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The Telaheart Digital Recorder can be used in Holter mode and Event Recorder mode.

Holter Mode
Detection of Arrhythmias, Efficacy of Pharmacological Treatment, and Pacemaker Evaluation.

Event Recorder
The Telaheart 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 via telephone for evaluation.

The device includes the Auto Detect feature which can be used as a looping event recorder to capture events automatically or when activated by the patient. When one or more events are captured the patient may transmit his/her recordings transtelephonically.

NorthEast Monitoring will offer versions with the Auto Detect feature.

• Telaheart DR200/E-a Event Recorder with Auto Detect feature (using a black background).
• DR200/HE-a Holter and Event Recorder with Auto Detect feature (using white background).

The Auto Detect feature can be used as a looping event recorder to capture events automatically or when activated by the patient. When one or more events are captured the patient may transmit his/her recordings transtelephonically. The device stores the events in memory. There is a display counter for the events and an audible beep to remind the user to transmit the data to the physician.

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.

The provided text focuses on a 510(k) summary for the "Auto Detect for Telaheart" device. It outlines the device description, its similarity to predicate devices, and its intended use. However, it does not contain information on acceptance criteria for device performance or a detailed study proving the device meets such criteria.

The document states:

• "The subject device has been subjected to and passed electrical safety and EMC testing requirements." (Page 4)
• "We believe the changes are minor and conclude that the subject device is as safe and effective as the predicate devices" (Page 4)

This implies that the device's performance was deemed adequate based on its substantial equivalence to predicate devices and compliance with electrical safety and EMC standards. There is no mention of a specific performance study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement for the "Auto Detect" feature's clinical performance.

Therefore, I cannot provide the requested information from the given text. The text does not describe a study that proves the device meets specific acceptance criteria related to its "Auto Detect" feature's clinical performance.

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The Telaheart Digital Recorder can be used in Holter mode and Event Recorder mode.

Holter Mode

Detection of Arrhythmias, Efficacy of Pharmacological Treatment, and Pacemaker Evaluation.

Event Recorder

The Telaheart 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 via telephone for evaluation.

An ambulatory monitor, sometimes called a Holter, is a painless method to monitor the heart for a period of time (such as 24 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 Telaheart Digital 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 herefit 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 Holtec 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 Telaheart Digital Recorder package includes:

• . Telaheart Digital Recorder
• . Operation Manual
• SD Card .
• Patient Cable

The Telaheart 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 Lqurbattery. 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 are not provided with the subject device. The user is instructed to purchase standard silver / silver chloride ECG electrodes.

The Telaheart digital recorder uses NorthEast Monitoring Telaheart patient cables with either 2, 5, or 7 patient leads. The patient cable connects to the recorder via a connector on the recorder. A patient cable is provided with the Telaheart Digital Recorder.

The Telaheart 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 Telaheart digital recorder is stored on a removable SD Card.

The Telaheart is packaged in a plastic bag in a cardboard shipping carton. The shipping carton will also include a patient cable and an SD Card.

This 510(k) submission (K061293) for the Telaheart Digital Recorder does not contain a study that establishes performance against acceptance criteria in the way a typical clinical performance study would.

This submission is for a medical device (an ambulatory ECG recorder, also known as a Holter or Event Recorder) that does not perform automated analysis. Its primary function is to record physiological data (ECG signals) for later analysis by compatible software (TelePro Software, cleared under K930564). Therefore, the "performance data" and "acceptance criteria" presented here relate to the device's functional and safety aspects, not its ability to diagnose conditions or assist human readers.

Here's the breakdown of the information based on your request, focusing on what is available in the provided text:

Acceptance Criteria and Reported Device Performance (Table)

Since the device's function is data acquisition and not analysis, the "acceptance criteria" are related to its physical and electrical specifications and compliance with safety standards rather than diagnostic performance metrics.

Study Details for Performance Evaluation:

As mentioned, this 510(k) does not describe a clinical performance study in the traditional sense (e.g., comparing diagnostic accuracy). Instead, it focuses on the device's engineering, safety, and software validation.

2. Sample Size for Test Set and Data Provenance:
* N/A. The document does not describe a clinical test set with patient data for diagnostic performance evaluation. The "tests" mentioned are for electrical safety, EMC, and software validation, which typically use engineering samples, test signals, and software testing methodologies rather than a clinical test set of patients.

3. Number of Experts and Qualifications for Ground Truth:
* N/A. There is no mention of experts establishing a ground truth for a clinical test set, as no such study is presented.

4. Adjudication Method:
* N/A. Not applicable, as there is no clinical test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
* No. This type of study would compare human readers with and without AI assistance to assess diagnostic improvement. The Telaheart Digital Recorder is a data acquisition device, not an AI-powered diagnostic tool, and it does not perform automated analysis. Therefore, an MRMC study is not relevant to this submission.

6. Standalone (Algorithm Only) Performance Study:
* No. The device itself does not contain an algorithm for standalone diagnostic performance. It records raw ECG data. The separate "TelePro Software" (cleared under K930564) is responsible for analysis, but its standalone performance is not detailed in this 510(k) for the recorder.

7. Type of Ground Truth Used:
* N/A. For the device itself, "ground truth" would relate to accurate signal acquisition and storage (e.g., comparing recorded waveforms to known input signals for electrical performance, or verifying software functionality against specifications). It does not involve "expert consensus," "pathology," or "outcomes data" for diagnostic purposes.

8. Sample Size for Training Set:
* N/A. There is no mention of a training set for an AI algorithm, as this device does not utilize AI for diagnostic analysis.

9. How Ground Truth for Training Set was Established:
* N/A. Not applicable, as there is no training set mentioned.

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• Detection of Arrhythmias: The NorthEast Monitoring, Inc. SD360 Digital Recorder is indicated for use in continuous monitoring of cardiac rhythm when intermittent arrhythmia are suspected due to patient symptoms such as palpitations, transient ischemic attacks (TIAs), syncope (fainting), or other such symptoms as determined by the physician.
• Efficacy of Treatment: The NorthEast Monitoring Inc. SD360 Digital Recorder is indicated for use to determine whether current pharmacological treatment(s) of known arrhythmia is effective by measuring the frequency and duration of the arrhythmia compared to the frequency and duration prior to treatment.
• Pacemaker Evaluation: The NorthEast Monitoring Inc. SD360 Digital Recorder is indicated for use to evaluate the function of implanted pacemakers to insure that the pacemaker is functioning within prescribed limits.
• The NorthEast Monitoring SD360 Digital Recorder is to be used by or on the order of a physician.

An ambulatory monitor, sometimes called a Holter, is a painless method to monitor the heart beat for a period of time (usually 24, 48, 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 recorder. The patient is asked to write down a diary of daily activity including the time and character of any symptoms.

The patient can push a patient event button to mark an event. The patient must write down details about the event in their diary so that physician or technician can relate the event to specific symptoms or activities.

The NorthEast Monitoring SD360 Digital Recorder is a holter monitor designed to facilitate the ambulatory cardiac monitoring, on the order of a physician, of those patients who may benefit from such monitoring including but not limited to those with complaints of palpitations, syncope, chest pains, shortness of breath, or those who need to be monitored to judge their current cardiac function, such as patients who have recently received pacemakers.

The SD360 Digital Recorder package includes:

• SD360 Digital Recorder
• Operation Manual
• SD Card
• Patient Cable
• Pouch

The data obtained by 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 analysis system to be analyzed. The Holter Analysis Software was cleared by FDA under K930564.

The SD360 is not intended to replace real time telemetry monitoring for patients suspected of having life-threatening arrhythmias.

The SD360 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 SD360 digital recorder uses NorthEast Monitoring SD360 patient cables with either seven leads or five leads for a 3-channel holter recording. The patient cable connects to the recorder via a 9-pin female connector on the recorder. A patient cable is provided with the SD360 Digital Recorder.

The SD360 has a small LCD that is used to display either time of day (during the recording), error messages (during the hookup procedure or during recording), or lead quality (during the hookup procedure).

The data collected by the SD360 digital recorder is stored on a removable SD Card. To store 24 hours in normal mode, the minimum capacity of the SD Card should be 28 megabytes; 56 megabytes are required for 24 hours in high resolution mode. To store 24 hours in 360 samples/sec mode, 112 megabytes are required. To stored 24 hours in 720 samples/sec, 224 megabytes are required. Double all storage requirements for 48 hour recordings, and triple them for 72 hour recordings. The SD360 is provided with an SD memory card with at least 32 megabytes.

The SD360 is packaged in a plastic bag in a cardboard shipping carton. The shipping carton will also include a patient cable and a pouch. The pouch is used by the patient to hold the digital recorder while in use.

The physician or technician can optionally use a PC as an interface to key in patient information. If a PC were used, the patient information would be keyed into the SD card using the NorthEast Monitoring Holter Analysis software (cleared under a separate 510k).

Another option for entering patient information is through the use of a PDA (i.e. Palm Pilot). Patient information such as patient name, sex, date of birth, identification number, scan number, hookup tech name or initials, physician name, indications, and medications.

The provided text describes a 510(k) submission for the NorthEast Monitoring SD360 Digital Recorder, an ambulatory ECG recorder (Holter monitor). The document focuses on demonstrating substantial equivalence to a predicate device and outlines the device's characteristics and intended use. However, it does not contain information about a study proving the device meets specific acceptance criteria based on its performance metrics.

The "Performance Data" section merely states: "The subject device has been subjected to and passed electrical safety and EMC testing requirements." This indicates compliance with general safety and electromagnetic compatibility standards, but not clinical performance or accuracy in detecting arrhythmias, evaluating treatment efficacy, or pacemaker function.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• MRMC comparative effectiveness study results or effect size.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This is because the provided submission asserts substantial equivalence based on technological characteristics and functional identity with a predicate device, rather than a clinical performance study with defined acceptance criteria for diagnostic accuracy or similar metrics. The focus is on physical specifications, battery life, memory, and connectivity, alongside basic electrical safety.

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1.) use for long-term monitoring of cardiac rhythm when intermittent arrhythmias are suspected due to patient symptoms such as palpitations, transient attacks (TIA's), syncope (fainting), or other such symptoms as determined by the physician.
2.) Efficacy of Treatment: The NorthEast Monitoring DR180-R/Oxy is indicated for use to determine if current pharmacological treatment of known arrhythmias is effective by measuring the frequency and duration of the arrhythmia compared to the frequency and duration prior to treatment.
3.) evaluate the function of implanted pacemakers to insure that the pacemaker is functioning . within prescribed limits.
4.) Trending of oxygen saturation (SpO2) in the blood for periods of up to 24 hours. If the device is to be used for home monitoring, periods of activity or excessive movement are to be omitted due to the artifact that would be generated.
5.) . The NorthEast Monitoring DR180-R/Oxy is to be used only on the order of a physician.

The DR180-R/Oxy Holter and Pulse Oximetry Recorder is the predicate device (DR180 Holter recorder, 510(k) K960925) with the addition of a Nonin Xpod pulse oximetry probe. The probe cable is attached to the DR180 with the electrode lead wires. ECG and pulse oximetry are recorded simultaneously for periods up to the hours. This data is recorded onto PCMCIA Flashdisk memory storage cards. When recording is complete, the card is removed from the DR180-R/Oxy, inserted into a slot in the analysis system, and the data is downloaded and analyzed as previously. The oximetry data is simply presented to the operator; no manipulation or editing is allowed.

The acceptance criteria and device performance information provided is limited to the pulse oximetry component of the DR180-R/Oxy device, given the focus of the 510(k) summary on the addition of this functionality.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance (for Pulse Oximetry)

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