(141 days)
The Guiding Catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vasculature.
The TXM Guiding Catheter is a guiding catheter, for application in intravascular vessels. It consists of a lubricous inner liner made from Teflon, a stainless steel braid over the inner liner. The outer shaft consists of durometer hardness and different lengths of colored Polyether block amide. A Polycarbonate hub is attached to the proximal end of the Guiding Catheter. A strain relief is placed at the proximal end of the Guiding Catheter and over the distal end of the device shafts will have an outer diameter of 5 French sizes (0.070") and 6 French sizes (0.082) respectively for each catheter. The 5 French sizes will have an inner diameter of 0.058" and the 6 French sizes will have an inner diameter of 0.070". The device is available in length of 100cm. The device is supplied sterile and is intended for single use.
This document is a 510(k) premarket notification for a guiding catheter, indicating its substantial equivalence to a predicate device. It doesn't describe the evaluation of an AI/ML powered device, but rather a traditional medical device (catheter). Therefore, most of the requested information regarding AI/ML device evaluation (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable or cannot be extracted from this document.
However, I can extract the acceptance criteria and results for the bench testing and biocompatibility testing as presented for this traditional medical device.
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device, the "acceptance criteria" are implied by meeting the specified standards or internal test methods, and the "reported device performance" is a simple "Pass" or "Fail" against those criteria.
| Test Name | Applicable Standard or Internal Test Method | Acceptance Criteria (Implied by standard and "Pass" result) | Reported Device Performance |
|---|---|---|---|
| Air Leak | ISO 10555 | Meet ISO 10555 requirements | Pass |
| In-Vitro Track Force | Internal Test Method | Meet internal method requirements | Pass |
| Stiffness | Internal Test Method | Meet internal method requirements | Pass |
| Tensile Strength | ISO 10555 | Meet ISO 10555 requirements | Pass |
| Gravity Flow Rate | ISO 10555 | Meet ISO 10555 requirements | Pass |
| Liquid Leak | ISO 10555 | Meet ISO 10555 requirements | Pass |
| Power Injector (Static Burst Pressure) | ISO 10555 | Meet ISO 10555 requirements | Pass |
| Tip Shape Retention | Internal Test Method | Meet internal method requirements | Pass |
| Dimensional & Physical Attributes | ISO 10555 | Meet ISO 10555 requirements | Pass |
| Kink Testing | Internal Test Method | Meet internal method requirements | Pass |
| Buckling Test | Internal Test Method | Meet internal method requirements | Pass |
| Corrosion Resistance | ISO 10555 | Meet ISO 10555 requirements | Pass |
| Radiopacity | ASTM-F640-12 | Meet ASTM-F640-12 requirements | Pass |
| Torque Response | Internal Test Method | Meet internal method requirements | Pass |
| Torque to Failure | Internal Test Method | Meet internal method requirements | Pass |
| Ovalization | Internal Test Method | Meet internal method requirements | Pass |
| Simulated Use | Internal Test Method | Meet internal method requirements | Pass |
| Seal Strength (Pouch) | ASTM F88/F88M-09 | Meet ASTM F88/F88M-09 requirements | Pass |
| Dye Penetration Test | ASTM-F1929-12 | Meet ASTM-F1929-12 requirements | Pass |
| Female Luer Verification | ISO 594 | Meet ISO 594 requirements | Pass |
| Shipping and Transportation | ISTA 3A | Meet ISTA 3A requirements | Pass |
| Accelerated Aging | ASTM F1980-07 | Meet ASTM F1980-07 requirements | Pass |
| Biocompatibility Tests | |||
| Cytotoxicity | ISO10993-5 | Meet ISO10993-5 requirements | Pass |
| Irritation | ISO10993-10 | Meet ISO10993-10 requirements | Pass |
| Sensitization | ISO10993-10 | Meet ISO10993-10 requirements | Pass |
| Systemic Toxicity | ISO10993-11 | Meet ISO10993-11 requirements | Pass |
| Pyrogenicity | USP, ISO10993-11, USP | Meet specified USP and ISO requirements | Pass |
| Hemocompatibility | ISO10993-4 | Meet ISO10993-4 requirements | Pass |
| Toxicological Hazard | ISO10993-17 | Meet ISO10993-17 requirements (Risk Assessment) | Pass |
| Sterilization Test | |||
| Ethylene Oxide Gas | Relevant validation standards (implicit) | Sterility Assurance Level (SAL) of 10-6 | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "non-aged devices (T=0)" and "devices subject to 3 years of accelerated aging (T=3)" for bench testing, but the specific number of devices tested for each test is not detailed. The data provenance is also not specified, as this is a device submission focused on bench and biocompatibility testing, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a traditional medical device (catheter) and does not involve AI/ML or expert evaluation for establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a traditional medical device (catheter) and does not involve AI/ML or expert adjudication for test sets.
5. 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 a traditional medical device (catheter) and does not involve AI/ML.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a traditional medical device (catheter) and does not involve AI/ML.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation is primarily based on meeting the specifications outlined in recognized international and national standards (e.g., ISO 10555, ASTM F640-12, ISO 10993 series, USP) and internal test methods. For example, for tensile strength, the ground truth is simply whether the device withstood the specified force according to the standard. For biocompatibility, it's whether the biological responses fall within acceptable limits defined by the ISO 10993 series.
8. The sample size for the training set
Not applicable. This is a traditional medical device (catheter) and does not involve AI/ML or training sets.
9. How the ground truth for the training set was established
Not applicable. This is a traditional medical device (catheter) and does not involve AI/ML or training sets.
§ 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).