(31 days)
Not Found
No
The summary describes a standard electronic thermometer and does not mention any AI or ML capabilities. The performance studies focus on measurement time and accuracy, not algorithmic performance.
No
The device is an electronic thermometer used to measure body temperature, not to treat or cure any medical condition.
No
Explanation: This device is a thermometer used to measure body temperature, which is a vital sign. While vital signs can be indicators of health, measuring them is not considered a diagnostic act itself. Diagnostic devices typically identify diseases, conditions, or the nature of illnesses.
No
The device description explicitly states "Electronic Thermometer," which implies a physical hardware component for temperature measurement. The summary also discusses performance studies related to temperature measurement time and range, further indicating a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Flexible Tip Thermometer measures body temperature directly from the patient (orally, rectally, or axillarily). It does not analyze samples taken from the body.
Therefore, based on the provided information, the Flexible Tip Thermometer is a medical device, but it falls under the category of a clinical thermometer rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Flexible Tip Thermometer is an electronic thermometer to measure patient body temperature orally, rectally or axilliary (under arm).
The Teddy Bear Flexible Tip Thermometer is intended for professional and over-the-counter use. A pediatric model will be available. The plastic end of the thermometer has a molded Teddy Bea
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
Electronic Thermometer
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body temperature orally, rectally or axilliary (under arm)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional and over-the-counter use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Flexible Tip Thermometer measures patient body temperature in approx. 60 seconds. The thermometer is programmed to display the current body temperature. The temperature detected is graduated on 0.1ºF intervals, reading a range of 90.0ºF. The ambient temperature environment in which the device is intended for use is 60.8°-104°F (95% Relative Humidity).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510k Submission Global Treasures Industrial, Inc. Flexible Tip Thermometer
- ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(K) SUBMISSION PAGE 7 OF 67
510 (K) SUMMARY
Date of Summarv
January 26, 2003
Product Name:
Flexible Tip Thermometer
Manufacturer:
Global Treasures Industrial Ltd. Nan Fung Ind. Cit 18 Tin Hau Road Tuen Mun N.T. , HK
Correspondent:
Fran White MDC Associates 163 Cabot Street Beverly, MA 01915
Substantially Equivalent Device:
Product: GT010706 Digital Thermometer (K021052) Manufactured by: Global Treasures Industrial, Ltd.
Product Description:
Electronic Thermometer
Intended Use:
The Flexible Tip Thermometer is an electronic thermometer to measure patient body temperature orally, rectally or axilliary (under arm).
The Teddy Bear Flexible Tip Thermometer is intended for professional and over-the-counter use. A pediatric model will be available. The plastic end of the thermometer has a molded Teddy Bea
Performance Characteristics:
The Flexible Tip Thermometer measures patient body temperature in approx. 60 seconds. The thermometer is programmed to display the current body temperature. The temperature detected is graduated on 0.1ºF intervals, reading a range of 90.0ºF. The ambient temperature environment in which the device is intended for use is 60.8°-104°F (95% Relative Humidity).
Conclusion:
The Flexible Tip Thermometer substantially equivalent to the electronic thermometer manufacture by Global Treasures. GT010706 Digital Thermometer (K021052).
APR 0 4 2003
Sponsor
Global Treasures, Industrial, Inc. Nan Fung Ind. Cit 18 Tin Hau Road Tuen Mun, N.T., HK
1
Image /page/1/Picture/11 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of an eagle's head in profile, with three stylized lines representing the feathers. The words "DEPARTMENT OF HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle's head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 4 2003
Global Treasure Industrial Limited C/O Ms. Fran White MDC Associates 163 Cabot Street Beverly, Massachusetts 01915
Re: K030673
Trade/Device Name: Flexible Tip Thermometer Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 25, 2003 Received: March 4, 2003
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 vour 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.
2
Page 2 - Ms. White
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 vours.
Chr L
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
3
510k Submission Global Treasures Industrial, Inc. Flexible Tip Thermometer
GLOBAL TREASURES, INC. 510(K) SUBMISSION PAGE 8 OF 67
510(k) Number:
Device Name: Flexible Tip Thermometer
Indication for Use:
The Flexible Tip Thermometer is an electronic thermometer to measure patient temperature. Targeted users include professional and over-the-counter users.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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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) |
ivision Sign-C Insion of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K030673