(62 days)
Not Found.
No
The summary describes a simple digital thermometer and lacks any mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
A thermometer is a diagnostic device used to measure temperature, not a therapeutic device designed to treat a condition or disease.
No
A talking digital thermometer is primarily used to measure body temperature, which is a symptom and not a diagnosis itself. While temperature can be an indicator of illness, the device does not provide a medical diagnosis on its own.
No
The device description explicitly states "Talking Digital Thermometer," which implies a physical hardware component (the thermometer itself) in addition to any potential software for the "talking" function. The predicate devices also appear to be physical thermometers.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: This crucial section for identifying an IVD is "Not Found". IVDs have specific intended uses related to examining specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description "Talking Digital Thermometer" indicates a device that measures body temperature, which is a physiological measurement taken directly from the body, not from a specimen.
- Lack of IVD-related information: The absence of mentions of image processing, AI/ML (which can be used in some advanced IVDs), input imaging modality, anatomical site (relevant for some IVDs), patient age range, intended user/care setting (often specified for IVDs), and performance study details (especially metrics like sensitivity and specificity which are key for IVDs) further supports that it's not an IVD.
- Predicate Devices: The listed predicate devices are all digital thermometers, which are not IVDs.
Therefore, the information strongly suggests this is a standard medical device for measuring body temperature, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
Talking Digital Thermometer
Mentions image processing
Not Found.
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Not Found.
Anatomical Site
Not Found.
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
Not Found.
Description of the training set, sample size, data source, and annotation protocol
Not Found.
Description of the test set, sample size, data source, and annotation protocol
Not Found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
は
510(k) SUMMARY FOR ULTMOST INDUSTRIAL CORP.'s TALKING DIGITAL THERMOMETER
AUG 20 199
Submitter's Name, Address, Telephone Number, And Contact Person
Ultmost Industrial Corp. - 4F, No. 52, Ming Chuang Road Hsintien, Tapei Taiwan, R.O.C.
| Contact: | Howard M. Holstein or
Hogan & Hartson, L.L.P. | Stephen Fang
Ultmost Industrial Corp. |
|------------|--------------------------------------------------|------------------------------------------|
| Phone: | (202) 637-5813 | 011 886 2 917 99 01 |
| Facsimile: | (202) 637-5910 | 011 886 2 917 76 03 |
Date Prepared
May 15, 1996
Name of the Device
Talking Digital Thermometer
Common or Usual Name
Digital Thermometer with Verbal Announcement
Classification Name
Clinical Electronic Thermometer (21 C.F.R. § 880.2910)
Product Code
FLL