(31 days)
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 Flexible Tip Thermometer is an electronic thermometer to measure patient temperature. Targeted users include professional and over-the-counter users.
Electronic Thermometer
The provided 510(k) submission for the Flexible Tip Thermometer is a premarket notification and does not contain the detailed study results or acceptance criteria that would typically be found in a clinical trial report or a performance testing document. The submission is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device (GT010706 Digital Thermometer K021052).
Therefore, based only on the provided text, I cannot complete most of the requested sections. The document states "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)." However, this describes the device's functional characteristics, not specific acceptance criteria or performance metrics from a validation study.
Here's a breakdown of what can be extracted and what cannot, based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text. Acceptance criteria for a thermometer would typically involve accuracy (e.g., ±0.2°F), response time, and stability over its operating range. These are not present.
- Reported Device Performance: Only general functional characteristics are mentioned.
| Performance Characteristic | Reported Device Performance (from text) |
|---|---|
| Measurement Time | Approximately 60 seconds |
| Temperature Display | Displays current body temperature |
| Graduation | 0.1ºF intervals |
| Measurement Range | 90.0ºF (This phrasing is a bit ambiguous; typically it would be a range like 90.0-108.0ºF, but only "reading a range of 90.0ºF" is stated.) |
| Ambient Operating Range | 60.8°-104°F (95% Relative Humidity) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document mentions the device is "substantially equivalent" to a predicate device but does not detail any specific test set for the Flexible Tip Thermometer itself to prove performance against specified criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. The provided document does not describe a study involving expert-established ground truth for the device's performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. No such study or adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a medical device (thermometer), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not specified. This refers to an algorithm's performance, which is not relevant for a thermometer in this context. The document implies performance testing was done to ensure the device functions as intended and is equivalent to the predicate, but specific "standalone" algorithmic performance data is not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified. For a thermometer, ground truth would typically be established by a highly accurate reference thermometer (e.g., a calibrated mercury thermometer or a high-precision electrical thermometer) in a controlled environment. The document does not describe how any "ground truth" was established for testing within this submission. Its primary argument is substantial equivalence.
8. The sample size for the training set
- Not applicable/Not specified. This device is a thermometer, not an AI-based system that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not specified. Not an AI-based system.
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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
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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.
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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
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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
§ 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.