(321 days)
The Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are intended for use in clinical settings for the intermittent measurement and monitoring of surface skin temperature on people of all ages.
The Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are a hand held instrument that measures skin temperature based on measuring infrared radiation. It is designed for ease of patient use with clearly marked patient intensity buttons. The indications for use are to measure and monitor the patient's skin temperature. It is intended for use on people of all ages.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not contain a specific table of acceptance criteria or detailed device performance metrics beyond stating that the device is "substantially equivalent" to predicate devices. The document explicitly states: "The primary function of the ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are the same as the J & J Engineering, Inc. Thermistor Thermometer and the Exergen Corporation DermaTemp DT 1001 and raises no new questions of safety and effectiveness." This implies that the acceptance criteria for this device are met by demonstrating equivalence to the legally marketed predicate devices, which would have themselves met their respective performance standards.
Without specific performance data, it's impossible to create a table. However, if performance data were present, it would typically look something like this (hypothetical example):
| Performance Metric | Acceptance Criteria (from predicate/standards) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Accuracy Range | ±0.2°C from 36°C-39°C | ±0.15°C from 36.5°C-38.5°C | Yes |
| Response 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.