(64 days)
The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as the following: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
The Confirm Rx™ ICM System consists of the following key features and components: Confirm Rx™ ICM Model DM3500 Implantable Device, Implant Tools (Incision tool model DM3520 and Insertion tool model DM3510), Confirm Rx ICM Accessory Kit DM3500A, Magnet, Clinician Programmer (Merlin PCS Programmer Model 3650), myMerlin™ Mobile Application (Model APP1000 (Android) and APP1001 (iOS)), and Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator). The ICM is a minimally invasive, implantable diagnostic monitoring device with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability.
The provided text does not contain information about acceptance criteria for device performance or a study proving that the device meets specific performance criteria. Instead, it details a 510(k) premarket notification for an Abbott (St. Jude Medical) Confirm Rx™ Insertable Cardiac Monitor system (K202876).
This submission is for an Accessory Kit DM3500A and an updated incision tool DM3520 blade design for an already cleared device (predicate K193310). The document asserts substantial equivalence to the predicate device, meaning it argues that the new components do not raise new questions of safety or effectiveness and perform as well as the predicate.
The document states:
- "Completion of all verification and validation activities demonstrated that the Confirm Rx ICM accessory kit meets its predetermined design and performance specifications and that the product is substantially equivalent to the current device (Model DM3500, K193310)." (Page 9)
- "The results of the verification and validation tests and the risk analysis have demonstrated the candidate Confirm Rx ICM system with Accessory Kit DM3500A and updated incision tool DM3520 blade design functions in accordance with product specifications." (Page 9)
- "Product verification and validation testing demonstrate that the candidate Confirm Rx ICM system is as safe and as effective and performs as well as the predicate system (K193310)." (Page 9)
However, it does not provide a table of acceptance criteria and reported device performance for the new components or the system as a whole. It also does not describe a specific study with a test set, training set, expert ground truth, or adjudication methods in the context of device performance metrics (e.g., sensitivity, specificity for arrhythmia detection). The non-clinical test summary mentions a "risk analysis method... a Failure Mode and Effects Analysis (FMEA/FMECA)," but this is for assessing hazards and mitigating risks, not for evaluating performance against clinical acceptance criteria.
Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided FDA document.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).