(48 days)
- 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.
§ 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).