(311 days)
The left-heart delivery system is intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus.
The Attain Select™ II + SureValve™ delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left-heart venous anatomy. The delivery catheter system is indicated for use with outer guide catheters.
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 Attain Command™ + SureValve™ Left Heart Delivery System and Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery are intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus. The Attain Command™ + SureValve™ Left-Heart Delivery System kits each contain two outer guide catheters with an integrated hemostasis valve (SureValve™), up to two valve tools, one dilator, one guide wire, and one slitter. The Attain Command™ + Sure Valve™ Left-Heart Delivery System is available in two models: Attain Command™ + SureValve™ 6250VC Left Heart Delivery System and Attain Command™ + SureValve™ 6250VS Left Heart Delivery System. With the exception of the two guide catheters, all system components packaged in each kit are identical. Each guide catheter model is different with respect to the guide catheter shape and length.
The Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery individual packs each contain one guide catheter with an integrated hemostasis valve (SureValve™), up to two valve tools, and one dilator. The Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery are available in 12 models. Each model is different with respect to the guide catheter shape and length and dilator length.
The Attain Select™ II + SureValve™ delivery catheter system is designed to facilitate leftheart lead delivery to a desired cardiac vein. The Attain Select™ II + SureValve™ delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left-heart venous anatomy. The delivery catheter system is indicated for use with outer guide catheters. Together, the catheters function as a telescoping system that can provide additional sub selecting capabilities.
The delivery catheter system consists of a delivery catheter with an integrated hemostasis valve (SureValve™), an inner catheter, and up to two valve tools. The Attain Select™ II + SureValve™ delivery catheter system is available in 8 models. The Attain Select™ II + SureValve™ inner catheter is identical for all configurations. Each model is different with respect to delivery catheter shape and length.
This FDA 510(k) Premarket Notification is for a medical device family that involves delivery catheters. Based on the provided document, the device in question is a delivery catheter system and its substantial equivalence is being argued based on non-clinical data rather than a study concerning algorithm performance or accuracy.
Therefore, many of the requested fields related to a study proving acceptance criteria for AI or algorithm performance are not applicable in this context. The acceptance criteria here would be for the physical device itself, tested through mechanical, functional, sterilization, and biocompatibility testing.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance (Non-Clinical)
The acceptance criteria for these medical devices are based on ensuring they meet specified design and performance requirements through various non-clinical tests. The document states that the devices met all specified design and performance requirements, which serves as the "reported device performance."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Testing | All specified design and performance requirements were met. |
| Functional Testing | All specified design and performance requirements were met. |
| Sterilization Testing | All specified design and performance requirements were met. |
| Biocompatibility Testing | All specified design and performance requirements were met; the devices were verified to be biocompatible. |
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a comprehensive set of non-clinical tests performed to demonstrate that a change in the tip material of the subject devices (Attain Select™ II + SureValve™ Delivery Catheter System, Attain Command™ + SureValve™ Left Heart Delivery System, Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery, C315 Delivery Catheter) does not negatively impact their performance or safety compared to their predicate devices.
The change in tip material involved adding a hydrolysis inhibitor stabilizer and a hindered amine light stabilizer to the Tungsten Carbide Pebax material.
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A table of acceptance criteria and the reported device performance:
(See table above) -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the exact sample sizes for each non-clinical test (mechanical, functional, sterilization, biocompatibility). However, it implies that sufficient samples were tested to establish the safety and effectiveness of the devices with the new tip material.- Data Provenance: Not explicitly stated, but typically non-clinical device testing is performed by the manufacturer or contracted laboratories. The applicant is Medtronic Ireland, based in Galway, Ireland, suggesting the testing likely occurred in a similar region or within the company's global facilities. This would be prospective testing, as it's designed to evaluate a new device configuration before market clearance.
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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):
Not applicable. This is not a study requiring expert clinical assessment for ground truth. The "ground truth" for non-clinical testing is adherence to predefined engineering specifications, regulatory standards, and established testing protocols. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for clinical studies or studies involving human judgment (e.g., expert consensus on medical images). This document describes non-clinical engineering and biological safety testing. -
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. This is not an AI or algorithm-based device. No MRMC study was conducted. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is not an AI or algorithm-based device. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this submission is based on engineering specifications, regulatory standards, and established scientific methodologies for evaluating physical medical devices. This includes:- Device integrity against design requirements.
- Demonstrated functionality according to intended use.
- Validation of sterilization processes.
- Compliance with biocompatibility standards (e.g., ISO 10993-1).
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The sample size for the training set:
Not applicable. This is not an AI or machine learning study; there is no "training set." -
How the ground truth for the training set was established:
Not applicable. As there is no training set for an AI model, there is no ground truth established for one.
§ 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).