(121 days)
Not Found
No
The description mentions "predictive digital thermometer" and "predictive quick read," but there is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The predictive function is likely based on a simpler algorithm or model, not AI/ML.
No.
The device is a digital thermometer intended to measure human body temperature. It is a diagnostic tool, not a therapeutic one that treats or cures a condition.
Yes.
The device's intended use is to "measure the human body temperature," which provides information used to diagnose and monitor medical conditions.
No
The device description explicitly states it is a "hand held device" with a "flexible tip" and an "LCD" for displaying results, indicating it is a physical hardware device. While it mentions "software validation" in the performance studies, this refers to the software within the hardware device, not a standalone software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "measure the human body temperature in regular mode orally, rectally or under the arm". This is a direct measurement of a physiological parameter within the body.
- Device Description: The description details a device that measures temperature directly from the body surface or cavity.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease. This thermometer does not perform any analysis on such specimens.
Therefore, the Digital Thermometer DMT-4756 is a medical device, but it falls under the category of a clinical thermometer rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Digital Thermometer DMT-4756 is intended to measure the human body temperature in regular mode orally, rectally or under the arm, and the device is reusable for clinical or home use on people of all ages, including children under 8 with adult supervision.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The digital thermometer DMT-4756 is hand held device which can measure human body's temperature orally, axillary (under the arm), and rectally. The results can be displayed on LCD.
The flexible tip is foldable,when the flexible tip folded, DMT-4756 is used to measure human body's temperature rectally, while the flexible tip unfolded, it is used to measure temperature orally and axillary (under the arm).
The digital thermometer have several functions,such as beep alarm,unit switchable, low battery detection,memories,backlight,auto power off functions.
DMT-4756 is a predictive digital thermometer. Users only need 10 seconds for predictive quick read and 30 seconds for final temperature readings.
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
all ages, including children under 8 with adult supervision
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)
Performance testing was conducted to validate and verify that Digital Thermometer, DMT-4756 met all requirements of related international standards, including electrical safety, EMC, biocompatibility, software validation and product specifications. Results of these tests demonstrate compliance to the requirements of the below consensus standards.
Electrical Safety and performance requirements:
- AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 Medical Electrical Equipment
- ISO 80601-2-56:2017 Medical electrical equipment Part 2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- ASTM E1112:00(Reapproved 2011) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
Home-used medical equipment requirements and environmental test:
- IEC 60601-1-11:2015 General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home health care environment
Electromagnetic compatibility requirements:
- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Biocompatibility Evaluation for patient contacting components:
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
Guidance Document:
- Guidance on the content of Premarket Notifications [510(k)] Submissions for clinical electronic thermometers
The software/firmware verification and validation was provided in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
Clinical tests: The clinical tests were conducted on the DMT-4756 for each measurement site. The clinical tests evaluated 450 subjects. The thermometer was evaluated in three groups: 1) infants-newborn to one year; 2) children-greater than one to five years; and 3) adults-greater than five years old. The clinical performance test protocol and data analysis was conducted in accordance with ISO 80601-2-56. The test report showed the clinical performance of the subject device complied with the requirement of ISO 80601-2-56.
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
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July 8, 2020
Joytech Healthcare Co., Ltd Mr. Yunhua Ren General Manager No. 365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City 311100 Zhejiang China
Re: K200599
Trade/Device Name: Digital Thermometer, Model DMT-4756 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 5, 2020 Received: June 8, 2020
Dear Mr. Yunhua Ren:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-devices/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200599
Device Name Digital Thermometer, Model DMT-4756
Indications for Use (Describe)
The Digital Thermometer DMT-4756 is intended to measure the human body temperature in regular mode orally, rectally or under the arm, and the device is reusable for clinical or home use on people of all ages, including children under 8 with adult supervision.
| 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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Image /page/3/Picture/0 description: The image shows the logo for JOYTECH. The logo is in blue and red. The word "JOYTECH" is in blue, except for the "T", which is in red. To the right of the word "JOYTECH" are some Chinese characters in blue.
510(k) Summary
The assigned 510(k) number is: K200599
-
- Date Prepared: 2020.07.08
2. Submitter's Identification:
Name: JOYTECH HEALTHCARE CO., LTD.
Add.:No.365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou city,
311100 Zhejiang,China
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 Model: DMT-4756 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:880-2910
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Image /page/4/Picture/0 description: The image shows the logo for JOYTECH. The logo is in blue and red. The word "JOYTECH" is in blue, except for the "T", which is in red. To the right of the word "JOYTECH" are three Chinese characters in blue.
Predicate Device Information: 5.
The Digital Thermometer DMT-4756 is substantially equivalent to the following device:
| 510k number | model | Product code | manufacturer |
|---|---|---|---|
| K183393 | DMT-4726 | FLL | JOYTECH HEALTHCARE CO., LTD. |
Intended use / Indication for Use: 6.
The Digital Thermometer DMT-4756 is intended to measure the human body temperature in regular mode orally, rectally or under the arm, and the device is reusable for clinical or home use on people of all age, including children under 8 with adult supervision.
7. Device Description:
The digital thermometer DMT-4756 is hand held device which can measure human body's temperature orally, axillary (under the arm), and rectally. The results can be displayed on LCD.
The flexible tip is foldable,when the flexible tip folded, DMT-4756 is used to measure human body's temperature rectally, while the flexible tip unfolded, it is used to measure temperature orally and axillary (under the arm).
The digital thermometer have several functions,such as beep alarm,unit switchable, low battery detection,memories,backlight,auto power off functions.
DMT-4756 is a predictive digital thermometer. Users only need 10 seconds for predictive quick read and 30 seconds for final temperature readings.
8. Substantial Equivalence Comparison:
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Image /page/5/Picture/0 description: The image shows the logo for JOYTEC-11建拓. The text "JOYTEC" is in blue, with the "C" stylized with a red triangle. The "11建拓" is in blue and is to the right of the "JOYTEC" text.
| SE
Comparisons | Subject device K200599
DMT-4756 | Predicate device K183393
(Model:DMT-4726) | Comparison
Result |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Intended Use
/Indication for use | The Digital Thermometer DMT-4756 is
intended to measure the human body
temperature in regular mode orally,
rectally or under the arm, and the
device is reusable for clinical or home
use on people of all age, including
children under 8 with adult supervision | The Digital Thermometer DMT-4726 is
intended to measure the human body
temperature in regular mode orally,
rectally or under the arm. The device is
reusable for clinical or home use on
people of all ages, including children
under 8 with adult supervision. | Identical
(Only change
in model
number) |
| Fundamental
technology&
Operating
principle | A change of thermistor resistance,
caused by changes of temperature. The
resistance is measured by MCU, so
changes of temperature will correspond
to changes of resistance | A change of thermistor resistance,
caused by changes of temperature. The
resistance is measured by MCU, so
changes of temperature will correspond
to changes of resistance | Identical |
| Sensor | Thermistor | Thermistor | Identical |
| Signal processing
and display | -Internal firmware and local
LCD display | -Internal firmware and local
LCD display | Identical |
| Measurement
Site | orally, rectally or under the arm | orally, rectally or under the arm | Identical |
| Range | $32.0°C43.9°C (89.6°F-111.0°F)$ | $32.0°C43.9°C (89.6°F-111.0°F)$ | Identical |
| 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
$107.6°F)$ | $±0.1°C$ 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 |
| Display resolution | $0.1 °C/0.1 °F$ | $0.1 °C/0.1 °F$ | Identical |
| components | Sensor, buzz film, housing, stainless
steel cap, LCD display, measurement
control module. | Sensor, buzz film, housing, stainless
steel cap, LCD display, measurement
control module. | Identical |
| Memories | 10 memories | 10 memories | Identical |
| Material | ABS,TPE,Stainless steel | ABS,TPE,Stainless steel | Identical |
| Operating range | Temperature:
$41°F104°F (5°C40°C)$
Relative humidity: 15%95%RH104°F (5°C~40°C)$
Atmospheric Pressure :
700hPa ~ 1060hPa | Temperature:
$41°F
Relative humidity: 15%95%RH131°F (-20℃~55℃)
Atmospheric Pressure :
700hPa ~ 1060hPa | Identical |
| Construction | The probe is foldable into the body of the thermometer | Flexible Digital Thermometer | Different
(Note1) |
| Measurement method & time | 10s Predictive read
30s Final read. | Approximate 5 ~ 10s | Different
(Note 2) |
| Weight | Approx. 40 grams including battery | Approx. 23 grams including battery | Different
(Note3) |
| Thermometer Size | 10.6cm3.2cm2.5cm (L x W x H) | 13.5cm3.4cm1.7cm (L x W x H) | Different
(Note3) |
| LCD Size | 2.5cm1.4cm | 2.7cm2.1cm | Different
(Note3) |
| Color &Coding | White(R9003),
Green(P564C) | White(R9003),
Blue(P294C) | Different
(Note3) |
| Predictive mode | Yes | Optional | Different
(Note2) |
| Storage and transportation condition | Temperature:
-4°F
Relative humidity: 15%95%RH131°F (-20℃~55℃)
Atmospheric Pressure:
700hPa ~ 1060hPa | Temperature:
-4°F
Relative humidity: 15%~95%RH
Atmospheric Pressure:
700hPa ~ 1060hPa | Identical |
| Battery type | One 3.0V CR2032 battery | One 3.0V CR2032 battery | Identical |
| Biocompatibility | Comply with ISO 10993-5 and ISO 10993-10 | Comply with ISO 10993-5 and ISO 10993-10 | Identical |
| Electrical Safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 | Identical |
| EMC | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 | Identical |
6
Analysis
From the comparison table, the subject device and predicate device(K183393) have the similar Intended use & Indications for Use, Measurement place, Scale selection, Display screen, Auto power-off while no operation & Conformance standard;
There are slightly differences between the subject device and predicate device(K183393) as follows and we have conducted the tests to verify that the differences do not raise new questions of safety and effectiveness,please see below::
| Note 1 | Add foldable
construction function | Performance testing shows the subject device
complies with standard ISO 80601-2-56. The
difference does not raise new questions of safety and
effectiveness |
|--------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note 2 | Measure time changed
from approximate
5~10s to “10 second
predictive quick read,30 | Performance test including clinical test shows the
subject device complies with performance standard.
The differences do not raise new questions of safety
and effectiveness |
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Image /page/7/Picture/0 description: The image shows the logo for JOYTECH. The logo is in blue and red. To the right of the word JOYTECH is Chinese characters in blue.
| | second for final
temperature reading",
and predictive mode
changed from optional
to have this function | |
|--------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note 3 | Weight,Size,color
changed; | Biocompatibility test and performance bench test met
the requirements in the standards. The differences do
not raise new questions of safety and effectiveness |
9. Performance data
The following performance data were provided in support of the substantial equivalence determination:
Performance testing was conducted to validate and verify that Digital Thermometer, DMT-4756 met all requirements of related international standards, including electrical safety, EMC, biocompatibility, software validation and product specifications. Results of these tests demonstrate compliance to the requirements of the below consensus standards.
Electrical Safety and performance requirements:
- AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 Medical Electrical Equipment
- · ISO 80601-2-56:2017 · Medical electrical equipment Part 2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- . ASTM E1112:00(Reapproved 2011) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
Home-used medical equipment requirements and environmental test:
-
· IEC 60601-1-11:2015 General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home health care environment
Electromagnetic compatibility requirements: -
IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Biocompatibility Evaluation for patient contacting components: -
· ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
-
· ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
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Image /page/8/Picture/0 description: The image shows the logo for JOYTECH. The logo is blue and red. To the right of the word JOYTECH are three Chinese characters.
Guidance Document:
· Guidance on the content of Premarket Notifications [510(k)] Submissions for clinical electronic thermometers
The software/firmware verification and validation was provided in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
10. Discussion of Clinical Tests Performed:
The clinical tests were conducted on the DMT-4756 for each measurement site. The clinical tests evaluated 450 of subjects. The thermometer was evaluated in three groups 1) infants-newborn to one year; 2) children-greater than one to five years; and 3) adults-greater than five years old.The clinical performance test protocol and data analysis was conducted in accordance with ISO 80601-2-56. The test report showed the clinical performance of the subject device complied with the requirement of ISO 80601-2-56.
11. Conclusions:
Based on the performance testing,comparison and analysis in the submission, the subject digital thermometer DMT-4756 are substantially equivalent to the predicate thermometer DMT-4726(K183393).