(238 days)
The TXM Support Catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. TXM Support Catheters are intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
The TXM Support Catheter is an over the wire (OTW) single lumen catheter with atraumatic tapered tip. The distal tip catheter shaft has 6 radiopaque markers (including the tip) that works as an aid to estimate positioning within the vasculature. It consists of a lubricious inner liner made from Teflon, and stainless steel braid over the liner and an outer layer that consists of clear Nylon 12 polymer. One gold marker band is positioned on the proximal side of the tip. A polycarbonate hub is attached to the proximal end of the TXM Support Catheter. The TXM Support Catheter system is offered in 8 models, four with a straight tip and four with an angled tip, and the angled tip configuration has an angle of 30°. All models will have an outer diameter of the 4 French size (0.052") and an inner diameter of 0.039" tapered down to 0.0355" towards the distal tip so that is compatible with a 0.035" guidewires. The device is available in lengths of 65cm, 90cm. 135cm, and 150cm. The catheter is coated with a lubricious hydrophilic coating. The device is supplied sterile and is intended for single use only.
This document describes the TXM Support Catheter and its substantial equivalence to a predicate device, focusing on bench and biocompatibility testing. It is a 510(k) submission, used for medical devices that are substantially equivalent to a legally marketed predicate device.
Here's an analysis of the provided text in relation to your request about acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a summary of bench testing performed on the TXM Support Catheter. For each test, it lists the applicable standard or internal test method and indicates "Pass" for both non-aged (T=0) and accelerated-aged (T=2) devices. While it doesn't explicitly state quantitative acceptance criteria for each test in a compact table, the "Pass" result implies that the device met these criteria.
| Test Name | Applicable Standard or Internal Test Method | Acceptance Criteria | Reported Device Performance (T=0 & T=2) |
|---|---|---|---|
| Dimensional And Physical Attributes | Internal Test Method | (Implicit: Conformance to specifications) | Pass |
| Catheter Compatibility | Internal Test Method | (Implicit: Compatibility with specified components) | Pass |
| Air Leakage | ISO 10555-1 | (Implicit: No air leakage as per standard) | Pass |
| Trackability | Internal Test Method | (Implicit: Meets specified trackability performance) | Pass |
| Crossability | Internal Test Method | (Implicit: Meets specified crossability performance) | Pass |
| Catheter Stiffness | ASTM D747-10 | (Implicit: Meets specified stiffness range) | Pass |
| Gravity Flow Rate | ISO 10555-1 | (Implicit: Meets specified flow rate) | Pass |
| Power Injection for Flow Rate | ISO 10555-1 | (Implicit: Meets specified power injection flow rate) | Pass |
| Lubricity of Hydrophilic Coating | Internal Test Method | (Implicit: Meets specified lubricity) | Pass |
| Durability of Hydrophilic Coating | Internal Test Method | (Implicit: Meets specified coating durability) | Pass |
| Liquid Leakage | ISO 10555-1 | (Implicit: No liquid leakage as per standard) | Pass |
| Static Burst Pressure | ISO 10555-1 | (Implicit: Withstands specified burst pressure) | Pass |
| Tensile Strength | ISO 10555-1 | (Implicit: Withstands specified tensile forces) | Pass |
| Radiopacity | ASTM-F640-12 | (Implicit: Meets specified radiopacity levels) | Pass |
| Torqueability | Internal Test Method | (Implicit: Meets specified torqueability performance) | Pass |
| Torque Strength | Internal Test Method | (Implicit: Withstands specified torque strength) | Pass |
| Kink Resistance | Internal Test Method | (Implicit: Resists kinking under specified conditions) | Pass |
| Corrosion Resistance | ISO 10555-1 | (Implicit: Shows no significant corrosion) | Pass |
| Coating Integrity and Particulates | Internal Test Method | (Implicit: Coating remains intact; minimal particulates) | Pass |
| Packing Integrity (Seal Strength) | ASTM F88 / F88M - 15 | (Implicit: Seal strength meets standard) | Pass |
| Packing Integrity (Packing Dye Penetration) | ASTM F1929-15 / F1886-09 | (Implicit: No dye penetration as per standard) | Pass |
| Shipping and Transit | ISTA 3A | (Implicit: Withstands shipping and transit stresses) | Pass |
| Accelerated Aging | ASTM F1980-07 | (Implicit: Demonstrates anticipated shelf-life) | Pass |
| Female Luer Verification | ISO 594 | (Implicit: Conforms to luer connection standard) | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Testing was performed on non-aged devices (T=0) as well as on devices subject to 2 years of accelerated aging (T=2)." However, the specific sample sizes for each test are not provided. The data provenance indicates that these were bench tests, meaning they were performed in a laboratory setting. There is no information regarding country of origin of the data as it's not clinical data, and the tests are inherently prospective in nature for a new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This report describes bench testing for a medical device (catheter), not a diagnostic or prognostic algorithm involving human interpretation of medical images or data. Therefore, the concept of "ground truth established by experts" and their qualifications as you might typically find in AI/CADe submissions is not applicable here. The "ground truth" for these tests is defined by the technical specifications, standards (like ISO or ASTM), and internal test methods that define acceptable performance for physical and material properties.
4. Adjudication Method for the Test Set:
Similar to point 3, adjudication methods are not applicable for these types of bench tests. The evaluation of test results against predefined acceptance criteria is typically a technical assessment by engineers or technicians, not a consensus-based adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a MRMC comparative effectiveness study was not done. This document is for a physical medical device (catheter), not an AI or imaging diagnostic software. Therefore, the concept of human readers improving with or without AI assistance is not relevant.
6. Standalone (Algorithm Only) Performance:
No, a standalone (algorithm only) performance study was not done. This is a physical support catheter, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for the performance testing cited is based on engineering specifications, recognized industry standards (ISO, ASTM), and internal test methods. These standards and specifications define the expected physical, chemical, and functional properties of the device. For example, for "Air Leakage," the ground truth is defined by the criteria within ISO 10555-1.
8. Sample Size for the Training Set:
Not applicable. This document describes a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for a physical device, there is no ground truth to be established for it in this context.
§ 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).