(28 days)
The RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapentic agents, to selected sites in the peripheral vascular system. The RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The RenovoCath is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath is intended for use in arteries from 3mm in diameter for vessel entry and to occlude vesses ranging between 3mm to 11mm in diameter.
The diagnostic and/or therapents are to be used in accordance with specifications outlined by the respective agent manufacturer.
The RenovoCath is a multi-lumen, dual-balloon catheter with a two-part handle that is designed for targeted delivery of fluids, including radiopaque material and therapeutic agents, to selected sites in the peripheral vascular system. The distance between the proximal and distal balloons is adjustable. The effective length is 75cm to 85cm (adjustable). Radiopaque markers are located between the balloons to allow for identification of targeted site and position adjustment under fluoroscopic guidance. The RenovoCath is intended to be used with 6 Fr guide sheaths and 7 Fr guide catheters and is compatible with 0.014" guidewires.
Here's a breakdown of the acceptance criteria and study information for the RenovoCath device, based on the provided text:
Key Takeaway: This submission is for a device that is substantially equivalent to a previously cleared device. The "study" here refers to bench testing performed to demonstrate that the new device performs comparably to the predicate device (the previously cleared version) despite minor design changes. Therefore, there isn't a typical "study" in the sense of a clinical trial with human subjects, AI assistance, or complex ground truth establishment as might be seen for novel AI/ML devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission seeking substantial equivalence to a predicate device, the "acceptance criteria" are implicitly that the subject device performs functionally the same as the predicate device across various performance measures. The "reported device performance" demonstrates this equivalence.
| Acceptance Criteria (Implicit: Performance same as Predicate) | Reported Device Performance (Subject Device) |
|---|---|
| Indications for Use: Identical to Predicate | Identical: Intended for isolation of blood flow & delivery of fluids (diagnostic/therapeutic) to peripheral vascular system; temporary vessel occlusion (arteriography, preoperative occlusion, chemotherapeutic drug infusion); general intravascular use in peripheral vasculature in arteries 3mm+; occludes vessels 3mm-11mm. Diagnostic/therapeutic agents used per manufacturer. |
| Contraindications: Identical to Predicate | Identical: Physician determines physical impairment/vascular abnormality/contrast medium reaction contraindicates use. Not for use in coronary/intracranial arteries. Not for embolic protection or as an aspiration catheter. |
| Single Use: Identical to Predicate | Yes |
| Patient Contacting Materials: Identical to Predicate | Silicone, Pebax, Platinum Iridium |
| Effective Length: Meets specification | Adjustable, 75cm-85cm (Predicate: 76cm-86cm). Slight difference but considered equivalent as per statement "changes impacted the balloon to balloon distance and effective length" and overall conclusion of substantial equivalence. |
| Sheath Compatibility: Identical to Predicate | 6Fr |
| Catheter Size: Identical to Predicate | 0.076" (1.93mm) Max diameter |
| Guidewire Compatibility: Identical to Predicate | Long 0.014" |
| Balloon Configuration: Identical to Predicate | Dual: Distal and Proximal |
| Balloon Type: Identical to Predicate | Compliant, low pressure |
| Balloon Distance: Meets specification | Adjustable, 15mm-109mm (Predicate: 25mm-120mm). Slight difference but considered equivalent as per statement "changes impacted the balloon to balloon distance and effective length" and overall conclusion of substantial equivalence. |
| Balloon Occlusion Vessel Range: Identical to Predicate | Proximal and Distal: 3mm-11mm |
| Recommended Balloon Inflation Volume: Identical to Predicate | 0.10cc-1.07cc |
| Radiopaque Marker: Identical to Predicate | Two markers |
| Shaft Design: Identical to Predicate | Dual lumen inner shaft within a multi-lumen shaft (one lumen for distal balloon inflation, one for guidewire); outer catheter is multi-lumen shaft (one houses inner shaft, one for proximal balloon inflation, one for drug infusion). |
| Fluid Delivery: Identical to Predicate | Dual Lumen - one for saline, one for diagnostic/therapeutic fluid. |
| Contrast Medium Ratio: Identical to Predicate | 70/30 saline to contrast |
| Accessories: Identical to Predicate | Not applicable; no syringes included. |
| Functional Performance: Same as Predicate | Bench testing confirmed that "functionally the RenovoCath performs the same as the predicate device in facilitating the delivery of fluids to the peripheral vasculature." This was demonstrated through: Dimensional Inspection, Insertion and Tracking Testing, Balloon Testing, Infusion Flow Rate Testing, and Simulated In-Vivo Testing. The collective results demonstrate it "meets its specifications and performs as intended." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for each of the bench tests (Dimensional Inspection, Insertion and Tracking Testing, Balloon Testing, Infusion Flow Rate Testing, Simulated In-Vivo Testing). It generally refers to these as "testing" using "the same methods previously established."
- Data Provenance: The data is from bench testing performed by RenovoRx, Inc. It is prospective testing designed to evaluate the new device against the predicate. The country of origin for the testing would be the USA, where RenovoRx, Inc. is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of information is generally not applicable to this 510(k) submission. The "ground truth" for this device, which is a physical catheter, is its physical and functional specifications. The "ground truth" for its performance is derived from bench testing that measures physical characteristics and operational performance against predefined engineering specifications and comparison to the predicate device's known performance. This does not involve clinical "experts" establishing ground truth in the way an AI/ML diagnostic device would.
4. Adjudication Method for the Test Set
Not applicable. The 'adjudication' in this context is the comparison of bench testing results to the predicate device's performance and to engineering specifications. There is no mention of a human adjudication process for interpreting results in a subjective manner.
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
Not applicable. This is a medical device (catheter), not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned or relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device. There is no algorithm or AI component.
7. The Type of Ground Truth Used
The ground truth used for the subject device is its engineering specifications and the established performance characteristics of the legally marketed predicate device (RenovoCath® K191606). The goal of the testing was to demonstrate that the new device met its own specifications and performed comparably to the predicate.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device. There is no training set in the context of AI/ML.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set in the AI/ML sense, this question is not relevant.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).