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This device is for endovascular coagulation, not an imaging-based diagnostic AI device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a medical instrument (catheter and generator) for a surgical procedure, not an algorithm or AI system.
7. The type of ground truth used:
- The ground truth for effectiveness (occlusion rate, reflux-free rate) was established through clinical assessment during the 30-day follow-up, likely using imaging techniques (e.g., ultrasound) to determine vein patency and reflux. The basis for determining initial "incompetent perforator veins" would also be clinical and imaging findings. For safety, ground truth was based on the absence of "significant adverse outcomes."
8. The sample size for the training set:
- This question is not applicable as the device is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- This question is not applicable for the same reason as above.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.