(210 days)
Not Found
No
The document explicitly states that some models are "non-predictive" and others are "predictive," but the description of the predictive models and the performance studies do not mention any AI or ML techniques. The predictive function appears to be based on standard algorithms or extrapolation rather than learned patterns.
No
The device is a digital thermometer, which measures body temperature for diagnostic purposes, not for treating a disease or condition.
No
The device measures human body temperature, which is a physiological parameter, but it does not diagnose a specific disease or condition. It provides data that a healthcare professional might use as part of a diagnostic process, but it is not a diagnostic device itself.
No
The device description explicitly lists hardware components such as a sensor, buzz films, housing, stainless steel cap, and LCD display.
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 examine these samples outside of the body.
- Device Function: The description clearly states that the digital thermometers are intended to measure human body temperature in vivo (within the body) orally, rectally, or under the arm.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the body. It directly measures a physical parameter (temperature) of the body itself.
Therefore, the function and intended use of these digital thermometers fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Digital Thermometers MT series are intended to measure the human body temperature in regular mode orally, rectally or under the arm. The devices are reusable for clinical or home use on people of all ages.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
Models MT-1027, MT-4127, MT-4132, MT-4132, MT-4335, MT-4335, MT-4326, MT-09, MT-30, MT-31, and MT-36 are non-predictive digital thermometers. Models MT-4726 and MT-4735 are predictive digital thermometers. Both predictive and non-predictive models include a sensor, buzz films, housing, a stainless steel cap, a LCD display, and a measurement control module. The thermometers include a dustproof case as an accessory. Additionally, both models do not need to be used in conjunction with a disposable probe cover when taking temperature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orally, rectally or under the arm
Indicated Patient Age Range
people of all ages
Intended User / Care Setting
clinical or home use
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)
A clinical accuracy evaluation has been conducted according to clause 201.102 of ISO 80601-2-56:2009 for predictive models MT-4726 and MT-4735. The Sponsor performed a risk assessment based on the changes made to their predicate device and determined that the following non-clinical testing was necessary to demonstrate that the changes did not introduce any new risks to the subject device. Laboratory testing was conducted to validate and verify that the thermometers continued to meet all requirements of related international standards, including electrical safety, EMC, software, biocompatibility, and cleaning/disinfection. Results of these tests demonstrated compliance to the requirements of the below consensus standards and FDA Guidance documents. Software validation testing was only performed for predictive Models MT-4726 and MT-4735.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +/-0.1 degrees C between 35.5 degrees C to 42.0 degrees C (+/-0.2 degrees F, 95.9 degrees F - 107.6 degrees F), +/-0.2 degrees C under 35.5 degrees C or over 42.0 degrees C (+/-0.4 degrees F under 95.9 degrees F or over 107.6 degrees F)
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.
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Image /page/0/Picture/1 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 heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 27, 2016
Sejoy Electronics & Instruments Co., Ltd. Mr. Ren Yunhua General Manager Building 2, No. 202, Zhenzhong Road West Lake Economy & Technology Zone Hangzhou, 310030 CHINA
Re: K153149
Trade/Device Name: Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: April 15, 2016 Received: May 13, 2016
Dear Mr. Yunhua:
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 yours,
Tina Kiang -
for Erin I. Keith, M.S. 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) K153149
Device Name
Digital Thermometer, Models MT-1027, MT-4127, MT-4333, MT-4326, MT-4726, MT-4726, MT-4735, MT-09, MT-30, MT-31, MT-36
Indications for Use (Describe)
The Digital Thermometers MT series are intended to measure the human body temperature in regular mode orally, rectally or under the arm. The devices are reusable for clinical or home use on people of all ages.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the logo for SEJOY. The logo is blue and has a yellow triangle above the "J". The letters are bold and easy to read. The logo is simple and modern.
世佳电子有限公司 Sejoy Electronics & Instruments Co.,Ltd.
510(k) Summary
The assigned 510(k) number is: K153149
1. Date Prepared:
May 25, 2016
2. Submitter's Identification:
Name: Sejoy Electronics & Instruments Co., Ltd. Address: Building 2, No.202, Zhenzhong Road, West Lake Economy & Technology Zone, Hangzhou, China 310030 Contact Person: Yunhua Ren Phone: +86-571-81957767 Fax: +86-571-81957750 Email: RENYH@SEJOY.COM
3. Name of the Device:
Trade Name: Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-રેસ
Common Name: Digital Thermometer
Classification name: Clinical Electronic Thermometer
4. Classification Information:
Product Code: FLL- Clinical Electronic Thermometer Device Class: II Panel: 80 Regulation number: 21 CFR 880.2910
5. Predicate Device Information:
Digital Thermometers Models MT-4119 and MT-4320 manufactured by SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
510(k) number: K110776
6. Intended use / Indication for Use:
The Digital Thermometers MT series are intended to measure the human body temperature in regular mode orally, rectally or under the arm. The devices are reusable for clinical or home use on people of all ages.
The intended uses/ indication for use of the Digital Thermometers, models: MT series are Identical to the predicate devices, Digital Thermometers, models: MT-4119, MT-4320.
7. Device Description:
Models MT-1027, MT-4127, MT-4132, MT-4132, MT-4335, MT-4335, MT-4326, MT-09, MT-30, MT-31, and MT-36 are non-predictive digital thermometers. Models MT-4726 and MT-4735 are predictive digital thermometers.
4
Both predictive and non-predictive models include a sensor, buzz films, housing, a stainless steel cap, a LCD display, and a measurement control module. The thermometers include a dustproof case as an accessory.
Additionally, both models do not need to be used in conjunction with a disposable probe cover when taking temperature.
8. Principles of Operation:
The basic principle of the MT series digital thermometers is that a change in thermistor resistance is caused by a change in temperature. The resistance is measured by a microcontroller unit, so that changes in temperature will correspond to changes in resistance.
Compared to the non-predictive thermometers, the following is a description of the predictive thermometer models MT-4726 and MT-4735:
The predictive thermometer models display the temperature results in a short period of time. The displayed temperature is equivalent to the balanced temperature after 5 minutes according to the proprietary algorithm. Therefore, users only need about 5 seconds to take temperature readings. The measurement time may vary depending on the anatomical site of the temperature reading; however the measurement time should remain between 5-10 seconds. If the predictive temperature cannot be measured, the device will take the actual temperature (regular mode) automatically.
9. Modifications to Predicate Device:
The subject device models have each been altered in at least one of the following ways as noted in the table below:
-Addition of predictive algorithm for Models MT-4735 and MT-4726
-New battery type to support added backlight feature
- -Modification of labeling including cleaning/disinfection instructions
- -Temperature associated color light indication with updated labeling
- -Thermometer response time
- -Battery life
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| Technological
Characteristics
of Comparison | Subject Device: | Predicate Device
Model MT-4119
(K110776): | Predicate Device
Model MT-4320
(K110776) | Comparison
on
Result | Remark | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Digital
thermometers | Models:
MT-1027,MT-4127,MT-1032,MT-
4132,MT-4333,MT-4326,MT-
4726,MT-4335, MT-4735,MT-09,MT-
30,MT-31,MT-36 | Model: MT-4119
(Rigid tip thermometer) | Model: MT-4320
(Flexible tip
thermometer) | / | / | |
| Intended use/
Indication for Use | Measuring the human body temperature in regular mode orally, rectally or under the arm, and the
devices are reusable for clinical or home use on people of all ages. | | | Identical | / | |
| Components | Sensor, buzz film, housing, stainless steel cap, LCD display, measurement control module. | | | Identical | / | |
| Accessory | Dustproof case | | | Identical | / | |
| Sensor | Thermistor | | | Identical | / | |
| Power
Requirements | MT-1027,MT-4127
MT-1032,MT-4132
MT-4333,MT-
4326, MT-
4335,MT-09, MT-
30,MT-31,
MT-4726,MT-4735 | 1.5V d.c (LR41 or
SR41,UCC392)
3.0V d.c(CR2032) | 1.5V d.c (LR41 or SR41,UCC392) | Similar | Change in
battery type
from 1.5V
d.c. (LR41 or
SR41,UCC392)
to 3.0V d.c.
(CR2032) | |
| Backlight function | MT-1027,MT-4127
MT-1032,MT-4132
MT-4333,MT-4326,
MT-4335,MT-09,
MT-30,MT-31,
MT-36 | No backlight function | No backlight function | | Identical | / |
| | MT-4726,MT-4735 | Yes | No backlight function | | Different | / |
| Material used | MT-1027,MT-4127
MT-1032,MT-4132
MT-09,MT-30,
MT-31
MT-4333,MT-4326,
MT-4726,MT-4335,
MT-4735,MT-36 | Housing: ABS
Probe: Stainless
steel | Housing: ABS
Probe: Stainless steel | Housing: ABS
Flexible tip: TPE
Probe: Stainless steel | Identical | Flexible tip
thermometers
are identical to
MT-4320 and
rigid tip
thermometers
are identical to
MT-4119 |
| Measure range | MT-1027,MT-4127
MT-1032,MT-4132
MT-4326,MT-4335,
MT-4333,MT-09,
MT-30,MT-31,
MT-36
MT-4726,MT-4735 | 32°C42.9°C109.9°F) | 32°C
(90°F42.9°C109.9°F) | | Similar | Meet the
(90°F
requirement of
ASTM E1112 |
| | MT-1027,MT-4127
MT-1032,MT-4132
MT-4333,MT-4326, | | Direct Mode | | | |
| Operating mode | MT-4335,MT-09,
MT-30,MT-31,
MT-36 | Direct Mode | | Similar | / | |
| | MT-4726,MT-4735 | Adjusted mode :
Oral mode/
Rectal mode/
Underarm mode
Direct Mode:
Bath mode | | | / | |
| Accuracy | $±0.1°C$ between $35.5°C$ to $42.0°C$ ( $±0.2°F,95.9°F-107.6°F$ ),
$±0.2°C$ under $35.5°C$ or over $42.0°C$ ( $±0.4°F$ under $95.9°F$ or over $107.6°F)$ | | | Identical | / | |
| Humidity range | 15%~95%,non-condensing | | | Identical | / | |
| Storage | Temperature: $-20℃55℃$ ( $-4°F131°F$ ) | | | Identical | / | |
| Environment | Humidity:15% ~95% RH; Atmospheric Pressure:800hPa ~ 1060hPa | | | Identical | / | |
| Color-temperature
light indicators | MT-4132,MT-4333 | Different colored lights | | Different | / | |
| | MT-4335,MT-4735
MT-4726,MT-4326 | corresponding to
different temperatures. | No this function | | / | |
| | MT-1027,MT-4127
MT-1032, MT-09,
MT-30,MT-31,
MT-36 | | No this function | Identical | / | |
| Response time | MT-4326,MT-4127
MT-4132,MT-4333
MT-4335,MT-30 |