(35 days)
Not Found
No
The device description and performance summary indicate a standard electronic thermometer using a thermistor and basic electronics, with no mention of AI or ML.
No
The device is described as an electronic contact thermometer "intended for taking body temperature." It is a diagnostic device used to measure temperature, not to treat or alleviate a medical condition.
No
The device is a thermometer used for measuring body temperature. While temperature can be a symptom, the device itself simply measures a physiological parameter and does not interpret the measurement to diagnose a condition or disease.
No
The device description explicitly states it is an "electronic contact thermometer" consisting of hardware components like a thermistor, PCBA, LCD, buttons, and battery.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is done outside of the body (in vitro).
- ThermoTek Q5 Function: The ThermoTek Q5 is a thermometer that measures body temperature directly from the body (orally, rectally, or under the arm). It does not analyze any specimens taken from the body.
Therefore, based on its intended use and how it functions, the ThermoTek Q5 is a clinical thermometer, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ThermoTek Q5 is intended for taking body temperature orally, rectally or under the arm.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The device is an electronic contact thermometer. It consists of a commercial thermistor in a stainless steel cap, a tip and rigid plastic housing that contains a PCBA, a LCD and two flexible buttons (On and Mode). The device is operated on a single 3V Lithium battery. Thanks to its small size, the thermistor reaches a thermal equilibrium with the measured subject in about 5 seconds in a bath and in oral and rectal modes, and in about 20 sec in axial mode,.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral, rectal, under the arm
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)
The ThermoTek Q5 was tested in a series of safety and performance tests, showing its compliance with the relevant standards, without raising any safety and/or effectiveness issues.
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
| UL 22 2004 | 510(k) Summary
ThermoTek™ Q5
510(k) Number K041646 |
|-------------------|----------------------------------------------------------|
| | |
| Applicant's Name: | SAAT Ltd. |
| | 17 Nachshon Street, |
| | Segula, Petach Tikva, 49277, Israel |
| | Tel.: +972-3-9050200 |
| | Fax.: +972-3-9345577 |
| Contact Person: | Mr. E.J. Smith |
| | Smith Associates, |
| | 1468 Harwell Avenue |
| | Crofton, Maryland 21114 |
| | Tel.: 410-451-0639 |
| | Fax.: 410-793-0448 |
| Date Prepared: | January 27 , 2004 |
| Common Name: | Oral Thermometer |
| Trade Name: | ThermoTek™ Q5 |
| Classification: | Name: Thermometer, Electronic, Clinical. |
| | Product Code: FLL |
| | Regulation No.: 880.2910 |
| | Class: II |
| | Panel: 80 (General Hospital) |
Device Description
The device is an electronic contact thermometer. It consists of a commercial thermistor in a stainless steel cap, a tip and rigid plastic housing that contains a PCBA, a LCD and two flexible buttons (On and Mode). The device is operated on a single 3V Lithium battery. Thanks to its small size, the thermistor reaches a thermal equilibrium with the measured subject in about 5 seconds in a bath and in oral and rectal modes, and in about 20 sec in axial mode,.
Intended Use
The ThermoTek Q5 is intended for taking body temperature orally, rectally or under the arm.
Performance Data
The ThermoTek Q5 was tested in a series of safety and performance tests, showing its compliance with the relevant standards, without raising any safety and/or effectiveness issues.
1
Statement of substantial equivalence
The device is substantially equivalent to the following products in commercial distribution:
-
- Manufacturer: SAAT Ltd. Product Name: ThermoTek Quickcare 510(k) No.: K010502
-
- Manufacturer: Becton Dickinson & Co. Product Name: B-D Digital Thermometer, Model 403001 510(k) No.: K935267
-
- Manufacturer: Toshiba Glass Co., LTD. Product Name: Toshiba Digital Clinical Thermometer, Model ME-171B 510(k) No.: K881909
The device defers from these cleared products mainly by its short response time, which is about 5 seconds.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus symbol, surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The caduceus symbol is composed of three abstract, intertwined shapes, resembling a stylized representation of a staff with a serpent coiled around it. The text is written in a bold, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 2 2004
SAAT Limited C/O Mr. Neil Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
Re: K041646
Trade/Device Name: ThermoTek™ Q5 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: July 19, 2004 Received: July 20, 2004
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known) 上 041646
Device Name: ThermoTek™ Q5
Indications for Use:
The ThermoTek Q5 is intended for taking body temperature orally, rectally or under the arm.
Prescription Use _ Or (Part 21 CFR 801 Subpart D)
Over The Counter Use _ X (21 CFR 807 Subject C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE TO ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Viola Hubbard for Anthony W. Watson
nesthesiolog ontrol. Der
510(k) Number: K041646