(8 days)
Indicated use- Measure of individual temperature
Measurements- Oral, Axillary -under arm, Rectal
Range of measurement- 90.0 degrees - 109.9 degrees F (32.0 degrees - 43 degrees C)
Accuracy- +/-0.2 degrees 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.
{
"acceptance_criteria_and_study": {
"acceptance_criteria_table": {
"headers": [
"Parameter",
"Acceptance Criteria",
"Reported Device Performance"
],
"rows": [
[
"Temperature range",
"Not explicitly stated as an acceptance criterion for the subject device but compared to predicate device's 89.6-109.4° F",
"90.0-109.9° F"
],
[
"Ambient temperature",
"Not explicitly stated as an acceptance criterion for the subject device but compared to predicate device's 60.8-104° F",
"60.8-104° F"
],
[
"Response time",
"Not explicitly stated as an acceptance criterion for the subject device but compared to predicate device's ~1 minute",
"About 20 seconds"
],
[
"Accuracy and Performance",
"Meets ASTM E1112",
"Meets ASTM E1112"
],
[
"Accuracy (for indications for use)",
"+/- 0.2° F",
"+/- 0.2° F (stated in Indications for Use, implies conformance)"
],
[
"Material safety",
"Non-toxic and in compliance with EN ISO 10993",
"All materials used are non-toxic and in compliance with EN ISO 10993"
]
]
},
"study_details": {
"sample_size_test_set": "Not specified. The document states \"Performance testing,\" and notes that the device \"meets ASTM E1112,\" but does not detail the sample size for this testing.",
"data_provenance": "Not specified. The testing was conducted to meet ASTM E1112 standards.",
"number_of_experts_ground_truth": "Not applicable. The ground truth for performance and accuracy is based on compliance with a recognized standard (ASTM E1112) rather than expert interpretation of data.",
"qualifications_experts": "Not applicable.",
"adjudication_method": "Not applicable.",
"mrmc_comparative_effectiveness_study": "No. This is a digital thermometer, not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant.",
"standalone_performance_study": "Yes, a standalone performance study was conducted to demonstrate compliance with ASTM E1112. The data provenance and sample size are not explicitly detailed beyond the standard reference.",
"type_of_ground_truth": "Standard compliance (ASTM E1112) for accuracy and performance, and safety standard compliance (EN ISO 10993) for materials.",
"sample_size_training_set": "Not applicable. This is a physical device, not an AI algorithm requiring a training set.",
"ground_truth_training_set_established": "Not applicable."
}
}
}
{0}------------------------------------------------
APR = 9 2002
K021652
FS LIMITED
GLOBAL TREASURE INDUSTRIES LIMITE
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
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: March 12, 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: | GT010706 sec Digital 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 GlobalTreasure IndustriesGT010706 | 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 and ThermoplasticElastomer | ABS | ||
| Sensor cover | Stainless steel | aluminium | ||
| e. | Performance testing | |||
| Temperature range | 90.0-109.9° F | 89.6-109.4° F | ||
| Ambient temperature | 60.8-104° F | 60.8-104° F | ||
| Beeps alarum | Yes | Yes | ||
| Response time | About 20 seconds | About 1 minute | ||
| Automatic shut off | Yes | Yes | ||
| f. | Accuracy and Performance meets | |||
| ASTM E1112 | Yes | Yes | ||
| 10.2 | Difference |
{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}------------------------------------------------
| (a) | There are several difference in between the subject and legally marketed devices: |
|---|---|
| the subject device has a quicker response timethe subject device compose of different material: thermoplastic elastomers and stainless steel probethe subject device has a slight difference in the working range of measurement | |
| (b) | Although there are differences in between the subject device and the legally marketed one, they do not affect the safety, performance and accuracy of the subjected device. All the materials used are non-toxic and in compliance with EN ISO 10993. The performance and accuracy are in compliance with ASTM requirements. The subject device is still considered to be substantially equivalent to the legally marketed one. |
and the comments of the comments of the comments of
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
11 - 1 - 1 - 1 - 1 - 1 -
and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contraction of the contribution of the
.
:
.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with flowing lines.
MAY 1 4 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Global Treasure Industries Limited C/O Mr. Ned Devine, Jr Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
Re: K021052
Trade/Device Name: Model GT010706 Electronic Thermometer Regulation Number: 880.2910 Regulation Name: Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 12, 2002 Received: April 1, 2002
Dear Mr. Devine:
This letter corrects our substantially equivalent letter of April 9, 2002 regarding the company name.
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). 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 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.
{4}------------------------------------------------
Page 2 - Mr. Devine
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 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
Victor
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
{5}------------------------------------------------
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- | $90.0^\circ$ - $109.9^\circ$ F ( $32.0^\circ$ - $43^\circ$ 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)
. . . . . . . . . .
Patrica Cuscente
(Division Sign-Off) ് wision of Dental, Infection Control, and General Hospital Dev 510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 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.