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. And 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.

Device Description

The Digital Thermometers DMT series(Except DMT-455) are used to measure the human body temperature in regular mode orally, rectally, or under the arm.The device model DMT-455 is intended to measure temperature orally.

The Digital Thermometers DMT series consists of a temperature sensor, low power consumption integrated circuit (IC), LCD display, and buzzer. The resistance of 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.Only model DMT-4726 and DMT-4735 are predictive optional thermometers.The patient contacting materials are Stainless Steel,TPE and Acrylonitrile Butadiene Styrene (ABS).

AI/ML Overview

1. A table of acceptance criteria and the reported device performance

Criteria	Acceptance Criteria (from ISO 80601-2-56 and ASTM E1112)	Device Performance
Accuracy (Standard Models excluding predictive and 0.01°C resolution models)	±0.1°C between 35.5°C to 42.0°C (±0.2°F, 95.9°F-107.6°F)	Reported to comply with ISO 80601-2-56 and ASTM E1112
	±0.2°C under 35.5°C or over 42.0°C (±0.4°F under 95.9°F or over 107.6°F)	Reported to comply with ISO 80601-2-56 and ASTM E1112
Accuracy (0.01°C resolution models: DMT-301, DMT-3032, DMT-3033, DMT-3018)	±0.10°C between 35.5°C to 42°C	Reported to comply with ISO 80601-2-56 and ASTM E1112
Electrical Safety	Complied with IEC 60601-1	Complied with IEC 60601-1
EMC	Complied with IEC 60601-1-2	Complied with IEC 60601-1-2
Biocompatibility	Complied with ISO 10993-5 and ISO 10993-10	Complied with ISO 10993-5 and ISO 10993-10
Home-use medical equipment requirements and environmental test	IEC 60601-1-11:2015	Complied with IEC 60601-1-11:2015
Software/firmware validation	In accordance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.	Performed and reported as compliant.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The clinical tests for the predictive optional thermometers (DMT-4726 and DMT-4735) were conducted on 450 subjects. The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective, but the context of a 510(k) submission for a new device typically implies prospective data collection for safety and effectiveness.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document states that the "clinical performance test protocol and data analysis were conducted in accordance with the requirement of ISO 80601-2-56," which is a standard for clinical thermometers, but it does not detail the specific methodology for establishing ground truth or the qualifications of any experts involved in that process.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. The document mentions compliance with ISO 80601-2-56 for clinical performance, but does not specify any adjudication method related to ground truth establishment.

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 is not applicable. The device is a digital thermometer, which directly measures temperature and does not involve "human readers" or "AI assistance" in the context of interpretation of medical images or other diagnostic data where MRMC studies are typically conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone thermometer. The performance data presented refers to the direct measurement capabilities of the thermometer. The "clinical tests" described for models DMT-4726 and DMT-4735 assessed the device's ability to measure body temperature in living subjects against clinical standards, which inherently evaluates its standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For clinical thermometers, the "ground truth" for temperature measurement is typically established by highly accurate reference thermometers or other established methods considered the gold standard, consistent with the requirements of standards like ISO 80601-2-56 and ASTM E1112. The document states the clinical tests were conducted in accordance with ISO 80601-2-56, which would imply the use of such a reference.

8. The sample size for the training set

This is not applicable. The device is a digital thermometer, which operates based on physical principles of thermistor resistance. It is not an AI/ML-based device that would require a "training set" in the conventional sense of machine learning. The performance data relates to validation and verification against established standards and clinical performance for the manufactured product.

9. How the ground truth for the training set was established

This is not applicable as the device is not an AI/ML-based device requiring a training set. The "ground truth" in the context of thermometer calibration and performance testing would be derived from laboratory standards and validated reference measurements.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 18, 2019

Joytech Healthcare Co., LTD Mr. Ren Yunhua General Manager No. 365 Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Zhejian, 311100 China

Re: K183393

Trade/Device Name: Digital Thermometer DMT series (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-3018, DMT-4238, DMT-4338)

Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: October 14, 2019 Received: October 17, 2019

Dear Mr. Ren 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. 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.

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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 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 (QS) 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-device-safety/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 Advice (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 Geeta Pamidimukkala 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

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Indications for Use

510(k) Number (if known) K183393

Device Name

Digital Thermometer DMT series(DMT-101.DMT-411.DMT-301.DMT-202.DMT-412.DMT-423.DMT-433.DMT-455.DMT-108.DMT-418.DMT-106.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-4121,DMT-209,DMT-1030,DMT-2030,DMT-4130,DMT-1031,DMT-4131,DMT-4226,DMT-4326,DMT-4726,DMT-1027,DMT-2027,DMT-4127,DMT-1032,DMT-2032,DMT-4132,DMT-3033,DMT-4233,DMT-4233,DMT-4235,DMT-4335,DMT-4735,DMT-4236,DMT-4336,DMT-3018,DMT-4238,DMT-4338)

Indications for Use (Describe)

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)

区 Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

The assigned 510(k) number is: K183393

1. Date Prepared: 2019.11.18

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

Model: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-3018, DMT-4238、DMT-4338

Common Name: Digital Thermometer

Classification name: Clinical Electronic Thermometer

4. Classification Information:

Product Code: FLL

Device Class: II

Panel: 80

Regulation number:21 C.F.R.880.2910

Regulation Description: Clinical electronic thermometer

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5. Predicate Device Information:

The Digital Thermometers are substantially equivalent to the following devices: Digital Thermometers, Models: DMT series;

FDA 510(k)number: K 163518;

Manufactured by JOYTECH HEALTHCARE CO., LTD.

Intended use / Indication for Use: 6.

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.

7. Device Description:

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8.Model List

Features	A	B	C	D	E	F	G	H	I	J	K
Models
DMT-101	○	●	○	○	○	○	○	○	≤60 Seconds	12.3 x 1.8x 0.9	Approx. 10 g
DMT-411	○	●	○	●	○	●	○	○	≤45 Seconds	12.3 x 1.8x 0.9	Approx. 10 g
DMT-301	○	●	○	○	○	●	○	○	≤60 Seconds	12.3 x 1.8x 0.9	Approx. 10 g
DMT-102	○	●	○	○	○	○	○	○	≤60 Seconds	12.4 x 1.8x 1.1	Approx. 10 g
DMT-202	○	●	●	○	○	○	○	○	≤60 Seconds	12.4 x 1.8x 1.1	Approx. 10 g
DMT-412	○	●	●	●	○	●	○	○	≤45 Seconds	12.4 x 1.8x 1.1	Approx. 10 g
DMT-423	●	○	●	○	○	○	○	○	≤60 Seconds	12.4 x 2.4x 1.2	Approx. 12 g
DMT-433	●	○	●	●	○	●	○	○	≤45 Seconds	12.4 x 2.4x 1.2	Approx. 12 g
DMT-455	○	●	○	○	○	○	○	○	≤60 Seconds	5.8x 4.1x 4.3	Approx. 13 g
DMT-108	○	●	○	○	△	○	○	○	≤60 Seconds	13.9 x 2.3x 1.2	Approx. 12 g
DMT-418	○	●	○	●	△	●	○	○	≤45 Seconds	13.9 x 2.3x 1.2	Approx. 12 g
DMT-106	○	●	○	○	○	○	○	○	≤60 Seconds	12.2 x 1.9x 1.1	Approx. 11 g
DMT-206	○	●	●	○	○	○	○	○	≤60 Seconds	12.2 x 1.9x 1.1	Approx. 11 g
DMT-416	○	●	●	●	○	●	○	○	≤45 Seconds	12.2 x 1.9x 1.1	Approx. 11 g
DMT-427	●	○	●	○	○	○	○	○	≤60 Seconds	12.4 x 1.9x 1.1	Approx. 11 g
DMT-437	●	○	●	●	○	●	○	○	≤45 Seconds	12.4 x 1.9x 1.1	Approx. 11 g
DMT-4218	●	○	●	○	△	○	○	○	≤60 Seconds	13.9 x 2.2x 1.3	Approx. 11 g
DMT-4318	●	○	●	●	△	●	○	○	≤45 Seconds	13.9 x 2.2x 1.3	Approx. 11 g
DMT-3018	●	○	●	○	△	●	○	○	≤60 Seconds	13.9 x 2.2x 1.3	Approx. 11 g
DMT-1019	○	●	○	○	△	○	○	○	≤60 Seconds	13.9 x 2.3x 1.3	Approx. 11 g
DMT-2019	○	●	●	○	△	○	○	○	≤60 Seconds	13.9 x 2.3x 1.3	Approx. 12 g
DMT-4119	○	●	●	●	△	●	○	○	≤45 Seconds	13.9 x 2.3x 1.3	Approx. 12 g
DMT-4220	●	○	●	○	△	○	○	○	≤60 Seconds	13.9 x 2.3x 1.3	Approx. 13 g
DMT-4320	●	○	●	●	△	●	○	○	≤45 Seconds	13.9 x 2.3x 1.3	Approx. 13 g
DMT-2021	○	●	●	○	△	○	○	○	≤60 Seconds	12.2 x 1.9x 1.0	Approx. 11 g
DMT-4121	○	●	●	●	△	●	○	○	≤45 Seconds	12.2 x 1.9x 1.0	Approx. 11 g
DMT-209	○	●	●	○	○	○	○	○	≤60 Seconds	12.8 x 2.0x 1.2	Approx. 11 g
DMT-1030	○	●	○	○	○	○	○	○	≤60 Seconds	13.2 x 2.3x 1.2	Approx. 11 g
DMT-2030	○	●	●	○	○	○	○	○	≤60 Seconds	13.2 x 2.3x 1.2	Approx. 11 g
DMT-4130	○	●	●	●	○	●	○	○	≤45 Seconds	13.2 x 2.3x 1.2	Approx. 11 g
DMT-1031	○	●	○	○	○	○	○	○	≤60 Seconds	13.0 x 1.9x 1.0	Approx. 12 g
DMT-2031	○	●	●	○	○	○	○	○	≤60 Seconds	13.0 x 1.9x 1.0	Approx. 12 g
DMT-4131	○	●	●	●	○	●	○	○	≤45 Seconds	13.0 x 1.9x 1.0	Approx. 12 g
DMT-4226	●	○	●	○	△	○	○	○	≤60 Seconds	13.5 x 3.4x 1.7	Approx. 22 g
DMT-4326	●	○	●	●	△	●	○	○	≤45 Seconds	13.5 x 3.4x 1.7	Approx. 22 g
DMT-4726	●	○	●	●	Δ	●	Δ	Δ	≤45 Seconds	13.5 x 3.4x 1.7	Approx. 22 g
DMT-1027	○	●	○	○	○	○	○	○	≤60 Seconds	12.2 x1.8 x 1.1	Approx. 10 g
DMT-2027	○	●	●	○	○	○	○	○	≤60 Seconds	12.2 x1.8 x 1.1	Approx. 10 g
DMT-4127	○	●	●	●	○	●	○	○	≤45 Seconds	12.2 x 1.8 x 1.1	Approx. 10 g
DMT-1032	○	●	○	○	Δ	○	○	○	≤60 Seconds	13.8 x 2.2 x 1.2	Approx. 12 g
DMT-2032	○	●	●	○	Δ	○	○	○	≤60 Seconds	13.8 x 2.2 x 1.2	Approx. 12 g
DMT-3032	○	●	●	○	○	●	○	○	≤60 Seconds	13.8 x 2.2 x 1.2	Approx. 12 g
DMT-4132	○	●	●	●	Δ	●	○	○	≤45 Seconds	13.8 x 2.2 x 1.2	Approx. 12 g
DMT-3033	●	○	●	○	○	●	○	○	≤60 Seconds	13.9 x 2.2x 1.2	Approx. 12 g
DMT-4233	●	○	●	○	Δ	○	○	○	≤60 Seconds	13.9 x 2.2x 1.2	Approx. 12 g
DMT-4333	●	○	●	●	Δ	●	○	○	≤45 Seconds	13.9 x 2.2 x 1.2	Approx. 12 g
DMT-4235	●	○	●	○	Δ	○	○	○	≤60 Seconds	13.4 x 3.1 x 1.6	Approx. 23 g
DMT-4335	●	○	●	●	Δ	●	○	○	≤45 Seconds	13.4 x 3.1 x 1.6	Approx. 23 g
DMT-4735	●	○	●	●	Δ	●	Δ	Δ	≤45 Seconds	13.4 x 3.1x 1.6	Approx. 23 g
DMT-4236	●	○	●	○	○	○	○	○	≤60 Seconds	13.1 x 2.0x 1.2	Approx. 10 g
DMT-4336	●	○	●	●	○	●	○	○	≤45 Seconds	13.1 x 2.0x 1.2	Approx. 10 g
DMT-4343	●	○	●	●	○	●	○	○	≤45 Seconds	14.2 x 2.3x 1.3	Approx. 11 g
DMT-4238	●	○	●	○	○	●	○	○	≤60 Seconds	12.5 x 2.1x 1.2	Approx. 12.8 g
DMT-4338	●	○	●	●	○	●	○	○	≤45 Seconds	12.5 x 2.1x 1.2	Approx. 12.8 g
DMT-4139	○	●	●	●	○	●	○	○	≤60 Seconds	13.2 x 2.3x 1.3	Approx. 14.5 g
DMT-4340	●	○	●	●	○	●	○	○	≤45 Seconds	13.2 x 2.3x 1.3	Approx. 14.5 g

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A=Flexible tip

B=Rigid tip

C=Waterproof

D=Instant

E=TEMPERATURE ARROW INDICATING function

F=°C/°F switchable

G=Backlight function

H=Predictive

I=Water Bath Response time

J=Physical dimensions(L x H x W in cm) K=Weight(

including battery in grams )

• = Yes

o = No

△ =Optional

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9. Comparing to Predicate Device:

SE Comparisons	Subject device application K183393	Predicate device K163518(Model:DMT series)	ComparisonResult
Intended Use/Indication for use	DMT series(except DMT-455) areintended to measure 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.including children under 8 with adultsupervision.DMT-455 is intended to measuretemperature orally, and the device isreusable for clinical or home use forchildren less than 4 years old withadult supervision.	DMT series(except DMT-455) areintended to measure 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.including children under 8 with adultsupervision.DMT-455 is intended to measuretemperature orally, and the device isreusable for clinical or home use forchildren less than 4 years old withadult supervision.	Identical
Measurement Site	DMT series (except DMT-455):orally, rectally or under the armDMT-455:orally	DMT series (except DMT-455):orally, rectally or under the armDMT-455:orally	Identical
Range	DMT series(except DMT-30XX, DMT-47XX):$32.0°C~~43.9°C (90.0°F~~111.9°F)$DMT-301,DMT-3032,DMT-3033,DMT-3018:$32.00°C~~43.99°C(90.00°F~~111.99°F)$DMT-4735,DMT-4726: $32.0°C~~43.9°C (89.6°F~~111.0°F)$	DMT series(except DMT-30XX,DMT-47XX):$32.0°C~~42.9°C (90°F~~109.9°F)$DMT-301,DMT-3032,DMT-3033:$32.00°C~~42.99°C (90.00°F~~109.99°F)$DMT-4735,DMT-4726: $32.0°C~~42.9°C (89.6°F~~109.2°F)$	Similar
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$107.6°F$ )DMT-301, DMT-3032, DMT-3033, DMT-3018: $±0.10 °C$ between $35.5°C$ to $42°C$	$±0.1°C$ 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

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		DMT series(except DMT-301,DMT-3032,DMT-3033,DMT-3018):0.1°C/0.1 °FDMT-301,DMT-3032,DMT-3033,DMT-3018:0.01℃/0.01°F	DMT series(except DMT-301,DMT-3032,DMT-3033):0.1°C/0.1 °FDMT-301,DMT-3032,DMT-3033:0.01 ℃/0.01°F	Identical
Display resolution
components		Sensor, buzz film, housing, stainlesssteel cap, LCD display, measurementcontrol module.	Sensor, buzz film, housing, stainlesssteel cap, LCD display,measurement control module.	Identical
Principle of operation		A change of thermistor resistance,caused by changes of temperature.The resistance is measured bymicrocontroller unit (MCU), sochanges of temperature willcorrespond to changes of resistance.	A change of thermistor resistance,caused by changes of temperature.The resistance is measured bymicrocontroller unit (MCU), sochanges of temperature willcorrespond to changes of resistance	Identical
Operating range		Temperature: 41°F~104°F (5°C~40°C) Relative humidity:15%~95%RHAtmospheric Pressure : 700hPa ~1060hPa	Temperature: 41°F~104°F (5°C~40°C) Relative humidity:15%~95%RHAtmospheric Pressure : 700hPa ~1060hPa	Identical
Patient contactmaterial		ABS,TPE,Stainless Steel	ABS,TPE,Stainless Steel	Identical
Colour coding	ABS	9003	ABS	9003	Identical
	TPE	P351C,P288C,P374C,P284C,P2715C,P109C,P428C,P427C	TPE	P351C,P288C,P374C,P284C,P2715C,P109C,P428C,P427C
Storage andtransportationcondition	Temperature:	-4°F~131°F (-20℃~55℃)Relative humidity: 15%~95%RHAtmospheric Pressure : 700hPa ~	Temperature:	-4°F~131°F (-20℃~55℃)Relative humidity: 15%~95%RHAtmospheric Pressure : 700hPa ~	Identical

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	1060hPa	1060hPa
Battery type	One 1.5 V DC. button battery (sizeLR41or SR41, UCC 392)DMT-4726,DMT-4735:One 3.0V CR2032 battery	One 1.5 V DC. button battery (sizeLR41or SR41, UCC 392)DMT-4726,DMT-4735:One 3.0V CR2032 battery	Identical
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

The differences between two devices are:

Changed thermometer chip to extend temperature measuring range from 32.0~~42.9℃ to 32.0~~43.9 ℃ ,as new version of standard ISO 80601-2-56:2017 required, no other functions changed.

2.New model DMT-3018: it is a new model that have same appearance and same electrical scheme with predicate device model DMT-4318 but have only different temperature range and PCB with the predictive device.

10. 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 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
ISO80601-2-56:2017 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

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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
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.

11. Discussion of Clinical Tests Performed:

Clinical tests were conducted on the DMT-4726 and DMT-4735. The clinical tests evaluated 450 of subjects. and 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 were conducted in accordance with the requirement of ISO 80601-2-56. The test report showed the clinical performance of the subject devices complied with the requirement of ISO 80601-2-56.

12. Conclusions:

Based on the information provided in this submission,the subject digital thermometers DMT series are substantially equivalent to the predicate thermometers, model: DMT series.

Regulation Number and Section

§ 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.