(373 days)
Orantech Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Philips Model MP30 and Nihon Kohden Model BSM-6301A. These devices are indicated for used by qualified medical personnel only.
Reusable temperature probes are used during patient temperature measurement for multi-patient use. These probes consist of a phone plug connector on the monitor end and a thermistor on the patient end. Temperature probes measure temperature by a resistor that is sensitive to temperature changes. These probes are connected to the patient monitor either directly by using a phono plug or by an interconnect cable. These probes have a skin or core contact with a patient.
These temperature probes are typically used with legacy Philips monitor model MP30 and Nihon Kohden monitor model BSM-6301A.
The medical device in question is the Orantech Inc. Temperature Probe, models TS-Y400-AG30, TS-Y400-AS30, TS-PH-AG30, and TS-PH-AS30.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by Standard or Performance Goal) | Reported Device Performance | Outcome |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity (ISO 10993 series) | No cytotoxicity detected | Pass |
| Sensitization (ISO 10993 series) | No sensitization detected | Pass |
| Irritation (ISO 10993 series) | Negligible irritation | Pass |
| Safety | ||
| Electrical Safety (IEC 60601-1) | Meets requirements of IEC 60601-1 | Pass |
| Performance (Continuous Clinical Thermometer) | ||
| Laboratory Accuracy (25-45°C range) | Not greater than 0.3°C (Accuracy: ± 0.1°C stated below) | Pass |
| Time Response | Heating transient time |
§ 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.