← Product Code [FLL](/productcode/FLL) · K101322 # JOINSOON ELECTRONICS MFG CO., LTD INFRARED EAR THERMOMETER, MODEL TT-001 (K101322) _Joinsoon Electronics Mfg Co, Ltd. · FLL · Jul 28, 2010 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K101322 ## Device Facts - **Applicant:** Joinsoon Electronics Mfg Co, Ltd. - **Product Code:** [FLL](/productcode/FLL.md) - **Decision Date:** Jul 28, 2010 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 880.2910 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Pediatric ## Indications for Use The device is a clinical electronic thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting. ## Device Story The TT-001 is an infrared ear thermometer for home use. It utilizes an infrared sensor and an ambient temperature sensor to detect thermal radiation from the tympanic membrane and adjacent ear canal tissue. The device features a waveguide to direct radiation to the sensor. Upon insertion into the auditory canal and activation by the user, the device captures electrical signals from the sensors, which are then amplified, digitized, and processed to calculate core body temperature. The result is displayed on an LCD within one second. The device assists users in monitoring body temperature for clinical decision-making. ## Clinical Evidence Bench testing only. Compliance with ASTM E1965-98, IEC60601-1, and IEC60601-1-2 standards was demonstrated to support substantial equivalence. ## Technological Characteristics Infrared sensor-based clinical electronic thermometer. Features an ambient temperature sensor and waveguide for radiation collection. Operates via signal amplification, digitization, and calculation. Complies with ASTM E1965-98, IEC60601-1, and IEC60601-1-2. Form factor is a handheld ear probe with LCD display. ## Regulatory 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 - TempTeller - Infrared Ear Thermometer, Models CT-31/32DX/32/32DX ([K030299](/device/K030299.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Klo1322 ### 510(k) Summary This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. # Date prepared: May 5, 2010. - 1. Applicant: Joinsoon Electronics MFG. Co., Ltd. 19F., No. 79, Sec. 1, Sintai 5th Rd., Sijhih City, Taipei County 221, Taiwan, R.O.C. Phone: +886-2-2698-4882 Fax: +886-2-2698-4883 JIII 2.8 2010 # 2. Submitter: Mr. Jigar Shah Official Correspondent for Joinsoon Electronics MFG. Co., Ltd. mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021 Tel: 516-482-9001 Fax: 516-482-0186 Jigar@mdiconsultants.com # 3. Trade/proprietary Name: Joinsoon Electronics Mfg. Co., Ltd. Infrared Ear Thermometer, Model TT-001 #### 4. Classification name: Common Name: Clinical Electronic Thermometer Regulation: 21 CFR Part 880.2910 - 5. Product Code: FLL #### 6. Predicate Devices: TempTeller - Infrared Ear Thermometer, Models CT-31/32DX/32/32DX Cleared 510(k) number: K030299 #### 7. Device Description The device TT-001 is an electronic thermometer using an infrared sensor to detect body temperature from the auditory canal. Its operation is based in the measuring the natural thermalradiation emanating from the tympanic membrane and the adjacent tissue. The tympanic membrane (eardrum) is thin and flooded with blood at the core temperature. The waveguide, usually a cylindrical pipe with a highly reflective inner surface for confining the radiation, is adaptive to the outer without 1 {1}------------------------------------------------ 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 waveguide. 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 Fundamental Scientific technology of the modified device remains the same as that of the 510(k) cleared device. #### 8. Intended Use: The device is a clinical electronic thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting. #### 9. Substantial Equivalence Discussion: The Joinsoon Electronics MFG. Co., Ltd. High Speed Digital Thermometer Model TT-001 is substantially equivalent to the original 510(K) 030299, Model CT-32DX in all aspects, e.g., technological characteristics, modes of operation, performance characteristics, intended use, etc., The only differences in the predicate version of the Digital thermometer are PCB layout involving Performance Specifications and Housing for Ergonomics of the Patient-Ul. The Fundamental Scientific technology of the modified device remains the same as that of the 510(k) cleared device. # 10. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows: Compliance to applicable voluntary standards includes ASTM E1965-98, as well as IEC60601-1 and IEC60601-1-2 requirements. Guidance documents included the "FDA Guidance on the content of Premarket Notification (510(k)) Submissions for Clinical Electronic Thermometers". #### 11. Conclusion: The Joinsoon Electronics MFG. Co., Ltd. High Speed Digital Thermometer Model TT-001 has the same intended use and similar technological characteristics as the Predicate device. Moreover, bench testing contained in this submission supplied demonstrate that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus the Joinsoon Electronics MFG. Co., Ltd. High Speed Digital Thermometer Model TT-001, is substantially equivalent to the predicate device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. 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 or other bird with its wings spread, rendered in a simple, bold line drawing. The bird appears to be in flight or poised for flight. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Joinsoon Electronics Manufacturing Company Limited C/O Mr. Jigar Shah Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021 **JUL 28 2009** Re: K101322 Trade/ Device Name: Infrared Ear Thermometer, Model TT-001 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: June 24, 2010 Received: June 28, 2010 Dear Mr. Shah: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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}------------------------------------------------ Page 2- Mr. Shah 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Susan Runne Anthony D. Watson, B.S., M.S., M.B.A. 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): JUL 28 2010 Unknown at this time Device Name: K 10/322 Joinsoon Electronics Mfg. Co., Ltd. Infrared Ear Thermometer. Model TT-001 # Indications for Use: The device is a clinical electronic thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use X (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Ai C. 7/28/10 (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page 1 of 1 510(k) Number: K/01322 --- **Source:** [https://fda-staging.innolitics.com/device/K101322](https://fda-staging.innolitics.com/device/K101322) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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