(121 days)
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.
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.
This document is a 510(k) summary for the Joytech Healthcare Co., Ltd. Digital Thermometer, Model DMT-4756. It outlines the device's characteristics, its comparison to a predicate device, and the testing conducted to demonstrate its substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria (from predicate or standard) | Reported Device Performance (DMT-4756) |
|---|---|---|
| Accuracy (Temperature) | ±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 to predicate device. Clinical performance test protocol and data analysis 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." |
| Measurement Range | 32.0°C~43.9°C (89.6°F-111.0°F) | Identical to predicate device. |
| Display Resolution | 0.1 °C/0.1 °F | Identical to predicate device. |
| Measurement Time | Predicate: Approximate 5 ~ 10s | DMT-4756: 10s Predictive read, 30s Final read. "Performance test including clinical test shows the subject device complies with performance standard." |
| Predictive Mode | Predicate: Optional | DMT-4756: Yes (has this function). "Performance test including clinical test shows the subject device complies with performance standard." |
| Construction (Foldable Probe) | Predicate: Flexible Digital Thermometer | DMT-4756: The probe is foldable into the body of the thermometer. "Performance testing shows the subject device complies with standard ISO 80601-2-56." |
| Biocompatibility | Comply with ISO 10993-5 and ISO 10993-10 | Complied with ISO 10993-5 and ISO 10993-10. "Biocompatibility test and performance bench test met the requirements in the standards." |
| Electrical Safety | Complied with IEC 60601-1 / AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012, ISO 80601-2-56:2017, ASTM E1112:00(Reapproved 2011) | Complied with IEC 60601-1 / AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012, ISO 80601-2-56:2017, ASTM E1112:00(Reapproved 2011). "Performance testing was conducted to validate and verify that Digital Thermometer, DMT-4756 met all requirements of related international standards, including electrical safety... Results of these tests demonstrate compliance to the requirements of the below consensus standards." |
| Electromagnetic Compatibility (EMC) | Complied with IEC 60601-1-2:2014 | Complied with IEC 60601-1-2:2014. "Performance testing was conducted to validate and verify that Digital Thermometer, DMT-4756 met all requirements of related international standards, including ... EMC... Results of these tests demonstrate compliance to the requirements of the below consensus standards." |
| Home-used medical equipment requirements | Complied with IEC 60601-1-11:2015 | Complied with IEC 60601-1-11:2015. "Performance testing was conducted to validate and verify that Digital Thermometer, DMT-4756 met all requirements of related international standards... Results of these tests demonstrate compliance to the requirements of the below consensus standards." |
| Software Validation | "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005 | "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." |
2. Sample size used for the test set and the data provenance:
- Sample Size: 450 subjects for the clinical tests. These were divided into three groups:
- Infants: newborn to one year
- Children: greater than one to five years
- Adults: greater than five years old
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "The clinical tests were conducted on the DMT-4756 for each measurement site." Without further information, it's not possible to determine the geographical origin of the subjects. The description of the test as "clinical tests were conducted" implies a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The clinical performance was evaluated against the requirements of ISO 80601-2-56, which are standards for clinical thermometers.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe any adjudication method. The clinical performance was evaluated against a standard (ISO 80601-2-56) rather than against expert consensus on individual cases.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This information is not applicable. The device is a digital thermometer, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This information is not applicable in the context of a digital thermometer. The device itself is standalone in its function of measuring temperature. The clinical tests evaluate the device's accuracy in direct measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical tests, the ground truth is implicitly established by the performance standard ISO 80601-2-56. This standard defines the acceptable accuracy limits for clinical body temperature measurement devices. The study aimed to show that the device's readings fell within these established accuracy criteria.
8. The sample size for the training set:
- This information is not applicable. This is a traditional medical device (digital thermometer) and does not involve machine learning or AI models that require a separate "training set" in the conventional sense. The device's calibration and internal algorithms are developed through engineering and testing, not by training on a dataset of patient readings.
9. How the ground truth for the training set was established:
- This information is not applicable, as there is no "training set" for an AI model in this context.
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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.
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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
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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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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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| SEComparisons | Subject device K200599DMT-4756 | Predicate device K183393(Model:DMT-4726) | ComparisonResult |
|---|---|---|---|
| Intended Use/Indication for use | The Digital Thermometer DMT-4756 isintended to measure the human bodytemperature in regular mode orally,rectally or under the arm, and thedevice is reusable for clinical or homeuse on people of all age, includingchildren under 8 with adult supervision | The Digital Thermometer DMT-4726 isintended to measure the human bodytemperature in regular mode orally,rectally or under the arm. The device isreusable for clinical or home use onpeople of all ages, including childrenunder 8 with adult supervision. | Identical(Only changein modelnumber) |
| Fundamentaltechnology&Operatingprinciple | A change of thermistor resistance,caused by changes of temperature. Theresistance is measured by MCU, sochanges of temperature will correspondto changes of resistance | A change of thermistor resistance,caused by changes of temperature. Theresistance is measured by MCU, sochanges of temperature will correspondto changes of resistance | Identical |
| Sensor | Thermistor | Thermistor | Identical |
| Signal processingand display | -Internal firmware and localLCD display | -Internal firmware and localLCD display | Identical |
| MeasurementSite | orally, rectally or under the arm | orally, rectally or under the arm | Identical |
| Range | $32.0°C~43.9°C (89.6°F-111.0°F)$ | $32.0°C~43.9°C (89.6°F-111.0°F)$ | 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, stainlesssteel cap, LCD display, measurementcontrol module. | Sensor, buzz film, housing, stainlesssteel cap, LCD display, measurementcontrol module. | Identical |
| Memories | 10 memories | 10 memories | Identical |
| Material | ABS,TPE,Stainless steel | ABS,TPE,Stainless steel | Identical |
| Operating range | Temperature:$41°F | Temperature:$41°F | Identical |
| Construction | The probe is foldable into the body of the thermometer | Flexible Digital Thermometer | Different(Note1) |
| Measurement method & time | 10s Predictive read30s 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 | 2.5cm*1.4cm | 2.7cm*2.1cm | 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~131°F (-20℃~55℃)Relative humidity: 15%~95%RHAtmospheric Pressure:700hPa ~ 1060hPa | Temperature:-4°F~131°F (-20℃~55℃)Relative humidity: 15%~95%RHAtmospheric 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 |
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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 foldableconstruction function | Performance testing shows the subject devicecomplies with standard ISO 80601-2-56. Thedifference does not raise new questions of safety andeffectiveness |
|---|---|---|
| Note 2 | Measure time changedfrom approximate5~10s to “10 secondpredictive quick read,30 | Performance test including clinical test shows thesubject device complies with performance standard.The differences do not raise new questions of safetyand effectiveness |
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| second for finaltemperature reading",and predictive modechanged from optionalto have this function | ||
|---|---|---|
| Note 3 | Weight,Size,colorchanged; | Biocompatibility test and performance bench test metthe requirements in the standards. The differences donot 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).
§ 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.