(10 days)
Not Found
No
The summary describes a standard electronic digital thermometer with no mention of AI or ML capabilities.
No
A therapeutic device is used to treat or alleviate a medical condition. This device is a thermometer, used for measurement and diagnosis, not treatment.
No
Explanation: A diagnostic device is used to identify or determine the nature of a disease or condition. While a thermometer measures a physiological parameter (temperature), it does not, by itself, diagnose a disease. It provides data that a healthcare professional might use as part of a diagnostic process, but it is a measurement tool, not a diagnostic one.
No
The device description explicitly states it is an "electronic digital thermometer," which is a hardware device. The summary also details performance testing related to temperature range, ambient temperature, and response time, all indicative of a physical sensor and processing unit.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside of the body (in vitro) to analyze these samples.
- This device's function: This device is an electronic digital thermometer that measures body temperature directly from the patient (oral, axillary, rectal). It does not analyze any specimens taken from the body.
Therefore, based on the provided information, this device falls under the category of a general medical device for measuring a physiological parameter (body temperature), not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Indicated use- Measure of individual temperature
Measurements-
Oral
Axillary -under arm
Rectal
Range of measurement- 90.0° - 108.0° F (32.0° - 42.0° C)
Accuracy- +/-0.2° F
Targeted population- Individuals requiring temperature measurements
Environment of use- Hospital and home
Disposable / reusable- Reusable, clean with alcohol
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The intended product is an electronic digital thermometer for measuring patient temperature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral, Axillary, Rectal
Indicated Patient Age Range
Any patient requiring body temperatures measured / Individuals requiring temperature measurements
Intended User / Care Setting
Hospital and home
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)
Performance testing
Temperature range: 90.0-108.0° F
Ambient temperature: 60.8-104° F
Beeps alarum: Yes
Response time: About 1 minute
Automatic shut off: Yes
Accuracy and Performance meets ASTM E1112: Yes
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy- +/-0.2° F
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.
Wiltec Industries Ltd-Electronic Thermometer-K961879
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
GLOBAL TREASURE INDUSTRIES LIMI
Block 2, 5/F, Room 8, Nan Fung Ind. City, No. 18, Tin Hau Road,
Tuen Mun, New Territories, Hong Kong
Tel: (852)24541493; Fax: 24546187; E-mail: glotr@netvigator.com
APR - 8 2002
The Non-confidential summary of safety and Effectiveness
The summary of 510k safety and effective new information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR807.92. The assigned 510k number is K __________________(to be assigned)
Dated of summary prepared: Feb.25, 2002
| 1. | Submitter's identification
Global Treasure Industries Limited
Block 2,5F., Room 8, Nan Fung Ind. City, 18 Tin Hau Road, Tuen Mun, N.T., Hong Kong
Tel:(852)24541883 FAX:(852)24546187 | | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------|
| 2. | Official contact: | Ben Ma - General Manager | |
| 3. | Trade name: | GT980201 Electronic thermometer | |
| 4. | Common name: | Clinical electronic thermometer | |
| 5. | Classification name: | 80FLL, Clinical electronic thermometer subsection 880.2910 | |
| 6. | Intended device: | Clinical electronic thermometer | |
| 7. | Predicate devices: | Wiltec Industries Ltd-Electronic Thermometer-K961879 | |
| 8. | Device description: | The intended product is an electronic digital thermometer for measuring patient
temperature. | |
| 9. | Intended use: | | |
| 9.1 | Indicated use-to measure patient temperatures-orally, axillary and rectal. | | |
| 9.2 | Targeted population-Any patient requiring body temperatures measured | | |
| 9.3 | Environment of use-Hospital and home | | |
| 10. | Comparison to predicate devices: | | |
| 10.1 | Side by side Comparison Table | | |
| Element of comparison | | Subject device Global
Treasure GT980201 | Claimed SE device
Wiltec:K961879 |
| a. | Use | | |
| | Indicated for taking temperature | Yes | Yes |
| 10.1 | Side by side Comparison Table (continued) | | |
| b. | Types of temperature | | |
| | Oral | Yes | Yes |
| | Underarm | Yes | Yes |
| | Rectal | Yes | Yes |
| | Digital/electronic thermometer | Yes | Yes |
| C. | Design | | |
| | LCD display | Yes | Yes |
| | Temperature increments of 0.1 ° F | Yes | Yes |
| | Sensor type- thermistor | Yes | Yes |
| | Signal processing-CMOS | Yes | Yes |
| | Power -Button battery 1.5V | Yes | Yes |
| | On / off button | Yes | Yes |
| | Buzzer | Yes | Yes |
| | Removable battery case | Yes | Yes |
| | Cleaned with alcohol | Yes | Yes |
| d. | Material | | |
| | Case | ABS | ABS |
| | Sensor cover | aluminum | aluminum |
| e. | Performance testing | | |
| | Temperature range | 90.0-108.0° F | 89.6-109.4° F |
| | Ambient temperature | 60.8-104° F | 60.8-104° F |
| | Beeps alarum | Yes | Yes |
| | Response time | About 1 minute | About 1 minute |
| | Automatic shut off | Yes | Yes |
| f. | Accuracy and Performance meets | | |
| | ASTM E1112 | Yes | Yes |
| 10.2 | Difference | | |
| (a) | No significant difference in between the subject and legally marketed devices. The subject device is claimed to be
substainally equivalent to the legally marketed one. | | |
1
GLOBAL TREASURE INDUSTRIES LIMITED
Block 2, 5/F, Room 8, Nan Fung Ind. City, No. 18, Tin Hau Road, Tuen Mun, New Territories, Hong Kong Tel: (852)24541493; Fax: 24546187; E-mail: glotr@netvigator.com
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Global Treasure Limited C/O Mr. Ned Devine, Jr Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
APR = 8 2002
Re: K021028
Trade/Device Name: Model GT980201 Electronic Thermometer Regulation Number: 880.2910 Regulation Name: Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 15, 2002 Received: March 29, 2002
Dear Mr. Devine:
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
3
Page 2 - Mr. Devine
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 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
A. Ulatowski Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
4
D. Indications for Use Statement
Pursuant to the Notice regarding listing of indications for Use on a separate sheet, the following is per that request.
510(k) Number______________(To be assigned)
| Device name: | Clinical electronic thermometer |
|---|---|
| -------------- | --------------------------------- |
Indications for use:
| Indicated use- | Measure of individual temperature |
|---|---|
| Measurements- | Oral |
| Axillary -under arm | |
| Rectal | |
| Range of measurement- | 90.0° - 108.0° F (32.0° - 42.0° C) |
| Accuracy- | +/-0.2° F |
| Targeted population- | Individuals requiring temperature measurements |
| Environment of use- | Hospital and home |
| Disposable / reusable- | Reusable, clean with alcohol |
Concurrence of CDRH, Office of Device Evaluation(ODE)
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
PRESCRIPTION USE
OR
OVER-THE-COUNTER USE
(PER 21 CFR 801.109)
Patras Cucenitt
Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices F10(k) Number _ 102008