(58 days)
The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal. The probe cover is provided non-sterile and for single use only.
The Probe Cover is a disposable plastic cover made of a biocompatible clarified polypropylene material that is dimensionally manufactured to set tolerances so that it can be fitted on the probe tip of the thermometer. The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal to prevent any ear secretions or particulates from being transferred between different people. The subject device is used as barriers between Braun Thermoscan® PRO3000 series/PRO4000 series/PRO6000 series ear thermometer and users' auditory canal measuring sites to avoid possible contamination and infection during temperature measuring. The probe covers are transparent, colorless and odorless, non-sterile and intended for single use only.
The provided text is a 510(k) summary for Probe Covers (YF-001, YF-002). The acceptance criteria for this device are based on its equivalence to a predicate device and compliance with established standards, primarily ASTM E1104-98 for Clinical Thermometer Probe Covers and Sheaths.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Required Performance | Reported Device Performance |
|---|---|---|
| Physical Properties | Conforms to ASTM E1104-98 (Reapproved 2016) Standard Specification for Clinical Thermometer Probe Covers and Sheaths | Conforms to ASTM Standard E1104. "The stability validation of the probe cover after accelerated aging condition meet the ASTM E1104 requirement for physical properties." |
| Material | Biocompatible Polypropylene | Polypropylene |
| Biocompatibility | ISO 10993-5 (Cytotoxicity) | Complies with ISO 10993-5:2009 |
| ISO 10993-10 (Skin Sensitization) | Complies with ISO10993-10:2021 | |
| ISO 10993-23 (Irritation) | Complies with ISO10993-23:2021 | |
| Shelf Life | 5 years (demonstrated through accelerated aging) | 5 years. "An accelerated aging test was conducted per ASTM F1980." |
Study Proving Acceptance Criteria:
A non-clinical study was conducted to verify that the subject devices met all design specifications and were substantially equivalent to the predicate device. The study involved testing against the mentioned standards.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the test set used for the non-clinical tests. The tests were likely conducted on a representative sample of the manufactured probe covers.
Data Provenance: Not explicitly stated, however, the manufacturer is Shenzhen Yi Fang Blister Packaging Co., Ltd. in China, implying the testing was likely conducted in China or by organizations partnered with the manufacturer. The tests are non-clinical (laboratory-based).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The "ground truth" for the performance of this device (probe covers) is established through adherence to technical standards (e.g., ASTM E1104, ISO 10993 series) and direct physical/chemical testing, not through expert human assessment of diagnostic output.
4. Adjudication Method for the Test Set
Not applicable as the testing involves objective measurement against engineering and biocompatibility standards, not interpretive human assessment.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a passive medical device (probe cover), not an AI-assisted diagnostic tool or an imaging device that would typically involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device does not involve an algorithm. The testing is for the physical and biological characteristics of a disposable product.
7. Type of Ground Truth Used
The ground truth used for this type of device is compliance with established international and national standards (e.g., ASTM E1104 for physical properties, ISO 10993 for biocompatibility). This involves objective measurements and scientific testing against predefined criteria, rather than expert consensus, pathology, or outcomes data, which are more relevant for diagnostic or therapeutic devices.
8. Sample Size for the Training Set
Not applicable. This device is a physical product and does not involve AI or machine learning, which would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set for this 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.