(24 days)
The Attain™ 6216A-MP Multi-purpose Guide Catheter for Left-heart delivery is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.
The Attain™ 6216A-MP Multi-purpose Guide Catheter for Left-heart delivery features one (1) Muli-purpose shaped guide catheter for passing balloon catheters or appropriate leads and one (1) guide catheter dilator to facilitate guide catheter passage.
The Attain™ 6216A-MP Multi-purpose Guide Catheter for Left-heart delivery contains a dilator that is cleared for market distribution via 510(k).
The key change being made to the catheter is the change in the shape of the distal section in order to respond to the needs of physician preferences and to address subtle anatomical differences between patients. Other changes include the elimination of the existing system components (i.e. adjustable hemostasis valves, guidewires, guidewire clip, guide catheter slitters) which are commercialised with the Attain™ Access 6218A Left-heart delivery system, with the exception of the guide catheter dilator. The revised configuration of one (1) guide catheter and one (1) guide catheter dilator per package has necessitated changes to the associated packaging and labelling. In addition, the modified device will be given a new model number, Attain™ 6216A-MP.
The provided document is a 510(k) premarket notification for a medical device (Attain™ 6216A-MP Multi-purpose Guide Catheter for Left-heart delivery). It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies or standalone algorithm performance.
Therefore, many of the requested categories are not applicable as this type of submission generally relies on bench testing, material comparisons, and a comparison of intended use to predicate devices, rather than extensive clinical performance studies with specific statistical endpoints.
Here's a breakdown based on the provided text:
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Table of acceptance criteria and the reported device performance
This information is not explicitly provided in the document. The submission states: "In vitro testing, packaging and sterilization validation testing was performed to support substantial equivalence to the predicate devices. The results of this testing indicate that the Attain™ 6216A-MP Multi-purpose Guide Catheter for Left-heart delivery meets all of its design and performance requirements." However, the specific acceptance criteria (e.g., tensile strength, flexibility, lubricity) and their corresponding performance values are not detailed. The performance is summarized as "meets all of its design and performance requirements."
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "In vitro testing" but does not provide details on the number of units tested.
- Data Provenance: Not specified. "In vitro testing" typically implies laboratory testing, not human subject data.
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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 device is a catheter, and its performance evaluation for a 510(k) submission generally involves physical and mechanical testing, not interpretation by medical experts to establish "ground truth."
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this type of testing does not involve adjudication of expert opinions.
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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
Not applicable. The device is a physical catheter, not an AI or diagnostic imaging device that would 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
Not applicable. The device is a physical catheter, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's evaluation would be engineering specifications and standards for physical and mechanical properties, not expert consensus, pathology, or outcomes data, which are relevant for diagnostic or treatment efficacy studies.
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The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a training set.
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How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm, so there is no training set or associated ground truth establishment process.
§ 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).