(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
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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.
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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
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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.
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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.
§ 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).