(29 days)
The Jot Dx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained 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 Jot Dx™ ICM DM4500 System consists of the Jot Dx™ ICM Model DM4500 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.
This document is a 510(k) premarket notification for the Abbott Jot Dx™ Insertable Cardiac Monitor (ICM) DM4500. The core of this submission is to demonstrate substantial equivalence to an existing predicate device, the Abbott Confirm Rx™ ICM DM3500 (K202888).
Therefore, the study supporting acceptance criteria isn't a traditional clinical study with human readers and ground truth established by experts. Instead, the "study" is a non-clinical test summary demonstrating that the new device is identical to the predicate device in all relevant aspects affecting safety and effectiveness.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Since the submission claims identity to a predicate, the acceptance criteria are effectively that the Jot Dx™ ICM DM4500 must perform identically to the Confirm Rx™ ICM DM3500.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Identity: The Jot Dx™ ICM DM4500 must possess the same intended use, indications for use, operating rules, device/tool functionality, software, packaging materials and process, shelf life, and device longevity as the predicate Confirm Rx™ ICM DM3500. | "The candidate Jot Dx™ ICM DM4500 is identical to the predicate Confirm Rx™ ICM DM3500 (K202888), aside from name, model number, and corresponding laser marking." |
"The fundamental technological characteristics of the candidate Jot Dx™ ICM DM4500 are not changing in comparison to the predicate device, the current Confirm Rx™ ICM DM3500 (510(k) K202888). The candidate Jot Dx™ ICM DM4500 system has the same:
- Intended Use and Indications for Use
- Operating rules
- Device/tool functionality
- Packaging materials and process
- Shelf life
- Device Longevity
- Software"
"The candidate Jot Dx™ ICM DM4500 is identical in design and function and has the same indications and intended use as the predicate Confirm Rx™ ICM DM3500 (K202888)." |
| Safety and Effectiveness: The minor differences (name, model number, laser marking) do not raise new issues of safety and effectiveness. | "The minor differences in name, model number, and laser marking do not raise new issues of safety and effectiveness."
"Completion of all verification and validation activities demonstrated that the candidate Jot Dx™ ICM DM4500 meets its predetermined design and performance specifications and that the product is substantially equivalent to the predicate device (Model DM3500, K202888)."
"The results of the testing show that the candidate Jot Dx ICM DM4500 system performs as intended and is safe for its intended use."
"The candidate Jot Dx™ ICM system is substantially equivalent in terms of safety and technological characteristics to the identified predicate device (Confirm RxTM ICM System; K202888). Product verification and validation testing demonstrate that the candidate Jot Dx ICM system is as safe and as effective and performs as well as the predicate system (K202888)." |
| Risk Assessment: Acceptable risk profile. | "The risk analysis method used to assess the impact of the addition of the candidate Jot Dx™ ICM DM4500 documents the investigation of hazards and mitigation of associated risks and reports the result of the investigation. The risk analysis method used to assess the impact of the modifications was a Failure Mode and Effects Analysis (FMEA/FMECA). It was determined that the overall risk is acceptable." |
2. Sample Size for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in a traditional sense. The "test set" here refers to the engineering verification and validation testing performed on the single design of the Jot Dx™ ICM DM4500 to confirm its identity and performance against the predicate. This isn't a statistical sample of independent clinical cases.
- Data Provenance: Not applicable for a traditional clinical study. The "data" comes from internal engineering verification and validation activities. It's retrospective in the sense that they are comparing it to an already cleared predicate device's specifications and performance. No country of origin is specified for these internal engineering tests, but the company is based in the USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. Ground truth, in the context of substantial equivalence for an identical device, is established by its adherence to the design and performance specifications of the predicate device, not through expert human interpretation of clinical data on the new device.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. There is no ambiguous clinical data requiring adjudication.
5. 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:
- MRMC Study: No. This submission does not involve an AI component or a comparative effectiveness study with human readers. The device is an insertable cardiac monitor that automatically detects events.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Stand-alone Performance: While the device automatically detects cardiac arrhythmias (an "algorithm" in a broad sense), the submission doesn't present a standalone performance study with metrics like sensitivity and specificity against a clinical ground truth. Instead, it relies on the established performance of the identical predicate device. The document explicitly states the "Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are detected" and "Automated triggering of EGM storage when atrial fibrillation (AF) is detected." The performance of these detection algorithms is considered equivalent to the predicate.
7. The Type of Ground Truth Used:
- Type of Ground Truth: The "ground truth" for this submission is the established design, performance specifications, and safety/effectiveness profile of the legally marketed predicate device (Confirm Rx™ ICM DM3500, K202888). The new device is asserted to be identical in these respects, making the predicate the reference "truth."
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. There is no machine learning or AI algorithm being trained for this device submission as it is presented as a re-branding/model number change of an existing technology.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth for Training Set: Not applicable, as there is no training set mentioned in this 510(k) application.
§ 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).