(50 days)
The 93 NeuFlex™ Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The Piraeus Medical 93 NeuFlex™ Catheter is a single lumen guide catheter that provides access to peripheral, coronary and neuro vasculature. The catheter is comprised of a hollow cylindrical tube bonded at the proximal end to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The catheter features a hydrophilic coating to enhance tracking through tortuous vasculature and facilitate the introduction of interventional devices to the peripheral, coronary and neuro vasculature. The 93 NeuFlex™ guide catheter is compatible with 0.035" or smaller guidewires. The distal soft tip facilitates tracking past vessel branches. A radiopaque marker provides visual confirmation of the distal tip location under fluoroscopy. The 93 NeuFlex™ Catheter has an inner diameter of 0.093" (compatible with 6F outer diameter catheters), and a maximum outer diameter of 0.110". The catheter is offered in working lengths of 110 cm and 100 cm. The 93 NeuFlex™ guide catheter is packaged with a loading tool to aid in insertion of the catheter into a short sheath.
Accessory devices required, but not supplied include:
- Guidewires
- Support/diagnostic catheters
- Introducer sheaths
- Rotating hemostasis valves (RHVs)
The provided text describes the FDA 510(k) clearance for the "93 NeuFlex Catheter." This is a medical device clearance document for a physical catheter, not a software-based artificial intelligence/machine learning (AI/ML) device. Therefore, the "acceptance criteria" and "study proving the device meets the acceptance criteria" in this document relate to the physical and functional performance of the catheter itself, primarily through non-clinical bench testing, rather than AI/ML performance metrics like sensitivity, specificity, or AUC, which would be derived from a clinical study with human readers or standalone algorithm performance.
The questions you've posed (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set ground truth) are highly specific to AI/ML software validation studies. Since the provided document is for a physical medical device (a catheter) and relies on bench testing for substantial equivalence, most of these questions are not applicable to the data provided.
However, I can extract the relevant "acceptance criteria" (in the context of bench testing) and the "reported device performance" from the document.
Acceptance Criteria and Reported Device Performance for 93 NeuFlex Catheter
The acceptance criteria for this physical medical device are implied by the "Pass" results in the performance testing. These are not statistical metrics related to diagnostic accuracy, but rather engineering and functional performance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Test (Imacceptance Criteria) | Test Method Summary (Standard/Guidance) | Reported Device Performance |
|---|---|---|
| Visual Inspection: Catheter free of surface defects, extraneous matter; distal tip smooth, tapered/rounded. | N/A | Pass |
| Dimensional Verification: Catheter outer diameter, inner diameter, usable length, coating length within specifications. | N/A | Pass |
| Delivery, Compatibility, and Retraction (Trackability): Able to be prepped, inserted, tracked, retracted, and removed per IFU in simulated use without damage. | ISO 10555-1, FDA guidance PTA and Specialty Catheters | Pass |
| Flexibility and Kink Resistance: No kinking of shaft (permanent deformation) after simulated use. | FDA guidance PTA and Specialty Catheters | Pass |
| Compatibility with Other Devices (External): Compatible with 8F introducer (short) sheath. | ISO 10555-1, FDA guidance PTA and Specialty Catheters | Pass |
| Guidewire Compatibility: Able to be delivered over maximum size guidewire indicated in labeling. | ISO 10555-1, FDA guidance PTA and Specialty Catheters | Pass |
| Interventional Device Compatibility (Internal): Able to accommodate other interventional devices (e.g., support catheter, diagnostic catheter) up to maximum size indicated in labeling. | ISO 10555-1, FDA guidance PTA and Specialty Catheters | Pass |
| Accessory Compatibility: Compatible with accessories such as RHVs and the accessory loading tool. | N/A | Pass |
| Catheter Bond Strength: Sufficient tensile bond strength to remain intact throughout a procedure. | ISO 10555-1, FDA guidance PTA and Specialty Catheters | Pass |
| Freedom from Leakage – Positive Pressure: No liquid leakage from hub or catheter shaft at 317 kPa (46 psi) for 30 seconds. | ISO 10555-1 | Pass |
| Freedom from Leakage – Negative Pressure: No air leakage into a 20cc syringe when vacuum pulled for 15 seconds. | ISO 10555-1 | Pass |
| Kink Resistance: No kinking of catheter shaft (permanent deformation) after wrapping around anatomically relevant bend radii. | FDA guidance PTA and Specialty Catheters | Pass |
| Pushability: Proximal shaft has sufficient stiffness for easy pushing to target anatomy without buckling. | ISO 10555-1, FDA guidance PTA and Specialty Catheters | Pass |
| Access Force: Does not require excessive force to navigate and track to target anatomy. | ISO 10555-1, FDA guidance PTA and Specialty Catheters | Pass |
| Static Burst: Static burst pressure compared with maximum pressure generated with manual syringe injection. | ISO 10555-1 | Pass |
| Torque Strength: Navigated through clinically relevant tortuous path; proximal end rotated until failure without issues. | FDA guidance PTA and Specialty Catheters | Pass |
| Distal Tip Flexibility: Compressive force exerted by side of catheter at defined distance from distal tip (when tip deflected) compared to predicate. | N/A | Pass |
| Particulate: Amount of particulate matter generated during simulated use compared to predicate. | FDA guidance PTA and Specialty Catheters | Pass |
| Coating Lubricity, Durability, and Integrity: Frictional forces measured (pinch test); hydrophilic coating examined for damage after simulated use. | N/A | Pass |
| Corrosion: Metallic components contacting fluid path evaluated for corrosion resistance. | ISO 10555-1 | Pass |
Inapplicable AI/ML Specific Questions:
The following questions are geared towards AI/ML software performance studies. Since this FDA clearance is for a physical medical device (a catheter) and the supporting evidence is non-clinical bench testing, these questions are not applicable in the context of the provided document.
- Sample sizes used for the test set and the data provenance: Not applicable. The "test set" here refers to physical catheter samples tested in benchtop models, not a dataset of medical images or patient records. The provenance is internal company testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device performance is established through adherence to engineering specifications and standardized test methods, not expert consensus on medical findings.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in interpreting medical images or data where human variability in judgment exists. This is a bench test for a physical device.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the catheter's performance is derived from standardized engineering and material science tests, often defined by international standards (e.g., ISO 10555-1) and FDA guidance for catheter performance, rather than clinical outcomes or expert medical consensus on diagnostic findings.
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study Proving Device Meets Criteria (Based on Provided Text):
The manufacturer, Piraeus Medical, conducted a series of non-clinical bench performance tests on the 93 NeuFlex Catheter. These tests were performed per company-approved protocols, test methods, and performance standards, many of which reference international standards like ISO 10555-1 and FDA guidance for PTA and Specialty Catheters. The results of all listed tests indicated "Pass," meaning the device met the predefined performance specifications for each test. This extensive bench testing, along with comparison to a predicate device (87 NeuGlide Catheter, K240971) which shares similar intended use and basic technological characteristics, formed the basis for demonstrating substantial equivalence and thus FDA clearance. Biocompatibility and sterilization were leveraged from the predicate device's existing validations. Shelf-life was supported by accelerated aging based on ASTM F1980, also leveraging the predicate's packaging configuration.
§ 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).