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 an anchoring to aid the user in establishing greater support near the treatment site.

The provided text is a 510(k) summary for the NovaCross™ Microcatheter, focusing on demonstrating substantial equivalence to a predicate device. It explicitly states that the submission is a "Special 510(k) submission" to implement modifications to an already cleared device. This type of submission relies on performance testing to assure that the modified device remains as safe and effective as the predicate.

Here's an analysis of the acceptance criteria and study described:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of explicit acceptance criteria with numerical targets. Instead, it describes various performance tests conducted to ensure the modified device functions similarly to the predicate. The "reported device performance" is generally stated as the tests being successfully completed and demonstrating similarity to the predicate.

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

The document does not specify the sample sizes used for any of the individual tests (simulated use, mechanical, biocompatibility, or the GLP animal study).

The data provenance is within the manufacturer's testing facilities or accredited labs, as it pertains to engineering and preclinical testing of a medical device intended for regulatory submission. There is no mention of country of origin for the data or whether it's retrospective or prospective in the context of human clinical data, as this is a device modification submission based on non-clinical performance.

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

For this type of device modification submission, which relies on engineering and preclinical testing, the concept of "ground truth" established by human experts in a clinical context is not directly applicable. The "ground truth" for these tests is defined by engineering specifications, recognized standards (like ISO for biocompatibility), and animal model observation by veterinary and scientific staff.

Therefore, the document does not mention a number of experts or their qualifications for establishing ground truth in the way it would for an AI-based diagnostic device. The expertise would be in the form of engineers, toxicologists, veterinarians, and study directors overseeing the performance and animal studies.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers or evaluators assess patient data (e.g., medical images) to establish a consensus ground truth. This is not applicable to the engineering and preclinical tests described for the NovaCross™ Microcatheter. The test results are objective measurements or observations defined by the test protocols.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses human reader performance, often with and without AI assistance, and is relevant for AI-powered diagnostic devices. The NovaCross™ Microcatheter is a physical interventional medical device, not a diagnostic imaging or AI tool.

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

No, a standalone algorithm-only performance study was not done. This is relevant for AI algorithms. The NovaCross™ Microcatheter is a physical device that functions in conjunction with a steerable guidewire and is manipulated by a human operator (physician).

7. The Type of Ground Truth Used

The "ground truth" for the various performance tests is based on:

• Engineering Specifications: For mechanical tests, the ground truth is adherence to design specifications and established performance parameters.
• Industry Standards: For biocompatibility, the ground truth is compliance with recognized standards such as ISO 10993.
• Physiological Response/Observation: For the GLP animal study, the ground truth is the objective observation of device performance in a living system and the histological assessment of tissue reaction.
• Intended Use Definition: For simulated use, the ground truth is the successful demonstration of the device's ability to achieve its intended function (e.g., guidewire exchange, access discrete regions).

8. The Sample Size for the Training Set

Not applicable. The NovaCross™ Microcatheter is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of AI model development.

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

Not applicable, as there is no training set for this device.

Ask a specific question about this device

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

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 Body 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 an anchoring to aid the user in establishing greater support near the treatment site.

Subsequent to conventional guidewire placement, therapeutic devices such as atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit. The NovaCross™ Microcatheter by itself does not provide therapeutic benefit beyond simple facilitation of guidewire support. The NovaCross™ Microcatheter is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate devices.

Here's a breakdown of the acceptance criteria and study information for the NovaCross Microcatheter:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table detailing acceptance criteria alongside exact numerical performance metrics for each criterion. Instead, it states that "All [mechanical] tests met the predefined acceptance criteria" and "The Test Item successfully achieved all performance criteria defined in the study protocol" for the animal study.

Here's an inferred table based on the information provided:

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

• Test Set Sample Size:

  • Animal Study: 6 pigs.
  • Mechanical Testing: Not specified, but implied to be sufficient for each distinct test.
  • Biocompatibility / Sterilization / Packaging / Shelf Life: Not specified, but implied to be sufficient for each distinct test.

• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the animal study is described as a "GLP animal study," indicating it was a prospective, controlled study conducted under Good Laboratory Practice regulations, typically for regulatory submission.

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

• Animal Study: The study involved evaluation of gross pathology and histopathology. While not explicitly stated how many experts or their specific qualifications (e.g., "veterinary pathologist with X years experience") were involved, the execution of a "GLP animal study" strongly implies that qualified veterinary professionals, including veterinarians, surgeons, and pathologists specialized in animal models, were involved in the assessment and establishment of ground truth for the animal tissue analysis.

• Other Testing (Mechanical, Biocompatibility, etc.): Ground truth for these tests is typically established by engineering specifications, international standards (e.g., ISO), and defined acceptance limits rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

• Animal Study: The text mentions "Pathology and histopathology analyses confirmed the results of the study." This suggests a formal pathological review process. However, the exact adjudication method (e.g., blinded review, multiple pathologists, consensus meeting) is not detailed.
• Other Testing: Adjudication methods are not applicable in the same way as clinical or image-based studies. Tests are pass/fail based on predefined criteria.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices to assess human reader performance with and without AI. The NovaCross Microcatheter is a medical device (microcatheter) used in interventional procedures, not an AI-powered diagnostic tool.

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

No, a standalone algorithm performance study was not done. The device described is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used

• Biocompatibility: Established by standardized biological assays and compliance with ISO 10993-1.
• Sterilization, Packaging, Shelf Life: Established by adherence to ISO 11135-1 and company-defined stability/integrity protocols.
• Mechanical Testing: Established by engineering specifications and predefined acceptance criteria, often derived from industry standards or predicate device performance.
• Animal Study: "No discernible pathological adverse effects were detected, in terms of local and systemic effects" and "Pathology and histopathology analyses confirmed the results of the study." This indicates that pathology and histopathology (tissue analysis) served as the ground truth for safety and effectiveness in the animal model.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or machine learning algorithm that requires a "training set" in the computational sense.

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

Not applicable for the reason stated above.

Ask a specific question about this device