(51 days)
The RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic 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 76cm to 86cm (adjustable). Radiopague 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.
The provided text is a 510(k) Premarket Notification from the FDA for the RenovoCath device. This document focuses on demonstrating substantial equivalence to a predicate device (RenovoCath™ RC120 Catheter K160067) rather than detailing a study that proves the device meets specific performance acceptance criteria in the manner one might see for a novel AI/software as a medical device (SaMD).
For a SaMD, acceptance criteria often relate to clinical performance metrics like sensitivity, specificity, AUC, or reader agreement improvement. For this medical device (a catheter), the "acceptance criteria" are demonstrated through engineering bench testing and comparison to an existing similar device.
Therefore, many of the requested items (e.g., sample size for training/test sets, expert adjudication methods, MRMC studies, standalone performance of an algorithm) are not applicable to this type of medical device submission. This document highlights a predicate pathway where the primary goal is to show that the new device is as safe and effective as a legally marketed device, not to prove clinical superiority or novel diagnostic capabilities via extensive clinical studies involving human readers or AI algorithms.
Here's how to address the request based on the provided document:
Acceptance Criteria and Device Performance (as demonstrated for a medical device)
1. Table of "Acceptance Criteria" and Reported Device Performance
For this medical device, "acceptance criteria" are demonstrated by a battery of engineering and bench tests, ensuring the device functions as intended and is comparable to the predicate. The "reported device performance" is essentially that the new device passed these tests and functions similarly to the predicate.
| "Acceptance Criteria" (Demonstration Type) | Reported Device Performance (Summary from Submission) | Notes/Comparison to Predicate |
|---|---|---|
| Flow Rate (40% Glycerol in distilled water) | "Flow Rate 40% Glycerol in distilled water: 10±6 mL/min" | Tested using the same methods as previously established for the predicate. |
| Vessel Occlusion (using 70% Saline and 30% Omnipaque 300) | Performed effectively. Bench testing confirms functional similarity. | Tested using the same methods as previously established for the predicate. |
| Visibility Under Fluoroscopy | Achieved. Radiopaque markers (two) are present and visible. | Tested using the same methods as previously established for the predicate. |
| Bench testing for 3mm occlusion | Confirmed successful occlusion of 3mm diameter vessels. | This expands the vessel size range from the predicate (4mm-11mm) to 3mm-11mm. Bench testing supports this new lower limit. |
| Visual inspection | Passed | Standard quality control. |
| Dimensional verification | Passed | Standard quality control. Catheter size and effective length are consistent with predicate. |
| Insertion and tracking testing | Passed | Standard performance testing. |
| Balloon performance verification | Passed, consistent with low pressure compliant balloons. Recommended inflation volume 0.10-1.07cc. | Predicate had recommended inflation volume 0.12-1.07cc, indicating minor adjustment but similar function. |
| Infusion flow rate testing | Passed | Consistent with intended fluid delivery. |
| Simulated use testing | Passed | Demonstrates functionality in a simulated environment. |
| Bonds strength testing | Passed | Ensures structural integrity. |
| Infusion port burst testing | Passed | Ensures integrity under pressure. |
| Material Compatibility | Silicone, Pebax, Platinum Iridium | Same as predicate. |
| Sterilization Method | Ethylene Oxide | Same as predicate. Change in contract sterilizer noted, but method remains the same. |
| Indication for Use and Technological Characteristics | Substantially equivalent to predicate. | Minor changes include removal of power injector contraindication, clarification of coronary/intracranial/embolic protection contraindications, revised contrast dilution ratio (70/30 vs 50/50), expanded vessel diameter for occlusion (3mm vs 4mm), and other minor IFU improvements. These changes were supported by the bench testing. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for each bench test (e.g., number of catheters tested for flow rate or bond strength). It refers to "the RenovoCath was tested for the following using the same methods previously established." This implies standard quality control and engineering test sample sizes appropriate for device manufacturing and validation, but not formal clinical study sample sizes.
- Data Provenance: Not applicable in the context of clinical data for AI/SaMD. The data comes from internal engineering and bench testing. It's not clinical data from patients or a specific country.
- Retrospective/Prospective: Not applicable. These are lab-based tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth for a catheter's physical and functional performance is established by engineering specifications, validated test methods (often based on ISO or ASTM standards), and comparison to a predicate device's established performance, not by human experts interpreting clinical images or outcomes.
4. Adjudication Method for the Test Set
Not applicable. This is not a clinical study involving human interpretation or consensus. Performance is measured objectively through engineering tests.
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 device is a physical catheter, not an AI or software device. No human readers or AI assistance are involved in its primary function or evaluation for this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. There is no algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Engineering Specifications: Defined parameters for flow rate, dimensions, material properties, etc.
- Bench Testing Results: Objective measurements from controlled laboratory experiments (e.g., burst pressure, flow rate measurement).
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (RenovoCath™ RC120 Catheter K160067) serves as the reference for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. There is no training set as this is not an AI/ML product.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set.
Study Summary
The "study" in this context is the 510(k) Premarket Notification process, which demonstrates substantial equivalence to a predicate device.
- Objective: To show that the RenovoCath is as safe and effective as the predicate device (RenovoCath™ RC120 Catheter K160067) for its stated indications for use.
- Methodology: The manufacturer conducted a series of bench tests and engineering evaluations to compare the RenovoCath to its predicate and to ensure it met its own performance specifications. These tests included:
- Flow Rate
- Vessel Occlusion
- Visibility Under Fluoroscopy
- Bench testing for 3mm occlusion (specifically to support the expanded vessel diameter range)
- Visual inspection
- Dimensional verification
- Insertion and tracking testing
- Balloon performance verification
- Infusion flow rate testing
- Simulated use testing
- Bonds strength testing
- Infusion port burst testing
- Key Findings: The collective results of these tests demonstrated that the RenovoCath meets its specifications and performs as intended, and that its technological characteristics and performance are substantially equivalent to the predicate device, despite minor changes in indications for use/contraindications (e.g., expanded vessel diameter range, updated contrast ratio, moved contraindications).
In summary, for a traditional medical device like the RenovoCath, "acceptance criteria" are primarily related to engineering performance and functional equivalence to a predicate, rather than the statistical clinical performance metrics typical of an AI/SaMD. The "study" proving this is a series of comprehensive bench and engineering tests.
§ 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).