(84 days)
Rectal Temperature Probe:
The Disposable Rectal Temperature Probes are intended to be used for monitoring temperature from the rectum. The temperature probes are non-sterile and designed for single patient use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for use by qualified medical personnel only.
Skin Temperature Probe:
The Disposable Skin Temperature Probes are intended to be used for monitoring temperature from skin. The temperature probes are non-sterile and designed for single patient use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for use by qualified medical personnel only.
Disposable temperature probes are used during patient temperature measurement. These probes consist of a plug connector on the adapter cable 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 by using an interconnect cable. These probes have a skin or rectal contact with adult patients. Both the skin and rectal probe are single use and provided non-sterile.
These temperature probes are typically used with legacy Nihon Kohden monitors BSM-5135A.
Products are packed individually into a plastic bag in non-sterile condition. Package label describes product LOT codes, CE-mark, legal entity information and a caution "Rx Only ".
Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance, formatted to address your specific questions.
Based on the provided document, the device in question is a "Disposable Temperature Probe" (Rectal and Skin types). This is a 510(k) submission, meaning the manufacturer is demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness from scratch. Therefore, the "acceptance criteria" and "study" are primarily focused on showing that the new device performs comparably to the predicate and meets relevant safety and performance standards for its intended use.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for a temperature probe, the "acceptance criteria" are intrinsically tied to the performance standards for clinical electronic thermometers and the performance of the predicate device. The document explicitly states the criteria and the results obtained for the subject device.
| Acceptance Criteria (Standard / Predicate Performance) | Reported Device Performance (Subject Device) |
|---|---|
| Biocompatibility: Conformed with ISO 10993 series standard (no cytotoxicity, negligible irritation, no sensitization). | |
| *(For skin probes: surface contact > 24 hours, |
§ 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.