(279 days)
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No
The document describes a standard digital thermometer and does not mention any AI or ML capabilities.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is a digital thermometer, which is used for measurement and diagnosis, not treatment.
No
A digital thermometer measures body temperature, which is a physiological parameter. While this measurement can be used as one piece of data to inform a diagnosis, the thermometer itself does not interpret data to identify a disease or condition. It simply provides a measurement.
No
The device description explicitly states it is a "hand-held, reusable, multi-user, battery operated device," indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device function: The DT100 Digital thermometer measures human body temperature directly from the body (axillary, oral, rectal). It does not analyze any specimens taken from the body.
Therefore, based on the provided information, the DT100 Digital thermometer falls under the category of a clinical thermometer, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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 nonsterile. The device is for people of all ages.
Product codes (comma separated list FDA assigned to the subject device)
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
axillary, oral, rectal
Indicated Patient Age Range
all ages
Intended User / Care Setting
hospital or home, doctor or consumers
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance data was provided in support of substantial equivalence. This included:
- 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 IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11.
- Performance Testing: ISO 80601-2-56 and ASTM E1112.
- Software Verification and Validation: A system level software 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.
No clinical testing data was included in the submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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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)
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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: +86-0757-88818786
| Primary Contact Person: | Mag Mei |
|---|---|
| General manager | |
| Smart Technology Co., Ltd. | |
| Tel: +86-0757-88818786 | |
| Consultant: | Olivia Meng |
| Regulatory Affairs Manager | |
| OSMUNDA Medical Device Consulting Co., Ltd. | |
| Tel: (+86)-20-6231 6262 | |
| 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 |
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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
of
Differences |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Device name | DT100 Digital Thermometer | Fudakang Digital thermometer
(BTA41-CN) | |
| K number | K203731 | K101387 | |
| | | | |
| Indications 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. | Fudakang Digital thermometer
are intended for the
measurement and monitoring of
human body temperature by
doctor or consumers in the
hospital or home. | Similar |
| Measurement site | axillary, oral and rectal
measurement. | axillary, oral and rectal
measurement. | Same |
| Use of probe cover | Measure oral or rectal position:
Use probe cover
Measure axillary position: no
require of probe cover | Measure oral or rectal position: no
Use probe cover
Measure axillary position: no
require of probe cover | Same |
| Temperature
Measurement
Technology | NTC thermistor resistance
technology | NTC thermistor resistance
technology | Same |
| Power source | 1.55V, LR41 alkaline or SR41 silver
oxide type | 1.5V button battery | Similar |
| composition | Main part, display screen, control
button, probe tip | Main part, display screen, control
button, probe tip | Same |
| Display resolution | 0.1 | 0.1 | Same |
| Material | Enclosure: Acrylonitrile Butadiene
Styrene
probe: stainless steel
button: silicone | Enclosure and button:
Acrylonitrile Butadiene Styrene
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) : +/-
0.1 °C (+/-0.2°F) | 35°C (95.0°F)- 39.0°C (102.0°F):
+/-0.1 °C (+/-0.2°F) | Same |
| Response time | 60 seconds | 60 seconds | Same |
| Low
battery
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
Measurement
Technology | NTC thermistor resistance
technology | NTC thermistor resistance
technology | Same |
| Key
temperature
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
ISO10993-5 ISO10993-10 | Comply with ISO 10993-1
ISO10993-5 ISO10993-10 | Same |
| Voluntary Standards
for clinical Electronic
Thermometer | ASTM E1112 | ASTM E1112 | Same |
| Medical Electrical
Safety and EMC | IEC 60601-1
IEC60601-1-2 | IEC 60601-1
IEC60601-1-2 | Same |
| Operating
and
storage condition | Operation: 16 to 40° C(60.8 to
104° F) and 15 to 95% humidity
noncondensing;
Storage: -20 to 50° C (-4 to 120°
F) and 15 to 95% humidity
noncondensing | Operation: 16 to 40° C(60.8 to
104° F) and 15 to 95% humidity
noncondensing;
Storage: -20 to 50° C (-4 to
120° F) and 15 to 95% humidity
noncondensing | Same |
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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:
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। 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.
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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.