(233 days)
Skin Temperature Sensor (487M and 499B): The CSZ skin temperature sensor is intended for use in routine continuous monitoring skin temperature when the other sensors which might better reflect core body temperature are not indicated clinically. The sensor is designed for placement on the surface of the skin.
Tympanic Temperature Sensor (495M and 495M-P): The tympanic temperature sensor is intended for use in routine continuous monitoring tympanic temperature as an indicator of core body temperature when this type of measurement is clinically indicated.
Instrument Cables (4872MS and 4900B): The intended use of the instrument cable is to interconnect the disposable temperature sensor/probe with the temperature monitoring instrument.
The basic component of these sensors is a resistance chip, which is sensitive to changes in temperature. The chip is in the form of "400" series thermistor connected to a lead wire and encapsulated in a PVC cup. At the end of the lead wires an insert molded connector or standard phone connector provides for the interconnection with the instrument cable.
These sensors are inserted in the structure that fits specific anatomy where the temperature is measured.
The skin sensor is placed on the surface of the skin and is a part of the foam enclosure which provides thermal insulation for more accurate temperature measurement.
The tympanic probe is designed for placement in proximity to the tympanic membrane, The probe incorporates a small foam tip for atraumatic insertion and a large compressible foam cylinder for securement and thermal insulation.
The distal end of the skin sensor and the tympanic sensor is terminated with a Molex or phone connector for interconnection with the instrument cable.
The probes are individually packaged in sterilizable bags. There are 20 probes per box and 10 boxes per shipping carton. Probes are ethylene oxide sterilized.
The following probes and cables are included in this 510k application:
Probes:
Skin Temperature Sensor (487M, 499B) Tympanic Temperature Sensor (495M, 495M-P) Cables (4872MS, 4900B)
These probes can be used with Smith's Level 1 TM-200 temperature/monitors or any other multi-channel patient monitor compatible with the "400" series thermistors or equivalent.
Here's an analysis of the provided text regarding the acceptance criteria and study for the device, organized as requested:
Device: Disposable Temperature Probes (Skin Temperature Sensor, Tympanic Temperature Sensor)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Accuracy | "400" series thermistor requirements for temperature/resistance curve and accuracy. | "Thermistor's temperature/resistance curve and the accuracy within the measurement range are the same" (as predicate device). |
| Electrical Safety | Current leakage test (ICE601-1EN60601-1) | Device was tested against this standard. (Implied compliance, no specific value given) |
| Biocompatibility | ISO 10993 Biological evaluation of Medical Devices | Device materials assessed against this standard. (Implied compliance) |
| General Safety | IEC 60601-1:1988 & Amdt. 1:1991& Amdt. 2:1995 (General Requirements for Safety) | Device was tested against this standard. (Implied compliance) |
| Patient Monitoring Equipment Safety | IEC 60601-2-49:2001 (Particular requirements for the safety of multi-function patient monitoring equipment) | Device was tested against this standard. (Implied compliance) |
| Electrical Thermometer Performance | EN12470-4:2001 Performance of electrical thermometers | Device was tested against this standard. (Implied compliance) |
| Cables and Cords | 21CFR Part 898, IEC 601-1 sub clause 56,3©, 60227-1-7, -7.60245-1-8 60799 | Device was tested against these standards. (Implied compliance) |
| Labeling Symbols | ISO 15223:2000, EN 980 + A1 + A2 (Symbols for use with Medical Devices labeling and information) | Device assessed against these standards. (Implied compliance) |
| Risk Management | ISO 14971:2000 (Application of risk management to medical devices) | Device assessed against this standard. (Implied compliance) |
| Sterility | 510(k) Sterility Review Guidance K90-1: Guidance for Industry and FDA, August -30, 2002 | Device assessed against this guidance. (Implied compliance) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text for non-clinical tests.
- Data Provenance: The tests were conducted in "the laboratory" of the manufacturer (Cincinnati Sub-Zero Products, Inc). This implies the data is retrospective and likely from in-house testing. No country of origin for specific testing data is mentioned beyond the company's location in Ohio, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. The study is a non-clinical, laboratory-based assessment against standards and comparison to a predicate device. It does not involve human expert interpretation of device output in a diagnostic or clinical context.
4. Adjudication Method for the Test Set
- Not applicable. This was a non-clinical testing and comparison study, not a study requiring adjudication of expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No. This is a temperature probe, not an imaging or diagnostic AI device that would typically undergo an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, effectively. The "study" described is a standalone non-clinical evaluation of the device's technical specifications, safety, and performance against established standards and comparison to a predicate device. It assesses the device's inherent characteristics without directly involving human-in-the-loop performance for interpretation or decision-making.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is based on technical standards and specifications for thermistors and medical devices (e.g., "400" series thermistor requirements, IEC, ISO standards for accuracy, safety, biocompatibility) and comparison to the established performance of the legally marketed predicate device.
8. The Sample Size for the Training Set
- Not applicable. This device is a hardware temperature probe, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable as there is no training set for this type of device.
§ 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.