(56 days)
The Attain Access 6218 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, an adjustable hemostasis valve 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. A steerable 7 French or smaller intracardiac catheter is recommended for use to assist in placing guiding catheters to access cardiac veins via the coronary sinus. The Attain Access 6218 is intended for single use only and will be distributed independently for use with current and future leads. The Attain Access Model 6218 combines components that are either cleared for market distribution via 510(k) or are exempt from premarket notification because of Class I designation.
This document describes the Medtronic Attain Access 6218 Left-heart delivery system, a Class II medical device intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.
Here's an analysis of the provided information regarding acceptance criteria and studies:
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Performance | All in vitro specified requirements for the Attain Access 6218 (implied to include various mechanical and functional aspects of the system components such as guide catheters, dilator, valve, guide wires, and slitters). | "Attain Access passed all of the in vitro specified requirements, and ensures that the Attain Access 6218 meets all of its design and performance requirements." |
| Biocompatibility | Found to be biocompatible according to ISO 10993-1 for blood-contacting materials. | "Complete testing according to ISO 10993-1 was conducted and all materials were found to be biocompatible." |
| Sterilization | Sterilization using 100% Ethylene Oxide (ETO) process. Appropriate processes for sterilizing the devices were validated. | "The Attain Access 6218 Left-heart delivery system is sterilized using a 100% Ethylene Oxide (ETO) sterilization process. Appropriate processes for sterilizing the devices were validated." |
| Clinical Performance | Performed as expected in the clinical environment during venogram imaging and left ventricular lead placement via the coronary sinus. | "The Attain Access 6218 was included in two (2) Medtronic sponsored IDE clinical studies... The Attain Access 6218 Left-heart delivery system has performed as expected in the clinical environment during venogram imaging, and left ventricular lead placement via the coronary sinus." |
| Substantial Equivalence | Demonstrate substantial equivalence to legally marketed predicate devices. | The document extensively lists predicate devices and states, "Medtronic Inc, considers the Attain Access 6218 Left-heart delivery system to be substantially equivalent to the previously discussed legally marketed predicate devices." |
Study Details:
The provided document describes the device's performance through various tests and clinical observations, primarily for demonstrating substantial equivalence for 510(k) clearance.
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Sample size used for the test set and the data provenance:
- In vitro testing (Mechanical/Physical Performance): No specific sample size is provided, but it states "all of the in vitro specified requirements" were passed, implying a sufficient number of tests were conducted to cover the specified requirements. The data provenance is from Medtronic's internal testing.
- Biocompatibility Testing: No specific sample size of tested materials is given, but it states "Complete testing according to ISO 10993-1 was conducted." The data provenance is from Medtronic's internal testing or contracted labs.
- Sterilization Validation: No specific sample size is provided for devices undergoing sterilization validation. The data provenance is from Medtronic's internal testing or contracted labs.
- Clinical Studies: The device "was included in two (2) Medtronic sponsored IDE clinical studies." No specific sample size (number of patients or procedures) is provided for these clinical studies. The data provenance is prospective, from clinical studies sponsored by Medtronic.
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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):
- For the in-vitro, biocompatibility, and sterilization testing, the "ground truth" is typically defined by established engineering standards, laboratory protocols, and regulatory guidelines (e.g., ISO 10993-1), rather than expert clinicians. The specific number and qualifications of technical experts or engineers involved in setting up and validating these tests are not provided.
- For the clinical studies, without further details, it's impossible to determine the number and qualifications of experts involved in establishing "ground truth." However, in IDE clinical studies, clinical investigators (physicians) are responsible for patient evaluations and outcomes, effectively establishing the clinical ground truth. Their specific qualifications are not detailed in this summary.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- For in-vitro, biocompatibility, and sterilization testing, a formal adjudication method like "2+1" is typically not applicable. The results are compared directly against predefined criteria.
- For the clinical studies, no details on adjudication methods for clinical outcomes are provided.
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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 MRMC comparative effectiveness study was mentioned. The device described is a medical delivery system (catheter, guidewires, etc.), not an imaging or diagnostic AI-powered device that would typically involve "human readers" or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not an AI/algorithm-based device. Therefore, the concept of "standalone algorithm performance" is not applicable. The device is a physical instrument intended for use by a clinician.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Mechanical/Physical Performance, Biocompatibility, Sterilization: The ground truth is based on pre-defined engineering specifications, international standards (e.g., ISO 10993-1), and validated protocols.
- Clinical Studies: The ground truth is based on clinical observations and outcomes data from patients treated in the IDE studies, specifically regarding "venogram imaging, and left ventricular lead placement via the coronary sinus." This would involve physician assessment of the procedure's success and safety.
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The sample size for the training set:
- This is not an AI/machine learning device. Therefore, the concept of a "training set" in the context of algorithm development is not applicable. For physical device development, iterative design and testing would occur, but it's not referred to as a "training set."
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How the ground truth for the training set was established:
- Not applicable as this is not an AI/machine learning device. Design and performance requirements for the device would have been established through a combination of engineering principles, clinical needs, and regulatory requirements.
§ 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).