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C315: This non-therapeutic delivery system is intended to aid in the introduction and placement of cardiac leads into the right chambers of the heart. The leads are implanted in patients who are indicated for a cardiac implantable electronic device (CIED) for treatment of heart rhythm disorders. Refer to the respective CIED instructions for use for details about the types of heart rhythm abnormalities or patient conditions treated by each type of CIED.

C304: This non-therapeutic delivery system is intended to aid in the introduction and placement of cardiac leads into the right chambers of the heart. The leads are implanted in patients who are indicated for a cardiac implantable electronic device (CIED) for treatment of heart rhythm disorders. Refer to the respective CIED instructions for use for details about the types of heart rhythm abnormalities or patient conditions treated by each type of CIED.

C315 Delivery System: The Medtronic C315 Delivery System 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.

SelectSite C304 Deflectable Catheter System: The SelectSite C304 Deflectable Catheter System contains a single deflectable catheter, deflectable catheter dilator, universal slitter, valve, guidewire, needle, and 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 to 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 three models which are the C304-S59, C304-L69, and C304-XL74. All components except the deflectable catheter and dilator are identical in each model.

This document, a 510(k) Premarket Notification from Medtronic Inc., describes two catheter delivery systems, the SelectSite C304 Deflectable Catheter System and the C315 Delivery System. The notification primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study proving a novel device meets specific acceptance criteria based on performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic device).

Therefore, the provided text does NOT contain the information necessary to answer the questions about acceptance criteria and a study proving a device meets these criteria in the context of, for example, an AI/ML diagnostic or predictive device.

The document states:

• "The technology of the subject devices is identical to the respective predicates." (Page 6)
• "There are no changes to the design, physical characteristics, materials, packaging, or sterilization presented in this submission." (Page 6)
• "The subject devices have identical indications for use to the respective predicate devices." (Page 6)
• The only difference mentioned is "updated instructions for use (IFU) to indicate warning for potential small-bore misconnection." (Page 6)
• "The labeling modification is supported by verification activities and makes the products compliant with clause 7f of ISO 80369-7." (Page 6)

This indicates that the submission is about demonstrating that the modified devices (with updated IFUs) are still substantially equivalent to the original predicate devices, implying that their performance is expected to be the same as the already cleared devices. This is typical for a 510(k) submission where there are minor changes but the fundamental performance of the device is not being re-evaluated through a new clinical performance study.

To answer your specific questions, the document does not provide the following information:

1. A table of acceptance criteria and the reported device performance: Not applicable. Performance is established through the predicate device.
2. Sample size used for the test set and the data provenance: No test set in the context of clinical performance evaluation is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This document is not about AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable for this type of submission.
9. How the ground truth for the training set was established: Not applicable for this type of submission.

In summary, this document is a regulatory submission for a medical device that has undergone minor labeling changes, and its purpose is to demonstrate substantial equivalence to existing devices, not to present a de novo study proving new performance criteria.

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