(30 days)
The deflectable catheter system is indicated to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.
The Medtronic SelectSite Model C304 Deflectable Catheter System is designed to facilitate the introduction of transvenous devices within the chambers and coronary vasculature of the heart and the introduction of leads in the left heart via the coronary sinus.
The Model C304-S59 deflectable catheter has a single lumen for passage of transvenous devices with a maximum outer diameter of 5.6 French (1.9 mm) and a usable length of 30 cm.
The Model C304-L69 deflectable catheter has a single lumen for passage of transvenous devices with a maximum outer diameter of 5.6 French (1.9 mm) and a usable length of 40 cm.
The deflectable catheter features a deflecting distal section controlled by the deflectable catheter handle for placement of transvenous devices within the chambers of the heart and for coronary sinus cannulation. The body of the deflectable catheter is radiopaque for visibility on fluoroscopy.
The provided text describes a 510(k) summary for the Medtronic SelectSite™ Model C304 Deflectable Catheter System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting on a clinical effectiveness study with specific performance metrics for the device itself.
Therefore, much of the requested information regarding acceptance criteria, performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, and ground truth types is not available in the provided text, as these are typically part of a clinical trial or performance study, which this summary does not detail beyond "In Vitro testing".
Here's what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| All specified design and performance requirements (for in vitro tests) | "The SelectSite Model C304 Deflectable Catheter System met all specified design and performance requirements." |
| Biocompatibility consistent with ISO-10993 | "All materials were found to be biocompatible and in compliance to ISO 10993-1." |
| Sterilization validation (100% Ethylene Oxide) | "The SelectSite Model C304 Deflectable Catheter System will be sterilized using a validated 100% Ethylene Oxide (EtO) sterilization process." |
| Substantial equivalence to predicate device(s) | "Medtronic, Inc. considers the SelectSite Model C304-S59 and C304-L69 Deflectable Catheter Systems to be substantially equivalent to legally marketed predicate device(s)." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The study mentioned is "In Vitro testing".
- Data Provenance: Not specified, but "In Vitro testing" implies laboratory-based testing, not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable, as this was an "In Vitro testing" study.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable, as this was an "In Vitro testing" study.
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:
- MRMC Study: No. This is a medical device (catheter) and the study described is "In Vitro testing", not an AI diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Type of Ground Truth: For the "In Vitro testing", the ground truth would be based on engineering specifications, physical measurements, and adherence to established standards (e.g., ISO-10993 for biocompatibility) to verify the device's design and performance.
8. The sample size for the training set:
- Sample Size: Not applicable. This document describes "In Vitro testing" for a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable.
§ 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).