(161 days)
No
The document explicitly states "no manipulation or editing is allowed" for the oximetry data, and there is no mention of AI, DNN, or ML in the text. The analysis is described as a straightforward download and presentation of recorded data.
No.
The device is used for monitoring and evaluation, not for providing direct treatment or therapy.
Yes
The device is used for monitoring cardiac rhythm, measuring the frequency and duration of arrhythmias, evaluating pacemaker function, and trending oxygen saturation, all of which are diagnostic activities.
No
The device description explicitly states it is a "Holter and Pulse Oximetry Recorder" and includes hardware components like a recorder, a pulse oximetry probe, and memory storage cards.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The description clearly states that the device is a Holter and Pulse Oximetry Recorder. It records physiological signals from the patient's body (ECG and pulse oximetry) over time.
- Intended Use: The intended uses all relate to monitoring and evaluating the patient's cardiac rhythm, pacemaker function, and oxygen saturation in vivo (within the living body).
- No Sample Analysis: There is no mention of the device analyzing samples taken from the patient's body.
Therefore, the NorthEast Monitoring DR180-R/Oxy is a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NorthEast Monitoring DR180-R/Oxy is indicated for 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.
Pacemaker Evaluation: The NorthEast Monitoring DR180-R/Oxy is indicated for use to 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.
Product codes
FLL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
To be used only on the order of a physician.
May be used for home monitoring, but periods of activity or excessive movement are to be omitted due to artifact.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The Xpod was clinically tested (human subjects) by its manufacturer, Nonin, and found to have
§ 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.
0
3/23/99
510(k) Summary
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 Xpod was clinically tested (human subjects) by its manufacturer, Nonin, and found to have