(79 days)
The NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
The NanoCross catheter is an over-the-wire (OTW) coaxial lumen percutaneous transluminal angioplasty (PTA) balloon catheter compatible with 0.014"guidewires with a distally mounted semi-compliant inflatable balloon and an atraumatic tapered tip. The distal portion of the catheter has a lubricious coating. The manifold includes a lumen marked "THRU". This is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum diameter of 0.014". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon.
The NanoCross Elite catheter is available in balloon sizes ranging from 1.5 mm to 6 mm in diameter, and from 20 mm to 210 mm in length; reference labeling for introducer sheath compatibility.
The provided text describes a medical device, the NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter, and its substantial equivalence to predicate devices, rather than an AI/ML device with specific acceptance criteria and performance metrics. Therefore, many of the requested categories for AI/ML device studies are not applicable or cannot be extracted from this document.
However, I can extract information related to the device's performance testing and its acceptance criteria implicitly met through comparison to predicates.
Here's the information that can be extracted and how it relates to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "The NanoCross Elite catheter met all acceptance criteria for the bench testing with results similar to the predicates." It then lists the types of bench tests performed. The specific numerical acceptance criteria and precise performance results are not detailed in this summary. Instead, it relies on the concept of "similarity to predicates" and conformance to "requirements for its intended use."
| Acceptance Criteria Category (Implicit, based on tests performed) | Reported Device Performance (Summary) |
|---|---|
| Dimensional Verification: | Met all acceptance criteria with results similar to predicates. |
| - Crossing Profile | |
| - Balloon OD | |
| - Balloon Length | |
| - Tip/Lesion Entry Profile | |
| - Tip ID | |
| - Catheter Working Length | |
| Balloon Performance: | Met all acceptance criteria with results similar to predicates. |
| - Rated Burst Pressure | Notably, the device has "Identical balloon rated burst pressures" and "Identical balloon nominal pressure" to predicate devices. |
| - Rated Burst Pressure (In Stent) | |
| - Compliance | |
| - Fatigue | |
| - Inflation/Deflation Time | |
| Mechanical Properties & Usability: | Met all acceptance criteria with results similar to predicates. |
| - Radiopacity | |
| - Balloon Pull-back Force | |
| - Presence of Coating | The device has "A lubricious coating," similar to predicates. |
| - Pushability | |
| - Catheter Bond Strength | |
| - Wire Movement | |
| - Kink | |
| - Re-Insertion Force | |
| - Device Tracking | |
| - Insertion Force | |
| - Torque Strength | |
| - Particle Generation | |
| - Coating Durability | |
| Biocompatibility: | Met all acceptance criteria, leveraging tests from predicate devices. (Biocompatibility per ISO 10993-1) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for each individual bench test. The document mentions tests were performed "for one or more model sizes" or "leveraged from predicate devices for one or more model sizes." It does not provide specific numbers for units tested.
- Data Provenance: The testing was "Bench testing," meaning it was conducted in a laboratory setting, likely by the manufacturer (ev3 Inc.). It is not clinical data (retrospective or prospective). Country of origin is implied to be where ev3 Inc. operates (USA, as per address).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a physical medical device (catheter), not an AI/ML diagnostic tool or image analysis software. "Ground truth" in this context refers to the verifiable physical properties and performance characteristics of the device, established through standardized engineering and materials testing, not through expert human interpretation of data.
4. Adjudication Method for the Test Set:
- Not Applicable. As above, the "test set" here refers to physical devices undergoing bench testing. The results are typically quantitative measurements against predefined specifications, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, Not Applicable. This type of study assesses human reader performance with and without AI assistance, which is irrelevant for a physical medical device like a dilatation catheter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, Not Applicable. There is no algorithm described for this physical device.
7. The Type of Ground Truth Used:
- For the performance data listed (e.g., burst pressure, dimensions, fatigue): The ground truth is established through physical measurement against engineering specifications and international standards (like ISO 10993-1 for biocompatibility). The acceptance criteria are based on conformance to these specifications and demonstrated similarity to predicate devices that have prior FDA clearance.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. No training set exists.
In summary of the provided text:
The NanoCross™ Elite catheter demonstrated conformance to established performance requirements and substantial equivalence through a series of bench tests (physical and material properties, mechanical performance in simulated use) and biocompatibility testing. The "acceptance criteria" were implicitly met by achieving "results similar to the predicates" and adhering to "the requirements for its intended use" as determined by internal risk analysis procedures and industry standards. The submission is focused on demonstrating that the new device is as safe and effective as equivalent legally marketed devices based on these non-clinical tests.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).