Search Results

The NovaCross™ Microcatheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.

The NovaCross™ Microcatheter is a sterile, single-use, single lumen, over-the-wire, disposable percutaneous support catheter designed for use in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature for guidewire exchange.

The NovaCross™ Microcatheter consists of telescopic shaft, over tube, and a proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. A key element of the device is a temporarily deployable and retractable distal Nitinol Scaffold, which is visible through fluoroscopy when deployed by the user, and expands to the width of the artery to provide anchoring to aid the user in establishing greater support near the treatment site.

This document is a 510(k) summary for the Nitiloop NovaCross™ Microcatheter, indicating it is a modified version of a previously cleared device (K143608). As such, the focus is on demonstrating substantial equivalence to the predicate device rather than presenting a comprehensive study proving novel acceptance criteria.

The acceptance criteria are implicitly defined by maintaining key performance characteristics to be "as safe and effective" as the predicate device, despite minor modifications. The study performed is a series of engineering tests designed to ensure these characteristics are maintained.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a special 510(k) for a modified device, the "acceptance criteria" are implied to be maintaining the performance of the predicate device. The reported device performance is that it met these implied criteria.

Note: The document explicitly states, "The following tests are the same as those submitted in the original submission," implying that the methods and success criteria for these tests were already established and met by the predicate device. The current submission confirms these tests were repeated and the modified device performed equivalently.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size for Test Set: The document does not specify the exact sample sizes (N values) for each of the mechanical performance tests (Simulated use, Tensile Strength, Kink Resistance, Tip Flexibility). It only states that the tests were performed.
• Data Provenance: The tests would have been performed by Nitiloop Ltd. or a contracted testing facility. The data provenance is retrospective in the sense that it's comparing a modified device's performance to an already-cleared predicate, but the specific testing conducted for the K160389 submission is prospective with respect to that submission. The country of origin of the data is implied to be Israel, given the submitter's address, or wherever the contract testing was conducted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to this submission. This is a submission for a physical medical device (microcatheter) and the "tests" refer to engineering and mechanical performance assessments, not clinical studies or AI algorithm validation that would require expert-established ground truth. The "ground truth" here is the physical performance measurement itself, compared against pre-defined engineering specifications.

4. Adjudication Method for the Test Set

Not applicable. As noted above, these are objective engineering tests, not clinical assessments requiring adjudication. The results are quantitative measurements against established specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This is a clearance for a physical medical device, not an AI algorithm, and therefore an MRMC study is not relevant or included in this document.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not Applicable. This device is a microcatheter, a physical instrument. There is no AI algorithm involved in the function or clearance of this device.

7. The Type of Ground Truth Used

For the engineering tests (Simulated use, Tensile Strength, Kink Resistance, Tip Flexibility), the "ground truth" is based on pre-defined engineering specifications and performance characteristics established for the predicate device. The modified device's performance is measured and compared to confirm it meets these specifications, ensuring it is "as safe and effective" as the predicate. This is based on objective measurement data rather than expert consensus, pathology, or outcomes data, which are more relevant for diagnostic or therapeutic efficacy claims.

8. The Sample Size for the Training Set

Not applicable. This device is a physical microcatheter, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no AI model or training set, this question is irrelevant.

Ask a specific question about this device