(90 days)
These devices are indicated for use as a barrier accessory to digital thermometers while taking rectal, oral or axillary temperature measurements. These sheaths are non-sterile and intended for single use only. This accessory is contraindicated for use with broken skin.
The Medline Digital Thermometer Non-Lubricated Probe Sheath is an accessory to a clinical electronic thermometer, which is intended to measure body temperature. The Medline Digital Thermometer Non-Lubricated Probe Sheath is a flexible plastic sheath that is used to cover the transducer of clinical electronic thermometers while taking body temperature measurements from the oral, axillary, or rectal measurement sites and acts as a barrier to prevent possible contamination of the device during temperature measurement. The sheath is an over-the-counter (OTC), disposable, single use, nonlubricated, and non-sterile device that is compatible with most digital stick thermometers.
The Medline Digital Thermometer Non-Lubricated Probe Sheath is an accessionary to a clinical electronic thermometer. This device aims to prevent contamination of the thermometer during temperature measurement by acting as a barrier. The device is non-sterile and intended for single use only. This accessory is contraindicated for use with broken skin.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Testing Standards | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Compatibility | ASTM E1104-98(2016) § 5.4 | The probe cover shall not degrade the measurement time or accuracy of the temperature-taking device such that the probe and temperature-taking unit fail to meet the requirements of ASTM E1112 – § 4.2. | Met (conformance to the standard is implied by the conclusion of substantial equivalence) |
| Leakage | ASTM E1104-98 (2016) § 5.3 | There shall be no continuous bubble stream observed from the probe cover within 5 seconds of applying an internal pressure of 8.4 kPa. | Met (conformance to the standard is implied by the conclusion of substantial equivalence) |
| Biocompatibility - Cytotoxicity | ISO 10993-5 | Not explicitly stated, but generally implies non-toxic and compliant with the standard. | Performed and deemed acceptable (implied by the conclusion of substantial equivalence following ISO 10993 guidance). |
| Biocompatibility - Skin Sensitization | ISO 10993-10: 2010 | Not explicitly stated, but generally implies no significant skin sensitization. | Performed and deemed acceptable (implied by the conclusion of substantial equivalence following ISO 10993 guidance). |
| Biocompatibility - Skin Irritation | ISO 10993-10: 2010 | Not explicitly stated, but generally implies no significant skin irritation. | Performed and deemed acceptable (implied by the conclusion of substantial equivalence following ISO 10993 guidance). |
| Tensile Strength | Not explicitly stated, but implies performance during use. | Not explicitly stated | Performed (listed as "tensile strength" in the performance testing section). |
2. Sample Size for the Test Set and Data Provenance:
The provided document does not explicitly state the sample sizes used for the non-clinical performance and biocompatibility testing. It only mentions that testing was conducted to demonstrate safety and effectiveness. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This device is a physical accessory and does not involve AI or human interpretation for diagnosis, thus no experts were used to establish ground truth in the context of clinical interpretation. Ground truth for its performance is established through adherence to engineering and biological safety standards.
4. Adjudication Method for the Test Set:
Not applicable. As no human interpretation for diagnosis or AI performance evaluation is involved, no adjudication method was used. Performance was assessed directly against pre-defined engineering and biological standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. A MRMC comparative effectiveness study was not done as this is a non-AI medical device accessory.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
No. This device is a physical accessory and does not involve an algorithm. Performance testing was purely on the physical properties and biological safety of the device.
7. Type of Ground Truth Used:
The ground truth for evaluating the device's performance relies on established engineering standards (ASTM E1104-98 and ASTM E1112 for compatibility and leakage, and general tensile strength properties) and biological safety standards (ISO 10993 series for cytotoxicity, skin sensitization, and skin irritation).
8. Sample Size for the Training Set:
Not applicable. As this is a physical medical device accessory and not an AI algorithm, there is no training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set.
§ 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.