MODEL GT980201 ELECTRONIC THERMOMETER

{0}------------------------------------------------ # GLOBAL TREASURE INDUSTRIES LIMI Block 2, 5/F, Room 8, Nan Fung Ind. City, No. 18, Tin Hau Road, Tuen Mun, New Territories, Hong Kong Tel: (852)24541493; Fax: 24546187; E-mail: glotr@netvigator.com APR - 8 2002 The Non-confidential summary of safety and Effectiveness The summary of 510k safety and effective new information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR807.92. The assigned 510k number is K __________________(to be assigned) Dated of summary prepared: Feb.25, 2002 | 1. | Submitter's identification<br>Global Treasure Industries Limited<br>Block 2,5F., Room 8, Nan Fung Ind. City, 18 Tin Hau Road, Tuen Mun, N.T., Hong Kong<br>Tel:(852)24541883 FAX:(852)24546187 | | | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------| | 2. | Official contact: | Ben Ma - General Manager | | | 3. | Trade name: | GT980201 Electronic thermometer | | | 4. | Common name: | Clinical electronic thermometer | | | 5. | Classification name: | 80FLL, Clinical electronic thermometer subsection 880.2910 | | | 6. | Intended device: | Clinical electronic thermometer | | | 7. | Predicate devices: | Wiltec Industries Ltd-Electronic Thermometer-K961879 | | | 8. | Device description: | The intended product is an electronic digital thermometer for measuring patient<br>temperature. | | | 9. | Intended use: | | | | 9.1 | Indicated use-to measure patient temperatures-orally, axillary and rectal. | | | | 9.2 | Targeted population-Any patient requiring body temperatures measured | | | | 9.3 | Environment of use-Hospital and home | | | | 10. | Comparison to predicate devices: | | | | 10.1 | Side by side Comparison Table | | | | Element of comparison | | Subject device Global<br>Treasure GT980201 | Claimed SE device<br>Wiltec:K961879 | | a. | Use | | | | | Indicated for taking temperature | Yes | Yes | | 10.1 | Side by side Comparison Table (continued) | | | | b. | Types of temperature | | | | | Oral | Yes | Yes | | | Underarm | Yes | Yes | | | Rectal | Yes | Yes | | | Digital/electronic thermometer | Yes | Yes | | C. | Design | | | | | LCD display | Yes | Yes | | | Temperature increments of 0.1 ° F | Yes | Yes | | | Sensor type- thermistor | Yes | Yes | | | Signal processing-CMOS | Yes | Yes | | | Power -Button battery 1.5V | Yes | Yes | | | On / off button | Yes | Yes | | | Buzzer | Yes | Yes | | | Removable battery case | Yes | Yes | | | Cleaned with alcohol | Yes | Yes | | d. | Material | | | | | Case | ABS | ABS | | | Sensor cover | aluminum | aluminum | | e. | Performance testing | | | | | Temperature range | 90.0-108.0° F | 89.6-109.4° F | | | Ambient temperature | 60.8-104° F | 60.8-104° F | | | Beeps alarum | Yes | Yes | | | Response time | About 1 minute | About 1 minute | | | Automatic shut off | Yes | Yes | | f. | Accuracy and Performance meets | | | | | ASTM E1112 | Yes | Yes | | 10.2 | Difference | | | | (a) | No significant difference in between the subject and legally marketed devices. The subject device is claimed to be<br>substainally equivalent to the legally marketed one. | | | {1}------------------------------------------------ ## GLOBAL TREASURE INDUSTRIES LIMITED Block 2, 5/F, Room 8, Nan Fung Ind. City, No. 18, Tin Hau Road, Tuen Mun, New Territories, Hong Kong Tel: (852)24541493; Fax: 24546187; E-mail: glotr@netvigator.com {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Global Treasure Limited C/O Mr. Ned Devine, Jr Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548 ## APR = 8 2002 Re: K021028 Trade/Device Name: Model GT980201 Electronic Thermometer Regulation Number: 880.2910 Regulation Name: Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 15, 2002 Received: March 29, 2002 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. 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 {3}------------------------------------------------ #### Page 2 - Mr. Devine 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 A. Ulatowski Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ ### D. Indications for Use Statement Pursuant to the Notice regarding listing of indications for Use on a separate sheet, the following is per that request. 510(k) Number______________(To be assigned) | Device name: | Clinical electronic thermometer | |--------------|---------------------------------| |--------------|---------------------------------| Indications for use: | Indicated use- | Measure of individual temperature | |------------------------|------------------------------------------------| | Measurements- | Oral | | | Axillary -under arm | | | Rectal | | Range of measurement- | 90.0° - 108.0° F (32.0° - 42.0° C) | | Accuracy- | +/-0.2° F | | Targeted population- | Individuals requiring temperature measurements | | Environment of use- | Hospital and home | | Disposable / reusable- | Reusable, clean with alcohol | Concurrence of CDRH, Office of Device Evaluation(ODE) …………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… PRESCRIPTION USE OR OVER-THE-COUNTER USE (PER 21 CFR 801.109) Patras Cucenitt Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices F10(k) Number _ 102008