(47 days)
The devices models DT-K11B, DT-K111B, DT-K111D, DT-111D, DT-111G, DT-11G, DT-Y111D are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.
Rapid digital thermometer DT-K11B, Rapid digital flexible thermometer DT-K111B DT-K111D, Digital flexible thermometer DT-111G DT-111D, Digital Thermometer (Water-proof) DT-11G, Predictive Digital Thermometer DT-Y111D
The provided text outlines the FDA's 510(k) clearance for several digital thermometers. While it confirms the clearance and lists the indications for use, it does not include detailed information about the acceptance criteria and the study that proves the device meets those criteria.
Therefore, I cannot provide the requested information from the given text. The document is an FDA clearance letter, not a detailed technical report of the device's validation study.
To answer your request, I would need a different type of document, such as:
- A summary of safety and effectiveness data (SSE) submitted to the FDA.
- A clinical study report.
- A test report detailing performance validation.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 7, 2012
Mr. Ahneo Yang
Regulatory Affairs & Quality Assurance Manager Hangzhou Hua'an Medical & Health Instruments Company, Limited Building 2, Baimiao Industrial Park, Economic Development Zone Wuchang Hangzhou, Zhejiang 310023 P.R. China
Re: K122912
Trade/Device Name: Rapid Digital Thermometer DT-K11B, Rapid Digital Flexible Thermometer DT-K111B DT-K11D, Digital Flexible Thermometer DT-111G DT-111D, Digital Thermometer (Water-proof) DT-11G, Predictive Digital Thermometer DT-Y111D
Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: October 16, 2012 Received: October 19, 2012
Dear Mr. Yang:
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.
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Page 2 - Mr. Yang
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,
Digitally signed by Anthony D. Watson
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Anthony D. Watson, 0.9.2342.19200300.100.1.1=1300092402 Date: 2012.11.07 12:19:09 -05'00'
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital,
Respiratory. Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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Special 510(K) submission
HangZhou Hua'an
Attachment 2
K122912/5001
Indications for Use Statement
510(k) Number (if known):
Device Name:
Rapid digital thermometer Rapid digital flexible thermometer Digital flexible thermometer Digital thermometer(Water-proof) Predictive digital thermometer
DT-K11B DT-K111B DT-K111D DT-111G DT-111D DT-11G DT-Y111D
Indications for Use
The devices models DT-K11B, DT-K111B, DT-K111D, DT-111D, DT-111G, DT-11G, DT-Y111D are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use_ (Part 21 CFR 801 Subpart C)
034
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
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Actm. fr
Richard Chaym
ision Sian-Off on of Anesthesiology, General Hospital tion Control, Dental Devices
510(k) Number: K122912
§ 880.2910 Clinical electronic thermometer.
(a)
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.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(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.