(151 days)
The Confirm RxIM ICM is indicated for the monitoring and diagnostic evaluation of patients who experience wersplained symptoms such as: 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 RxIM ICM has not been specifically tested for pediatric use.
The ICM is intended as a minimally invasive, implantable diagnostic monitoring device, with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability, which help physicians monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias. It has a two-year longevity, MR conditional labeling, sensing and detection algorithms, and Bluetooth communication. Specific features include:
- Patient-initiated triggering of EGM storage using the myMerlin™™ Patient App for o mobile devices. This includes capability for the patient to identify symptoms, which are stored with the EGM for physician review.
- Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are o detected; with physician-programmable values for pause duration, bradycardia rate, tachycardia rate, and number of tachycardia intervals.
- Automated triggering of EGM storage when atrial fibrillation (AF) is detected, with O physician programmable values for AF duration.
- The ability to identify EGM anomalies as a consequence of noise or vigorous activity o and inhibit EGM storage as applicable.
- Remote care monitoring. o
Here's an analysis of the provided text regarding the Abbott Confirm Rx Insertable Cardiac Monitor (ICM) System, Model DM3500, focusing on acceptance criteria and the supporting study:
Important Note: The provided document is a 510(k) clearance letter and related submission materials. It primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a detailed standalone performance study with comprehensive acceptance criteria and results for the new device. Therefore, some of the requested information (like specific performance metrics and their ranges) is not explicitly listed as "acceptance criteria" and "reported device performance" in the way one might expect for a de novo device clearance. The document emphasizes that the fundamental technological characteristics are not changing, and the focus is on minor firmware updates and a manufacturing material change.
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, the document doesn't explicitly define a table of new acceptance criteria with numerical performance targets and reported results for the DM3500 in the way a clinical study report would. Instead, it states that the device "meets its predetermined design and performance specifications" and "performs as intended and is safe for its intended use."
The "acceptance criteria" are implied by the verification and validation activities conducted to ensure the device with the minor changes:
- Functions in accordance with product specifications.
- Performs as intended.
- Is safe for its intended use.
- Is substantially equivalent to the predicate (K163407).
The reported device performance is therefore that these criteria were met, specifically through:
- Firmware Verification and System Validation: This would ensure the updated firmware functions correctly and that the overall system operates as specified.
- Mechanical Performance Testing: This would verify the mechanical integrity and function of the device with the new UV Cure material.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device functions in accordance with product specifications | Confirmed by Firmware Verification & System Validation |
| Device performs as intended | Confirmed by Firmware Verification & System Validation |
| Device is safe for its intended use | Confirmed by various testing, including Firmware & Mechanical |
| Device remains substantially equivalent to predicate (K163407) (incl. same Indications for Use, operating rules, device functionality, longevity) | Confirmed by comparison, minor differences do not raise new issues |
| ERI (End of Service Indicator) alert clearing in shipped settings | Updated firmware contains minor changes, implying successful testing |
| Response to magnet placement in shipped settings | Updated firmware contains minor changes, implying successful testing |
| Mechanical integrity with UV Cure material | Confirmed by Mechanical Performance testing |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" sample size in terms of patient data or clinical cases. The testing conducted was primarily bench testing and system validation for the firmware and mechanical changes. No clinical study on human subjects is mentioned for this particular 510(k) submission.
- Sample Size: Not applicable in the context of human clinical data. For engineering verification and validation, it would refer to the number of devices or test units, which is not stated.
- Data Provenance: Not applicable for clinical data. The testing described is internal engineering and validation testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission is for a device modification (firmware update and material change) and relies on engineering verification and validation, not on expert adjudication of diagnostic performance on a test set of clinical cases. The "ground truth" here would be the predefined functional and performance specifications of the device.
4. Adjudication Method for the Test Set
Not applicable. As no clinical test set requiring human adjudication is described, there is no adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done and none is described. This device is an insertable cardiac monitor, and its capabilities are assessed through its detection algorithms and hardware performance, not through human interpretation of its outputs in a comparative effectiveness study involving reader performance improvement with AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device's core function is automatic detection of cardiac events (tachycardia, bradycardia, pauses, AF). The document states:
- "Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are detected"
- "Automated triggering of EGM storage when atrial fibrillation (AF) is detected"
- "The ability to identify EGM anomalies as a consequence of noise or vigorous activity and inhibit EGM storage as applicable."
The "Firmware Verification and System Validation" would have evaluated the performance of these algorithms in a standalone manner (without human intervention) against known inputs. However, no specific metrics (e.g., sensitivity, specificity for AF detection) from such a study are provided in this regulatory document. The statement implies that the existing algorithms (from the predicate) have been verified with the updated firmware.
7. Type of Ground Truth Used
For the Firmware Verification and System Validation, the ground truth would be:
- Predefined system specifications: The expected behavior and output of the device's firmware and algorithms under various conditions.
- Known input signals: Simulated or recorded ECG/EGM data with precisely defined events (e.g., specific heart rates, AF episodes, pauses) to test the detection algorithms.
- Mechanical engineering standards: For the mechanical performance testing.
8. Sample Size for the Training Set
Not applicable. The document does not describe the development of new AI algorithms that require a "training set." The firmware updates are described as "minor changes" to an existing ERI detection algorithm and magnet response, implying fine-tuning or bug fixes rather than a re-training of a predictive model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for new AI algorithms is described.
§ 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).