(104 days)
Not Found
No
The summary describes a standard digital thermometer and does not mention any AI or ML capabilities.
No
The device is a digital thermometer used for measuring body temperature, not for treating a condition.
No
A digital thermometer measures body temperature, which is a vital sign, but it does not diagnose a specific medical condition. While an abnormal temperature can indicate a health issue, the thermometer itself does not identify the underlying cause or disease.
No
The device is described as a "digital thermometer" and performance studies involve "electronic thermometers," indicating a physical hardware component for temperature measurement.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure body temperature using oral, rectal, or axillary sites. This is a direct measurement of a physiological parameter within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
This device measures a physical property (temperature) directly from the body, not from a sample taken from the body. Therefore, it falls outside the scope of IVD devices.
N/A
Intended Use / Indications for Use
The Faichney Medical Company and Becton-digital thermometers are intended for measuring body temperature using oral, rectal, or axillary sites.
Product codes
FLL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral, rectal, or axillary sites
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Laboratory tests of the Faichney digital fever thermometer were conducted by an independent testing house.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Bench Data
Key Results:
- 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."
- Response Time: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 |
| Establishment | |
| Registration Number: | 1933255 |
| Classification: | Class II (21 CFR 880.2910) |
| Panel: | Panel 80, General Hospital and Personal Use Device Section of |
| the General Medical Devices Panel | |
| Procode: | FLL -- thermometer, electronic, clinical |
1
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.
2
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