Microlife Digital Infrared Ear Thermometer

K170219 · Microlife Intellectual Property GmbH · FLL · Jul 20, 2017 · General Hospital

Device Facts

• Record ID: K170219
• Device Name: Microlife Digital Infrared Ear Thermometer
• Applicant: Microlife Intellectual Property GmbH
• Product Code: FLL · General Hospital
• Decision Date: Jul 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Microlife Digital Infrared Ear Thermometer, Model IR1DR1-1 device, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

Device Story

Device is an electronic infrared ear thermometer for home use. It utilizes a thermopile sensor to detect natural thermal radiation from the tympanic membrane and surrounding auditory canal tissue. Infrared energy is captured by a lens, converted into temperature values by an application-specific integrated circuit (ASIC), and displayed on an LCD. Features include a position indication system to assist with probe placement and an elevated temperature alarm (audible beeps if >37.5°C). Operated by the user via Start and O/I keys. Output is a digital temperature reading used by the patient or caregiver to monitor body temperature. Benefits include non-invasive, rapid temperature assessment.

Clinical Evidence

Clinical validation conducted per ASTM E1965-98 and IEC 80601-2-56. Studies evaluated clinical uncertainty and clinical repeatability of the IR1DR1-1. Results demonstrated the device meets performance requirements for accuracy and repeatability in the intended population.

Technological Characteristics

Infrared thermopile sensor (TPS23B); lens-based optical system; ASIC-based processing; LCD display with backlight; 3.0V battery power. Dimensions: 7.3mm tip width. Connectivity: None. Sterilization: Not applicable (non-sterile). Software: Embedded firmware for temperature calculation and position indication.

Indications for Use

Indicated for neonatal, pediatric, and adult populations for body temperature measurement via the auditory canal in a home setting.

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

• Microlife Digital Infrared Ear thermometer, Model IR1DE1-1 (K034023)

Submission Summary (Full Text)

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

July 20, 2017

Microlife Intellectual Property GmbH % Susan Goldstein-Falk MDI Consultants. Inc. 55 Northern Boulevard Suite 200 Great Neck, New York 11021

Re: K170219

Trade/Device Name: Microlife Digital Infrared Ear Thermometer, Model IR1DR1-1 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 1, 2017 Received: June 1, 2017

Dear Ms. Goldstein-Falk:

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.

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

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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Tara A. Ryan -S

for Lori Wiggins Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K170219

Device Name

Microlife Digital Infrared Ear Thermometer, Model IR1DR1-1

Indications for Use (Describe)

The Microlife Digital Infrared Ear Thermometer, Model IR 1 device, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediation used in the home setting.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="text-decoration: underline;">☐</span> Research Use (Part 21 CFR 201. Subject to Review) | <span style="text-decoration: underline;">☒</span> Gene Therapy Studies (21 CFR 201. Subject to Review) |
|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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## K170219 510(K) SUMMARY

| Manufacturer's Name: | Microlife Intellectual Property GmbH, Switzerland<br>Espenstrasse 139<br>9443 Widnau / Switzerland |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Corresponding Official: | Mr. Gerhard Frick<br>Vice President of Technical and Service |
| Telephone Number: | Microlife Intellectual Property GmbH, Switzerland<br>[phone] |
| Email: | [e-mail] |
| Preparation Date: | July 13, 2017 |
| Trade Name: | Microlife Digital Infrared Ear Thermometer, Model IR1DR1- |
| Common or Usual Name: | Clinical Electronic Thermometer |
| Regulation Name:<br>Regulation Number:<br>Product Code:<br>Device Class: | Clinical Electronic Thermometer<br>21 CFR 880.2910<br>FLL<br>Class II |
| Primary Predicate Device: | K034023 Microlife Digital Infrared Ear thermometer, Model<br>IR1DE1-1 |

#### Device Description:

The Microlife Digital Infrared Ear Thermometer, Model IR1DR1-1 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces.

Mode of operation:

The unit measures the infrared energy emitting from the middle ear and the surrounding tissue. This energy is absorbed by lenses and converted into temperature values.

The Microlife Digital Infrared Ear thermometer, Model IR1DR1-1, consists of the following parts: a) Thermopile Sensor b) Application-Specific Integrated Circuit d) Lens

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e) LCD and Backlight f) 2 Keys (Start key, O/I key) g) 1 battery 3.0V

The new Model IR1DR1-1 has the same intended use and temperature measurement fundamental algorithm as the predicate device 510(k) K034023 Microlife Model IR1DE1-1.

## Indications For Use

The Microlife Digital Infrared Ear Thermometer, Model IR1DR1-1 device, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

# Substantial Equivalence Discussion

Both devices use infrared technology to measure and monitor the body temperature by the site of ear canal.

Microlife Digital Infrared Ear Thermometer IR1DR1-1 (cover free series products) has been compared to the cleared "Microlife Digital Infrared Ear Thermometer IR1DE1-1" (510(k) K#034023) as a reference for substantial equivalence. A table comparing the two devices is provided as follow:

| Attribute | Subject Device –<br>K170219: Microlife Ear<br>Thermometer 1R1DR1-1 | Predicate Device - K034023<br>: Microlife Ear<br>Thermometer 1R1DE1-1 | Comparison |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Thermometer<br>Type: | Infrared Thermometer | Infrared Thermometer | Same |
| Intended use | The device is an electronic<br>clinical thermometer using<br>an infrared sensor to detect<br>body temperature from the<br>auditory canal in the<br>neonatal, pediatric and<br>adult population used in<br>the home setting. | The device is an electronic<br>clinical thermometer using<br>an infrared sensor to detect<br>body temperature from the<br>auditory canal in the<br>neonatal, pediatric and adult<br>population used in the home<br>setting. | Same |
| Indications for use | The Microlife Digital<br>Infrared Ear Thermometer,<br>Model IR1DR1-1 device,<br>is an electronic clinical<br>thermometer using an<br>infrared sensor to detect<br>body temperature from the<br>auditory canal in the | The device is an electronic<br>clinical thermometer using<br>an infrared sensor to<br>detect body temperature<br>from the auditory canal in<br>the neonatal, pediatric and<br>adult population used in the<br>home setting. | Same |
| neonatal, pediatric and<br>adult population used in<br>the home setting. | | | |
| Thermometer Measurements | | | |
| Device<br>Measurement<br>Technology | Infrared | Same | - |
| Measurement<br>location | Ear Canal | Same | - |
| Probe cover<br>needed? | No | Same | - |
| Measurement<br>Range | 32.0- 42.2°C<br>(89.6 -108.0 °F) | 0 - 100°C<br>(32.0 - 212.0°F) | Different |
| Display<br>Resolution | 0.1°C or 0.1°F | Same | - |
| Accuracy Tested<br>(blackbody) | <35.5°C ±0.3°C<br>35.5°C-42.0°C ±0.2°C<br>>42.0°C ±0.3°C | Same | - |
| Positioning<br>Indication | Yes | No | Different |
| Elevated<br>Temperature<br>Alarm | Yes (10 short beeps when<br>measured temperature is<br>greater than 37.5 °C) | Same | - |
| Operating/Storage Environment | | | |
| Operating<br>Conditions | 10.0°C-40°C<br>(50.0°F~104.0°F)<br>with relative humidity 95% | 5°C-40°C (41°F~104°F)<br>with relative humidity 95% | Different |
| Storage Conditions | -25°C to 55 °C/-13°F<br>~131°F<br>with relative humidity 95% | Same | - |
| Device Internal Components | | | |
| Display type | LCD | Same | - |
| Memory | One temperature memory | Twelve temperatures<br>memory | Different |
| Sensor Type | TPS23B sensor | Same | - |
| Lens Type | Transparent | Same | - |
| Probe Head Dimensions | | | |
| Probe head : Tip<br>Width | 7.3 mm | Same | - |
| Probe Head:<br>Thickness at 5 mm<br>height | 8.56 mm | 8.35 mm | Different |
| Probe Head:<br>Thickness at 10 | 10.32 mm | 10.22 mm | Different |

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| Item | Test Name | Results |
|------|-----------|---------|
|------|-----------|---------|

| mm height | | | |
|---------------------------------------|-----------|------------|-----------|
| Integrated Circuit Model and Features | | | |
| Power Supply<br>Voltage | 2.2-3.6 V | 2.4- 5.5 V | Different |
| RAM Space | 512 Bytes | 256 Bytes | Different |

The indications for use statement and the intended use of the subject device is identical to the predicate device. The differences in the device are:

- 1. Measurement temperature range has been narrowed to more physiologically relevant temperatures. This does not introduce any new risk to the device.
- 2. Addition of the Position Indication Feature, which has been validated and verified through performance testing and clinical testing.
- 3. The integrated circuit model and its features have changed. These changes have been verified through performance testing.
- 4. The thermometer's memory can recall the last temperature measurement, which has been decreased from predicate which recalled the last 12 temperature measurements.
- 5. The Probe head and the rest of the device is dimensionally larger than the predicate device. This does not change how the device operates. The size difference was validated through clinical studies.
- 6. The operating condition has been narrowed. .

Based on the aforementioned modifications to the subject device, the subject device does not raise different types of safety and effectiveness questions when compared to the predicate device.

Performance TestingTesting information demonstrating performance of the Microlife Digital Infrared Ear Thermometer, Model IR1DR1-1 in the intended environment of use is supported by testing that was conducted in accordance with Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers.

The following testing was conducted to prove safety and effectiveness as well as substantial equivalence to the predicate devices:

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| 1 | IEC 60601-1: 2005 and A1:2012 | Passed all testing requirements |
|----|-----------------------------------------------------------------------------------------|---------------------------------|
| 2 | ANSI/AAMI ES60601-1:2005/(R2012)<br>and A1:2012, C1:2009/(R)2012 and<br>A2:2010/(R2012) | Passed all testing requirements |
| 3 | IEC 60601-1-2: 2014 | Passed all testing requirements |
| 4 | ASTM E 1965-98 (2009) | Passed all testing requirements |
| 5 | ISO 14971: 2007 | Passed all testing requirements |
| 6 | AAMI/ANSI/ISO 10993-1: 2010 | Passed all testing requirements |
| 7 | AAMI/ANSI/ISO 10993-5: 2010 | Passed all testing requirements |
| 8 | AAMI/ANSI/ISO 10993-10: 2010 | Passed all testing requirements |
| 9 | AAMI/ANSI/ISO 10993-12: 2012 | Passed all testing requirements |
| 10 | AAMI/ANSI/ISO 80606-2-56: 2009 | Passed all testing requirements |
| 11 | IEC 60601-1-11:2010 | Passed all testing requirements |

#### Performance Testing Summary:

Measurement accuracy of the subject thermometer was tested per and complies with the following standard:

Specification for IR thermometers : ASTM E1965-98 (2009)

Electrical and Electromagnetic Compatibility testing were conducted in accordance with the following standards:

Electrical Safety: IEC 60601-1, IEC 60601-1-11 EMC: IEC 60601-1-2

Software Verification and Validation: per the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices dated May 11, 2005

## Clinical Tests

Controlled human clinical studies were conducted in accordance with ASTM E1965-98, IEC80601-2-56 Test Report using the Microlife Digital Infrared Ear Thermometer r Model IR1DR1-1. Clinical data was presented evaluating clinical uncertainty and clinical repeatability per clinical validation for Microlife IR1DR1-1.

#### Conclusions

The modifications to the subject device include the addition of the position indication feature, the measurement reading range, the operating conditions, the integrated circuit system, temperature memory, and the physical dimensions of the device. There are no changes to the basic measurement technology. The modifications do not raise new or different questions of safety and effectiveness and are supported by non-clinical and clinical testing.

The Microlife Digital Infrared Ear Thermometer IR1DR1-1 is substantially equivalent to the Microlife Digital Infrared Ear Thermometer IR1DE1-1, cleared under K034023.