(10 days)
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
The intended product is an electronic digital thermometer for measuring patient temperature.
The provided document is a 510(k) premarket notification for the Global Treasure Industries GT980201 Electronic Thermometer. It details the device's characteristics and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the GT980201 are primarily established by its claim of substantial equivalence to the predicate device (Wiltec Industries Ltd - K961879) and its compliance with the ASTM E1112 standard.
| Acceptance Criteria / Performance Metric | Reported Device Performance (GT980201) | Predicate Device Performance (Wiltec: K961879) |
|---|---|---|
| Indicated Use | ||
| Measures patient temperature | Yes | Yes |
| Types of Temperature Measurement | ||
| Oral | Yes | Yes |
| Underarm (Axillary) | Yes | Yes |
| Rectal | Yes | Yes |
| Design Characteristics (Examples) | ||
| Digital/Electronic Thermometer | Yes | Yes |
| LCD display | Yes | Yes |
| Temperature increments of 0.1°F | Yes | Yes |
| Sensor type - Thermistor | Yes | Yes |
| Performance Testing | ||
| Temperature Range (Fahrenheit) | 90.0 - 108.0°F | 89.6 - 109.4°F |
| Ambient Temperature (Fahrenheit) | 60.8 - 104°F | 60.8 - 104°F |
| Beeps alarm | Yes | Yes |
| Response time | About 1 minute | About 1 minute |
| Automatic shut off | Yes | Yes |
| Accuracy Standard | ||
| Meets ASTM E1112 | Yes | Yes |
| Stated Clinical Accuracy (from Indications for Use) | +/-0.2°F | Not explicitly stated in the comparison table, but implicitly covered by meeting ASTM E1112. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for a specific test set or the data provenance (country of origin, retrospective/prospective). The primary evidence for meeting acceptance criteria is through comparison to a predicate device and compliance with ASTM E1112. This implies that the testing to meet these standards would have been performed, but the specifics of that testing (sample size, data origin) are not described in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not mention the use of experts to establish ground truth for a test set in the context of device performance. The device is a clinical electronic thermometer, and its performance is typically assessed against established metrology standards (like ASTM E1112) or by comparison to reference thermometers, rather than expert consensus on a test set in the way one might evaluate diagnostic imaging.
4. Adjudication Method for the Test Set
As explained above, the document does not describe a test set with human assessment of ground truth, and therefore, an adjudication method is not applicable or mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic devices where human interpretation is crucial. For a digital thermometer, the performance is objective (e.g., accuracy of temperature reading).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
For the GT980201 Electronic Thermometer, the device itself is a "standalone" system in its function. Its performance, such as temperature range, accuracy, and response time, would have been evaluated without human intervention during the measurement process, aside from operating the device. However, the term "standalone" in this context usually refers to AI algorithms. Since this is not an AI-powered device, this question is not directly applicable in the way it's usually posed for AI. The performance metrics listed (e.g., accuracy, response time) are intrinsic to the device's function.
7. The Type of Ground Truth Used
The ground truth for this device's performance would primarily be established by:
- Reference Standards: Measurements would be compared against highly accurate, calibrated reference thermometers in controlled environments.
- Compliance with Industry Standards: The device's ability to meet the requirements of ASTM E1112 (Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature) serves as a primary form of ground truth for its performance characteristics, especially accuracy.
8. The Sample Size for the Training Set
This document does not describe a "training set" in the context of machine learning or AI. The GT980201 is a traditional electronic thermometer, not an AI-driven device.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned for an AI/ML algorithm, this question is not applicable.
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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 identificationGlobal Treasure Industries LimitedBlock 2,5F., Room 8, Nan Fung Ind. City, 18 Tin Hau Road, Tuen Mun, N.T., Hong KongTel:(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 patienttemperature. | |
| 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 GlobalTreasure GT980201 | Claimed SE deviceWiltec: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 besubstainally equivalent to the legally marketed one. |
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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
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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
§ 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.