(136 days)
No
The description focuses on standard infrared technology for temperature measurement and does not mention any AI or ML components. The performance studies describe clinical accuracy and repeatability, not AI/ML model performance metrics.
No.
The device is intended for the measurement and monitoring of human body temperatures, not for therapeutic purposes.
Yes
The device is intended for the "intermittent measurement and monitoring of human body temperatures," which is a form of physiological measurement used to assess a health state. While it doesn't provide a diagnosis itself, the data it collects (temperature) is used by consumers as an indicator of health, such as fever, which is a symptom that can lead to further diagnostic investigation. Therefore, it serves a role in the diagnostic process by providing essential data.
No
The device description explicitly states it is a "hand-held, non-sterile, reusable, battery powered device" that utilizes infrared technology, indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Dual Mode Infrared Thermometer measures human body temperature by detecting infrared energy emitted from the ear canal or forehead. This is a direct measurement of a physical property of the body, not an analysis of a sample taken from the body.
- Intended Use: The intended use is for "intermittent measurement and monitoring of human body temperatures," which is a physiological measurement, not a diagnostic test performed on a sample.
Therefore, the device falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear canal, skin of the forehead
Indicated Patient Age Range
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.
Intended User / Care Setting
non-professional use by consumers at home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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 years 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical study to determine clinical accuracy and comparison with predicate device.
Sample Size: 105 subjects.
Key Results: The clinical test results showed that there is substantial clinical agreement and repeatability between the proposed device and 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s):
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
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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)
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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
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7. Performance Summary
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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.