(157 days)
No
The description focuses on standard infrared detection and processing, with no mention of AI, ML, or related concepts.
No
The device is intended for "measuring human body temperature" and provides "reference" information. It does not actively treat or mitigate a disease or condition.
Yes
An infrared thermometer measures body temperature, which is used as an indicator of a person's health status, making it a diagnostic device.
No
The device description explicitly states that the product is composed of "built-in infrared detector and related hardware and software," indicating it is a physical device with integrated software, not a software-only device.
No, 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 Infrared Thermometer (model: ZST-A) measures human body temperature by detecting infrared heat emitted from the forehead. It does not analyze any biological specimens taken from the body.
- Intended Use: The intended use is for measuring body temperature, which is a direct measurement of a physiological parameter, not an analysis of a sample.
Therefore, based on the provided information, the Infrared Thermometer (model: ZST-A) is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Infrared Thermometer (model: ZST-A) is a non-sterile, reusable, non-contact and 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
The Infrared Thermometer, Model ZST-A is a non-contact long-distance infrared thermometer which is specialized in measuring human body temperature. It contains buzzer prompt, memory reading, backlight reminder, temperature offset setting, alarm threshold setting, automatic shutdown and common functions of equipment.
The Infrared Thermometer measures the temperature by using the principle of receiving infrared.
♦ All objects radiate energy to their surroundings.
◆The temperature of an object is directly proportional to the intensity of radiation energy, that is, the higher the temperature, the greater the radiation energy.
♦ The energy radiated from human body is mainly infrared radiation. Therefore, human body temperature can be calculated by measuring the intensity of infrared energy radiated from human body to its surroundings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared heat
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Clinical tests were conducted per ASTM E1965-98(Reapproved 2016) Specification for Infrared Thermometers for for Intermittent Standard Determination of Patient Temperature. This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consists of a minimum of 105 subjects which were divided into three group age ranges- A Infant group (Group A1- 0 up to 3 months; Group A2- 3 months up to 1 year), B Child group (greater than 1 to 5 years old) and C Over 5 years old (Above 5 years old). Each group at least has 35 subjects.
Based on the result, it is demonstrated the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016).
Key Metrics
Accuracy: ±0.2°C (0.4°F) within 33.0°C ~ 39.0°C (91.4°F ~ 102.2°F), ±0.3°C(0.5°F) other range
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.
0
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.
Shandong Zhushi Pharmaceutical Group Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K203454
Trade/Device Name: Infrared Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: March 26, 2021 Received: March 30, 2021
Dear Boyle Wang:
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 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
1
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
2
Indications for Use
510(k) Number (if known) K203454
Device Name Infrared Thermometer
Indications for Use (Describe)
Infrared Thermometer (model: ZST-A) is a non-sterile, reusable, non-contact and 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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3
510(k) Summary (K203454)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 submitter's Information
Name: Shandong Zhushi Pharmaceutical Group Co., Ltd. Address: No.6 Shande Road,Shan County, Heze City, Shandong, China Tel: 86-15764021131 Fax: 86-530-4265777 Contact: Junhui Zhu Date of Preparation: Mar.26,2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Infrared Thermometer Common name: Infrared Thermometer Classification name: Clinical electronic thermometer Model(s): ZST-A
3.0 Classification
Production code: FLL Regulation number: 21CFR 880.2910 Classification: Class II Panel: General Hospital
4.0 Predicate Device Information
Manufacturer: Shenzhen Changkun Technology Co., Ltd. Infrared Thermometer (Models: CK-T1501, CK-T1502, CK-T1503) Device: 510(k) number: K193253
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5.0 Device Description
The Infrared Thermometer, Model ZST-A is a non-contact long-distance infrared thermometer which is specialized in measuring human body temperature. It contains buzzer prompt, memory reading, backlight reminder, temperature offset setting, alarm threshold setting, automatic shutdown and common functions of equipment.
The Infrared Thermometer measures the temperature by using the principle of receiving infrared.
♦ All objects radiate energy to their surroundings.
◆The temperature of an object is directly proportional to the intensity of radiation energy, that is, the higher the temperature, the greater the radiation energy.
♦ The energy radiated from human body is mainly infrared radiation. Therefore, human body temperature can be calculated by measuring the intensity of infrared energy radiated from human body to its surroundings.
♦Through the accurate measurement of the weak infrared radiation energy released by the human body, the non-contact infrared thermometer can accurately obtain the human body temperature after complex calculation processing and various compensation correction. The product is composed of built-in infrared detector and related hardware and software, which can receive, analyze and record the measured object and ambient temperature. Therefore, once the user approaches the specific part of the human body (forehead) and presses the measurement key, the infrared sensor can be activated immediately, and the thermal energy generated by the arterial blood flow can be detected quickly through the passive infrared sensor, so as to accurately measure the body temperature of the human body.
The measurement distance of the subject device is 1~5 cm from the middle of the forehead.
6.0 Indication for Use Statement
Infrared Thermometer (model: ZST-A) is a non-sterile, reusable, non-contact and 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.
7.0 Comparison to the Predicate Device
5
| Item | Subject Device K203454 | Predicate Device K193253 | Remark |
|---|---|---|---|
| Type of | |||
| Thermometer | Infrared Thermometer | ||
| ZST-A | Infrared thermometer | ||
| CK-T1501,CK-T1502, | |||
| CK-T1503 | -- | ||
| Product Code | FLL | FLL | Same |
| Regulation No. | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Class | II | II | Same |
| Intended Use& | |||
| Indications for | |||
| use | Infrared Thermometer | ||
| (model: ZST-A) is a | |||
| non-sterile, reusable, | |||
| non-contact and 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. | Infrared Thermometer | ||
| (model:CK-T1501, | |||
| CK-T1502,CK-T1503) is | |||
| a non-sterile, reusable, | |||
| non-contact and | |||
| 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. | Same | ||
| Prescription/ove | |||
| r-the-counter | |||
| use | over-the-counter use | over-the-counter use | Same |
| Measurement | |||
| technology | Infrared radiation detection | ||
| that converts a user's | |||
| forehead temperature using | |||
| the infrared energy emitted in | |||
| the area around the user's | |||
| forehead to a reference site | |||
| equivalent temperature | Infrared radiation | ||
| detection | Same | ||
| Measurement | |||
| place | Forehead | Forehead | Same |
| Measurement | |||
| Range | Forehead mode: | ||
| 32.0°C ~43.0°C | |||
| (89.6 to 109.4 ° F) | 32.0°C ~42.5°C | ||
| (89.6 to 108.5 ° F) | |||
| Accuracy | ±0.2°C (0.4°F) within | ||
| 33.0°C ~ 39.0°C | |||
| (91.4°F ~ 102.2°F), | |||
| ±0.3°C(0.5°F) other range | ±0.2°C (0.4°F) within | ||
| 35.0°C ~ 42.0°C | |||
| (95.0°F ~ 107.6°F), | |||
| ±0.3°C(0.5°F) other | |||
| range | Different | ||
| 1 | |||
| Display | |||
| resolution | 0.1°C(0.1°F) | 0.1°C(0.1°F) | Same |
| C/F switchable | Yes | Yes | Same |
| Measurement | |||
| distance | 1~5 cm | 3~5 cm | Different |
| 2 | |||
| Response time | 1s | 1s | Same |
| Sensor type | Thermopile | Thermopile | Same |
| Memory | 32 sets | 32 sets | Same |
| Buzzer | Yes | Yes | Same |
| Auto power-off | |||
| while no | |||
| operation | Yes | Yes | Same |
| Power supply | 2*1.5V AA battery | DC 3V (2 of AA alkaline | |
| batteries) | Same | ||
| Display screen | LCD | LCD | Same |
| Operation | |||
| Environment | 15.0°C | ||
| 104°F) | |||
| RH≤90% | |||
| 70.0kPa-106.0kPa | 10°C ~ 40°C; | ||
| 15% ~ 85%RH; | |||
| 80kPa~106kPa | Different | ||
| 3 | |||
| Storage | |||
| Environment | -20.0℃~55.0°F | ||
| (-4.0°F~131.0°F) | |||
| RH≤90% | |||
| 70.0kPa-106.0kPa | Not Publicly available | -- | |
| Dimension | 1594cm | Not Publicly available | -- |
| Weight | ≤93g | Not Publicly available | -- |
| Materials | User contacting materials are | ||
| ABS (Device Plastic Case, | |||
| Button & Battery Cover) | ABS | Same | |
| Conformance | |||
| standard | ISO80601-2-56, | ||
| IEC60601-1, | |||
| IEC60601-1-2, | |||
| IEC 60601-1-11 | |||
| ASTM E1965-98 | ISO80601-2-56, | ||
| IEC60601-1, | |||
| IEC60601-1-2, | |||
| IEC 60601-1-11 | |||
| ASTM E1965-98 | Same | ||
| Biocompatibility | ISO 10993-5 | ||
| ISO 10993-10 | ISO 10993-5 | ||
| ISO 10993-10 | Same |
6
Analysis:
From the comparison table, the subject devices and predicate device have the same Intended use & Indications for Use, Measurement place, Display resolution, Display screen, Auto power-off while no operation and
7
Conformance standard. There are slightly differences between the devices and predicate device as follows:
Different 1: Both devices have different measurement range, but they have the same accuracy and the measurement range of subject devices meet the requirements of ASTME1965-98. The different does not raise new performance questions.
Different 2: Measurement distance of the subject devices is 1-5cm, the predicate device's is 3-5cm. Although the "measurement distance" of subject device is a little different from the predicate devices. The clinical trial report of the subject device demonstrates the device meets the clinical accuracy requirements of the standards ISO 80601-2-56 and ASTM E1965-98 within the distance range, the differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
Different 3: Both devices have slightly different Operation &Storage Environment, but the subject devices meet the requirements of IEC60601-1.In conclusion, these differences do not raise any new safety or performance questions.
8.0 Non-Clinical Test Conclusion
Non-Clinical Performance Testing:
Non clinical tests were conducted to verify that the subject devices met all design specifications as were Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
IEC 60601-1: 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 compatibility - Requirements and tests -
ISO 80601-2-56: 2017+A1:2018 Medical electrical equipment Particular
requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement. -
●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
8
Biocompatibility Testing:
The biocompatibility evaluation for the ZST-A Infrared Thermometer were conducted in accordance with International Standards ISO 10993-1:2018, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, and ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and sensitization, as recognized by FDA, and per FDA guidance document entitled Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process,dated on September 4, 2020. The testing conducted included the following:
- · Cytotoxicity
- Irritation
- Sensitization
Software Information:
Software validation was conducted in accordance with a moderate level of concern designation in accordance with the FDA November 2005 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
9.0 Clinical Test Conclusion
Clinical tests were conducted per ASTM E1965-98(Reapproved 2016) Specification for Infrared Thermometers for for Intermittent Standard Determination of Patient Temperature. This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consists of a minimum of 105 subjects which were divided into three group age
ranges- A Infant group (Group A1- 0 up to 3 months; Group A2- 3 months up to 1 year), B Child group (greater than 1 to 5 years old) and C Over 5 years old (Above 5 years old). Each group at least has 35 subjects.
Based on the result, it is demonstrated the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016).
Based on the result, it is demonstrated the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016).
9
10.0 Conclusion
Performance testing contained in this submission demonstrates the minor differences in technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness. And based on the performance testing and compliance with acceptable voluntary standards, we believe the Infrared Thermometer ZST-A are substantially equivalent to its predicate device in K193253.