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The Attain™ Access 6218A Left-heart delivery system is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

The left-heart delivery system features two guide wires to facilitate venous access, adjustable hemostasis valves to reduce blood loss during the implant procedure, two guide catheters for passing venogram balloon catheters or appropriate leads, a guide catheter dilator to facilitate guide catheter passage, guide catheter slitters for removing guide catheters, and a guide wire clip to help contain the guide wire in the sterile field.

The Attain Access 6218A Left-heart delivery system combines devices that are either cleared for market distribution via 510(k) or are exempt from premarket notification because of Class I designation.

The key changes being made to the system are the addition of Tungsten Carbidefilled polyether block amide material to the guide catheter distal tip segment and the addition of extra slitters and adjustable hemostasis valves in a revised system configuration.

The provided text describes a 510(k) submission for the Medtronic Attain™ Access 6218A Left-heart delivery system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through a standalone study with defined endpoints.

Here's a breakdown based on the request, highlighting what is and isn't available in the provided text:

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

Explanation: The document does not explicitly state numerical acceptance criteria or specific performance metrics as would be found in a clinical trial or a detailed engineering specification report. Instead, it relies on demonstrating that the device performs as well as or similarly to a legally marketed predicate device, and that it meets general design and performance requirements supported by in vitro and biocompatibility testing.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for any particular test. The document mentions "representative samples" for biocompatibility testing.
• Data Provenance: Not explicitly stated. The testing was performed internally by Medtronic.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This submission does not involve clinical data requiring expert review for ground truth establishment. The evaluation is based on device characteristics, in vitro testing, and comparison to a predicate device.

4. Adjudication method for the test set:

• Not applicable. No adjudication method is mentioned as there's no expert review of cases or outcomes to adjudicate.

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:

• No. This is not an AI/software device and no MRMC study was performed or mentioned.

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

• Not applicable. This is a physical medical device (delivery system), not an algorithm or AI.

7. The type of ground truth used:

• Not explicitly stated as "ground truth" in the context of clinical outcomes or pathology. For biocompatibility, the "ground truth" is adherence to ISO 10993-1 standards. For sterilization, it's successful validation of the ETO process. For substantial equivalence, the "ground truth" is the established characteristics and performance of the predicate device.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

• Not applicable.

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

The "study" described is a set of in vitro testing, biocompatibility testing, and sterilization validation.

• Biocompatibility Testing: Performed on "representative samples" of the Attain product. The criteria for acceptance were based on adherence to ISO 10993-1, and the results indicated that "all materials were found to be biocompatible."
• Sterilization Validation: The device is sterilized using a 100% Ethylene Oxide (ETO) process. "Appropriate processes for sterilizing the devices were validated," implying that the validation study confirmed the sterilization method effectively renders the device sterile.
• In vitro Testing: Mentioned as being performed "to support substantial equivalence to the predicate device." The results indicated that the "Attain Access 6218A meets all of its design and performance requirements." Specific parameters or acceptance criteria for this in vitro testing are not detailed in the provided text, but it would likely include mechanical strength, flow characteristics, and component inter-compatibility, all compared against the predicate device or internal specifications.

The overall conclusion is based on demonstrating substantial equivalence to a previously cleared predicate device (Medtronic Attain Access 6218 Left-heart Delivery System, K012083) and adherence to recognized standards (ISO 10993-1 for biocompatibility). The 510(k) process accepts this approach for devices that are similar to existing ones.

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