← Product Code [FLL](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL) · K163256 # Dual Mode Infrared Thermometer (K163256) _Intelliworks, LLC · FLL · Apr 6, 2017 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K163256 ## Device Facts - **Applicant:** Intelliworks, LLC - **Product Code:** [FLL](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL.md) - **Decision Date:** Apr 6, 2017 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.2910 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Pediatric ## Indications for Use The Dual Mode Infrared Thermometer (Model DM-IR200) is intended for the intermittent measurement and monitoring of human body temperatures. It is for non-professional use by consumers at home. The ear canal mode is indicated for use by people above one year old and the skin/forehead mode is indicated for use by people of all ages. ## Device Story Hand-held, battery-powered infrared thermometer; measures thermal infrared energy from ear canal or forehead skin. Used by consumers at home for intermittent body temperature monitoring. Device converts detected infrared radiation into temperature readings displayed on LCD; includes buzzer for alerts. Provides 20-set memory storage. Enables non-professional users to track temperature; aids in identifying fever or monitoring health status at home. ## Clinical Evidence Clinical study of 105 subjects (including infants <1 year, children 1-5 years, and patients >5 years) with >30% febrile subjects. Evaluated clinical bias and repeatability per ASTM E1965. Results: clinical bias ≤ 0.06°C (uncertainty ≤ 0.02°C); clinical repeatability 0.1°C. Demonstrated substantial clinical agreement with predicate devices. ## Technological Characteristics Infrared radiation detection; dual-mode (ear/forehead). Powered by two 1.5V AAA batteries. LCD display with buzzer. Memory capacity: 20 sets. Complies with ASTM E1965, IEC 60601-1, IEC 60601-1-2, ISO 10993-1/5/10, IEC 62304, and ISO 14971. Biocompatible materials per ISO 10993. ## Regulatory 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 Dual Mode Thermometer, Model IFR1MJ1 ([K113141](/device/K113141.md)) - easystem duo, Dual Thermometer, Forehead/Ear, Model BT-021 ([K033077](/device/K033077.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, with the profiles overlapping each other. The profiles are positioned above a set of three wavy lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the top of the logo. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 6, 2017 Intelliworks, LLC Dr. Jessica Leonardi R&D Director 4910 Wright Road, Suite 120 Stafford, Texas 77477 Re: K163256 Trade/Device Name: Dual Mode Infrared Thermometer. Model DM-IR200 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: March 2, 2017 Received: March 8, 2017 Dear Dr. Jessica Leonardi: 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. {1}------------------------------------------------ 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Tina Kiang-S Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K163256 Device Name Dual Mode Infrared Thermometer, Model DM-IR200 Indications for Use (Describe) The Dual Mode Infrared Thermometer (Model DM-IR200) is intentittent measurement and monitoring of human body temperatures. It is for non-professional use by consumers at home. The ear canal mode is indicated for use by people above one year old and the skin/forehead mode is indicated for use by people of all ages. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| Prescription Use (Part 21 CFR 801 Subpart D) |X | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Section 2. 510(k) Summary K163256 #### 1. Submitter's Information | Name: | Intelliworks LLC | |----------|--------------------------------------------------------| | Address: | 4910 Wright Road, Ste 120
Stafford, TX 77477
USA | | Contact: | Dr. Jessica Leonardi, R&D Director | | Phone: | 832-715-9539 | | Email: | jess@innovogroups.com | Date Summary Prepared: November 15, 2016 #### 2. Proposed Device Name: Dual Mode Infrared Thermometer, Model DM-IR200 Common Name: Ear Canal IR Thermometer; Skin IR Thermometer Classification Name: Clinical Electronic Thermometer Review Panel: General Hospital Product Code: FLL Device Class: II Regulation Number: 21 CFR 880.2910 #### 3. Predicate Devices Predicate device #1: Microlife Dual Mode Thermometer, Model IFR1MJ1 510(k) Number: K113141 Predicate device #2: easystem duo, Dual Thermometer, Forehead/Ear, Model BT-021 510(k) Number: K033077 ## 4. Device Description The Dual Mode Infrared Thermometer (Model DM-IR200) is a hand-held, non-sterile, reusable, battery powered device designed to measure human body temperature via one of two body sites: the ear canal or skin of the forehead. The DM-IR200 thermometer utilizes infrared technology to measure the natural thermal infrared energy emitted from the surface of the forehead or from the eardrum tissue. ## 5. Indications for Use The Dual Mode Infrared Thermometer (Model DM-IR200) is intended for the intermittent measurement and monitoring of human body temperatures. It is for non {4}------------------------------------------------ professional use by consumers at home. The ear canal mode is indicated for use by people above one year old and the skin/forehead mode is indicated for use by people of all ages. #### 6. Comparison to Predicate Devices and Substantial Equivalence The Dual Mode Infrared Thermometer (Model DM-IR200) is substantially equivalent to the predicate devices, which uses the same fundamental technology, is similar in design and has the same intended use. The proposed device and predicate devices all utilize an infrared technology to measure natural infrared energy emitted from the skin surface of the forehead or from the eardrum tissue. The proposed device and predicate devices are intended for the intermittent measurement and monitoring of human body temperatures by detecting body temperatures from the forehead or auditory canal. The proposed and predicate devices are designed for nonprofessional use by consumers at home. The intended population of the proposed device is all ages for the forehead mode and above one year old for the ear mode. There is a minor difference with the predicate devices with intended population of all ages. The proposed and predicate devices mainly differ by the measurement range, memory sets, power supply and storage condition. A side-by-side comparison of the proposed device and the predicate device is included in the 510(k) submission. | Characteristics | Predicate Device #1 | Predicate Device #2 | Proposed Device | | |-------------------------|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-------------------| | 510(k) Number | K113141 | K033077 | K163256 | | | Device name | Microlife Dual
Mode Thermometer,
Model IFR1MJ1 | Easystem duo, Dual
Thermometer,
Forehead/Ear, Model
BT-021 | Dual Mode Infrared
Thermometer, Model
DM-IR200 | | | Indications for use | The device is | The device is intended | The device is intended | | | | intended for the
intermittent
measurement and | for the intermittent
measurement and
monitoring of human | for the intermittent
measurement and
monitoring of human | | | | monitoring of | body temperature in | body temperatures. It is | | | | human body | the home. It is | for non-professional use | | | | temperatures. The | intended for use on | by consumers at home. | | | | device is indicated | people of all ages. | The ear mode is | | | | for use by people | | indicated for use by | | | | above 12 years old
to geriatric for ear
mode and from
newborn to geriatric
for forehead mode in
the home. | | people above one year
old and the forehead
mode is indicated for use
by people of all ages. | | | Measurement
method | Infrared radiation
detection | Infrared radiation
detection | Infrared radiation
detection | | | Measurement mode | Dual mode – Ear
and Forehead mode | Dual mode – Ear and
Forehead mode | Dual mode – Ear and
Forehead mode | | | Measurement
range | Ear mode:
32.0°F-212.0°F
(0.0°C-100.0°C)
Forehead mode:
93.2°F-107.9°F
(34.0°C-42.2°C) | Ear mode:
32.0°F-212.0°F
(0.0°C-100.0°C)
Forehead mode:
71.6°F-109.4°F
(22.0°C-43.0°C) | Ear mode:
32.0°F-212.0°F (0.0°C-
100.0°C)
Forehead mode:
64.4°F-107.6°F (18.0°C-
42.0°C) | | | | Measurement
accuracy | ± 0.4°F /± 0.2°C | ± 0.4°F /± 0.2°C | ± 0.4°F / ± 0.2°C | | | Display resolution | 0.1°F/0.1°C | 0.1°F/0.1°C | 0.1°F/0.1°C | | | Signal output and
display | LCD, Buzzer | LCD | LCD, Buzzer | | °F/°C switchable | Yes | Yes | Yes | | | Memory | 12 sets | 10 sets | 20 sets | | | Power supply | One 3V CR2032
battery | One 3V CR2032
battery | Two 1.5V AAA batteries | | | Operating
conditions | Temperature:
50.0°F-104.0°F
(10.0°C-40.0°C)
Humidity: 15%-95%
RH | Temperature:
60.8°F-104.0°F
(16.0°C-40.0°C)
Humidity: 15%-95%
RH | Temperature:
50.0°F-104.0°F (10.0°C-
40.0°C)
Humidity: 15%-95% RH | | | Storage conditions | Temperature:
-13.0°F to +131.0°F
(-25.0°C to
+55.0°C)
Humidity: 15%-95%
RH | Temperature:
-4.0°F to +122.0°F (-
20.0°C to +50.0°C)
Humidity: 15%-95%
RH | Temperature:
-4.0°F to +122.0°F (-
20.0°C to +50.0°C)
Humidity: 15%-95% RH | | Comparison of basic technological characteristics {5}------------------------------------------------ ## 7. Performance Summary {6}------------------------------------------------ The Dual Mode Infrared Thermometer (Model DM-IR200) conforms to applicable standards that include: ASTM E1965 Standard specification for infrared thermometers for intermittent determination of patient temperature IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization IEC 62304 Medical device software - Software life cycle processes ISO 14971 Medical devices – Application of risk management to medical devices Guidance document includes the FDA Guidance on the Content of Premarket Notification 510(k) Submissions for Clinical Electronic Thermometers. #### 8. Clinical Testing A clinical study was performed to determine the clinical accuracy and to provide comparison with predicate device. The three groups of subjects being tested were: 1) infants under 1 year old, 2) children between 1 and 5 years old, and 3) patients over 5 vears old. The study included 105 subjects, with 33.3% febrile subjects. For each age group, the ratio of febrile subjects was more than 30%. The study excluded subjects with medical conditions such as inflammation at the measuring sites and subjects using medications known to affect body temperature. From each test site, a total of 105 data sets were collected. The clinical accuracy of the proposed device was evaluated by determining two kinds of errors in accordance with requirements of ASTM E1965 - clinical bias with stated uncertainty and clinical repeatability. The clinical test results showed that there is substantial clinical agreement and repeatability between the proposed device and {7}------------------------------------------------ predicate devices. The calculated clinical bias did not exceed 0.06°C, with uncertainty that did not exceed 0.02°C. The clinical repeatability was 0.1°C. #### 9. Conclusion The Dual Mode Infrared Thermometer (Model DM-IR200) has the same intended use and similar technological characteristics as the predicate devices. In addition, compliance with applicable voluntary standards, as well as performance testing demonstrate that any differences in technological characteristics do not raise any new questions of safety and/or effectiveness. Therefore, we conclude that the Dual Mode Infrared Thermometer (Model DM-IR200) is substantially equivalent to the predicate devices. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K163256](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K163256) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com