(277 days)
Not Found
No
The summary describes a standard infrared thermometer using a thermopile sensor and thermistor, with no mention of AI or ML in the device description, intended use, or performance studies.
No
A therapeutic device is a medical device that treats or prevents a disease or condition. This device is an infrared thermometer, which is used for measuring body temperature and does not provide therapy.
Yes
The device is an infrared thermometer intended for measuring human body temperature, which is a diagnostic indicator for various conditions like fever.
No
The device description explicitly states it is a "hand-held, battery powered, non-contact infrared thermometer" and details its physical components (sensor, PCB, buttons, LCD, enclosure), 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 diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Infrared Thermometer (model: STM-20) measures human body temperature by detecting infrared heat emitted from the forehead. This is a non-invasive measurement taken directly from the body, not from a sample taken from the body.
Therefore, the device falls under the category of a medical device, specifically a clinical thermometer, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Infrared Thermometer (model: STM-20) is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
Product codes
FLL
Device Description
Infrared Thermometer (model: STM-20) is a hand-held, battery powered, non-contact infrared thermometer that coverts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead, to an oral equivalent temperature when placed within 1-3 cm from the subject's forehead with no contact. The Infrared Thermometer referenced body site is oral temperature. The laboratory accuracy of rated output temperature range 34°C-42°C (93.2°F to 107.6°F) is ±0.2°C (0.4°F). The rated extended output range is 32°C33.9°C (89.6°F to 93.0°F), 42.1°C43°C (107.8°F to 109.4°F) and the laboratory accuracy is ±0.2°C (0.4°F) as well. The device can be used in the hospital or at home.
It uses a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the head of the thermometer for ambient temperature readings.
It composed by a measuring sensor, PCB, 3 buttons, a LCD and an enclosure. Press the measurement key to turn on the device. The screen of the device lights up. The LCD screen has the power symbol, measurement mode, temperature unit and measurement temperature. When measuring body temperature, users need to keep the measurement distance 1-3 cm from the subject's center of forehead with no contact. Press the measuring key, after 1 second with the sound of "beep", the measurement is completed and the temperature is displayed on the LCD screen. Without any operation, it will close automatically in 30±5 seconds.
User contacts components are the enclosure and keys. The materials of the components are ABS plastic and it no any color additives.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
forehead
Indicated Patient Age Range
people over one month old
Intended User / Care Setting
consumers in homecare environment and doctors in clinic
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
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Summary of Performance Studies
Clinical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2016). The test report showed the clinical performance of the subject device complied with ASTM E1965-98 (2016).
Clinical tests were conducted on the subject device Model STM-20. The clinical tests evaluated 240 of subjects. The proposed thermometer was evaluated in four groups A1 - one month up to three month, A2 - three months to one year; B1 -older than one years and younger than five years; and C - older than five years old. The clinical performance test protocol and data analysis were conducted in accordance with the ASTM E1965-98 (2016). The test report showed the clinical performance of the subject device complied with ASTM E1965-98 (2016).
Key Metrics
Measuring accuracy: ±0.2°C (0.4°F)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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March 9, 2021
Dongguan Prestige Sporting Goods Co., Ltd % Ms. Cassie Lee Official Correspondent Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou, Guangdong 510000 China
Re: K201508
Trade/Device Name: Infrared Thermometer, Model STM-20 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: February 4, 2021 Received: February 9, 2021
Dear Ms. Cassie Lee:
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.
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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 Payal Patel 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
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Indications for Use
510(k) Number (if known) K201508
Device Name Infrared Thermometer (Model: STM-20)
Indications for Use (Describe)
Infrared Thermometer (model: STM-20) is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
| 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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510(k) Summary for K201508
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
510(k) Owner's Name: Dongguan Prestige Sporting Goods Co., Ltd Address: 3rd industrial, Qiaotou Area, Houjie Town, Dongguan City, Guangdong province, China Tel: +86-13763128800 Fax: 86-769-85922505 Contact Person: Zhang, Zhao (General Manager) Email: leon@solaxtech.com
Application Correspondent:
Contact Person: Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com
Date of the summary prepared: February 23, 2021
2. Subject Device Information
Trade Name: Infrared Thermometer (model: STM-20) Common Name: Clinical electronic thermometer Classification name: Thermometer, electronic, clinical Review Panel: General Hospital Product Code: FLL Regulation Class: II Regulation Number: 21 CFR 880.2910
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3. Predicate Device Information
Sponsor: Intrinity Global Limited Trade Name: Non Contact Infrared Forehead Thermometer(model:TVT-200, TVT-200 PLUS) Classification Name: Clinical Electronic Thermometer Common Name: Infrared Thermometer 510(K) Number: K170662 Review Panel: General Hospital Product Code: FLL Regulation Number: 880.2910 Regulation Class: II
4. Device Description
Infrared Thermometer (model: STM-20) is a hand-held, battery powered, non-contact infrared thermometer that coverts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead, to an oral equivalent temperature when placed within 1-3 cm from the subject's forehead with no contact. The Infrared Thermometer referenced body site is oral temperature. The laboratory accuracy of rated output temperature range 34°C-42°C (93.2°F to 107.6°F) is ±0.2°C (0.4°F). The rated extended output range is 32°C33.9°C (89.6°F to 93.0°F), 42.1°C43°C (107.8°F to 109.4°F) and the laboratory accuracy is ±0.2°C (0.4°F) as well. The device can be used in the hospital or at home.
It uses a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the head of the thermometer for ambient temperature readings.
It composed by a measuring sensor, PCB, 3 buttons, a LCD and an enclosure. Press the measurement key to turn on the device. The screen of the device lights up. The LCD screen has the power symbol, measurement mode, temperature unit and measurement temperature. When measuring body temperature, users need to keep the measurement distance 1-3 cm from the subject's center of forehead with no contact. Press the measuring key, after 1 second with the sound of "beep", the measurement is completed and the temperature is displayed on the LCD screen. Without any operation, it will close automatically in 30±5 seconds.
User contacts components are the enclosure and keys. The materials of the components are ABS plastic and it no any color additives.
5. Intended Use / Indications for Use
Infrared Thermometer (model: STM-20) is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
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6. Comparison to predicate device
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Infrared Thermometer is substantially equivalent to the predicate device quoted above.
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Company | Dongguan Prestige Sporting | ||
| Goods Co., Ltd | Intrinity Global Limited | -- | |
| Trade Name | Infrared Thermometer | Non Contact Infrared Forehead | |
| Thermometer | -- | ||
| Classification | |||
| Name | Clinical Electronic Thermometer | Clinical Electronic Thermometer | Same |
| 510(k) | |||
| Number | K201508 | K170662 | -- |
| Product Code | FLL | FLL | Same |
| Intended Use | |||
| / Indications | |||
| for Use | Infrared Thermometer (model: | ||
| STM-20) is a non-sterile, | |||
| reusable, handheld device. It | |||
| can be used by consumers in | |||
| homecare environment and | |||
| doctors in clinic as reference. It | |||
| is intended for measuring human | |||
| body temperature of people over | |||
| one month old by detecting | |||
| infrared heat from the forehead. | Non Contact Infrared Forehead | ||
| Thermometer is a non-sterile, | |||
| reusable, handheld device. It | |||
| can be used by consumers in | |||
| homecare environment and | |||
| doctors in clinic as reference. It | |||
| is intended for measuring | |||
| human body temperature of all | |||
| ranges of people by detecting | |||
| infrared heat from the forehead. | Different | ||
| Note 3 | |||
| Display | LCD Digital Display | LCD Digital Display | Same |
| Measurement | |||
| method | Infrared radiation detection | Infrared radiation detection | Same |
| Measurement | |||
| mode | Forehead measure mode | Forehead measure mode | Same |
| Measuring | |||
| range | 32°C to 43°C (89.6°F to | ||
| 109.4°F) | 32° C to 43°C (89.6°F to | ||
| 109.4°F) | Same | ||
| Display | |||
| resolution | 0.1°C/0.1°F | 0.1°C/0.1°F | Same |
| C/F | YES | YES | Same |
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Verdict |
| switchable | |||
| Measuring | |||
| accuracy | $ \pm0.2°C (0.4°F) $ | $ \pm0.2°C (0.4°F) $ | Same |
| Measurement | |||
| distance | 1-3 cm | 1 cm | Similar |
| Note 1 | |||
| Memory | None | 16 sets. | Different |
| Note 2 | |||
| Power source | DC 3V | DC 3V | Same |
| Operating | |||
| condition | 5°C ~ 40°C; | ||
| 15% ~ 85%RH | 15°C~ 40°C (59°F~ 104°F); | ||
| ≤95% RH | Different | ||
| Note 2 | |||
| Transport | |||
| storage | |||
| environment | -20°C ~ 55°C; | ||
| ≤ 93%RH | Not public | Different | |
| Note 2 | |||
| Patient | |||
| contact | |||
| materials | ABS | ABS with colorants (pink, grey, orange and purple), Glass and Metal | Same |
| Cleaning/ | |||
| disinfection | The thermometer casing and the measuring probe should be cleaned and disinfected by 70% alcohol. | The thermometer casing and the measuring probe should be cleaned and disinfected by 70% alcohol. | Same |
| Electric | |||
| Safety and | |||
| EMC | IEC 60601-1 | ||
| IEC 60601-1-2 | |||
| IEC 60601-1-11 | |||
| ISO 80601-2-56 | IEC 60601-1 | ||
| IEC 60601-1-2 | |||
| IEC 60601-1-11 | |||
| ISO 80601-2-56 | Same |
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Comparison in Detail(s):
Note 1:
The "Measurement distance" of subject device is similar with predicate device, both of them meet the requirement of safety and essential performance standard ISO 80601-2-56. The differences between the predicate device and subject device does not affect the safety and effectiveness of the subject device.
Note 2:
The "Memory", "Operating condition" and "Transport storage environment" of subject device is different with predicate device. There is no memory feature in the subject device and memory
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feature is not an essential requirement of IR thermometers. The operating condition and transport storage environment met the requirements of standard ISO 80601-2-56. The performance test shows the subject device complies with performance standard. The differences between the predicate device and subject device does not affect the safety and effectiveness of the subject device.
Note 3:
The patient population of the subject device is a subset of the predicate device. The subject device met the requirements of the standards ISO 80601-2-56 and ASTM E1965-98. Based on the performance evaluation, the differences between the predicate device and subject device does not affect the safety and effectiveness of the subject device.
7. Summary of Non-Clinical Testing
7.1 Non-clinical testing was conducted to verify that the subject device met all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed: Infrared Thermometer has been evaluated the safety and performance by lab bench testing as following:
- � Electrical safety test according to ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD), IEC 60601-1-11 Edition 2.0 2015-01 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
- � Electromagnetic compatibility test according to IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- � Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)"
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- � ISO 80601-2-56 Second edition 2017-03, Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)].
- � ASTM E1965-98 (2016): Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
7.2 Discussion of Clinical Tests Performed
The clinical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2016). The test report showed the clinical performance of the subject device complied with ASTM E1965-98 (2016).
Clinical tests were conducted on the subject device Model STM-20. The clinical tests evaluated 240 of subjects. The proposed thermometer was evaluated in four groups A1 - one month up to three month, A2 - three months to one year; B1 -older than one years and younger than five years; and C - older than five years old. The clinical performance test protocol and data analysis were conducted in accordance with the ASTM E1965-98 (2016). The test report showed the clinical performance of the subject device complied with ASTM E1965-98 (2016).
8. Final Conclusion:
Based on the performance testing, comparison and analysis, the subject device Infrared Thermometer (model: STM-20) is substantially equivalent to the predicate device.