← Product Code [FLL](/productcode/FLL) · K121118 # FORA COMFORTSCAN EAR THERMOMETER (K121118) _Foracare, Inc. · FLL · Jun 15, 2012 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K121118 ## Device Facts - **Applicant:** Foracare, Inc. - **Product Code:** [FLL](/productcode/FLL.md) - **Decision Date:** Jun 15, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.2910 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Pediatric ## Indications for Use FORA ComfortScan Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages and for use in the home. It is also available to detect object's surface temperature including human skin. ## Device Story FORA ComfortScan Ear Thermometer (model TD-1261A/B) is an infrared electronic thermometer; detects infrared energy emitted from eardrum/surrounding tissues or surface radiation from objects; converts radiation into temperature values; intended for home use by patients of all ages; provides temperature readings for clinical decision-making; aids in monitoring body temperature. ## Clinical Evidence Bench testing only. Device validated against ASTM E1965-98 and prEN12470-5:2000 standards. Testing included laboratory accuracy, clinical accuracy (bias and repeatability), safety (IEC 60601-1), EMC (IEC 60601-1-2), storage stability, cleaning procedure, shock testing, and operating range verification. ## Technological Characteristics Infrared sensor technology; measures infrared energy from eardrum/tissues or surface radiation; handheld form factor; battery-powered; software-controlled; compliant with ASTM E1965-98 and prEN12470-5:2000 standards. ## 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 - FORA ComfortScan Ear Thermometer, model TD-1261A/B ([K081445](/device/K081445.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}------------------------------------------------ # K121118 # JUN 1 5 2012 ### Section 11. 510(k) Summary #### 510(K) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. The Assigned 510(k) number is: - l. Submitter Information: Application Correspondence: Contact Person: Pinjung Chen Address: 6F, No. 127, Wugong 2nd Rd., Wugu District, New Taipei City, 24888, Taiwan Phone: +886-2-6625-8188 #1176 Fax: +886-2-6625-0868 Email: pinjung.chen(@taidoc.com.tw Date of submission: March 215t, 2012 Applicant: Company Name: FORA Care Inc. Contact Person: Sophia Wu Address: 810 Lawrence Drive, Suite104, Newbury Park, CA 91320 Phone: (805) 498-8188 Fax: (805) 498-7188 E-mail: sophiawu@foracare.com - 2. Device name: Proprietary name: FORA ComfortScan Ear Thermometer, model TD-1261A/B Regulatory information: A. Regulation section: 21 CFR 880.2910 - Classification: B. Class II - C. Product Code: FLL, Clinical electronic thermometer - General Hospital (80) D. Panel: 11-page 1 of 3 {1}------------------------------------------------ ## 3. Intended Use: FORA ComfortScan Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages and for use in the home. It is also available to detect object's surface temperature including human skin. - 4. Device Description: FORA ComfortScan Ear Thermometer is characterized by measuring human body temperature and object's temperature in the ear canal and at the surface, respectively. It utilizes infrared technology to measure either infrared energy emitted from the eardrum and surrounding tissues or the surface radiation of the object when making a temperature measurement. It is able to detect skin temperature (only as a reference) when aimed at the target surface of human body. Substantial Equivalence Information: A. Predicate device name: FORA ComfortScan Ear Thermometer, model TD-1261A/B - B. Predicate K number: K081445 #### C. Comparison with predicate: The FORA ComfortScan Ear Thermometer has the following similarities to the predicate device: - 물 Same intended use. - Same operating principle. 1 - Same functions and physical appearance. - Same fundamental scientific technology. - I Incorporate the same basic circuit design. - l Incorporate the same materials. - 미 Same shelf life. . - Same user interface and software. - 1 Packaged using the same materials. - . Manufactured by the same process. {2}------------------------------------------------ The modifications: - 510(k) applicant for the device is FORA Care Inc. ■ - l Labeling changes due to the modifications. #### 5. Test Principle: The thermometer measures temperature by reading infrared radiation emitting from the eardrum and surrounding tissues or the surface radiation of the object and converts it into a temperature value. - 6. Performance Characteristics: The FORA ComfortScan Ear Thermometer was validated by the tests according to ASTM E1965-98 standard and met the requirements of prEN12470-5:2000 standard. A brief description for each test was given in this section. Table 1 lists items of tests, related standard complied and format of data presentation. | Item | Standard complied | Data presentation | Appendix | |-------------------------------------------|-------------------------------|-----------------------------------------|----------| | Laboratory
accuracy | ASTM E1965-98
prEN12470-5 | Measurement error | C.1 | | Clinical accuracy | ASTM E1965-98
prEN12470-5 | Clinical bias
Clinical repeatability | C.1 | | Safety | IEC 60601-1 · | Evaluated by ETC | C.3 | | Electromagnetic
compatibility
(EMC) | IEC 60601-1-2 | Evaluated by ETC | C.4 | | Storage stability | ASTM E1965-98 | Measurement error | C.5 | | Cleaning procedure
test | ASTM E1965-98
prEN 12470-5 | Measurement error | C.6 | | Shock test | ASTM E1965-98 | Measurement error | C.7 | | Displayed
temperature | ASTM E1965-98 | Measurement error | C.8 | | Operating range | ASTM E1965-98
prEN12470-5 | Measurement error | C.9 | #### Table 1. Summary of test {3}------------------------------------------------ # 7. Conclusion: Based on the information provided in this submission, the FORA ComfortScan Ear Thermometer, model TD-1261AB, is substantially equivalent to the predicate FORA ComfortScan Ear Thermometer, model TD-1261AB. {4}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 ## JUN 1 5 2012 FORA Care, Incorporated C/O Mr. Pinjung Chen Regulatory Affairs Specialist Taidoc Technology Corporation 6F, No.127, Wugong 2nd Road, Wugu District New Taipei City, Taiwan 24888 Re: K121118 . Trade/Device Name: FORA ComfortScan Ear Thermometer, Model TD-1261A/B Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 21, 2012 Received: April 12, 2012 Dear Mr. Chen: 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. {5}------------------------------------------------ Page 2- Mr. Chen 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 vours. S. Stuart Ryan 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 {6}------------------------------------------------ # Section 8. Indications for Use #### Indications for Use 510(k) Number: Device Name: FORA ComfortScan Ear Thermometer, model TD-1261A/B Indications for Use: Fora ComfortScan Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages for use in the home. It is also available to detect object's surface temperature including human skin. Prescription Use _ (21 CFR Part 801 Subpart D) Over the Counter Use __X And/Or -(21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Division Sign-Off Office of Device Evaluation (ODE) 510(k) K12 m8 lül lli for RZC June 11, 2012 (Division Sign-Off) Page 1 of Division of Anesthesiology, General Hospital Infection Control, Dental Devices K121118 510(k) Number: 12 11 8 8- page 1 of 1 --- **Source:** [https://fda-staging.innolitics.com/device/K121118](https://fda-staging.innolitics.com/device/K121118) **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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