(161 days)
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)
| Acceptance Criteria | Reported Device Performance |
|---|---|
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.