Search Results
Found 4 results
510(k) Data Aggregation
(122 days)
The NovaCross CTO Microcatheter is intended to facilitate the intraluminal placement of conventional and steerable guidewires beyond the stenotic lesions, including chronic total occlusions (CTOs), and prior to PTCA or stent intervention. It is also 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™ CTO Microcatheter is a sterile, single-use, single lumen, over-the-wire, disposable percutaneous support catheter designed to facilitate the intraluminal placement of conventional and steerable guidewires beyond stenotic lesions (including chronic total occlusions) prior to PTCA or stent intervention and to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature. The NovaCross™ CTO Microcatheter consists of stainless steel 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 collapsible 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.
Here's a breakdown of the acceptance criteria and study details for the NovaCross™ CTO Microcatheter, based on the provided FDA 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Primary Safety Endpoint (MI Rate) | Implied: MACE rate observed in the combined analysis of cohort A and B should be within an acceptable range, with an upper 97.5% confidence interval below a specific threshold (not explicitly stated, but derived from the p-value against some null hypothesis). | 12.3% for the ITT population, with an upper 97.5% CI of 19.41% |
| Primary Effectiveness Endpoint (Technical Success) | Implied: Technical success rate should be above a predefined threshold (not explicitly stated, but derived from the reported 75.3% success rate meeting the endpoint). | 75.3% for the ITT population (140/186) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 186 subjects across two cohorts (Cohort A: 145, Cohort B: 41).
- Data Provenance: Not explicitly stated, but the submission mentions "10 investigational sites," implying the study was conducted at various clinical locations. The document refers to the submitter's location as Israel, and the regulatory consultant in the US, but the study locations are not detailed. It is a prospective study as it's an "IDE Clinical Study" and a "pivotal study" conducted to assess safety and efficacy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study involved subjects undergoing Percutaneous Cardiac Intervention (PCI) for CTO, and the endpoints were clinical outcomes (MI rate, technical success). The determination of these outcomes would have been based on standard clinical practices, lab results (CK-MB), and interventional cardiologist assessment, but the specific number and qualifications of "experts" for ground truth adjudication are not detailed.
4. Adjudication Method for the Test Set
This information is not explicitly detailed for the clinical endpoints. Clinical trial data typically involves a Clinical Events Committee (CEC) for endpoint adjudication, but the specific method (e.g., 2+1, 3+1) is not mentioned in this summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a single-arm clinical trial assessing the device's safety and effectiveness, not comparing human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a physical medical device (microcatheter) and not an AI algorithm. Therefore, the concept of a "standalone" algorithm performance study is not applicable here. The study assesses the performance of the device in a clinical setting with human operators.
7. The Type of Ground Truth Used
- For the primary safety endpoint (MI rate): Outcomes data based on clinical events and objective biomarker measurement (CK-MB > 3X ULN) and urgent revascularization.
- For the primary effectiveness endpoint (technical success): Expert assessment/outcomes data based on the ability to successfully facilitate guidewire placement beyond the CTO in the true vessel lumen, as determined by the interventional cardiologists performing the procedure.
8. The Sample Size for the Training Set
This information is not applicable as the NovaCross™ CTO Microcatheter is a physical medical device and not an AI/machine learning algorithm that requires a training set. The "training" for this device would refer to its design, engineering tolerances, and preclinical testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above. The "ground truth" for the device's development and preclinical validation would involve engineering specifications, material properties, and various bench testing results (e.g., dimensional, torque response, tensile strength, scaffold durability) against predefined design criteria.
Ask a specific question about this device
(79 days)
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.
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Simulated Use Testing | Device performs as intended during simulated use, effectively guiding, tracking, and exchanging guidewires. | "successfully completed" (implied, as it supports substantial equivalence) |
| Biocompatibility | Meets ISO 10993 standards for contact with blood and tissue (cytotoxicity, hemolysis, etc.). | Passed based on biological risk assessment, cytotoxicity, and hemolysis testing. |
| Mechanical Tests: | ||
| - Bond Strength | Sufficient bond strength to ensure device integrity during use. | "successfully completed" (implied) |
| - Visibility Test | Radiopaque markers/features provide adequate visibility under fluoroscopy. | "successfully completed" (implied) |
| - Radial Force Test | Scaffold provides appropriate radial force for anchoring without causing damage. | "successfully completed" (implied) |
| - Axial Force Test | Device maintains structural integrity and pushability/trackability. | "successfully completed" (implied) |
| GLP Animal Study | Device functions safely and effectively, demonstrating adequate scaffold deployment, anchoring, and maneuverability without adverse tissue reaction. | "successfully completed" (implied, to assess new scaffold and device characteristics) |
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
(29 days)
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.
| Acceptance Criteria (Implied: Performance equivalent to predicate device K143608) | Reported Device Performance (NovaCross™ Microcatheter K160389) |
|---|---|
| Simulated Use: Maintain performance after assembly, sterilization, transportation, and accelerated aging. | Test performed at baseline, Time 0 (after sterilization/transportation), and Time 1 (after 1 year accelerated aging/transportation). The document states performance data demonstrates the modified device is "as safe and effective as the predicate." |
| Tensile Strength: Maintain strength after assembly, sterilization, transportation, and accelerated aging. | Test performed at baseline, Time 0, and Time 1. The document states performance data demonstrates the modified device is "as safe and effective as the predicate." |
| Kink Resistance: Maintain resistance to kinking after assembly, sterilization, transportation, and accelerated aging. | Test performed at baseline, Time 0, and Time 1. The document states performance data demonstrates the modified device is "as safe and effective as the predicate." |
| Tip Flexibility: Maintain flexibility after assembly, sterilization, transportation, and accelerated aging. | Test performed at baseline, Time 0, and Time 1. The document states performance data demonstrates the modified device is "as safe and effective as the predicate." |
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
(136 days)
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:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Complied with ISO 10993-1. All tests (cytotoxicity, irritation, acute systemic toxicity, sensitization, hemocompatibility) were successfully completed. |
| Sterilization, Packaging, Shelf Life | Sterilization validation (ISO 11135-1) successfully completed. Shelf life and packaging testing successfully completed to support labeled shelf life. |
| Mechanical Bench Testing | All tests (Dimensional, Simulated use, Tip flexibility, Tip and shaft durability, Torque response, Torque strength, Tensile strength, Hydrophilic coating integrity, Corrosion, Fluid leak, Air leakage, Pushability and retractability, Scaffold durability, Radial force) met the predefined acceptance criteria. (Specific numerical criteria not provided). |
| GLP Animal Study | The device could be used safely and effectively as a tool to provide support to the guidewire. No discernible pathological adverse effects were detected (local and systemic effects) in terms of treated vessel integrity, gross pathology, and histopathology 1 and 14 days post-procedure. Successfully achieved all performance criteria defined in the study protocol. |
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
Page 1 of 1