(278 days)
The Digital Thermometers DMT series(Except DMT-455) 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, including children under 8 with adult supervision.
The device model DMT-455 is intended to measure temperature orally, and the device is reusable for clinical or home use for children less than 4 years old with adult supervision.
The Digital Thermometers DMT series are used to measure the human body temperature in regular mode orally, rectally, or under the arm. They have the same test principles, performance specifications and intended use as the Predicate device. The Digital Thermometers DMT series consists of a temperature sensor, low power consumption integrated circuit (IC), LCD display, and buzzer. The resistance of the sensor changes with temperature and the IC converts the resistance to frequency and calculates the temperature according to the relation of resistance and frequency. The calculated temperature is displayed on the LCD. The products have similar structural designs and the patient contacting materials are the same as the Predicate devices (Stainless Steel, TPE and Acrylonitrile Butadiene Styrene (ABS)).
The document provided describes the Joytech Healthcare Co., Ltd. Digital Thermometer, DMT Series (K163518) and its substantial equivalence to a predicate device (K153149). The information requested pertains to the acceptance criteria and study details for the device's performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Requirement) | Reported Device Performance (as listed in document) |
|---|---|
| Accuracy (between 35.5°C to 42.0°C) | ±0.1°C (±0.2°F, 95.9°F-107.6°F) |
| Accuracy (under 35.5°C or over 42.0°C) | ±0.2°C (±0.4°F under 95.9°F or over 107.6°F) |
| Electrical Safety and essential performance (AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012, ISO 80601-2-56:2009) | "met all requirements of related international standards, including electrical safety...Results of these tests demonstrate compliance to the requirements of the below consensus standards." In the SE Comparison table, it also states: "Complied with IEC 60601-1" |
| Home-used medical equipment requirements (IEC 60601-1-11:2015) | "met all requirements of related international standards, including...product specifications. Results of these tests demonstrate compliance to the requirements of the below consensus standards." |
| Electromagnetic compatibility (IEC 60601-1-2:2014) | "met all requirements of related international standards, including...EMC...Results of these tests demonstrate compliance to the requirements of the below consensus standards." In the SE Comparison table, it also states: "Complied with IEC 60601-1-2" |
| Biocompatibility (ISO 10993-5:2009 and ISO 10993-10:2010) (for patient contacting components: Stainless Steel, TPE and Acrylonitrile Butadiene Styrene (ABS)) | "met all requirements of related international standards, including...biocompatibility...Results of these tests demonstrate compliance to the requirements of the below consensus standards." In the SE Comparison table, it also states: "Comply with ISO 10993-5 and ISO 10993-10" |
| Software/firmware verification and 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." |
| Clinical performance (ISO 80601-2-56) | "The clinical performance test protocol and data analysis followed the requirements of ISO 80601-2-56." and "Based on the performance testing and bench data the submit digital thermometers DMT series are substantially equivalent to the predicate thermometers..." Note: The specific clinical accuracy results are not explicitly stated in this section, but the table above provides the general accuracy claims which are presumably substantiated by this clinical performance testing. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided document. The document states, "The clinical performance test protocol and data analysis followed the requirements of ISO 80601-2-56," but does not explicitly mention the number of subjects or temperature readings used.
- Data Provenance (country of origin of the data, retrospective or prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided as the device is a digital thermometer, and the "ground truth" for temperature measurement typically refers to reference standards or highly accurate measurement techniques rather than expert consensus on interpretation. For clinical performance, the ground truth would typically be a reference thermometer reading. The document mentions "clinical performance test protocol and data analysis followed the requirements of ISO 80601-2-56," which would define the method for establishing the reference temperature.
4. Adjudication method for the test set
- Not applicable as the device measures a quantitative value (temperature) directly, rather than relying on interpretation that would require adjudication.
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
- Not applicable. This is not an AI-assisted device requiring human reader interpretation. It is a standalone digital thermometer.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, performance testing was done on the device (digital thermometer) itself, which functions as a standalone instrument. The "Performance data" section describes testing conducted to verify and validate that the Digital Thermometers, DMT series met "all requirements of related international standards, including electrical safety, EMC, biocompatibility, software validation and product specifications." The accuracy claim of ±0.1°C / ±0.2°C is a standalone performance metric.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the accuracy and clinical performance testing, the ground truth would be established by a reference thermometer or a highly accurate temperature measurement system as defined by the standards (e.g., ISO 80601-2-56). The document does not specify the exact method but indicates compliance with relevant standards.
8. The sample size for the training set
- Not applicable. Digital thermometers are typically calibrated and validated, not "trained" in the machine learning sense. The device's operation is based on physical principles (resistance change with temperature) and a programmed algorithm, not a learning model.
9. How the ground truth for the training set was established
- Not applicable for the reason stated above. The device does not have a "training set." Calibration and validation are instead performed against known temperature references.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three faces in profile. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 19, 2017
Joytech Healthcare Co., Ltd Yunhua Ren General Manager No. 365, Wuzhou Road Yuhang Economic Development Zone Hangzhou. 311100 China
Re: K163518
Trade/Device Name: Digital Thermometer, DMT Series Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: August 10, 2017 Received: August 21, 2017
Dear 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. 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.
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
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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,
Michael J. Ryan -S
for Tina Kiang, PhD 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) K163518
Device Name Digital Thermometer DMT series
Indications for Use (Describe)
The Digital Thermometers DMT series(Except DMT-455) 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, including children under 8 with adult supervision.
The device model DMT-455 is intended to measure temperature orally, and the device is reusable for clinical or home use for children less than 4 years old with adult supervision.
| 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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510(k) Summary(21 CFR §807.92)
The assigned 510(k) number is: K163518
1. Date Prepared: September 06, 2017
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, DMT series
Models:DMT-101、DMT-411、DMT-301、DMT-102、DMT-202、DMT-412、DMT-423、 DMT-433、DMT-455、DMT-108、DMT-418、DMT-106、DMT-206、DMT-416、 DMT-427、DMT-437、DMT-4218、DMT-4318、DMT-1019、DMT-2019、 DMT-4119、DMT-4220、DMT-4320、DMT-4340、DMT-4343、DMT-4139、 DMT-2021、DMT-4121、DMT-209、DMT-1030、DMT-2030、DMT-4130、 DMT-1031、DMT-2031、DMT-4131、DMT-4226、DMT-4326、DMT-4726、 DMT-1027、DMT-2027、DMT-4127、DMT-1032、DMT-2032、DMT-3032、 DMT-4132、DMT-3033、DMT-4233、 DMT-4333、DMT-4235、DMT-4335、 DMT-4735、DMT-4236、DMT-4336、DMT-4737、DMT-4238、DMT-4338
Common Name: Digital Thermometer
Regulation number: 21 CFR §880.2910
Classification name: Clinical Electronic Thermometer
Regulation Class: II
Product Code: FLL
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4. Predicate Device Information:
The Digital Thermometers are substantially equivalent to the following devices:
Trade Name:Digital Thermometer, DMT series
510(k) Reference:K153149
Common Name:Digital Thermometer
Regulation Number:21 CFR §880.2910
Requlation Name: Clinical Electronic Thermometer
Requlatory Class:II
Product Code: FLL
Classification Panel: General Hospital
5. Indication for Use:
The Digital Thermometers DMT series(Except DMT-455) 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, including children under 8 with adult supervision.
The device model DMT-455 is intended to measure temperature orally, and the device is reusable for clinical or home use for children less than 4 years old with adult supervision.
6. Device Description:
The Digital Thermometers DMT series are used to measure the human body temperature in regular mode orally, rectally, or under the arm. They have the same test principles, performance specifications and intended use as the Predicate device. The Digital Thermometers DMT series consists of a temperature sensor, low power consumption integrated circuit (IC), LCD display, and buzzer. The resistance of the sensor changes with temperature and the IC converts the resistance to frequency and calculates the temperature according to the relation of resistance and frequency. The
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calculated temperature is displayed on the LCD. The products have similar structural designs and the patient contacting materials are the same as the Predicate devices (Stainless Steel, TPE and Acrylonitrile Butadiene Styrene (ABS)).
7. Comparing to Predicate Device:
The subject devices and predicate devices have no characteristic differences which raise new questions of safety and effectiveness. All differences are verified as substantially equivalent through applicable standardized testing. For details please see the following table:
| SE Comparisons | Subject device | Predicate device K153149(Model:MT-4132、MT-4726) | ComparisonResult |
|---|---|---|---|
| Indication for use | DMT series(except DMT-455) areintended to measure the humanbody temperature in regular modeorally, rectally or under the arm. Andthe devices are reusable for clinicalor home use on people of all ages.DMT-455 is intended to measuretemperature orally, and the device isreusable for clinical or home use forchildren less than 4 years old. | Measuring the human bodytemperature in regular mode orally,rectally or under the arm, and thedevices are reusable for clinical orhome use on people of all ages. | Similar |
| Measurement Site | DMT series (except DMT-455):orally, rectally or under the armDMT-455:orally | orally, rectally or under the arm | Similar |
| Range | DMT series (except DMT-47XX):32℃ | MT-4132:32℃ | Identical |
| DMT-4735,DMT-4726:32℃~42.9℃ (89.6°F ~109.2°F ) | MT-4726:32℃~42.9℃ (89.6°F ~109.2°F ) | Identical | |
| DMT-4737:35.5℃~42.0℃ | MT-4132: | Different | |
| (96.0°F -109.0°F) | 32°C | ||
| 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°Funder 95.9°For over 107.6 °F | ±0.1°C between 35.5°C to42.0°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 over107.6°F) | Identical |
| Display resolution | DMT series(except DMT-301,DMT-3032,DMT-3033,DMT-4737):0.1 C/0.1 F | 0.1 C/0.1 F | Identical |
| DMT-301,DMT-3032,DMT-3033:0.01 °C/0.01°F | 0.1 C/0.1 F | Different | |
| DMT-4737:Analog Display | 0.1 C/0.1 F | Different | |
| Components | Sensor, buzz film, housing, stainlesssteel cap, LCD display,measurement control module. | Sensor, buzz film, housing, stainlesssteel cap, LCD display, measurementcontrol module. | Identical |
| Operating Range | Temperature: 41°F | Temperature: 41°F | Identical |
| Storage andTransportationCondition | Temperature:-4°F~131°F (-20°C~55°C)Relative humidity: 15%~95%RHAtmospheric Pressure : 700hPa ~1060hPa | Temperature:-4°F~131°F (-20°C~55°C)Relative humidity: 15%~95%RHAtmospheric Pressure: 700hPa ~1060hPa | Identical |
| One 1.5 V DC. button battery (sizeLR41or SR41, UCC 392) | MT-4132:One 1.5 V DC. buttonbattery (size LR41or SR41, UCC392) | Identical | |
| Battery Type | DMT-4726,DMT-4735:One 3.0V CR2032 battery | MT-4726:One 3.0V CR2032 battery | Identical |
| DMT-4737:One 3.0V CR1225 battery | MT-4726:One 3.0V CR2032 battery | Different | |
| Biocompatibility | Comply with ISO 10993-5 and ISO10993-10 | Comply with ISO 10993-5 and ISO10993-10 | 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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8. Performance data
The performance data listed below is provided in support of the substantial equivalence determination.
Performance testing was conducted to verify and validate that Digital Thermometers, DMT series 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 80601-2-56:2009 Medical electrical equipment Part 2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
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 healthcare 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
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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.
9. Discussion of Clinical Tests Performed:
The clinical performance test protocol and data analysis followed the requirements of ISO 80601-2-56.
Conclusions: 10.
Based on the performance testing and bench data the submit digital thermometers DMT series are substantially equivalent to the predicate thermometers, model: MT-4132 and MT-4726.
§ 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.