(208 days)
Not Found
No
The summary describes a standard digital thermometer and does not mention any AI or ML capabilities.
No.
The device is a digital clinical thermometer used to measure human body temperature, not to treat or alleviate a medical condition.
No
This device measures body temperature, which is a physiological parameter, but it does not diagnose a disease or condition. It provides a measurement that can be used as part of a diagnostic process by a healthcare professional, but it is not a diagnostic tool itself.
No
The device description explicitly states it is a "hand-held, reusable, battery operated device" and mentions "Surface contact: armpit" and "Invasive contact: oral," indicating physical hardware components for temperature measurement and display.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
- This Device's Function: The Duteck (micHealth) Digital Clinical Thermometer measures human body temperature by making direct contact with the body (oral or armpit). This is a direct measurement of a physiological parameter within the body, not a test performed on a sample taken from the body.
The description clearly states the device measures body temperature through direct contact (oral and armpit), which is a standard clinical measurement, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Duteck (micHealth) Digital Clinical Thermometer, DT2306 series (product code FLL) is used to measure human body temperature with the following features:
The device display body temperature in digital format at LCD The device make intended contact with patient in 2 ways
(1) Surface contact: armpit.
(2) Invasive contact: oral.
The device is used and installed by patients, Nurses, doctors and people with the exception of handicapped people and children.
The device is used in ENVIRONMENT of room temperature and normal environment condition.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
Duteck (micHealth) Digital Clinical Thermometer, DT2306 series is hand-held, reusable, battery operated device that can measure human body temperature via the human oral and armpit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral and armpit
Indicated Patient Age Range
all ages
Intended User / Care Setting
patients, Nurses, doctors and people with the exception of handicapped people and children. The device is used in ENVIRONMENT of room temperature and normal environment condition.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Duteck (micHealth) Digital Clinical Thermometer, DT2306, had been tested to the appropriate electrical tested standard and biocompatibility standards have been found safe for intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
0
K132140 EEB - 4 2014
Duteck: micHealth Digital Clinical Thermometer 510(K) Submission
510(K) Summary 807.92(C)
Company Name: Duteck Industrial Co., Ltd
Company Address: 3F-2, No 26, Ln513 Rui-Kuang Rd
Taipei 114, Taiwan ROC
Telephone number: 886-2-8797-5035.
Fax number
Contact person: Joseph Chan
Summary preparation: June 11, 2013
Device name:
807.92(a)(2)
Trade name: Duteck(micHealth) Digital Clinical Thermometer, DT2306
Regulation Name: Digital Clinical Thermometer
Product Code: FLL
Registration Number: 9616844
Regulation Number: 21 CFR 880.2910
Regulatory Class: II
Predicate device:
807 92(a)(3)
Duteck Digital Clinical Thermometer (K992327)
- Device description:
807.92(a)(4)
Duteck (micHealth) Digital Clinical Thermometer, DT2306 series is hand-held, reusable, battery operated device that can measure human body temperature via the human oral and armpit.
Device intended to use:
807.92(a)(5)
Duteck (micHealth) Digital Clinical Thermometer, DT2306 series is electronic thermometer using a thermopile detector to detect body temperature from the oral or armpit. It intended
1
Duteck: micHealth Digital Clinical Thermometer 510(K) Submission
for the intermittent measurement of human body temperature in people of all ages.
| ELEMENT
OF
COMPARISON | Duteck Digital
Thermometer | Clinical Duteck (micHealth) Digital Clinical
Thermometer, DT2306 series |
|-----------------------------------|-------------------------------|----------------------------------------------------------------------------|
| 510(K) Number | K992327 | New |
| Displayed
Temperature
Range | 32°C42.0°C(89.6.0°F109.2°F) | 32.00°C42.00°C(89.60°F109.20°F) |
| Operation
Environment | 16°C40°C(60.8°F104°F) | 16.00°C40.00°C(60.80°F104.00°F) |
| Power
Requirement | LR41 1.5V batteries x1 | CR 1620 3V x1 |
| Display
Resolution | ±0.1°C/°F | ±0.01°C/°F |
| Display | TN LCD | TN LCD |
| Response Time | 15 second | 4 second |
Comparison of technical characteristics: 807.92(a)(6)
Safety and effectiveness
807.92(b)
The Duteck (micHealth) Digital Clinical Thermometer, DT2306, had been tested to the appropriate electrical tested standard and biocompatibility standards have been found safe for intended use. (As Appendix III)
Conclusion:
807.92(b)(3)
The Duteck (micHealth) Digital Clinical Thermometer is as same as the predicate device in intended use and technological characteristics. After analyzing performance and safety. testing, it is the conclusions of Duteck (micHealth) Digital Clinical Thermometer is as safe and effective as the predicate devices and introduce no new questions concerning safety and effectiveness.
Sincerely Yours,
oseph Chen
7
2
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 4, 2014
Duteck Industrial Company, Limited C/O Joseph Chen, President 3F-2, Number 26, Lane 513 Rui-Kuang Road Taipei 114 Taiwan R.O.C.
Re: K132140
Trade/Device Name: Duteck (micHealth) Digital Clinical Thermometer, DT2306 series Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 7, 2014 Received: January 15, 2014
Dear Mr. 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.
3
Page 2 - Mr. 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
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for
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132140
Device Name
micHealth Digital Clinical Thermometer, DT2306 series
Indications for Use (Describe)
Duteck (micHealth) Digital Clinical Thermometer, DT2306 series (product code FLL) is used to measure human body temperature with the following features:
The device display body temperature in digital format at LCD The device make intended contact with patient in 2 ways
(1) Surface contact: armpit.
(2) Invasive contact: oral.
The device is used and installed by patients, Nurses, doctors and people with the exception of handicapped people and children.
The device is used in ENVIRONMENT of room temperature and normal environment condition.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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