(56 days)
The Renegade Fiber Braided Microcatheter is intended for general intravascular use, including neuro, peripheral, and coronary vasculature. The catheter can be coaxially tracked over a steerable quidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, or therapeutic agents to be used in accordance with specifications outlined by the manufacturer.
The device is a 3.0F/2.5F, single lumen catheter constructed with progressively softer shaft characteristics from its proximal to its distal ends. The device is tracked coaxially over a selectively placed guide wire. To facilitate catheter introduction, the device incorporates a hydrophilic coating applied to the outer sufface of the shaft. Once the subselective region has been accessed, the lumen of the catheter can be used for infusion of diagnostic agents, such as contrast medium, and therapeutic materials. The device is available in useable lengths of 130 cm and 150 cm and in distal segment lengths of 10cm, 20cm, and 30cm.
The provided document is a 510(k) summary for a medical device (intravascular infusion catheter) submitted to the FDA in 1997. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed studies that establish specific acceptance criteria and prove performance against those criteria in the way a modern clinical trial or AI/ML study would.
Therefore, the specific information requested in your prompt regarding acceptance criteria, study design for proving performance, and details related to AI/ML device testing (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, etc.) is not present in this document.
Historically, 510(k) submissions, especially from 1997, relied heavily on comparing device characteristics (materials, dimensions, mechanical properties, biocompatibility) and intended use to existing, legally marketed predicate devices. The "study" in this context refers to the comparison to predicate devices and bench/animal testing to show that any differences do not adversely affect safety and effectiveness.
Here's an attempt to answer based only on the provided text, highlighting what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself (e.g., specific tensile strength, burst pressure, or flow rate thresholds that would confirm it "meets" a standard). Instead, the acceptance criteria are implicitly that the device is "substantially equivalent" to the predicate devices and that any dimensional/material differences "do not adversely affect safety and effectiveness."
- Reported Device Performance: The document states that "mechanical, biocompatibility and animal testing demonstrated that these differences [between the proposed device and predicate] do not adversely affect safety and effectiveness." However, it does not provide specific performance values (e.g., actual tensile strength measurements, flow rates, or animal study outcomes) to put into a table.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified. The document mentions "mechanical, biocompatibility and animal testing," but doesn't detail the number of units tested, animals used, or the origin of any data (e.g., country).
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This concept is not applicable to this type of device submission. There is no "ground truth" established by experts in the context of an AI/ML device for this intravascular catheter. Testing would have involved engineering assessments and biological responses.
4. Adjudication method for the test set
- Not applicable. There's no mention of a process requiring expert adjudication for assessing the performance of this type of catheter.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- Not applicable. MRMC studies are specific to diagnostic devices (often imaging-based) involving multiple human readers interpreting cases, usually with and without AI assistance. This is an intravascular catheter.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-only device.
7. The type of ground truth used
- The "ground truth" (or basis for evaluation) for this device would be established by:
- Predicate Device Performance: The accepted safety and effectiveness profile of the Evolution Microcatheter, Eddy Infusion, TurboTracker Infusion Catheter, and Venture II™ Intravascular Infusion catheters.
- Biocompatibility Standards: Compliance with established biocompatibility testing standards to ensure the materials are safe for in-vivo contact.
- Mechanical Performance Specifications: The device's mechanical properties (e.g., flexibility, pushability, trackability, burst pressure) meeting internal design specifications and being comparable to predicate devices in a way that doesn't raise new safety/effectiveness concerns.
- Animal Study Endpoints: For animal testing, outcomes related to tissue reaction, thrombus formation, or successful navigation/infusion without adverse events.
8. The sample size for the training set
- Not applicable. There is no AI/ML component or "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable.
In summary: The provided document is a 510(k) summary for a conventionally regulated medical device from 1997. It demonstrates substantial equivalence primarily through comparison to predicate devices and confirmation that any differences do not negatively impact safety and effectiveness, based on "mechanical, biocompatibility and animal testing." It does not contain the specific details about acceptance criteria, study sizes, expert involvement, or AI/ML-specific testing methodologies that your prompt requests, as those concepts are either not relevant to this type of device or were not part of regulatory submissions in that era.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).