SUPER SOOTHER

K991914 · Mart Tiller Corp. · FLL · Oct 6, 1999 · General Hospital

Device Facts

• Record ID: K991914
• Device Name: SUPER SOOTHER
• Applicant: Mart Tiller Corp.
• Product Code: FLL · General Hospital
• Decision Date: Oct 6, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

THE DEVICE IS INTENDED TO READ THE TEMPERATURE OF ANY PEOPLE , WHEN NEEDED. 1) IT ADOPTS EITHER FAHRENHEIT OR CENTIGRADE DEPENDS ON NEED. 2) IT CAN BE ORAL, RECTAL OR AXILLLARY USE.

Device Story

Super Soother Clinical Electronic Thermometer; digital device for measuring human body temperature. Input: thermal energy via probe; processing: electronic conversion of thermal signal to digital temperature value; output: visual display of temperature in Fahrenheit or Centigrade. Used in clinical or home settings by patients or healthcare providers. Provides objective temperature data to assist in clinical decision-making regarding fever or health status monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electronic clinical thermometer; digital display; Fahrenheit/Centigrade selectable; oral, rectal, or axillary probe configuration. Powered by internal battery.

Indications for Use

Indicated for temperature measurement in all patient populations. Suitable for oral, rectal, or axillary use.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

1) IT ADOPTS EITHER FAHRENHEIT OR CENTIGRADE DEPENDS ON NEED.

2) 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 /

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