(102 days)
Not Found
No
The summary describes a standard digital thermometer using a thermistor and does not mention any AI or ML components or capabilities.
No
The device is described as an electronic thermometer used for clinical temperature measurement, which is a diagnostic tool, not a therapeutic one. It measures a physiological parameter but does not treat or cure any condition.
Yes
Explanation: The device is described as an electronic thermometer used for clinical temperature measurement, which is a diagnostic function used to identify fever, a common symptom of illness.
No
The device description explicitly states it uses a thermistor as a temperature sensor and a 1.5V button battery for operation, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "clinical temperature measurement." This is a direct measurement of a physiological parameter (body temperature) in a living person.
- Device Description: It's an "electronic thermometer using a thermistor as the temperature sensor." This describes a device that measures a physical property (temperature) directly.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This thermometer does not interact with or analyze such specimens.
- Anatomical Site: The anatomical sites (oral, axillaries, rectal) are all locations on or within the human body for direct temperature measurement.
In summary, this device is a medical device used for direct physiological measurement, not an in vitro diagnostic device used for analyzing specimens.
N/A
Intended Use / Indications for Use
The Rapid Digital Thermometer is an electronic thermometer used to measure body temperature in oral, axillaries (underarm use), and rectal.
It is an electronic thermometer used for clinical temperature measurement. It is intended for use at home and hospital environment for both children and adult.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Rapid Digital Thermometer is an electronic thermometer by using a thermistor as the temperature sensor.
The thermometer uses a 1.5V button battery for operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral, axillaries (underarm use), and rectal
Indicated Patient Age Range
children and adult
Intended User / Care Setting
home and hospital environment
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)
Various performance testing data which conducted according to ASTM E1112 standards, such as temperature range test. accuracy test, resolution test, cleaning test, demonstrate the same safety and effectiveness as that of cleared device.
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
510(K) SUMMARY 067010 1815F21
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92, and the relevant 510(K) submission guidance.
The assigned 510(K) number is:
1. Submitter's Identifications:
Mr. Victor Chau Global Treasure Industries Limited Room.8, 5/F, Block 2, Nan Fung Ind. City No.18 Tin Hau Road, Tuen Mun, Hong Kong Telephone: 852-2454 1493 FAX: 852-2454 6187
Date Summary Prepared: March 15, 2006
2. Name of the device:
Rapid Digital Thermorneter, Model RDT-18-XY (X=0-9, Y=1-9) Classification Name: Thermometer, Electronic, Clinical
3. Predicate Device Information and Substantial Equivalence: Electronic Thermometer GT010706 (K021052).
4. Device Description:
The Rapid Digital Thermometer is an electronic thermometer by using a thermistor as the temperature sensor.
The thermometer uses a 1.5V button battery for operation.
5. Intended Use:
The Rapid Digital Thermometer is an electronic thermometer used to measure body temperature in oral, axillaries (underarm use), and rectal.
1
(1.4624/0 (0.2 : 12)
6. Comparison to the 510(k) Cleared Device (Predicate Device):
The Rapid Digital Thermometer (RDT-18 series) has the same intended use and technological characteristics as the cleared device of Electronic Thermometer GT010706 (K021052). Although there are slight differences between the new device and the legally marketed one, these differences do not affect the safety, performance of the subject device. So the new device is substantial equivalence to the selected predicate device.
7. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
Both the predicted device and the Rapid Digital Thermometer (RDT-18 series) are in compliance to applicable voluntary standards. Various performance testing data which conducted according to ASTM E1112 standards, such as temperature range test. accuracy test, resolution test, cleaning test, demonstrate the same safety and effectiveness as that of cleared device.
Also both devices conform to IEC 60601-1, IEC 60601-1-2 requirements, and as well as ISO 10993-1:2003 biocompatibility testing on skin irritation, in vitro cytotoxicity and sensitivity.
Guidance documents included the "FDA Guidance on the Content of Premark Notification (510(k)) Submission for Clinical Electronic Thermometers"
8. Conclusions:
The Rapid Digital Thermometer (RDT-18 series) has the same intended use and technological characteristics as the predicted device. Various performance testing data which conducted according to ASTM E1112 standards, such as temperature range test, accuracy test, resolution test, cleaning test, demonstrate the same safety and effectiveness as that of cleared device. In the other words, the Rapid Digital Thermometer is substantial equivalence to predicted device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Global Treasure Industries, Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 N.W. Lake Road Camas, Washington 98607-8542
OCT 2 7 2006
Re: K062010
Trade/Device Name: Rapid Digital Thermometer, Model RDT-18-XY(X=0-9, Y=1-9) Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: October 10, 2006 Received: October 12, 2006
Dear Mr. Mouser:
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.
3
Page 2 - Mr. Mouser
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 (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), please contact the Office of Compliance at (240) 276-0115. 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/industry/support/index.html.
Sincerely rours,
Susan Dunne
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use Statement
510(k) Number (if known):
Rapid Digital Thermometer, Model RDT-18-XY(X=0-9, Y=1-9) Device name:
Indications for Use:
It is an electronic thermometer used for clinical temperature measurement. It is intended for use at home and hospital environment for both children and adult.
Prescription Use (Per 21CFR 801.109) OR
Over-The-Counter Use_ الا_____________________________________________________________________________________________________________________________________________________
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
and the control of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the contrib
Chairman Committee,
Control, Dallas Devices
Date: 4-06-2010
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