(171 days)
The RenovoCath™ RC120 Catheter 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™ RC120 is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath™ RC120 is intended for use in arteries from 3mm in diameter for vessel entry and to occlude vessels ranging between 4mm to 11mm in diameter.
The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the respective agent manufacturer.
The RenovoCath™ RC120 Catheter is not intended for use in coronary and intracranial arteries.
The RenovoCath™ RC120 Catheter is not intended for embolic protection or as an aspiration catheter.
The RenovoCath™ RC120 Catheter ("RenovoCath") is a multi-lumen, dual-balloon catheter. The RenovoCath is designed for targeted delivery of fluids, including diagnostic agents, to selected sites in the peripheral vascular system. The distance between the proximal and distal balloons is adjustable. The RenovoCath is provided with two off-the-shelf 3cc syringes that facilitate precise inflation of the balloons under fluoroscopic guidance.
The provided documentation describes the RenovoCath™ RC120 Catheter, a medical device, and its 510(k) premarket notification (K141175). This type of notification focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than providing extensive clinical study data proving performance against specific acceptance criteria in the same way a new drug or novel medical imaging AI might.
Therefore, the information provided does not contain acceptance criteria and a study proving the device meets those criteria in the typical sense of a detailed clinical performance study with statistical metrics. Instead, it focuses on demonstrating equivalence through bench testing.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) for a physical medical device (catheter) based on substantial equivalence, the "acceptance criteria" are primarily related to passing various engineering and materials tests to demonstrate it functions similarly and safely to the predicate device. The document states:
| Acceptance Criteria (Implied from testing categories) | Reported Device Performance (Summary) |
|---|---|
| Bench Testing Categories: |
- Biocompatibility
- Sterilization
- Shipping and Packaging
- Accelerated Aging
- Design Verification (Visual, Dimensional, Insertion/Tracking, Balloon Performance, Infusion Flow Rate, Simulated Use, Bonds Strength, Infusion Port Burst) | "All necessary bench testing was conducted on the RenovoCath to support a determination of substantial equivalence to the predicate device."
"The collective results of the testing demonstrate that the RenovoCath meets its specifications and performs as intended."
"The collective bench testing demonstrates that the RenovoCath does not raise new questions of safety or effectiveness as compared to the predicate device." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. For bench testing of physical devices, sample sizes are typically determined by engineering and quality assurance standards relevant to the specific test (e.g., number of catheters tested for burst pressure, number of samples for biocompatibility). These details are not provided in this summary document.
- Data Provenance: The testing was conducted by or for RenovoRx, Inc. in the USA. It is prospective testing designed to support the 510(k) application.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable in the context of this 510(k) submission. Bench testing for device functionality does not typically involve "experts" establishing a "ground truth" in the way clinical studies or AI algorithm evaluations do. The "truth" is determined by engineering specifications and physical measurements.
4. Adjudication method for the test set:
- Not applicable. This is not a study requiring adjudication of expert opinions.
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 physical medical device (catheter), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
7. The type of ground truth used:
- For the bench testing, the "ground truth" or reference for performance is established by engineering specifications, industry standards, and comparison to the predicate device's known performance characteristics. For example, a balloon must inflate to a certain diameter without bursting, or a catheter must withstand a certain tensile force.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established:
- Not applicable. This is a physical medical device.
In summary: The RenovoCath™ RC120 Catheter received 510(k) clearance based on demonstrating "substantial equivalence" to a predicate device (ThermopeutiX, Inc. TAPAS Catheters, K112219). This was supported by a range of bench tests (biocompatibility, sterilization, shipping/packaging, accelerated aging, and various design verification tests) that collectively confirmed the RenovoCath met its specifications, performed as intended, and did not raise new questions of safety or effectiveness compared to the predicate. The documentation does not provide specific quantitative acceptance criteria or detailed sample sizes for each test but indicates that "all necessary bench testing was conducted."
§ 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).