(288 days)
The GT Leggiero Catheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities and all coronary vessels. The GT Leggiero Catheter is also intended for drug infusion in intraarterial therapy and the infusion of embolic materials for hemostasis. The Catheter should not be used in cerebral vessels.
The GT Leggiero™ Catheter is a multilayer single-lumen catheter 100-150cm in length with a maximum injection pressure of 450 psi. The catheter shaft is reinforced the entire length by helically-cut stainless steel piping. The distal 15cm is fine-worked for high flexibility. The catheter is 2.9Fr. size (~0.96mm in outer diameter) and can be used with a guiding catheter 0.047" (1.20mm) or larger inner diameter. The catheter shaft has an inner diameter of ~0.6mm to admit a 0.018" or smaller sized guide wire. The catheter has a hydrophilic polymer coating on the outer surface with the exception of 30cm from its proximal end. A radiopaque marker (~0.8mm) is incorporated in the catheter tip for increased radiopacity.
The provided text describes the GT Leggiero Catheter, a medical device, and its substantial equivalence to a predicate device. This submission focuses on the physical and performance attributes of the catheter itself, not on an "AI device" or diagnostic software. Therefore, many of the requested points, such as sample size for test sets (as there are no "images" or "cases"), number of experts for ground truth, adjudication methods, MRMC studies, standalone performance studies, etc., are not applicable in this context.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" for an AI device's performance does not directly apply here. Instead, the GT Leggiero Catheter's performance was evaluated against the predicate device through a series of physical and functional tests to demonstrate substantial equivalence. The "specifications" table below shows key dimensional characteristics of the device and its predicate. The performance section lists the types of tests conducted.
| Feature/Metric | GT Leggiero (Reported Performance) | Predicate Device (Terumo Angiographic Catheter K915414) |
|---|---|---|
| Intended Use | Infusion of contrast media, drug infusion, infusion of embolic materials in peripheral, cervical, lower/upper extremity, and coronary vessels (not cerebral). | Same |
| Material/Design | Multilayer single-lumen catheter; 100-150cm length; helically-cut stainless steel reinforced; distal 15cm fine-worked; hydrophilic polymer coating (except 30cm proximal); radiopaque marker. | Similar (Differences in materials raise no new safety/effectiveness issues) |
| Outer Diameter | 2.9Fr. (0.96mm) | 3.0Fr. (1.00mm) |
| Inner Diameter | 0.60mm | 0.70mm |
| Catheter Length | 100-150cm | 100cm & 130cm |
| Maximum Injection Pressure | 450 psi | Not explicitly stated for predicate in this document, but implies equivalence. |
| Compatibility | Usable with guiding catheter 0.047" (1.20mm) or larger; accepts 0.018" or smaller guide wire. | Implied equivalence. |
| Performance Tests Conducted | Flexibility Test, Tensile Strength, Maximum Pressure Test, Flow Rate Test | Implied equivalent performance to predicate. |
| Sterilization | Validated according to AAMI guidelines, SAL 10-6 | Implied equivalent. |
| Ethylene Oxide Residuals | Will not exceed maximum residue limits | Implied equivalent. |
| Biocompatibility | Blood contacting materials tested per ISO-10993, found biocompatible. | Implied equivalent. |
| Expiration Dating | 24 months | Implied equivalent. |
Note: The acceptance criteria here are implicitly achieving performance comparable or superior to the predicate device in the specified tests, and meeting relevant regulatory and safety standards (e.g., AAMI, ISO-10993 for biocompatibility).
2. Sample Size for the Test Set and Data Provenance
As this is a physical medical device (catheter) and not an AI or diagnostic tool processing data, there is no "test set" in the context of images or patient data. The tests conducted were physical and functional performance tests on samples of the manufactured catheters. The document does not specify the exact number of catheters tested for each performance criterion (e.g., N=X for Flexibility Test).
- Sample Size for Test Set: Not specified for individual tests, but refers to physical samples of the GT Leggiero Catheter.
- Data Provenance: The 'data' refers to the results of physical device testing. The testing would have been conducted by the manufacturer, Terumo Medical Corporation, likely in their labs in the USA (Elkton, MD) where the company is located. This is effectively prospective testing of manufactured devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable. The "ground truth" for a physical device like a catheter is established through objective engineering measurements and industry standards (e.g., tensile strength in Newtons, flow rate in mL/min, biocompatibility as per ISO standards). There is no "ground truth" established by human experts in the way it applies to diagnostic image interpretation.
4. Adjudication Method for the Test Set
This question is not applicable as there's no diagnostic uncertainty to adjudicate. Test results are objective measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This question is not applicable because the device is a physical catheter, not an AI system for diagnostic interpretation. There are no "human readers" interpreting "cases" with or without "AI assistance."
6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)
This question is not applicable. The device is a physical catheter, not an algorithm. Its performance is inherent to its physical properties and design.
7. Type of Ground Truth Used
For the GT Leggiero Catheter, the "ground truth" for its performance is based on:
- Objective Engineering Measurements: Results from tests like flexibility, tensile strength, maximum pressure, and flow rate.
- Adherence to Standards: Compliance with recognized industry and regulatory standards for sterilization (AAMI) and biocompatibility (ISO-10993).
- Comparison to Predicate Device: The performance and specifications are deemed acceptable if they are substantially equivalent to the legally marketed predicate device (Terumo Angiographic Catheter K915414), which has an established safety and effectiveness profile.
8. Sample Size for the Training Set
This question is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are developed through engineering R&D, not by training an algorithm on a dataset.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as point 8.
§ 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).