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The Medtronic Attain Command™ 6250 Left Heart Delivery Systems and the Medtronic Attain Command™ 6250 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™ Left Heart Delivery Systems contain two guide catheters, one guide catheter dilator, one guide wire, one valve and one slitter. It is designed to access the coronary sinus and the chambers of the heart using the guidewire to access the vein, the valve to reduce blood loss during the implant procedure, the guide catheter to introduce a transvenous device, the guide catheter dilator to facilitate catheter passage and the slitter to remove the guide catheter.

The Attain Command™ Left Heart Delivery Systems are available in two models:
• Attain Command™ 6250C Left Heart Delivery System
• Attain Command™ 6250S Left Heart Delivery System.

All components with the exception of the two guide catheters are identical in both models. The guide catheters are different in each model with respect to the guide catheter shape and length.

The Attain Command™ Guide Catheters for Left Heart Delivery are individual packs, each containing one guide catheter and one guide catheter dilator. It is also designed to access the coronary sinus and the chambers of the heart using the guide catheter to introduce a transvenous device and the guide catheter dilator to facilitate catheter passage.

The Attain Command™ Guide Catheters for Left Heart Delivery are available in eleven models as follows:

• · Attain Command ™ 6250-45S Guide Catheter for Left Heart Delivery
• · Attain Command ™ 6250-50S Guide Catheter for Left Heart Delivery
• · Attain Command " 6250-57S Guide Catheter for Left Heart Delivery
• · Attain Command ™ 6250-AM Guide Catheter for Left Heart Delivery
• · Attain Command " 6250-EH Guide Catheter for Left Heart Delivery
• TH 6250-EHXL Guide Catheter for Left Heart Delivery · Attain Command
• ти 6250-MB2 Guide Catheter for Left Heart Delivery · Attain Command
• · Attain Command ™ 6250-MB2X Guide Catheter for Left Heart Delivery
• 6250-MP Guide Catheter for Left Heart Delivery · Attain Command T
• · Attain Command ™ 6250-MPR Guide Catheter for Left Heart Delivery
• · Attain Command ™ 6250-MPX Guide Catheter for Left Heart Delivery

Each model is different with respect to the guide catheter shape and length and the dilator length

This 510(k) summary describes a medical device submission for the Medtronic Attain Command™ 6250 Left Heart Delivery Systems and Attain Command™ 6250 Guide Catheters for Left Heart Delivery. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices through mechanical, functional, and biocompatibility testing.

Here's an breakdown of the requested information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document specifies that the device "met all specified design and performance requirements" in summary of studies but does not explicitly list the quantitative acceptance criteria for each test. The acceptance criteria are implied to be the successful demonstration of equivalency in mechanical, functional, and biocompatibility aspects.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set in terms of the number of devices or components tested. It broadly refers to "device integrity testing" and "biocompatibility evaluation."

• Data Provenance: The studies were performed by Medtronic Ireland as part of their 510(k) submission. The nature of the tests (mechanical, functional, biocompatibility) suggests they are laboratory-based studies rather than clinical trials with patient data. Thus, terms like "country of origin of the data" or "retrospective/prospective" in the context of patient data are not directly applicable here. The testing would have been conducted in a controlled lab environment.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The device is a medical catheter system, and the studies described are engineering and biological validations, not clinical studies requiring expert interpretation of diagnostic images or patient outcomes to establish ground truth. "Ground truth" in this context would refer to established engineering specifications and biological safety standards.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are technical evaluations (mechanical, functional, biocompatibility) against predetermined specifications, not clinical assessments that would require adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. The submitted device is a physical medical instrument (catheter system), not an AI-powered diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable. The device is a physical catheter system, not a software algorithm.

7. The Type of Ground Truth Used

For the studies described (mechanical, functional, biocompatibility), the "ground truth" would be the established engineering specifications, material standards, and biological safety standards (e.g., ISO 10993-1:2003 for biocompatibility). The device's performance was compared against these predefined criteria to determine if it "met all specified design and performance requirements."

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

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