K023538 · Medport, Inc. · FLL · Nov 1, 2002 · General Hospital
Device Facts
Record ID
K023538
Device Name
TIMEX ACCUCURVE TALKING 30 SECOND THERMOMTER
Applicant
Medport, Inc.
Product Code
FLL · General Hospital
Decision Date
Nov 1, 2002
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.2910
Device Class
Class 2
Indications for Use
The Timex AccuCurve ™ Talking 30 Second Thermometer is an electronic thermometers to measure patient body temperature orally. Timex AccuCurve ™ Talking 30 Second Thermometer is intended for professional and over-thecounter use.
Device Story
Electronic thermometer with curved probe for oral temperature measurement; designed to reach sublingual 'hot spot'. Device detects temperature via sensor; processes signal to provide digital display and audible voice announcement of results. Used in clinical or home settings by professionals or patients. Features Indiglo™ nightlight display. Provides 0.1°F interval readings (90.0°F to 108.0°F) with ±0.2°F accuracy. Output assists users in monitoring body temperature.
Clinical Evidence
No clinical data provided; performance characteristics based on bench testing of temperature measurement accuracy (±0.2°F) and response time (approx. 30 seconds).
Indicated for oral body temperature measurement in patients. Intended for both professional and over-the-counter 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.
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023538
## 510k Submission MedPort, Inc., The Ocean Group
Timex AccuCurve ™ Talking 30 Second Thermometer
## 510 (K) SUMMARY
Date of Summary
October 16, 2002
1 2002 NOV
#### Product Name:
Timex AccuCurve ™ Talking 30 Second Thermometer
#### Manufacturer:
Global Treasures Industrial Ltd. Nan Fung Ind. Cit 18 Tin Hau Road Tuen Mun N.T. . HK
## Sponsor
MedPort, Inc. The Ocean Group, Inc. 23 Acorn Street Providence, RI 02903
#### Correspondent:
Fran White MDC Associates 163 Cabot Street Beverly, MA 01915
#### Substantially Equivalent Device:
Product: GT010706 Digital Thermometer (K021052) Manufactured by: Global Treasures Industrial, Inc.
### Product Description:
Electronic Thermometer
#### Intended Use:
The Timex AccuCurve ™ Talking 30 Second Thermometer is an electronic thermometers to measure patient body temperature orally.
Timex AccuCurve ™ Talking 30 Second Thermometer is intended for professional and over-thecounter use.
#### Performance Characteristics:
The Timex AccuCurve ™ Talking 30 Second Thermometer measures patient body temperature in approx. 30 seconds. The thermometer is programmed to announce the current body temperature. Current body temperature is digitally displayed. The Thermometer is equipped with an Indiglo™ "nightlight" display to be easier reading. The thermometer is designed with a curved probe to more easily measure body temperature from the "hot spot" under the tongue. The temperature detected is graduated on 0.1°F intervals, reading a range of 90.0°F to 108.0°F, ±0.2°F. The ambient temperature environment in which the device is intended for use is 60°-94°F (95% Relative Humidity).
#### Conclusion:
Timex AccuCurve ™ Talking 30 Second Thermometer is substantially equivalent to the electronic thermometer manufactured by Global Treasures, GT010706 Digital Thermometer (K021052).
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Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is centered on the image. The font is a simple sans-serif font. The text is likely part of a document or presentation.
od and Drug Administra 9200 Corporate Boulevard Rockville MD 20850
#### 1 2002 NOV
MedPort, Incorporated The Ocean Group, Incorporated C/O Ms. Fran White - - - - - -MDC Associates 163 Cabot Street Beverly, Massachusetts 01915
Re: K023538
Trade/Device Name: Timex AccuCurve™ Talking 30 Seconds Thermometer Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: 80 FLL Dated: October 16, 2002 Received: October 21, 2002
Dear Ms. White:
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.
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.
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Page 2 - Ms. White
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 (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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski 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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# 510k Submission MedPort, Inc., The Ocean Group
Timex AccuCurve ™ Talking 30 Second Thermometer
510(k) Number:
.
Timex AccuCurve ™ Talking 30 Second Thermometer Device Name:
#### Indication for Use:
The Timex AccuCurve ™ Talking 30 Second Thermometer is an electronic thermometer to measure catient temperature orally. Targeted users include professional and over-the-counter users. The Thermometer is programmed to announce the current body temperature in a clear pleasant voice.
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#### Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over the Counter Use (Optional Format 1-2-96)
Patricia Cricht
on of Anesthesiology, General Hospital, ion Control, Dental Devices
510(k) Number. *N023538*
MedPort 510F Page 8 of 65 Submission
