(419 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 also indicated for temporary vessel occlusions including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. 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 yessel 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 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.
This document is a 510(k) premarket notification for the RenovoCath™ RC120 Catheter. It claims substantial equivalence to a predicate device, the Boston Scientific Equalizer™ Occlusion Balloon Catheter (K140273), rather than providing detailed acceptance criteria and a study to prove a device meets those criteria from scratch. Therefore, the information you're requesting, particularly specific acceptance criteria with numerical performance data like sensitivity/specificity, sample sizes for test and training sets, details on expert ground truthing, and MRMC studies, is not present in this type of regulatory submission.
Instead, the document focuses on demonstrating that the RenovoCath has the same intended use and similar technological characteristics as the predicate device, and that any differences do not raise new issues of safety or effectiveness.
Here's an analysis based on the information provided in the document, framed by your request, explaining why certain details are missing for this type of submission:
1. A table of acceptance criteria and the reported device performance
This document does not present quantitative acceptance criteria or reported device performance in the format of a table with specific metrics like sensitivity, specificity, or AUC, as would be common for diagnostic AI algorithms.
Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device and the results of the bench testing. The "performance" is described in qualitative terms:
| Implied Acceptance Criteria (via Substantial Equivalence and Bench Testing) | Reported Device Performance (RenovoCath™ RC120) |
|---|---|
| Similar Intended Use | The RenovoCath has the same intended use for isolation of blood flow and delivery of fluids, and temporary vessel occlusion, matching the predicate. |
| Similar Technological Characteristics | The RenovoCath is a multi-lumen, dual-balloon catheter with adjustable distance between balloons, and uses 3cc syringes for balloon inflation under fluoroscopic guidance, similar to the predicate. |
| Functional Equivalence (Bench Testing) | Balloon Inflation Time: Tested using the same methods as previously performed on RenovoCath, and results confirm similar design features to the predicate. |
| Infusion Flow Rate: Tested using the same methods as previously performed on RenovoCath, and results confirm similar design features to the predicate. | |
| Biocompatibility | Previous testing (for K141175) confirmed biocompatibility. |
| Sterilization Validation | Previous testing (for K141175) confirmed sterilization validation. |
| Shipping and Packaging Stability | Previous testing (for K141175) confirmed shipping and packaging stability. |
| Accelerated Aging | Previous testing (for K141175) confirmed accelerated aging performance. |
| Design Verification Testing | Previous testing (for K141175) confirmed design verification. |
| Material Integrity/Safety (Additional Testing) | Extractables/Leachables Profile: Determined after exposure to simulated use conditions (pre-conditioning to simulate expected clinical and infusate properties). Results collectively demonstrate the device meets specifications. |
| Material Changes Evaluation: Functional testing and SEM analysis confirm material integrity. Results collectively demonstrate the device meets specifications. | |
| Overall Performance | "The collective results of the testing demonstrate that the RenovoCath meets its specifications and performs as intended." "The bench testing on the predicate device confirms that functionally the Equalizer Catheter and RenovoCath have similar design features to facilitate the delivery of fluids to the peripheral vasculature." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes bench testing for physical characteristics of the device, not clinical studies involving patient data or images. Therefore, the concepts of "test set sample size" and "data provenance" (country/retrospective/prospective) related to patient data are not applicable here. The testing was conducted on devices and materials in a laboratory setting. No information on the specific number of units tested for each bench test is provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the study involves bench testing of a physical medical device, not evaluation of an AI algorithm based on human expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reasons as point 3.
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
This is not applicable. The device is a physical catheter, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing described, the "ground truth" would be established by engineering specifications, validated test methods, and industry standards for medical device performance. For example, a balloon inflation time would be measured against a specified range, or an infusion flow rate against a required minimum, rather than an expert consensus or pathology report.
8. The sample size for the training set
This is not applicable as this document describes bench testing for a physical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
§ 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).