(156 days)
The deflectable catheter system is indicated to provide a pathway though 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 SelectSite™ C304 Deflectable Catheter System contains 1 deflectable catheter, 1 deflectable catheter dilator, 1 universal slitter, 1 guidewire, 1 needle and 1 syringe. The SelectSite™ C304 Deflectable Catheter System is designed to access the coronary sinus and the chambers of the heart. The percutaneous needle and syringe are used to access the venous insertion site, the guidewire to access the vein, the introducer valve to reduce blood loss during the implant procedure, the deflectable catheter to introduce a transvenous device, the deflectable catheter dilator to facilitate deflectable catheter passage and the guide catheter slitter to remove the deflectable catheter. The SelectSite™ C304 Deflectable Catheter System is available in four models which are the C304-S59, C304-L69, C304-XS59 and C304-XL74. All components except the deflectable catheter and dilator are identical in each model.
The Medtronic SelectSite™ C304 Deflectable Catheter System is a medical device designed to provide a pathway for introducing diagnostic and therapeutic transvenous devices into the heart chambers and coronary vasculature.
Here's an analysis of the acceptance criteria and study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary for substantial equivalence, not a detailed study report with specific acceptance criteria metrics. Instead, it describes a more general approach to demonstrating equivalence.
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Mechanical Testing | Met all specified design and performance requirements. | Implies various mechanical properties (e.g., tensile strength, flexibility, deflection capabilities) were within pre-defined limits, but specific metrics are not detailed. |
| Functional Testing | Met all specified design and performance requirements. | Suggests the catheter performed its intended functions (e.g., introducibility, steerability, patency) as expected, but specific metrics are not detailed. |
| Biocompatibility Testing | Verified that the device is biocompatible based on ISO 10993-1. | Confirms the device does not cause adverse biological reactions when in contact with tissues. This is a qualitative assessment based on standardized tests. |
| Sterilization Validation | Will be sterilized using a validated Ethylene Oxide (EtO) sterilization process. | Assures the device achieves a specified sterility assurance level (SAL). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the "test set" in terms of number of devices or units tested for mechanical and functional performance. It generally refers to "Device integrity testing."
- Data Provenance: The testing was likely conducted in a laboratory setting by Medtronic Ireland, the applicant. The document does not specify country of origin for data, but the applicant is Medtronic Ireland. The studies are for a new iteration of an existing device, so it would be considered internal company data.
- Retrospective or Prospective: These engineering and biocompatibility tests are prospective in nature, designed and executed to evaluate the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (experts establishing ground truth for a test set) is typically relevant for studies involving subjective assessments, such as image interpretation or clinical outcomes. For mechanical, functional, and biocompatibility testing of a catheter, "ground truth" is defined by established engineering specifications, material standards, and biological safety guidelines. Experts in these fields (e.g., materials scientists, biomedical engineers, toxicologists) would define the acceptance limits and interpret test results, but their number and specific qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are usually for clinical trials or studies where there's a need to resolve discrepancies in expert opinions on an outcome. For the types of tests described (mechanical, functional, biocompatibility, sterilization), the "adjudication" is typically through adherence to pre-defined test protocols, objective measurement criteria, and statistical analysis of results against pre-established acceptance limits. There's no mention of a human-based adjudication method for these engineering and biological tests.
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 MRMC comparative effectiveness study was mentioned or conducted, as this is a physical medical device (catheter), not an AI-powered diagnostic or interpretive tool. Therefore, there's no mention of AI assistance or its effect size on human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm-only performance study was done for the same reason as point 5; this is a physical medical device.
7. The Type of Ground Truth Used
For the SelectSite™ C304 Deflectable Catheter System:
- Mechanical & Functional Testing: Ground truth is established by engineering specifications, design requirements, and performance standards derived from the intended use and comparison to predicate devices. These are objective, quantifiable criteria (e.g., force required for deflection, maximum torque, flow rates, durability cycles).
- Biocompatibility: Ground truth is established by international standards like ISO 10993-1, which define acceptable biological responses and testing methodologies based on the nature and duration of patient contact.
- Sterilization: Ground truth is established by validated sterilization cycles that achieve a specified sterility assurance level (SAL), typically 10^-6, in accordance with recognized standards for EtO sterilization.
8. The Sample Size for the Training Set
This concept is primarily relevant for machine learning or AI models. Given that this is a physical medical device and not an AI system, there is no "training set" in the context of data used to train an algorithm. The development of the device would involve materials selection, design iterations, and testing, but not in the sense of a data-driven training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this physical medical device. The "ground truth" for the development of the device lies in engineering principles, material science, and clinical needs that guided its design and subsequent validation testing.
§ 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).