(267 days)
Sizing catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed. Sizing catheters have marker bands that can be used for anatomical measurements.
The Sizing Catheters are sterile, single use devices designed for use in angiographic procedures. There are three categories of Sizing Catheters that differ based on the number and spacing of the marker bands, these categories include: White Sizing Catheters, Aurous Centimeter Sizing Catheters, and Cava Vessel Sizing Catheters. All Sizing Catheters are 5.0 French and are manufactured in lengths of 65, 70, 90, and 100 centimeters. Each configuration includes a nylon luer lock adapter and connecting cap, gold marker bands, and a nylon shaft.
The provided document describes testing for medical catheters (White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter) to demonstrate substantial equivalence for FDA 510(k) clearance. It does not describe an AI/ML-based device or a study involving human readers or ground truth established by experts. Therefore, many of the requested criteria about AI/ML acceptance and study design cannot be answered from the provided text.
However, I can extract the general acceptance criteria and the performance claimed for these specific medical devices based on the information provided.
Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (General) | Reported Device Performance and Confirmation |
|---|---|
| Biocompatibility: Device is biocompatible. | Tested in conformance with AAMI ANSI ISO 10993-1:2009(R)2013 for cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, hemocompatibility, complement activation, and partial thromboplastin time. Predetermined acceptance criteria were met. |
| Tensile Testing of Hub to Shaft Joint: Peak load value of connection meets standards. | Tested in accordance with BS EN ISO 10555-1:2013, Annex B. Predetermined acceptance criterion was met. |
| Liquid Leakage Testing: No liquid leakage under proper clinical use. | Tested in accordance with BS EN ISO 10555-1:2013, Annex C. Predetermined acceptance criterion was met. |
| Air Leakage Testing: No air leakage under proper clinical use. | Tested in accordance with BS EN ISO 10555-1:2013, Annex D. Predetermined acceptance criterion was met. |
| Static Burst Testing: Catastrophic failure pressure characterized. | Successfully characterized in accordance with BS EN ISO 10555-1:2013, Annex F. |
| Dimensional Verification Testing: Outer diameter, inner diameter, and marker band spacing are within specified tolerance. | Predetermined acceptance criteria were met. |
| Tensile Testing of Marker Bands: Peak load value of marker bands is sufficient for clinical use. | Predetermined acceptance criterion was met. |
| Tensile Testing of Sideports (if applicable): Peak load values of sideported area meet standards. | Tested in accordance with BS EN ISO 10555-1:2013, Annex B. Predetermined acceptance criterion was met. |
| Flow Rate Testing: Flow rates at designated injection pressures characterized. | Successfully characterized the flow rates of the device at designated injection pressures using saline and contrast. |
| Acute Performance Testing: Performance parameters are acceptable for clinical use. | Predetermined acceptance criteria were met. |
| Corrosion Testing: No observable signs of corrosion. | Tested in accordance with BS EN ISO 10555-1, Annex A. Predetermined acceptance criterion was met. |
Information Not Available in the Provided Document (Pertaining to AI/ML or Human Reader Studies):
The provided text describes the regulatory clearance process for a physical medical device (catheters) and its mechanical/biocompatibility testing. It specifically states "performance testing" was conducted. This document does not describe an AI/ML-based device or a study involving human readers for image interpretation. Therefore, the following points, which are relevant to AI/ML device evaluations, cannot be answered from this submission:
- Sample sizes used for the test set and the data provenance: Not applicable to this type of device and testing. The "test set" here refers to the physical devices subjected to various engineering/biocompatibility tests, not a dataset for software validation.
- 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 by engineering standards and measurements, not expert consensus interpretation of data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for these physical tests is typically defined by adherence to recognized international standards (e.g., ISO, BS EN ISO) and pre-defined pass/fail criteria for physical properties and biocompatibility.
- The sample size for the training set: Not applicable, no training set for a physical device.
- How the ground truth for the training set was established: Not applicable, no training set.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).