(71 days)
GP probes (REF M1024231 and M1024229): The General Purpose Temperature Probe is intended for continuous temperature monitoring. The probe is inserted into the esophagus or the rectum. It is sterile and individually packaged. It has a low-friction surface finish to make the insertion easier. The temperature probe beneath the cuff at the distal tip is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes.The device is indicated for use by qualified medical personnel only.
Skin probe (REF M1024222): The Skin Temperature Probe is intended for monitoring the skin surface temperature. It is sterile and individually packaged. There is a temperature sensor affixed to the center of the foam naterial on the adhesive cover. The disk-shaped adhesive cover has a reflective backing and a hypo-allergenic adhesive which follows closely the contour of the skin. The skin temperature probe is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Scries temperature probes. The device is indicated for use by qualified medical personnel only.
Esophageal probes (REF M1024205, M1024212, M1024215 and M1024218): The Esophageal Stethoscope with Temperature Probe is to be used for monitoring temperature, heart, and respiratory sounds on an anesthetized patient. The stethoscope tube is inserted into the esophagus. The probe is sterile, individually packaged and connes in different sizes. It has a low-friction surface finish to make the insertion easier, and a thin cuff to enhance sound transmission and fidelity. The stethoscope has a male luer fitting for attachment to a standard ear piece. The temperature probe, beneath the cuff at the distal tip, is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.
Disposable temperature probes (Table below) are used during patient temperature measurement. These probes consist of the "Molex" plug connector on the adapter cable end and a thermistor on the patient end. These probes are to be used with 400-series compatible temperature measurement systems only. Esophageal stethoscopes with temperature probes have a dual role, in addition to temperature probe they can be used also as a stethoscope. The temperature probe measures temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by using an interconnect cable. These probes have skin or core contact with a patient. Probes are shipped in sterile condition and there is a shelf life declared for each manufacturing batch.
The provided text describes disposable temperature probes and does not contain information about an AI/ML powered medical device. Therefore, it is not possible to describe acceptance criteria, a study proving the device meets the criteria, or any other related information for an AI/ML device.
The document discusses the regulatory submission (510(k)) for various types of disposable temperature probes (skin, general purpose, and esophageal with stethoscopes). The core of the submission focuses on the substantial equivalence of these probes to previously marketed predicate devices.
Key points from the document regarding the physical probes:
- Acceptance Criteria for the physical device: While specific numerical acceptance criteria for performance (e.g., temperature accuracy limits) are not explicitly detailed in the provided summary, the document states that the devices have been "thoroughly tested through validation and verification of specifications" against several standards. These standards implicitly define the performance acceptance criteria.
- Relevant standards mentioned:
- IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995 (Part 1: General requirements for safety)
- IEC 60601-2-49:2001 (Part 2:-49: Particular requirements for the safety of multifunction patient monitoring equipment)
- EN 12470-4, Performance of Electrical Thermometers (This standard would contain specific performance criteria for electrical thermometers, including accuracy).
- 21 CFR Part 898 (Likely pertains to performance standards for clinical electronic thermometers)
- ISO 15223:2000, EN 980+A1+A2 (Labeling and symbols)
- ISO 10993-x (Biological evaluation/biocompatibility)
- ISO 14971:2000 (Risk management)
- 510(k) Sterility Review Guidance K90-1 (Sterility)
- Relevant standards mentioned:
- Study Proving Acceptance Criteria: The document states that "The disposable temperature probes... have been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications." This indicates that studies (validation and verification testing) were performed to confirm compliance with the aforementioned standards. However, the details of these studies (e.g., sample sizes, specific test protocols, precise results against numerical thresholds) are not provided in this summary.
- Data Provenance/Sample Size/Experts/Adjudication/MRMC/Standalone/Ground Truth/Training Set: These questions are not applicable to the provided document, as it describes a physical medical device (temperature probes) and not an AI/ML software. The document focuses on the hardware's compliance with established safety and performance standards.
§ 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.