(28 days)
This non-therapeutic delivery system is intended to aid in the introduction and placement of cardiac leads 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.
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.
SelectSite C304 Deflectable Catheter System: The SelectSite C304 Deflectable Catheter System contains 1 deflectable catheter, 1 deflectable catheter dilator, 1 universal slitter, 1 valve, 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 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.
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.
The provided text is a 510(k) summary for the Medtronic SelectSite C304 Deflectable Catheter System and C315 Delivery System. It concludes that the devices are substantially equivalent to their predicate devices. However, the document does not describe specific acceptance criteria or an analytical study with performance metrics, but rather states that "All design verification activities were completed successfully" and "The results of the verification testing met the specified acceptance criteria."
Therefore, based on the provided text, I cannot extract the detailed information requested regarding specific acceptance criteria and the study that proves the device meets them. The document implies that such studies were performed as part of design verification, but the specifics are not included in this summary.
Here's what I can provide based on what is in the document, acknowledging the missing information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or specific reported device performance metrics. It only states: "The results of the verification testing met the specified acceptance criteria and did not raise new or different questions of safety or effectiveness." and "All design verification activities were completed successfully."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The general phrase "design verification activities" does not include details on sample size or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document describes a medical device, not an AI or diagnostic imaging device that typically requires expert-established ground truth for performance evaluation. The "design verification activities" would likely involve engineering and clinical testing, but not necessarily expert review of images for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This type of study is typically done for AI-assisted diagnostic devices. The devices described (catheter systems) are not AI devices, so an MRMC study comparing human readers with and without AI assistance would not be applicable or expected. The document does not mention any AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
As the devices are not AI algorithms, this type of study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided because the document relates to catheter systems, not diagnostic devices requiring ground truth in the sense of expert consensus or pathology for diagnostic accuracy. The "design verification activities" would involve testing the physical and functional aspects of the catheter, likely against engineering specifications and performance standards.
8. The sample size for the training set
This information is not provided, and a "training set" in the context of machine learning is not applicable here as these are physical medical devices, not AI models.
9. How the ground truth for the training set was established
Not applicable, as these are not AI models requiring training sets and associated ground truth.
§ 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).