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The Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery is intended for the delivery of contrast media and transvenous devices to the coronary sinus and left heart venotomy. The 6238TEL guide catheters are indicated for use with an outer guide catheter delivery system, forming a dual-catheter assembly.

The Attain Select 6238TEL Guide catheter set for left-heart delivery consists of a set of 3 catheters, one straight catheter; one catheter with a 90° curved tip and one catheter with a 180°curved tip. The Attain Select 6238TEL guide catheters are designed to facilitate access to the coronary sinus and left-heart venotomy. The catheters provide a pathway for the delivery of contrast medium and transvenous devices such as guide wires and guide catheters. The Attain Select 6238TEL guide catheters are provided sterile and are intended for single use only.

The catheters, which have a working length of 70cm, also have radiopaque, flexible tips. The catheter functions as an inner catheter and, when used with an outer guide catheter, forms a dual-catheter assembly. The Attai.1 Select 6238TEL guide catheters feature a lumen that allows for the passage of guide wires up to 0.89 mm (0.035 in) in diameter. The guide catheters have a maximum outer diameter of 7 French (2.4 mm) and may be used with delivery systems that accept a 7 French (2.4 mm) transvenous device. Medtronic recommends using the guide catheters with Medtronic Attain Fixed Shape catheters or the Medtronic Attain Deflectable catheter.

The provided document is a 510(k) Summary for a medical device (Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery) seeking substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance or a clinical trial with human subjects.

Instead, the summary focuses on device integrity testing, biocompatibility, and sterilization validation to demonstrate that the new device is as safe and effective as its predicate devices, which is the basis for 510(k) clearance.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set) are not applicable to the type of information presented in this regulatory submission.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable for diagnostic performance. The "test set" here refers to the actual physical devices subjected to various engineering and biological tests. The document does not specify sample sizes for these tests, nor does it provide details on the data provenance in terms of patient data. These were laboratory and manufacturing tests performed by Medtronic Ireland.

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)

• Not applicable. This information pertains to studies where expert consensus is needed to establish ground truth for diagnostic or clinical outcomes. The provided document describes engineering and biocompatibility testing, not clinical studies for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This refers to methods for resolving discrepancies in expert opinions for ground truth establishment in clinical studies. It's not relevant for device integrity or biocompatibility testing.

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

• Not applicable. This document is for a medical device (catheter) and not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an AI-powered device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For mechanical and functional testing: Ground truth would be defined by engineering specifications and performance standards established for such devices, against which the physical device performance is measured.
• For biocompatibility: Ground truth is established by the accepted standards and protocols defined in ISO 10993-1, using biological assays and tests.
• For sterilization: Ground truth is established by adherence to validated sterilization protocols and acceptable sterility assurance levels.

8. The sample size for the training set

• Not applicable. This is not an AI-powered device.

9. How the ground truth for the training set was established

• Not applicable. This is not an AI-powered device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study described is a series of device integrity tests (mechanical, functional), biocompatibility testing, and sterilization validation.

• Device Integrity Testing: This involved subjecting the Attain Select™ 6238TEL Guide Catheter Set to various mechanical and functional challenges to ensure it performs as intended and meets its design specifications. The document states that the device "met all specified design and performance requirements." These tests are typically performed in a laboratory setting.
• Biocompatibility Testing: The materials used in the catheter were tested for biocompatibility in accordance with International Standard ISO 10993-1: 2003 ("Biological Evaluation of Medical devices- Part 1: Evaluation and Testing"). This standard dictates methods for evaluating the biological response to medical devices. The device was classified as an "external communicating device with limited exposure (<24 hours) to circulating blood," and the testing confirmed its compliance with the standard for this classification.
• Sterilization Validation: The Ethylene Oxide (EtO) sterilization process used for the device was "validated." This means that the sterilization cycle was rigorously tested and proven to consistently achieve the required sterility assurance level, ensuring the device is sterile when packaged and ready for use.

These studies collectively support the manufacturer's claim of substantial equivalence to legally marketed predicate devices, forming the basis for its 510(k) clearance by the FDA.

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