(59 days)
The cable is designed for use only with the Medronic Achieve family of mapping catheters. It is intended to provide the connection of the catheter to a standard ECG interface box.
The Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable is licensed for single use only. It connects the catheter and console to provide a path of electrical transmission from the proximal end of an Achieve mapping catheter to standard shielded ECG pins that connect to standard EP pacing and recording equipment. The cable is designed to only be used with the Medtronic Achieve family of mapping catheters
The provided text describes a 510(k) premarket notification for a reprocessed medical device, the "Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)". It is fundamentally a comparison to a predicate device, arguing for substantial equivalence through non-clinical testing.
However, the information provided does not contain details about acceptance criteria or a study proving device performance against such criteria in the context of an AI/algorithm-driven medical device.
The document is a regulatory approval letter and a 510(k) summary for a reprocessed physical medical device (a cable), not an AI/software as a medical device (SaMD). Therefore, it does not include:
- Acceptance criteria for an AI/algorithm's performance (e.g., sensitivity, specificity, AUC).
- Details about a test set (sample size, provenance).
- Information on expert ground truth establishment (number of experts, qualifications, adjudication methods).
- Any multi-reader multi-case (MRMC) comparative effectiveness study.
- Stand-alone algorithm performance.
- Ground truth type for AI/algorithm evaluation.
- Training set details for an AI model.
The "Non-clinical Testing Summary" section describes the tests performed for this reprocessed physical device:
- Functional performance: simulated use and artificial soiling; visual inspection; continuity, isolation and resistance device functionality; Electrical Safety current leakage and hipot
- Cleaning Validation
- Sterilization Validation bioburden testing
- Packaging and shelf life validation
- Product stability
These are standard engineering and safety tests for a physical medical device, not performance evaluations for an AI/software.
Therefore, based on the provided text, it is not possible to answer the detailed questions about acceptance criteria and study design for an AI/algorithm-driven medical device. The document simply isn't about that kind of device.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).