(225 days)
The RVT CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries.
The RVT Extension Wire is designed to extend the RVT CTO Device so that a catheter can be exchanged for another catheter.
The RVT CTO Device is a sterile, disposable, steerable 0.018" OD Guidewire with an Active Tip for penetrating chronic total occlusions and is used with a sterile, disposable, battery-operated Control Unit during a single patient procedure.
The RVT CTO System consists of four (4) components: the RVT CTO Device, Control Unit, Shaping Tool, and the RVT Extension Wire.
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RVT CTO Device (Guidewire Assembly, Torquer, Motor Housing with integrated Connector Cable) - The RVT CTO Device consists of a distal 0.018" Guidewire Assembly and a Motor Housing with Connector Cable. The RVT CTO Device is 165 cm in working length and is hydrophilically coated. The RVT CTO Device has a shapeable Distal Tip and the cone-shaped portion of the Active Tip is diamond coated. The distal 3 cm is radiopaque to facilitate visualization under fluoroscopy.
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Control Unit - Pressing the Activation Button allows current to flow from the battery in the Control Unit to the DC Motor within the Motor Housing. Mechanical energy (via rotational torque) is generated and transferred from the DC Motor to the Nitinol Driveshaft located within the stationary hollow Outer Shaft. The Driveshaft turns the Active Tip at the very distal end of the Guidewire Assembly at approximately 13,000 revolutions per minute (RPM) under "no load" conditions. The hollow Outer Shaft remains stationary while the Active Tip rotates independently. In the Active Mode, the RVT Guidewire creates a pathway through the lesion via mechanical rotation. In the "Passive Mode" the operator steers the Guidewire Assembly to seek a path of least resistance through the lesion consistent with standard quidewires.
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Shaping Tool used to shape the tip of the RVT CTO Device, if desired.
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RVT Extension Wire Attachment of the RVT Extension Wire to the RVT CTO Device creates an extended guidewire that can be used to exchange a catheter without removing the RVT CTO Device from the artery.
Here's an analysis of the acceptance criteria and study details for the RVT CTO Device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Freedom from clinical perforation of the index lesion to 30 days (Primary Safety Endpoint) | 0.0% clinical perforations at time of intervention with RVT CTO Device; 1 (1.2%) patient experienced clinical perforation from a cutting balloon (deemed unlikely related to RVT CTO Device). |
| Advancement of the RVT CTO Device through the CTO and subsequent distal guide wire positioning (Primary Clinical Efficacy Endpoint) | Achieved in 65 out of 85 cases (76.5%). |
| Facilitation of crossing the CTO with any guide wire (Primary Performance / Technical Success Endpoint) | Achieved in 68 of 85 patients (80%). |
| Safety and effectiveness in facilitating crossing of CTOs in patients with PAD where conventional guidewires have failed. | Demonstrated that the device is safe and effective; did not increase perforation rate beyond that of conventional guidewires. |
| Does not raise new questions of safety or effectiveness when compared to predicate devices. | Evidence from non-clinical testing and the ReOPEN study indicates no new safety/effectiveness concerns. |
Note: The document explicitly states that the "studies were similar in design, both were prospective clinical studies of 85 patients... The inclusion/exclusion criteria were the same between the two studies as were the study endpoints and results" when comparing the Re-OPEN study to the FlowCardio predicate. This implies that the acceptance criteria for the RVT CTO Device were largely based on demonstrating equivalent (or superior) performance to the predicate device using similar endpoints.
Study Details
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Sample sizes used for the test set and the data provenance:
- Sample Size: 85 patients.
- Data Provenance: Prospective, multi-center, single-arm study (Re-OPEN Study) conducted in Europe between January and December 2009.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states that "All SAEs (Serious Adverse Events) were adjudicated by an independent CEC" (Clinical Events Committee). It also mentions the CEC reviewed all AEs in aggregate.
- Number of Experts: Not explicitly stated, but implies a committee (more than one).
- Qualifications: Not explicitly stated beyond "independent CEC."
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- "All SAEs (Serious Adverse Events) were adjudicated by an independent CEC." This implies a form of consensus or expert review, but the specific "x+y" method is not detailed.
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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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical medical device (guidewire) and not an AI/software product, so this type of study is not applicable.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm-only performance study was not done. This device is a physical guidewire used by a human operator, making an "algorithm-only" study irrelevant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Primary Safety Endpoint: Clinical events (e.g., clinical perforation) adjudicated by an independent Clinical Events Committee (CEC).
- Primary Clinical Efficacy Endpoint: Angiographic assessment (advancement of device and distal guidewire positioning).
- Primary Performance (Technical Success) Endpoint: Angiographic assessment (facilitation of crossing the CTO with any guidewire).
- Occlusion Confirmation: "occlusions treated under this protocol were all confirmed to be 100% CTOs that had been in existence for 30 days or greater" likely through angiographic or imaging means.
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The sample size for the training set:
- This device is a physical medical device, not a machine learning algorithm, so there is no "training set" in the conventional sense. The "training" comes from the device's design, engineering, and manufacturing processes, which are validated through non-clinical bench testing and animal studies.
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How the ground truth for the training set was established:
- Not applicable as there is no machine learning training set. Ground truth for the development and validation of the physical device and its components was established through various engineering specifications, bench test standards, and animal model results. E.g., "Results of the non-clinical testing demonstrate that the materials chosen, the manufacturing process, and design of the RVT CTO Device meet the established specifications necessary for consistent performance during its intended use."
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).