DT100 Digital Thermometer

K203731 · Smart Technology Co., Ltd. · FLL · Sep 26, 2021 · General Hospital

Device Facts

• Record ID: K203731
• Device Name: DT100 Digital Thermometer
• Applicant: Smart Technology Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Sep 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

DT100 Digital thermometer is intended for the measurement of human body temperature by doctor or consumers in the hospital or home. It can be used for axillary, oral and rectal measurement. The product is reusable and provided non-sterile. The device is for people of all ages.

Device Story

DT100 is a handheld, battery-operated digital thermometer; uses NTC thermistor resistance technology to measure body temperature via oral, axillary, or rectal sites. Operated by clinicians or patients in hospitals or homes. Device captures temperature data; processes signal via internal circuitry; displays result on screen. Provides memory function for last measurement. Assists healthcare providers or patients in monitoring body temperature for clinical decision-making. Reusable; non-sterile.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-5, -10), electrical safety/EMC (IEC 60601-1, -1-2, -1-11), and performance testing (ISO 80601-2-56, ASTM E1112).

Technological Characteristics

Enclosure: ABS; Probe: stainless steel; Button: silicone. Sensing: NTC thermistor resistance. Power: 1.55V LR41/SR41 battery. Dimensions/form: handheld. Connectivity: none. Sterilization: non-sterile. Standards: ASTM E1112, ISO 80601-2-56, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 10993-1/5/10.

Indications for Use

Indicated for human body temperature measurement in hospital or home settings for all ages; suitable for axillary, oral, and rectal use.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• Fudakang Digital thermometer (BTA41-CN) (K101387)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 26, 2021

Smart Technology Co., Ltd. % Yulan Gao Overseas Registration Assistant Specialist Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China

Re: K203731

Trade/Device Name: DT100 Digital Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: August 20, 2021 Received: August 24, 2021

Dear Yulan Gao:

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.

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

{1}------------------------------------------------

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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Payal Patel 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) K203731

Device Name DT100 Digital Thermometer

Indications for Use (Describe)

DT100 Digital thermometer is intended for the measurement of human body temperature by doctor or consumers in the hospital or home. It can be used for axillary, oral and rectal measurement. The product is reusable and provided nonsterile. The device is for people of all ages.

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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# K203731 - 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

#### SUBMITTER INFORMATION l.

Smart Technology Co., Ltd.

No. 8 Xingcheng East Road, Fuwan Industrial Area, Gaoming District, Foshan,

Guangdong Province, China

Phone: [phone]

| Primary Contact Person: | Mag Mei |
|-------------------------|---------------------------------------------|
| | General manager |
| | Smart Technology Co., Ltd. |
| | Tel: [phone] |
| Consultant: | Olivia Meng |
| | Regulatory Affairs Manager |
| | OSMUNDA Medical Device Consulting Co., Ltd. |
| | Tel: [phone] |
| | Fax: (+86) -20-8633 0253 |

Date Prepared:

September 24, 2021

#### II. SUBJECT DEVICE

| Name of Device: | DT100 Digital Thermometer |
|-----------------------|-----------------------------------|
| Model: | DT100 |
| Common/Usual Name: | Clinical electronic thermometer |
| Classification Names: | Thermometer, Electronic, Clinical |
| Regulation Number: | 21 CFR 880.2910 |
| Device Class: | II |
| Product Code: | FLL |

{4}------------------------------------------------

#### lll. PREDICATE DEVICE

Sponsor: Fudakang Industrial Co., Ltd Device Name: Fudakang Digital thermometer; Model: BTA41-CN 510(k) Number: K101387

#### IV. DEVICE DESCRIPTION

DT100 digital thermometer is a fast, highly accurate, and easy to use clinical instrument for measuring patient temperatures by oral, axillary or rectal means. The digital thermometer is a hand-held, reusable, multi-user, battery operated device. It has one model DT100.

#### V. INDICATION FOR USE

DT100 Digital thermometer is intended for the measurement of human body temperature by doctor or customers in the hospital or home. It can be used for axillary, oral and rectal measurement. The product is reusable and provided non-sterile. The device is for people of all ages.

VI.

DT100 Digital thermometer is intended for the measurement of human body temperature by doctor or consumers in the hospital or home. It can be used for axillary, oral and rectal measurement. The product is reusable and provided non-sterile. The device is for people of all ages.

#### VII. SUBSTANTIAL EQUIVELENCE

| Specification | Proposed Device | Predicate Device | Discussion<br>of<br>Differences |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Device name | DT100 Digital Thermometer | Fudakang Digital thermometer<br>(BTA41-CN) | |
| K number | K203731 | K101387 | |
| | | | |
| Indications for Use | DT100 Digital thermometer is<br>intended for the measurement of<br>human body temperature by<br>doctor or customers in the<br>hospital or home. It can be used<br>for axillary, oral and rectal<br>measurement. The product is<br>reusable and provided non-<br>sterile. The device is for people of<br>all ages. | Fudakang Digital thermometer<br>are intended for the<br>measurement and monitoring of<br>human body temperature by<br>doctor or consumers in the<br>hospital or home. | Similar |
| Measurement site | axillary, oral and rectal<br>measurement. | axillary, oral and rectal<br>measurement. | Same |
| Use of probe cover | Measure oral or rectal position:<br>Use probe cover<br>Measure axillary position: no<br>require of probe cover | Measure oral or rectal position: no<br>Use probe cover<br>Measure axillary position: no<br>require of probe cover | Same |
| Temperature<br>Measurement<br>Technology | NTC thermistor resistance<br>technology | NTC thermistor resistance<br>technology | Same |
| Power source | 1.55V, LR41 alkaline or SR41 silver<br>oxide type | 1.5V button battery | Similar |
| composition | Main part, display screen, control<br>button, probe tip | Main part, display screen, control<br>button, probe tip | Same |
| Display resolution | 0.1 | 0.1 | Same |
| Material | Enclosure: Acrylonitrile Butadiene<br>Styrene<br>probe: stainless steel<br>button: silicone | Enclosure and button:<br>Acrylonitrile Butadiene Styrene<br>probe: stainless steel | Same |
| Measurement Range | 32°C (89.6°F)- 42.9°C(109.2°F) | 32°C (89.6°F)- 42.9°C(109.2°F) | Same |
| Accuracy | 32°C (89.6°F)-42.9°C(109.2°F) : +/-<br>0.1 °C (+/-0.2°F) | 35°C (95.0°F)- 39.0°C (102.0°F):<br>+/-0.1 °C (+/-0.2°F) | Same |
| Response time | 60 seconds | 60 seconds | Same |
| Low<br>battery<br>indicator | Yes | Yes | Same |
| Memory function | Yes | Yes | Same |
| Memory capacity | Last one measurement record | Last one measurement record | Same |
| Reusable device | Yes | Yes | Same |
| Temperature<br>Measurement<br>Technology | NTC thermistor resistance<br>technology | NTC thermistor resistance<br>technology | Same |
| Key<br>temperature<br>sensor | NTC thermistor | NTC thermistor | Same |
| Power requirement | LR41 button cell | LR41 button cell | Same |
| Scale | Switchable | Switchable | Same |
| Biocompatibility | Comply with ISO 10993-1<br>ISO10993-5 ISO10993-10 | Comply with ISO 10993-1<br>ISO10993-5 ISO10993-10 | Same |
| Voluntary Standards<br>for clinical Electronic<br>Thermometer | ASTM E1112 | ASTM E1112 | Same |
| Medical Electrical<br>Safety and EMC | IEC 60601-1<br>IEC60601-1-2 | IEC 60601-1<br>IEC60601-1-2 | Same |
| Operating<br>and<br>storage condition | Operation: 16 to 40° C(60.8 to<br>104° F) and 15 to 95% humidity<br>noncondensing;<br>Storage: -20 to 50° C (-4 to 120°<br>F) and 15 to 95% humidity<br>noncondensing | Operation: 16 to 40° C(60.8 to<br>104° F) and 15 to 95% humidity<br>noncondensing;<br>Storage: -20 to 50° C (-4 to<br>120° F) and 15 to 95% humidity<br>noncondensing | Same |

{5}------------------------------------------------

{6}------------------------------------------------

Substantial equivalence conclusion:

Technical parameters are the same/similar between the proposed and predicate device. We believe that the Digital thermometer is as safe and effective, and performs in a substantially equivalent manner to the predicate device.

#### VIII. NON-CLINICAL PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence:

## Biocompatibility:

The thermometer has been evaluated according to ISO 10993-5 and ISO 10993-10, and has been demonstrated as biocompatible safety.

## Electrical Safety and EMC:

The device was tested in accordance with:

{7}------------------------------------------------

। IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.

- IEC 60601-1-2 Medical Electrical Equipment -- Part 1-2: General Requirements for Basic Safety and Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements and Tests

- IEC 60601-1-11 Medical electrical equipment - Part 1-11: 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

## Performance Testing:

- 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.

- ASTM E1112 Standard specification for electronic thermometer for intermittent determination of patient temperature

### Software Verification and Validation:

Per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", Smart Technology has provided appropriate software documentation based on Level of Concern. A system levelsoftware verification and validation protocol were developed to test each requirement. Results of each test are recorded and compared to the pass/fail criteria. All software verification and validation activities show that the software meets product requirements documentation.

#### IX. CLINICAL TESTING DATA

No clinical testing data is included in this submission.

{8}------------------------------------------------

#### CONCLUSION x.

The DT100 digital thermometer is substantially equivalent to the Fudakang Digital thermometer with respect to the technological characteristics, Indications for use, non-clinical and performance testing.