RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES

K062010 · Global Treasure Industries , Ltd. · FLL · Oct 27, 2006 · General Hospital

Device Facts

• Record ID: K062010
• Device Name: RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES
• Applicant: Global Treasure Industries , Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Oct 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Rapid Digital Thermometer is an electronic thermometer used to measure body temperature in oral, axillaries (underarm use), and rectal.

Device Story

Electronic thermometer using thermistor sensor; powered by 1.5V button battery. Measures body temperature via oral, axillary, or rectal routes. Used in home and hospital settings by patients or clinicians. Provides digital temperature readout to assist in clinical decision-making regarding patient health status.

Clinical Evidence

Bench testing only. Performance testing conducted per ASTM E1112 standards including temperature range, accuracy, resolution, and cleaning tests. Biocompatibility testing performed per ISO 10993-1:2003 (skin irritation, in vitro cytotoxicity, and sensitivity).

Technological Characteristics

Thermistor-based electronic thermometer; 1.5V button battery power source. Complies with ASTM E1112 (performance), IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for clinical temperature measurement in children and adults in home and hospital environments.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• Electronic Thermometer GT010706 (K021052)

Submission Summary (Full Text)

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#### 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: [phone] FAX: [phone]

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.

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# (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.

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#### 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.

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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 [phone]. 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 [phone] or [phone] 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

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K462410

# 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_____________________________________________________________________________________________________________________________________________________

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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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