(65 days)
The C315 is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
The Medtronic C315 Delivery Catheter contains one catheter and one dilator constructed of Polyether Block Amide and Polyethylene respectively. It is designed to aid in the introduction of various types of pacing or defibrillator leads and catheters. There are seven models in the Medtronic C315 Delivery Catheter product family, all of which have the same inner and outer diameter (5.4Fr and 7.0Fr respectively). The models differ in useable length, which varies from 20cm to 43cm. Proximally, the C315 is equipped with a hemostatic valve, and the distal tip is radiopaque to facilitate imaging under fluoroscopy. The C315 is designed to be slittable, thereby allowing its removal after device placement. A variety of curves are available to accommodate various anatomies and different lead locations.
The Medtronic C315 Delivery Catheter is a medical device designed to aid in the introduction of various types of pacing or defibrillator leads and catheters.
Here's an analysis of its acceptance criteria and the study that proves it meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Dimensional Measurement | Met specified design and performance requirements |
| Catheter Tensile Strength | Met specified design and performance requirements |
| Curve Stiffness | Met specified design and performance requirements |
| Straight Shaft Distal Segment Compression | Met specified design and performance requirements |
| Radiopacity | Met specified design and performance requirements |
| Curve Retention | Met specified design and performance requirements |
| Manual Slitting of Catheter | Met specified design and performance requirements |
| Guide Catheter Leakage Test (Catheter Shaft Related) | Met specified design and performance requirements |
| Guide Catheter Leakage Test (Valve Related) | Met specified design and performance requirements |
| Torsional Strength | Met specified design and performance requirements |
| Chemical Compatibility | Met specified design and performance requirements |
| Straight Shaft Kink Resistance | Met specified design and performance requirements |
| Guide Catheter Interface Testing | Met specified design and performance requirements |
| Transport Simulation | Met specified design and performance requirements |
| Seal Strength | Met specified design and performance requirements |
| Pouch Seal Area | Met specified design and performance requirements |
| Dye Penetration Test | Met specified design and performance requirements |
| Biocompatibility (various tests per ISO 10993-1:2009) | Verified to be biocompatible |
| Sterilization Validation (EtO sterilization process) | Data and information presented to support sterilization |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "Device integrity testing" using "C315 devices." However, it does not specify the exact sample size for each individual bench test. The data provenance is retrospective, as it refers to testing done on the device to prove its equivalency to predicate devices. The country of origin of the data is not explicitly stated beyond Medtronic Ireland being the applicant.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the described studies are in-vitro bench tests and biocompatibility evaluations, not studies requiring expert interpretation of clinical data. Therefore, there is no "ground truth" established by experts in this context.
4. Adjudication Method for the Test Set:
This information is not applicable as the studies are bench tests and do not involve human interpretation or adjudication of results in the way clinical studies would. The assessment is against pre-defined engineering and biocompatibility specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical investigation has been performed for this device."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This device is a physical catheter, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used:
For the in-vitro bench tests, the "ground truth" is defined by pre-established engineering specifications and performance requirements for medical device functionality and safety. For biocompatibility, the ground truth is established by adherence to international standards (ISO 10993-1:2009) and the results of various biological tests.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical catheter, 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 mentioned above, there is no training set for this type of 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).