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.

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.

AI/ML Overview

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

The provided document K122221 does not contain specific acceptance criteria or an explicit study proving the device meets said criteria in the format typically expected for medical device performance studies (e.g., a detailed clinical trial or rigorous bench test with statistical analysis against predefined thresholds). Instead, this 510(k) submission relies on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the information related to performance and substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not explicitly state specific acceptance criteria such as accuracy ranges (e.g., +/- 0.2°C at certain temperatures) or clinical performance metrics (e.g., sensitivity, specificity for fever detection). Instead, the performance is
demonstrated by asserting substantial equivalence to its predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
System accuracy	Substantially equivalent to predicate device U-RIGHT TD-1240 Thermometer (K113159).
Software verification and validation	Confirmed performance, safety, and effectiveness are equivalent to the predicate device.
Safety tests	Confirmed performance, safety, and effectiveness are equivalent to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" in the context of a clinical study with human subjects. The verification and validation activities mentioned are typically bench tests and engineering analyses rather than clinical trials. Therefore, information on sample size and data provenance (e.g., country of origin, retrospective/prospective) for a clinical test set is not provided in this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This type of information is not relevant or provided in this 510(k) summary, as it does not describe a clinical study where expert consensus would establish ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The device is a thermometer, and MRMC studies are typically for imaging or diagnostic tools where human interpretation of complex cases is involved.

6. Standalone (Algorithm Only) Performance

The device itself is a standalone thermometer; there is no "algorithm only" performance separate from the human interaction of taking a temperature reading. The performance of the device (system accuracy) is assessed as a complete unit. The document states that "A comparison of system accuracy performance demonstrated that Nexus IR30 Thermometer and U-RIGHT TD-1240 Thermometer (cleared under K113159) are substantially equivalent." This implies that quantitative tests were performed on the device to show its accuracy and that the results were comparable to the predicate. However, detailed results of these tests (e.g., mean difference, standard deviation, bias) are not included in this summary.

7. Type of Ground Truth Used

For a thermometer, the "ground truth" for accuracy testing is typically established using reference temperature standards (e.g., blackbody radiators for infrared thermometers) that are calibrated to a known precise temperature. The document states that "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." While not explicitly stated, it is inferred that these tests would involve comparing the device's readings to established metrological standards.

8. Sample Size for the Training Set

This information is not applicable. The Nexus IR30 Thermometer is not an AI/machine learning device that requires a "training set" in the conventional sense. Its function is based on infrared physics and sensor technology, not a learned model from data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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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: +886-2-6625-8188 #1176 Fax: +886-2-6625-0288 Email: pinjung.chen@taidoc.com.tw

Date of submission: JUL 23, 2012

1. 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) ·
1. 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. .

l of 3

MAR 2 9 2013

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4. Device Description:

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.
1. It has the same operating principle and fundamental scientific technology as the predicate.
1. It has the same basic circuit design as the predicate.
1. It incorporates the same materials.
1. It has the same shelf life.
1. It packaged using the same materials.
1. It manufactured by the same process.
1. 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.

1. 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.

1. 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 (800) 638-2041 or (301) 796-7100 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:

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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Regulation Number and Section

§ 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.