TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Oriental System Technology Inc. The logo consists of a circular graphic on the left and the company name on the right. The graphic is a stylized image of a swirl inside of a circle. # 510(K) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and CFR§807.92. The assigned 510(k) number is: צע 030299 FEB 2 5 2003 ### 1. Submitter's Identifications: Oriental System Technology Inc. 2F No.23, Industry E, Road 9th, Science Based Industrial Park Hsinchu, Taiwan, R.O.C ### Contact: Mr. Herman Lee General Manager Date of Summary Preparation: 30 December 2002 ### 2. Name of the Device: TempTeller® Infrared Ear Thermometers, Model CT-31/31DX/32/32DX ### 3. Information of the 510(k) Cleared Device (Predicate Device): TempTeller® Infrared Ear Thermometers, Model CT-30/30DX 510(k) Number: K#010235 ### 4. Device description: The OSTI TempTeller® Infrared Ear Thermometers, model CT-31/31DX/32/32DX, is an electronic thermometer using an infrared sensor to detect human body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane (eardrum) and the adjacent tissue. OSTI TempTeller® Infrared Ear Thermometers, model CT-31/31DX/32/32DX, consists mainly of five parts: an IR sensor packed together with an ambient temperature sensor, a waveguide, a heat sink made of zinc alloy, a LCD display and the associated circuit. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a logo with a circular design. Inside the circle, there is a spiral shape that resembles an eye or a swirling vortex. To the right of the logo, there is some text, but it is not clear enough to read. The tympanic membrane (eardrum) is thin and flooded with blood at the core temperature. The wavequide, usually a cylindrical pipe with a highly reflective inner surface for confining the radiation, is adaptive to the outer without contacting the eardrum. When inserting the probe into the ear canal, the radiation fluxes transfer among the tympanum membrane (eardrum), the IR sensor, and the inner surface of the wavequide. The ambient sensor is packed with the IR sensor to monitor the ambient temperature of the IR sensor. To measure core temperature, an ear thermometer is inserted into a patient's outer ear canal. An activation button is pressed to start the measurement through the radiation exchanges. The electrical signal readouts form the IR sensor and the ambient temperature sensor are fed to the circuit for amplification, digitization and calculation. The measured temperature then appears on the LCD. The total operation takes one second. The CT-31/31DX/32/32DX is identical in functionality and performance with the essential change being the external shape of the devices. The modifications to our original 510(k) cleared device, model CT-30/30DX, include dimensional and firmware. The fundamental scientific technology of the modified device remains the same as that of the 510(k) cleared device. # 5. Intended Use: The device is an electronic clinical thermometer using an infrared sensor to detect the body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting. # 6. Comparison to Predicate Devices: The OSTI TempTeller® Infrared Ear Thermometers, model CT-31/31DX/32/32DX are substantially equivalent to OSTI TempTeller® Infrared Ear Thermometers, CT-30/30DX. The new models CT-31/31DX/32/32DX have the same intended use as and are similar in design to the 510(k) cleared device. # 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows: Compliance to applicable voluntary standards include ASTM E 1965-98 and ASTM E 1104, as well as IEC 601-1-1 and IEC 601-1-2 requirements. FDA Guidance documents include the" Deciding When to Submit a 510(k) for a Change to An Exiting Device" and "The New 510(k) Paradigm: Alternate {2}------------------------------------------------ Image /page/2/Picture/0 description: The image contains the logo for Oriental System Technology Inc. The logo consists of a circular graphic on the left and the company name on the right. The graphic is a stylized circle with a swirl inside. The text is stacked in two lines, with "ORIENTAL SYSTEM" on the top line and "TECHNOLOGY INC." on the bottom line. Approaches to Demonstrating Substantial Equivalence in Premarket Notifications". # 8. Conclusions The OSTI TempTeller® infrared Ear thermometers, model CT-31/31DX/32/32DX have the same intended use and technological characteristics as the 510(k) cleared device. Moreover, verification and validation tests contained in this submission demonstrate that the modified portions maintained its original safety and effectiveness. Those engineering changes do not: (1) affect the intended use or (2) alter the fundamental scientific of the device. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 5 2003 Oriental System Technology, Incorporated C/O Ms. Susan D. Goldstein-Falk Official Correspondent Mdi Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021 Re: K030299 Trade/Device Name: Oriental System Technology Incorporated Temp Teller® Infrared Ear Thermometer, Model CT-31/31 DX/32/32DX Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: January 27, 2003 Received: January 29, 2003 Dear Ms. Falk: 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 vour 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. {4}------------------------------------------------ Page 2 - Ms. Falk 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, Susan Kinner Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a circular symbol that resembles a stylized eye or a hurricane. The symbol consists of a dark circle with a smaller, lighter circle in the center. Around the central circle, there are curved, dark shapes that create a swirling or spiral effect, giving the impression of movement or rotation. The overall design is simple and graphic, with a focus on contrast between the dark and light areas. 510(K) Number (If known): K030299 Device Name: Oriental System Technology Inc. TempTeller® Infrared Ear Thermometer, Model CT-31/31DX/32/32DX Indications for Use The device is an electronic clinical thermometer using an infrared sensor to detect the human body temperature from the auditory canal in the neonatal, pediatric and adult Populations used in the home setting. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | | We livinile in BRC | |---------------|-----------------------------------------------| | | (Division Sign-Off) | | | Division of Anesthesiology, General Hospital, | | | Infection Control, Dental Devices | | 510(k) Number | 030299 | | Prescription Use | Over-The- Counter Use | |------------------|-----------------------| |------------------|-----------------------| (Per 21 CFR 801.109) ﺎ i ne- Counter U (Optional Format 1-2-96) OR