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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."

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.

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Intended for use on adult patients only as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score. The ECG recording may be obtained at any location specified by a physician including home, hospital, or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is receiled to sinus rhythm in nature.

Holter LX Analysis is a software option to the Holter for Windows software (K930564). The software has been designed to detect sleep disordered breathing due to obstructive apneas or hyponneas. The software uses 2 channel ECG and oximetry data collected via the DR180+ Holter Recorder to calculate the patient's Apnea-Hypopnea Index (AHI). The Holter and Oxymetry ECG data obtained by monitoring is not analyzed at the time of recording is complete, the data must be downloaded to a compatible NorthEast Monitoring Holter LX Analysis with sleep apnea software system to be analyzed by a healthcare professional. The sleep apnea monitoring algorithm used in the subject device is the exact algorithm already cleared by FDA. The Sleep Technician or Physician will utilize standard Holter procedure to hook up the recorder to the patient. The patient will sleep with the recorder for one night in order to collect data. Either the patient or a sleep clinician will note the time that the patient falls asleep and awakens. The sampling rate is 180 samples/second. The Holter LX Analysis software detects each R-wave. The calculations of AHI are performed. The Holter LX Analysis software can only be used in conjunction with North East Monitoring Holter recorders.

Here's an analysis of the provided text regarding the Holter LX Analysis device, focusing on its acceptance criteria and the study used for validation:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria (e.g., minimum sensitivity, specificity) for the Holter LX Analysis software. Instead, it relies on demonstrating substantial equivalence to a predicate device.

Explanation: The filing states, "Comparison of test data between the Holter LX Analysis software and the LifeScreeen Apnea device found equivalent results for sensitivity, specificity, accuracy, and positive predictivity. We believe the subject device is substantially equivalent to the predicate device." This implies that the acceptance criteria were met by showing performance equivalent to the predicate, K042745 (LifeScreen Apnea).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the comparative test set.

• Sample Size: Not specified.
• Data Provenance: The text states, "The underlying algorithm remains the same, but the AHI is calculated using oximetry data from a study conducted by Biancamed." This suggests the test data (or at least the oximetry data used for AHI calculation) came from a prospective or retrospective study conducted by Biancamed. The country of origin is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. Given that the algorithm itself is the exact same as the predicate and the study focuses on the incorporation of oximetry, it's possible the original predicate study established a ground truth against which the algorithm was initially validated, and this submission leverages that, with a focus on verifying the oximetry data integration.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this submission. The study described is a comparison of the new device's computational output (Holter LX Analysis with oximetry) to a predicate device's computational output (LifeScreen Apnea, which used the same base algorithm). There is no mention of human readers.

6. Standalone Performance Study

Yes, a standalone (algorithm only) performance study was implicitly done. The "comparison of test data between the Holter LX Analysis software and the LifeScreeen Apnea device" constitutes a standalone performance comparison between two algorithms (one with an oximetry enhancement). However, it's a comparison between algorithms, not against an independent "gold standard" in this specific submission. The original validation of the algorithm (when used in LifeScreen Apnea) would have been the standalone validation.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the comparison study or the original algorithm validation. However, as it is a device to determine the "need for clinical diagnosis and evaluation by polysomnography," it is highly probable that the original algorithm's ground truth was established by polysomnography (PSG), which is the gold standard for sleep disorder diagnosis. The current submission focuses on equating results with the predicate device, not re-validating against the ultimate clinical ground truth itself.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It mentions the algorithm is "the exact algorithm already cleared by FDA" and sourced from Biancamed. This implies the training (if any was needed for the base algorithm) occurred prior to its use in the predicate device. For the oximetry enhancement, it's unclear if new training was involved or if it was a direct application of existing scientific principles.

9. How the Ground Truth for the Training Set Was Established

The document does not specify how the ground truth for the training set was established. Similar to the test set, it's highly probable that the original algorithm (developed by Biancamed) was trained and validated against polysomnography (PSG) as the ultimate ground truth for sleep apnea events. This submission focuses on the application of that already cleared algorithm, with the added oximetry data.

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