NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER

K122221 · Taidoc Technology Corporation · FLL · Mar 29, 2013 · General Hospital

Device Facts

• Record ID: K122221
• Device Name: NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER
• Applicant: Taidoc Technology Corporation
• Product Code: FLL · General Hospital
• Decision Date: Mar 29, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Nexus IR30 Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the surface of human skin without contact. It is for use by people of all ages in the homecare environment. .

Device Story

Nexus IR30 Thermometer is a non-contact infrared electronic thermometer for home use by patients of all ages. Device detects infrared radiation emitted from skin surface; converts radiation into temperature value. Operated by user/patient; provides temperature reading via LCD display. Features include 3-color LED indicator for temperature status and memory storage. Device replaces previous model (TD-1240) with updated measuring range, operating/storage temperature specs, reduced power-down time, battery change (AA to AAA), white LCD backlight, and modified physical appearance. Benefits include non-invasive, rapid temperature monitoring for home health management.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including software verification and validation, and performance/safety testing comparing the subject device to the predicate.

Technological Characteristics

Infrared sensor-based electronic thermometer. Measures infrared energy from skin surface. Powered by 1.5V AAA batteries. Features LCD display with white backlight and 3-color LED indicator. Memory storage capacity included. Form factor is a handheld device.

Indications for Use

Indicated for non-contact human body temperature measurement from skin surface for all ages (infants, children, adolescents, adults) in homecare settings.

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

• U-RIGHT TD-1240 Thermometer (k113159)

Submission Summary (Full Text)

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# Re:K122221

### 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The Assigned 510(k) number is:

- 1. Submitter's Identification: TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, 248, Taiwan
Correspondence: Pinjung Chen Regulatory Affairs Specialist Tel: [phone] #1176 Fax: [phone] Email: [e-mail]

Date of submission: JUL 23, 2012

- 2. Device name:
Proprietary name: Nexus IR30 Thermometer

Regulatory information:

- A. Regulation section: 21 CFR 880.2910
- B. Classification: Class II
- C. Product Code: FLL, Clinical electronic thermometer
- D. Panel: General Hospital (80) ·
- 3. Intended Use:

Nexus IR30 Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the surface of human skin without contact. It is for use by people of all ages in the homecare environment. .

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MAR 2 9 2013

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#### 4. Device Description:

Nexus IR30 Thermometer is characterized by measuring human body temperature from the surface of human skin. It utilizes infrared technology to measure infrared energy emitted from the skin surface when making a temperature measurement.

Substantial Equivalence Information:

A. Predicate device name:

U-RIGHT TD-1240 Thermometer, model TD-1240

Predicate K number: k113159 B.

#### C. Comparison with predicate:

The Nexus IR30 Thermometer is substantially equivalent to the predicate device U-RIGHT TD-1240 Thermometer (k113159) made by TaiDoc Technology Corporation, for the following reasons:

- 1) It has the same Indications for use as the predicate.
- 2) It has the same operating principle and fundamental scientific technology as the predicate.
- 3) It has the same basic circuit design as the predicate.
- 4) It incorporates the same materials.
- 5) It has the same shelf life.
- 6) It packaged using the same materials.
- 7) It manufactured by the same process.
- 8) It has same memory storage capacity.

The Nexus 1R30 Thermometer has some minor changes from the predicate device that include:

- (1) The Measuring Range has been change from "73.4ºF to 111.2ºF" to #99.6ºF to 109.4°F".
- (2) The Operating temperature has been change from "50°F to 104°F" to "60.8°F to 104°F'.
- (3) The Storage temperature range has been change from "-4°F to 140°F" to "-13°F to 131°F",
- (4) The power down time has been changed from 3mins to 15 seconds,
- (5) Change in battery type from 1.5V AA to 1.5V AAA.
- (6) LCD Backlight changes from blue to white.

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- (7) The indication icon of the 3-color LED is added.
(8) Changed the physical appearance.

(9) Labeling change due to the modifications

These changes have been verified and validated (as part of performance testing) and are included as part of this submission. A summary of these verification and validation activities is attached. These changes raise no new issues of safety and effectiveness.

- 5. Test Principle:
The thermometer measures temperature by reading infrared radiation emitting from the skin and converts it into a temperature value.

## 6. Performance Characteristics:

Nexus IR30 Thermometer has the same performance characteristics as the predicate device.

A comparison of system accuracy performance demonstrated that Nexus IR30 Thermometer and U-RIGHT TD-1240 Thermometer (cleared under k113159) are substantially equivalent.

Software verification and validation, performance and safety tests confirmed that the performance, safety and effectiveness of the Nexus IR30 Thermometer are equivalent to the predicate device.

- 7. Conclusion:
Based on the information provided in this submission, the Nexus IR30 Thermometer is substantially equivalent to the predicate U-RIGHT 1240 Thermometer, model TD-1240.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Ms. Pinjung Chen Regulatory Affairs Specialist TaiDoc Technology Corporation 6F, No. 127, Wugong 2nd Rd., Wugu District, New Taipei City, Taiwan 24888

March 29, 2013

Re: K12221

Trade/Device Name: Nexus IR30 Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 13, 2013 Received: March 15, 2013

Dear Ms. Chen:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

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Page 2 -- Ms. Chen

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Ruth
Urowitz

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

## 510(k) Number: K122221

Device Name: Nexus IR30 Thermometer

Indications for Use:

Nexus IR30 Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the surface of human skin without contact. It is for use on people of all ages (infants, children, adolescents, and adults) in the homecare environment.

Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use X _______ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Keith G. Marin ... ..

Division Sign-Off Office of Device Evaluation (ODE) 510(k) K122221

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