THERMOTEK Q5

K041646 · Saat , Ltd. · FLL · Jul 22, 2004 · General Hospital

Device Facts

• Record ID: K041646
• Device Name: THERMOTEK Q5
• Applicant: Saat , Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Jul 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The ThermoTek Q5 is intended for taking body temperature orally, rectally or under the arm.

Device Story

Electronic contact thermometer; utilizes thermistor in stainless steel cap to measure body temperature. Input: thermal energy from subject. Processing: PCBA converts thermistor resistance to temperature reading. Output: digital temperature displayed on LCD. Operation: battery-powered (3V Lithium); user-activated via 'On' and 'Mode' buttons. Used in clinical or home settings by patients or healthcare providers. Rapid thermal equilibrium achieved in ~5 seconds (oral/rectal) or ~20 seconds (axillary). Provides quick, accurate temperature readings to assist in clinical assessment of fever or health status.

Clinical Evidence

Bench testing only. Device demonstrated compliance with relevant safety and performance standards.

Technological Characteristics

Electronic contact thermometer; thermistor sensor; stainless steel cap; rigid plastic housing; LCD display; 3V Lithium battery power; PCBA-based processing.

Indications for Use

Indicated for body temperature measurement via oral, rectal, or axillary routes in patients of all ages.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• ThermoTek Quickcare (K010502)
• B-D Digital Thermometer, Model 403001 (K935267)
• Toshiba Digital Clinical Thermometer, Model ME-171B (K881909)

Submission Summary (Full Text)

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| UL 22 2004 | 510(k) Summary<br>ThermoTek™ Q5<br>510(k) Number K041646 |
|-------------------|----------------------------------------------------------|
| | |
| Applicant's Name: | SAAT Ltd. |
| | 17 Nachshon Street, |
| | Segula, Petach Tikva, 49277, Israel |
| | Tel.: [phone] |
| | Fax.: [phone] |
| Contact Person: | Mr. E.J. Smith |
| | Smith Associates, |
| | 1468 Harwell Avenue |
| | Crofton, Maryland 21114 |
| | Tel.: [phone] |
| | Fax.: [phone] |
| 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.

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# Statement of substantial equivalence

The device is substantially equivalent to the following products in commercial distribution:

- 1. Manufacturer: SAAT Ltd. Product Name: ThermoTek Quickcare 510(k) No.: K010502
- 2. Manufacturer: Becton Dickinson & Co. Product Name: B-D Digital Thermometer, Model 403001 510(k) No.: K935267
- 3. 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.

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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.

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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 [phone]. 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 [phone] or [phone] 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

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# 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