(18 days)
The devices models DT-01Fand DT-11F 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.
Digital Thermometer Model DT-01F & DT-11F
This document is a 510(k) premarket notification letter from the FDA regarding a digital thermometer. It confirms the device's substantial equivalence to legally marketed predicate devices. However, it does not contain the detailed information necessary to complete the acceptance criteria table or descriptions of a study proving the device meets those criteria. The provided text is primarily administrative and regulatory.
Therefore, I cannot fulfill your request for the acceptance criteria table and study details based on the given input. The document does not describe performance specifications, test methods, sample sizes, expert qualifications, or ground truth establishment.
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FEB 2 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hangzhou Hua'an Medical & Health Instruments Company C/O Mr. Ting Lu TING LU 4960 Tamarack Drive Barrington, Illinois 60010
Re: K030361
Trade/Device Name: Digital Thermometer Model DT-01F & DT-11F Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: January 6, 2003 Received: February 3, 2003
Dear Mr. Lu:
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.
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Page 2 -- Mr. Lu
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 (OS) 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 Runner
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
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Hangzhou Hua'an
510(k) Subumission Application
Indication for Use Statement
510(k) Number (if known):
Devices Name: Digital Thermometer Model DT-01F& DT-11F
Indication For Use:
The devices models DT-01Fand DT-11F 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.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR Over-The-Counter Use |
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| (Per 21 CFR § 801.109) |
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| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices |
510(k) Number. K030361
§ 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.