(121 days)
THE DEVICE IS INTENDED TO READ THE TEMPERATURE OF ANY PEOPLE , WHEN NEEDED.
- IT ADOPTS EITHER FAHRENHEIT OR CENTIGRADE DEPENDS ON NEED.
- IT CAN BE ORAL, RECTAL OR AXILLLARY USE.
SUPER SOOTHER CLINICAL ELECTRONIC THERMOMETER
The provided document is a 510(k) premarket notification letter from the FDA regarding the "SUPER SOOTHER CLINICAL ELECTRONIC THERMOMETER." This is a regulatory clearance letter, not a study report or a detailed performance evaluation. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methodologies.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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..."
This means the device's clearance is based on its substantial equivalence to a pre-existing device, not on a new, comprehensive clinical study validating specific performance metrics against pre-defined acceptance criteria as would be found in a performance study report.
Therefore, I cannot provide the requested information from the given document.
If you have a different document (e.g., a clinical study report or a detailed device specification document), I would be happy to analyze it for the criteria you've outlined.
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Image /page/0/Picture/1 description: The image contains the text "Public Health Service". The text is in a bold, sans-serif font. The text is black and the background is white. The text is centered in the image.
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 6 1999
Mr. Jimmy Dong General Manager Mart Tiller Corporation 4th Floor, No.2 Ming Tsu East Road Taipei, TAIWAN, R.O.C.
Re : K991914 Trade Name: Super Soother Requlatory Class: II Product Code: FLL Dated: July 8, 1999 Received: July 12, 1999
Dear Mr. Dong:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), 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 895. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Dong
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmama/"n.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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K991914 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: SUPER SOOTHER CLINICAL ELECTRONIC THERMOMETER
Indications For Use:
THE DEVICE IS INTENDED TO READ THE TEMPERATURE OF ANY PEOPLE , WHEN NEEDED.
-
IT ADOPTS EITHER FAHRENHEIT OR CENTIGRADE DEPENDS ON NEED.
-
IT CAN BE ORAL, RECTAL OR AXILLLARY USE.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Vicente
Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use /
..
(Optional Format 1-2-96)
§ 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.