(163 days)
The Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
The guiding catheter is a flexible plastic tube featuring a luer hub, a strain relief, a body, an intermediate tip, and a soft tip. The body and the intermediate tip exist of an inner liner (basecoat) and a outer jacket (topcoat) reinforced with a tightly wound stainless steel braid wire in between the layers. The central lumen of the catheter is used for the percutaneous, transluminal passage and placement of guidewires, diagnostic and therapeutic devices within the vascular system. After the catheter is inserted through the skin using a dilator, a sheath (introducer) and a guide wire it is brought into position. Subsequently, a guidewire is advanced through its lumen and tracked over by a diagnostic device (angiographic catheter, IVUS-catheter) and/or a therapeutic device (e.g., balloon dilatation catheter, stent and delivery system, embolization device) to the intended location. The distal section of the catheter has a variety of preformed shapes (e.g., Judkins Left (abbreviated as JL), Judkins Right (JR), Amplatz (AL), Multi-purpose, hockey stick) to facilitate placement of the catheter tip in the desired target vessel. Some catheter models feature two (2) small "in-line" side holes in the intermediate tip section to maintain perfusion of the target vessel. This device is a single-use device (i.e., single patient, single procedure, single purpose use). After finalizing the procedure, the catheter is withdrawn, removed and discarded. The intravascular guiding catheter is a cardiovascular catheter with GMDN-code 17846 (and ECRI-code 17846) with GMDN definition: A flexible tube with a central lumen used for the percutaneous, transluminal passage and placement of guidewires and diagnostic and therapeutic devices within the vascular system. After the tube is inserted in position, a guidewire is advanced through its lumen and tracked over by a diagnostic / therapeutic device (e.g., balloon dilatation catheter, stent and delivery system, or embolization device) to the intended location. The distal section of the tube can have a variety of preformed shapes (e.g., straight, multi- purpose, hockey stick, renal double curve); This is a single-use device. (Reference www.GMDNagency.org).
The PendraCare Convey™ Guiding Catheter (K120585) obtained 510(k) clearance by demonstrating substantial equivalence to predicate devices, namely the Medtronic Launcher™ Guide Catheter (5F and 6F). The device met its acceptance criteria through a combination of non-clinical design verification tests, biocompatibility testing, and two European clinical post-market surveillance studies.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Characteristic | Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|---|---|
| Biocompatibility | Hemolysis (ISO 10993-4) | Pass | Compliant (Implied by "completed") |
| In vitro Haemocompatibility (ISO 10993-4) | Pass | Compliant (Implied by "completed") | |
| Coagulation Tests PT (ISO 10993-4) | Pass | Compliant (Implied by "completed") | |
| Coagulation UPTT (ISO 10993-4) | Pass | Compliant (Implied by "completed") | |
| Cytotoxicity (ISO 10993-5, MEM-elution) | Pass | Compliant (Implied by "completed") | |
| Ethylene Oxide Sterilization Residuals (ISO 10993-7) | Pass | Compliant (Implied by "completed") | |
| Sensitization (ISO 10993-10) | Pass | Compliant (Implied by "completed") | |
| Irritation/Intracutaneous Reactivity (ISO 10993-10) | Pass | Compliant (Implied by "completed") | |
| Acute Systemic Toxicity (ISO 10993-11) | Pass | Compliant (Implied by "completed") | |
| Material Mediated Pyrogenicity (ISO 10993-11) | Pass | Compliant (Implied by "completed") | |
| Packaging Plastic Containers Leachables (USP ) | Pass | Compliant (Implied by "completed") | |
| Endotoxin-Mediated Pyrogenicity (USP ) | Pass | Compliant (Implied by "completed") | |
| Particulate Testing (USP ) | Pass | Compliant (Implied by "completed") | |
| In-vitro Performance | Shape Conformance (Shape retention) | Maintain defined shape characteristics | Compliant (Implied by "completed") |
| Inner Diameter | Within specified range | Compliant (Implied by "completed") | |
| Outer Diameter | Within specified range | Compliant (Implied by "completed") | |
| Catheter Usable Length | Within specified range | Compliant (Implied by "completed") | |
| Coating Length | Within specified range | Compliant (Implied by "completed") | |
| C-Kink (Bending Kink Diameter) | Meet minimum bending radii without kinking | Compliant (Implied by "completed") | |
| Euler Kink (Axial Kink Displacement) | Meet axial flexibility requirements | Compliant (Implied by "completed") | |
| Radial Stiffness (Collapse) | Resist collapse under specified pressure | Compliant (Implied by "completed") | |
| Coating Integrity (Visual Inspection) | Free from defects | Compliant (Implied by "completed") | |
| Outer Friction & Wear (Coating Integrity functional test) | Maintain functional integrity | Compliant (Implied by "completed") | |
| Three Point Bending Test (Bending Stiffness Body) | Meet flexibility specifications | Compliant (Implied by "completed") | |
| Pull Force (after simulated use) | Meet specified force retention | Compliant (Implied by "completed") | |
| Radiopacity | Clearly visible under fluoroscopy | Compliant (Implied by "completed") | |
| Torque Strength | Withstand specified torque without failure | Compliant (Implied by "completed") | |
| Clinical Performance | Post Market Surveillance (Comparison) Studies | No new safety or performance issues compared to predicate devices | Substantial equivalence demonstrated |
Note: The document states that the tests were "completed" and their results "provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing." This implicitly indicates that the device met its acceptance criteria for each test.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not explicitly stated for each test. For biocompatibility and in-vitro performance, the sample sizes would be determined by the specific ISO/USP standards. For the clinical studies, the sample size is also not specifically mentioned, only that there were "two European clinical post market surveillance (comparison) studies."
- Data Provenance:
- Biocompatibility and In-vitro Performance: Laboratory testing.
- Clinical Studies: Retrospective/Prospective (not specified, but likely retrospective given they are "post market surveillance" studies on existing device types, although comparison studies could be prospective). The country of origin is Europe.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not provided in the given text. For the bench testing and biocompatibility, expert interpretation may be involved in assessing results, but the document does not detail this. For the clinical post-market surveillance studies, the "ground truth" would be clinical outcomes and comparative performance data, which would typically be assessed by medical professionals in a clinical setting, but the number and qualifications of experts are not described.
4. Adjudication Method for the Test Set
- This information is not provided in the given text.
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
- No PendraCare Convey™ Guiding Catheter is a medical device (catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. As stated above, this is a physical medical device, not an algorithm or AI system. Standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used
- For biocompatibility and in-vitro performance tests, the "ground truth" is defined by the specific requirements and benchmarks set forth in the referenced ISO and USP standards. Meeting these standards is considered the ground truth for safety and performance characteristics.
- For the clinical post-market surveillance studies, the "ground truth" would refer to the observed clinical outcomes and performance of the device in comparison to the predicate devices in real-world clinical use. This would generally involve patient data, procedural success rates, and adverse event reporting.
8. The Sample Size for the Training Set
- Not Applicable. This submission is for a physical medical device. There is no machine learning algorithm involved that would require a "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As no training set is used for this device.
§ 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).