(389 days)
No
The device description and performance studies focus on basic temperature measurement principles and standard electrical/biocompatibility testing, with no mention of AI or ML algorithms.
No.
The device measures body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any medical condition.
No
The device is a digital thermometer, which measures body temperature. While temperature can be an indicator of health status, the device itself simply provides a measurement and does not perform any diagnostic interpretation or analysis to identify a disease or condition.
No
The device description explicitly states it uses a thermistor and microcontroller unit to measure temperature and displays the value on an LCD screen, indicating it is a hardware device with embedded software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The DT007/DT008 Digital Thermometer directly measures human body temperature. It does not analyze any specimens taken from the body.
- Intended Use: The intended use clearly states it's for "measurement of human body temperature."
Therefore, this device falls under the category of a general medical device, specifically a thermometer, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
DT007 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the rectal body temperature measurement cannot be used for multipatient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.
DT008 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the rectal body temperature measurement cannot be used for multipatient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The basic principle of Digital Thermometer is that a change in thermistor resistance is caused by a change in temperature. The device measure body temperature by using a direct mode. The resistance is measured by a microcontroller unit, so that changes in temperature will correspond to changes in resistance. And the temperature value is displayed on the LCD screen. The device can be used for axillary, oral in the home, and used for axillary, oral and rectal temperature measurement in the hospital. The device is reusable and provided non-sterile. The device is intended for use on people of all ages. The probe cover is required when measuring the oral or rectal temperature, but not when measuring the axillary temperature.
The Digital Thermometer includes two models: DT007 and DT008. The differences of these two models are in appearance, PCB layout, external dimension and weight. All of them have the same function and they have the following basic functions:
- Data displayed on LCD
- Automatic stop (energy saver)
- Small, convenient, easy to use
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
doctors or customers in the hospital or at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
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 Test Summary
The subject device has been tested in compliance with the following standards:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- 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
- IEC 60601-1-11:2015 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
Biocompatibility Test
The subject device and the cleared device (K163603) of the same manufacturer use the same human body contacting material, and has the same nature of body contact and contact duration. The safety of the material has been demonstrated in the submission of K163603, complying with the requirements of ISO 10993-1, ISO 10993-5 and ISO 10993-10.
Performance Test-Bench
The subject device has been tested in compliance with the following standards:
- ISO 80601-2-56: 2017+ A1:2018 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
Software Verification
The software documentation of the subject device was provided in accordance with FDA guidance document "Guidance for the Content of Premarket Submissions for Software in Medical Devices" issued May 11, 2005.
Clinical Test Summary
No clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Measuring accuracy:
- 32.0°C ~35.9°C +/-0.2°C
- 36.0°C ~39.0°C +/-0.1°C
- 39.1°C ~42.9°C +/-0.2°C
- Display resolution: 0.1°C (0.1°F)
- Response time: 30s
- Auto-off Time: 10 mins
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.
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).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
January 20, 2023
Guangzhou Berrcom Medical Device Co., Ltd. % Liz Li Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town Shenzhen, Guangdong 518000 China
Re: K214077
Trade/Device Name: Digital Thermometer, Model: DT007, DT008 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 14, 2022 Received: December 21, 2022
Dear Liz Li:
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.
1
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 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.
David Walloschek
David Wolloscheck, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K214077
Device Name Digital Thermometer, Model: DT007, DT008
Indications for Use (Describe)
DT007 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the rectal body temperature measurement cannot be used for multipatient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.
DT008 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the rectal body temperature measurement cannot be used for multipatient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.
| 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) |
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
K214077 - 510(k) Summary
This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92.
1. Administrative Information
| Preparation Date | Dec.20, 2021 |
|---|---|
| Manufacturer | Guangzhou Berrcom Medical Device Co., Ltd. |
| Address: | |
| No. 38 Huanzhen Xi Road, Dagang Town, Nansha, | |
| Guangzhou, China. | |
| Contact person: Zhigang Du | |
| TEL: +86-020-34938449 | |
| E-Mail: dube888@berrcom.com | |
| Submission | |
| Correspondent | Shenzhen Joyantech Consulting Co., Ltd. |
| 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian | |
| Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong | |
| Province, China. | |
| Contact person: Liz Li | |
| E-Mail: liz@cefda.com; grace@cefda.com | |
| Image: Logo | |
| Establishment | |
| registration number | 3008395508 |
2. Device Information
| Type of 510(K): | Traditional |
|---|---|
| Submission: | K214077 |
| Device Name: | Digital Thermometer |
| Model: | DT007, DT008 |
| Classification Name: | Clinical Electronic Thermometer |
| Review Panel: | General Hospital |
| Device Class: | II |
| Regulation Number: | 880.2910 |
| Product Code: | FLL |
3. Predicate Device
| Manufacturer: | Smart Technology Co., Ltd. |
|---|---|
| Device Name: | Digital Thermometer |
| Model: | DT100 |
| 510(k) Number: | K203731 |
| Product Code: | FLL |
4. Device Description
The basic principle of Digital Thermometer is that a change in thermistor resistance is caused by a change in temperature. The device measure body temperature by using a direct mode. The resistance is measured by a microcontroller unit, so that changes in temperature will correspond to
4
Product: Digital Thermometer
changes in resistance. And the temperature value is displayed on the LCD screen. The device can be used for axillary, oral in the home, and used for axillary, oral and rectal temperature measurement in the hospital. The device is reusable and provided non-sterile. The device is intended for use on people of all ages. The probe cover is required when measuring the oral or rectal temperature, but not when measuring the axillary temperature.
The Digital Thermometer includes two models: DT007 and DT008. The differences of these two models are in appearance, PCB layout, external dimension and weight. All of them have the same function and they have the following basic functions:
- Data displayed on LCD ।
- Automatic stop (energy saver)
- Small, convenient, easy to use -
5. Intended Use/ Indications for Use
DT007 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the hospital. The rectal body temperature measurement cannot be used for multi-patient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.
DT008 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the hospital. The rectal body temperature measurement cannot be used for multi-patient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.
5
6. Comparison with Predicate Device
| Items | Subject Device
(K214077) | Predicate Device
(K203731) | Comparison |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device name and
model | Digital thermometer,
(Model: DT007, DT008) | DT100 Digital Thermometer | / |
| Product code | FLL | FLL | Identical |
| Intended Use
/ Indications for
Use | Digital Thermometer is intended for
the measurement of human body
temperature by doctors or
customers in the hospital or at
home. It can be used for axillary,
oral temperature measurement at
home, and used for axillary, oral
and rectal temperature
measurement in the hospital. The
rectal body temperature
measurement cannot be used for
multi-patient use at home. The
product is reusable and provided
nonsterile. The device is intended
for use on people of all ages. | 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. | Similar#1 |
| Principle of
operation | Thermistor resistance technology. | Thermistor resistance
technology. | Identical |
| Measurement site | axillary, oral and rectal | axillary, oral and rectal | Identical |
| Where used | Hospital or home | Hospital or home | Identical |
| Operation
environment
condition | Ambient temperature: $5℃40℃$104°F)
(41°F
Relative humidity: ≤85%
Pressure altitude:
700hPa to 1060hPa | 16 to $40℃$ (60.8 to 104°F)
and 15 to 95% humidity
noncondensing; | Different#2 |
| Storage condition | Storage temperature: $-20℃55℃$131°F)
(-4°F
Storage humidity: ≤95%
Pressure altitude:
700hPa ~ 1060hPa | -20 to $50℃$ (-4 to 120°F)
and 15 to 95% humidity
noncondensing | |
| Components | Main part, display screen, control button, probe tip | Main part, display screen, control button, probe tip | Identical |
| Sensor name | Thermistor | Thermistor | Identical |
| Power
Requirements | 1.5V d.c | 1.55V | Similar |
| Material used | Housing (including button): ABS
Probe: Stainless steel | Enclosure: Acrylonitrile Butadiene Styrene
probe: stainless steel
button: silicone | Different#3 |
| Measure
temperature range | $32°C ~ 42.9°C$
(89.6°F~109.2°F) | $32°C ~ 42.9°C$
(89.6°F ~109.2°F) | Identical |
| Operating mode | Direct mode | Direct mode | Identical |
| Measuring
accuracy | $32.0°C ~35.9°C ±0.2°C$
$36.0°C ~39.0°C ±0.1°C$
$39.1°C ~42.9°C ±0.2°C$ | $32°C$ - $42.9°C$ : +/- $0.1°C$ | Different#4 |
| Display resolution | $0.1°C$ ( $0.1°F$ ) | $0.1°C/0.1°F$ | Identical |
| Response time | 30s | 60s | Different#5 |
| Auto-off Time | 10 mins | unknown | Different#6 |
| Probe cover | Measure oral or rectal position:
Use probe cover
Measure axillary position: no
require of probe cover | Measure oral or rectal
position: Use probe cover
Measure axillary position: no
require of probe cover | Identical |
| Types of Tips | SUS304 stainless steel | unknown | Different#7 |
| Biocompatibility | Comply with
ISO 10993-5,
ISO 10993-10, | Comply with
ISO 10993-5,
ISO 10993-10, | Identical |
| Electric Safety and
EMC | IEC 60601-1,
IEC 60601-1-2,
IEC 60601-1-11 | IEC 60601-1,
IEC 60601-1-2,
IEC 60601-1-11 | Identical |
| Performance | ASTM E1112,
ISO 80601-2-56 | ASTM E1112,
ISO 80601-2-56 | Identical |
| Device size | DT007: 1281810mm
DT008: 1251911mm | unknown | Different#8 |
| LCD size | 2311.39.15mm (LWH) | unknown | |
6
7
Similar#1
The intended use of the subject device is described in more detail. The rectal measurement should be used in hospital because the high-level disinfection may only be done in hospital by health professionals. This is also specified in 【Warnings and precautions】in the user manual. This difference does not raise safety and effectiveness issues.
Similar#2
Although the "Operating environment condition" and "Storage condition" of subject device is different to the predicate device, the subject device has passed the performance test according to ASTM E1112 and ISO 80601-2-56. Additionally, the subject device was conformed to IEC 60601-1 and IEC 60601-1-11. Therefore, this difference would not raise adversely impact on safety and effectiveness.
Different#3
The materials used in the subject device is the same as the cleared device (K163603) from the same manufacturer. And the safety of the material has been demonstrated in the submission of K163603. Therefore, this difference would not raise adversely impact on safety and effectiveness.
Different#4
The measuring accuracy of subject device can meet the requirements of ASTM E1112 and ISO 80601-2-56. Therefore, this difference would not raise adversely impact on safety and effectiveness.
Different#5
The subject device has passed the performance test according to ASTM E1112 and ISO 80601-2-56. Therefore, this difference in the response time would not raise adversely impact on safety and effectiveness.
Different#6
Although the auto-off time of the predicate device is unknown, the 10-minute auto-off time of the subject device is sufficient for the intended user to obtain temperature data. Therefore, this difference would not raise adversely impact on safety and effectiveness.
Different#7
Although the information about the tips of the predicate device is unknown, the material of subject device is the same as that of the cleared device (K163603) from the same manufacturer. Additionally, the subject device has passed the performance test according to ASTM E1112 and ISO 80601-2-56. Therefore, this difference would not raise adversely impact on safety and effectiveness.
Different#8
Although the information about the size of the predicate device is unknown, the subject device has passed the performance test according to ASTM E1112 and ISO 80601-2-56. Therefore, this difference would not raise adversely impact on safety and effectiveness.
7. Non-Clinical Test Summary
8
7.1.Electromagnetic Compatibility and Electrical Safety Test
The subject device has been tested in compliance with the following standards:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2) 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
- IEC 60601-1-11:2015 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
7.2.Biocompatibility Test
The subject device and the cleared device (K163603) of the same manufacturer use the same human body contacting material, and has the same nature of body contact and contact duration. The safety of the material has been demonstrated in the submission of K163603, complying with the requirements of ISO 10993-1, ISO 10993-5 and ISO 10993-10.
7.3.Performance Test-Bench
The subject device has been tested in compliance with the following standards:
-
ISO 80601-2-56: 2017+ A1:2018 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
7.4.Software Verification
The software documentation of the subject device was provided in accordance with FDA guidance document "Guidance for the Content of Premarket Submissions for Software in Medical Devices" issued May 11, 2005.
7.5.Clinical Test Summary
No clinical testing was performed.
8. Conclusion
The subject device digital thermometer (Model: DT007, DT008) is substantially equivalent to the predicate device (K203731). This conclusion is based upon comparison on intended use, technological characteristics and performance testing.