(104 days)
The Faichney Medical Company and Becton-digital thermometers are intended for measuring body temperature using oral, rectal, or axillary sites.
The Faichney Medical Company and Becton-digital thermometers are intended for measuring body temperature using oral, rectal, or axillary sites. There are no technological differences between these thermometers.
This 510(k) summary for the Faichney Medical Clinical Electronic Thermometer provides some, but not all, of the requested information. Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device references compliance with ASTM standards instead of setting specific acceptance criteria within the 510(k) itself. The reported performance is in comparison to a mercury-in-glass thermometer.
| Acceptance Criteria (ASTM E1112-86 or comparison to mercury-in-glass) | Reported Device Performance (Faichney Digital Thermometer) |
|---|---|
| Accuracy: (Implicitly, to be comparable or better than mercury-in-glass) | Better than mercury-in-glass thermometer's accuracy across temperature range (Mean & Standard Deviation). Within 0.10°F of mercury-in-glass accuracy (with 89% confidence interval) at every range except 96.40°F to 98.00°F. |
| Response Time: (Implicitly, to be comparable enough for clinical use) | Average 26 seconds to register peak temperature (without probe covers). Average 28 seconds to register peak temperature (with probe covers). (Not explicitly compared to mercury-in-glass for this metric, but noted as a "slight increase"). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set used in the "Summary of Bench Data." It refers to "the product" and "the same units" without specifying numbers.
- Sample Size (Test Set): Not explicitly stated.
- Data Provenance: The tests were conducted by an "independent testing house." The country of origin is not specified, but it's likely within the US given the FDA submission. The study was prospective bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not relevant or provided for a clinical electronic thermometer's bench testing. Accuracy is determined against a known standard or a reference thermometer (mercury-in-glass), not by expert interpretation.
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
Not applicable for a device that measures a physical property against a reference. The "investigator" made conclusions, but this is not an adjudication method in the context of clinical interpretation or diagnostic agreement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is typically for diagnostic imaging or interpretation where multiple human readers assess cases. For a thermometer, the measurement is objective.
6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done
Yes, the "Summary of Bench Data" describes standalone performance testing of the electronic thermometer. Its accuracy and response time were measured directly.
7. The Type of Ground Truth Used
The ground truth for accuracy was based on comparison to a "mercury-in-glass thermometer" which served as a reference standard. While not explicitly stated as the absolute ground truth, it was the comparator for assessing the electronic thermometer's performance. Response time was measured objectively.
- Ground Truth Type: Comparison to a reference standard (mercury-in-glass thermometer).
8. The Sample Size for the Training Set
This device does not use machine learning or AI, so there is no "training set."
- Sample Size (Training Set): Not applicable.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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Image /page/0/Picture/1 description: The image shows the date "OCT - 8 1996" on the left side. To the right of the date is a logo that includes a square with a white "F" shape inside. Next to the logo is the word "faichney" in a stylized font, with the word "MEDICAL" underneath.
September 23, 1996
Food & Drug Administration Center for Devices and Radiological Health Document Center (HFZ-401) 9200 Corporate Blvd. Rockville, MD 20850
510(k) #: Received: Product:
K962497 26-JUN-96 Q-TIPS®, FAICHNEY®, & PRIVATE LABEL CLINICAL ELECTRONIC THERMOMETER
510(k) SUMMARY
Name of Applicant: Faichney Medical Company, a division of Conopco, Inc.
Contact Person:
General Manager Faichney Medical Company 17159 Surrey View Drive Chesterfield, MO 63005
M. James Davis
Telephone: (314) 530-0077
Facsimile: (314) 530-9948
Device Identification
| Trade Name: | Q-tips®, Faichney®, Private Label |
|---|---|
| Common Name: | Clinical Electronic Thermometer |
| EstablishmentRegistration Number: | 1933255 |
| Classification: | Class II (21 CFR 880.2910) |
| Panel: | Panel 80, General Hospital and Personal Use Device Section ofthe General Medical Devices Panel |
| Procode: | FLL -- thermometer, electronic, clinical |
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Faichney Medical Company 510(k) Summary September 23, 1996 Page 2 of 3
Performance Standard:
Performance standards have not been adopted by the FDA for clinical electronic thermometers. This thermometer is compliant with the standards established by the American Society for Testing and Materials (ASTM), Designation E1112-86. The disposable probe cover for this thermometer is compliant with standards established by ASTM, Designation E1104-86. The specification is under the iurisdiction of ASTM Committee E-20 on Temperature Measurement and the direct responsibility of the ASTM Subcommittee E20.80 on Medical Thermometry.
Comparable Device
This device is substantially equivalent to other digital thermometers in commercial distribution such as the Becton-Dicital Fever Thermometer. The 510(k) Document Control Number for the Becton-Dickinson Digital Fever Thermometer. is K852954.
Description of Device and Intended Use
The Faichney Medical Company and Becton-digital thermometers are intended for measuring body temperature using oral, rectal, or axillary sites. There are no technological differences between these thermometers. The Becton-Dickinson digital thermometer is a Class II, Panel code 80 FLL, device approved for commercial market.
Summary of Bench Data
Laboratory tests of the Faichney digital fever thermometer were conducted by an independent testing house.
Regarding "Accuracy" the temperature Range, Mean & Standard Deviation of the digital thermometer is better than that of the mercury-in-glass thermometer (Reference Table #I and Table #2, Attachment #6a). The investigator concluded that ... "it may be stated with a confidence interval of 89 percent that the accuracy of the electronic thermometers (both with and without probe covers) is within 0.10F of the accuracy of the glass stem product or better at every range but the 96.40F to 98.00F."
Regarding "Response Time", as expected, there is a slight increase in the time required for the digital thermometer to reach Peak Temperature. The investigator concluded that... "When tested without probe covers, the product averaged 26 seconds to register peak temperature. The same units, when tested with probe covers, averaged 28 seconds to register peak temperature.
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Faichney Medical Company 510(k) Summary September 23, 1996 Page 3 of 3
Conclusions Regarding Safety and Effectiveness
The Faichney Medical Company digital thermometer, which is substantially equivalent to the Becton-Dickinson digital thermometer, is safe and effective for its intended use.
Sincerely,
Faichney Medical Company
By: M. Davis
M. James Davis, General Manager
Enclosures
§ 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.