(88 days)
Holter Mode: Detection of Arrhythmias, Efficacy of Pharmacological Treatment and Pacemaker Evaluation.
Event Recorder: The event recorder module is a patient activated device designed to record and for diagnostic evaluation of transient symptoms (such as dizziness, palpitations, syncope, and chest pain). Once data is recorded, the data is transmitted for evaluation.
The DR300 is an ambulatory monitor, sometimes called a Holter, which is a painless method to monitor the heart beat for a period of time (such as 24 hours, 48 hours, or 72 hours). The Holter is a small recording device that records the heart beat while being worn by the patient.
The physician or technician places electrodes and wires on the patient. The wires are connected to the Holter or digital recorder.
The DR300 Recorder has two modes that allow it to be used either as a standard Holter monitor or a looping Event recorder. The device is designed to facilitate ambulatory cardiac monitoring on the order of a physician, of those patients (including infants weighing less than 10 kg) who may benefit from such monitoring.
The data obtained during monitoring is not analyzed at the time of recording. After the recording is complete, the data must later be downloaded to a compatible NorthEast Monitoring Holter or Event analysis system (TelePro Software) to be analyzed. The Holter Analysis Software was cleared by FDA under K930564.
The device is not intended to replace real time telemetry monitoring for patient suspected of having life threatening arrhythmias.
The DR300 Digital Recorder package includes:
- . DR300 Digital Recorder
- Operation Manual
- SD Card ●
- Patient Cable
The DR300 digital recorder is powered by one 1.5 volt AA alkaline battery (MN1500 or the equivalent), one AA rechargeable NiMH (nickel metal hydride) battery, or one AA Eveready Lithium L91 battery. Batteries should not be re-used for a second patient. The batteries are not included; users are instructed to purchase 2 AA batteries.
The device is compatible with standard silver / silver chloride ECG electrodes. Electrodes are not provided with the subject device. The user is instructed to purchase standard silver / silver chloride ECG electrodes.
The DR300 digital recorder uses NorthEast Monitoring NorthEast Monitoring shielded patient cables with either 5 or 7 patient leads for a 3 channel recording or three leads for 2 channel Holter Recording.
The DR300 has an LCD that is used to display the time of day (during the recording), prompts and error messages (during the hookup procedure or during recording), or lead quality (during the hookup procedure).
The data collected by the DR300 digital recorder is stored on a removable SD Card.
The DR300 is packaged in a plastic bag in a cardboard shipping carton. The shipping carton will also include a patient cable and an SD Card.
The difference between the DR300 and the DR200/Telaheart is the wireless capability. The DR300 digital recorder is equipped with wireless Bluetooth transmitter. A NorthEast Monitoring Bluetooth Gateway or USB Dongle is able to receive the encrypted Holter and Event data.
In order for the wireless transmission to occur, the DR300 will need to come in range of a North East Monitoring transceiver - either a gateway or a PC with a USB Adapter. If there is sufficient data to send, the recorder will attempt to locate a transceiver every 20 minutes. When the transceiver is found the data will be sent. Transmission may be started manually by pressing the enter button.
The provided text describes the DR300 Holter Monitor and its substantial equivalence to a predicate device (Telaheart Digital Recorder / DR200, K061293) for FDA 510(k) clearance.
Here's an analysis of the acceptance criteria and study information, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria with numerical targets. Instead, it refers to compliance with several IEC standards and internal functional testing. The reported performance is generally stated as "functioned as intended" or "found no issues of safety or effectiveness."
| Acceptance Criteria Category | Specific Standard/Test | Reported Device Performance |
|---|---|---|
| Safety and Usability (General) | IEC 60601-1-6: 2010 (Usability) | Confirmed. |
| Safety (Home Healthcare) | IEC 60601-1-11: 2010 (Home Healthcare) | Confirmed. |
| Safety (General) | IEC 60601-1: 2012 (General Safety) | Confirmed. |
| Safety (Ambulatory ECG Systems) | IEC 60601-1-2-47 (Ambulatory ECG Systems) | Confirmed. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 (EMC) | Confirmed. |
| Wireless Functionality | FDA Guidance Radio Frequency Wireless in Medical Devices (August 14, 2013) | Confirmed. |
| Software Functionality | Software Verification and Validation | Confirmed. |
| Device Function (Holter & Event Modes without Wireless) | Simulated bench testing (11 Holter Tests) | "[D]evice functions as intended after the inclusion of the Bluetooth transmitter and additional shielding." |
| Device Function (Holter & Event Modes with Wireless) | Simulated bench and wireless testing | "All testing confirmed that the device using the wireless technology functioned as intended and found no issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "11 Holter Tests" for functional verification without wireless, and "Additional testing" for wireless that "ranged from monitoring over a 24 hour to 48 hour period." It doesn't specify how many distinct patient datasets or simulated cases were used within these tests. The number "11" seems to refer to the number of tests rather than a sample size of recordings or patients.
- Data Provenance: The testing was "Simulated bench and wireless testing." This indicates the data was likely generated in a controlled laboratory or simulated environment, rather than from human patients. The country of origin for such simulated data is not specified but is implicitly North East Monitoring's location (USA). This was retrospective in the sense that it describes device performance after the components (Bluetooth, shielding) were integrated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the involvement of experts or a ground truth established by experts for the performance testing. The "ground truth" for these tests was derived from the expected functional output based on engineering specifications and standard compliance.
4. Adjudication Method for the Test Set
No adjudication method is described, as the testing focuses on device functionality and compliance with standards rather than interpretation of clinical data by multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No MRMC comparative effectiveness study was done or mentioned. The submission focuses on device functionality and safety, not on human reader performance with or without AI assistance. The device records data; it does not analyze it. Analysis is performed by external software (TelePro Software, K930564).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The device itself is a Holter monitor, an acquisition device. It records ECG data. The document explicitly states: "The data obtained during monitoring is not analyzed at the time of recording. After the recording is complete, the data must later be downloaded to a compatible NorthEast Monitoring Holter or Event analysis system (TelePro Software) to be analyzed." Therefore, a "standalone algorithm-only" performance study is not applicable to the DR300 Holter Monitor itself, as it does not perform algorithmic analysis.
7. The Type of Ground Truth Used
The ground truth used for the performance testing was based on:
- Compliance with established international and FDA standards (IEC 60601 series, FDA Wireless Guidance).
- Expected functional behavior and output based on engineering design specifications for recording and wireless transmission of ECG data.
8. The Sample Size for the Training Set
Not applicable. The DR300 is a hardware device for data acquisition and does not involve AI or machine learning algorithms that require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 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).