(170 days)
No
The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and the device description is that of a standard infrared thermometer.
No.
The device is intended for measurement and monitoring of body temperature, which is a diagnostic function, not a therapeutic one. It does not exert any direct treatment or intervention to alleviate or cure a medical condition.
No
The device measures human body temperature, which is a physiological parameter, but it does not diagnose a condition or disease. It provides data that may be used in conjunction with other information for diagnostic purposes, but it is not a diagnostic device itself.
No
The device description explicitly states it is a "hand-held, battery powered, infrared thermometer" which indicates it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body. This includes things like blood, urine, tissue, etc., to provide information about a physiological state, health, disease, or congenital abnormality.
- This device measures body temperature directly from the forehead. It does not analyze any biological samples taken from the body.
The description clearly states its purpose is the "intermittent measurement and monitoring of human body temperature" by measuring "temperature from center of the forehead." This is a direct measurement of a physiological parameter, not an analysis of a biological specimen.
N/A
Intended Use / Indications for Use
Infrared Forehead Thermometer, model: HS-9802D is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
Infrared Forehead Thermometer, model: HS-9802D is a hand-held, battery powered, infrared thermometer that measures human body temperature from forehead. The reference body site is oral. The device measures temperature from center of the forehead.
Principle of operation:
Infrared Forehead Thermometer, model: HS-9802D is an electronic thermometer uses IR sensor (thermopile) to detect infrared radiation emitting from forehead, after then, the IR sensor outputs electrical signal which is fed to circuit for amplification and then being inputted to MCU, the MCU captures the temperature measured from center of forehead. The measured temperature will finally appear on LCD display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead (Measurement site), Oral (Reference site)
Indicated Patient Age Range
people of all ages
Intended User / Care Setting
Not Found
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)
The clinical accuracy test report and data analysis followed the requirements of the ASTM E 196598 (2016).
The clinical accuracy testing evaluated 105 of subjects, division of all subjects into (1) infantsnewborn up to one year, (2) children- greater than one to five years; and (3) adults-greater than five years ol. The test data showed the clinical accuracy of the subject device complied with the requirements of ASTM E1965-98 (2016).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
September 19, 2022
Jiaxing Shangjia Intelligence Technology Co., Ltd. % You Yijie Manager Oimmig Medical Consulting Service Co., Ltd. RM.1711, Building K, NO.101 Science Ave International Creative Valley Guangzhou, Guangdong 510663 China
Re: K213038
Trade/Device Name: Infrared Forehead Thermometer, model: HS-9802D Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL
Dear You Yijie:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 10, 2022. Specifically, FDA is updating this SE Letter typo in the trade name as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Payal Patel, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, 240-402-6029, payal.patel(@fda.hhs.gov.
Sincerely,
Danil WalloscheR
David Wolloscheck, Ph.D. For 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
1
Image /page/1/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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 10, 2022
Jiaxing Shangjia Intelligence Technology Co., Ltd. You Yijie Manager Oimmig Medical Consulting Service Co., Ltd. RM.1711. Building K. NO.101 Science Ave International Creative Valley Guangzhou, Guangdong 510663 China
Re: K213038
Trade/Device Name: Infrared Forehead Thermometer, model: HS-98020 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 31, 2022 Received: January 31, 2022
Dear You Yijie:
We have reviewed vour 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
2
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,
FDA
Gang Peng for 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
3
Section 4: Indications for Use Statement (Form FDA 3881)
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Infrared Forehead Thermometer, model: HS-9802D
Indications for Use (Describe)
Infrared Forehead Thermometer, model: HS-9802D is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.
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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5
Section 5: 510(k) Summary
1. Submitter's Information
Establishment Registration Information
Name: Jiaxing Shangjia Intelligence Technology Co., Ltd. Address: Room 102 and Room 202, Building No.9, Jiaxing Intelligence & Innovation Park, No.36, South Changsheng Road, Jiaxing, Zhejiang, China
Contact Person of applicant
Name: Lou Yongwei Address: Room 102 and Room 202, Building No.9, Jiaxing Intelligence & Innovation Park, No.36, South Changsheng Road, Jiaxing, Zhejiang, China TEL: +86 0573 89978800 Email: 100831552@qq.com
Contact Person of the Submission:
Name: Yijie You Address: RM.1711, Building K, No.101 Science Ave International Creative Valley Development Zone, Guangzhou China TEL: +86 020-8224 5821 FAX: +86 020-8224 5821 Email: Jet.you@qimmiq-med.com
Date prepared: Sep. 8, 2021
2. Device Information
| Device Common Name: | Clinical electronic thermometer |
|---|---|
| Trade Name: | Infrared Forehead |
| Thermometer | |
| Model: | HS-9802D |
| Regulation name: | Clinical electronic thermometer |
| Review Panel: | General Hospital |
| Product Code: | FLL |
| Regulation Class: | II |
| Regulation Number: | 880.2910 |
3. Predicate Device Information
| 510(k) submitter/holder: | Microlife Intellectual Property GmbH, Switzerland. |
|---|---|
| 510(K) Number: | K191829 |
| Trade Name: | Microlife Non-Contact Infrared Forehead Thermometer. |
6
Model: FR1DG1 (NC200) Clinical electronic thermometer Classification name: Review panel: General Hospital Product code: FLL Regulation Class: Regulation Number: 880.2910
4. Device description
Infrared Forehead Thermometer, model: HS-9802D is a hand-held, battery powered, infrared thermometer that measures human body temperature from forehead. The reference body site is oral. The device measures temperature from center of the forehead.
Principle of operation:
Infrared Forehead Thermometer, model: HS-9802D is an electronic thermometer uses IR sensor (thermopile) to detect infrared radiation emitting from forehead, after then, the IR sensor outputs electrical signal which is fed to circuit for amplification and then being inputted to MCU, the MCU captures the temperature measured from center of forehead. The measured temperature will finally appear on LCD display.
5. Indications for Use
Infrared Forehead Thermometer, model: HS-9802D is intended for the internittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.
Summary of technological characteristics of device compared to 6. the predicate device
| SE
Comparisons | Subject device
(Infrared Forehead Thermometer,
model: HS-9802D) | Primary predicate device
(K191829, Microlife Non-Contact Infrared
Forehead Thermometer, Model: FR1DG1
(NC200)) | Discussion of
difference |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Classification | 21CFR 880.2910 | 21CFR 880.2910 | Same |
| Product Code | FLL | FLL | Same |
| FDA Class | II | II | Same |
| Intended Use | Infrared Forehead Thermometer, model:
HS9802D is intended for the intermittent
measurement and monitoring of human body
temperature. The device is indicated for use
by people of all ages in the home. | The Microlife Non-Contact Infrared
Forehead Thermometer, Model FR1DG1
(NC200) is intended for the intermittent
measurement and monitoring of human
body temperature. The device is
indicated for use by people of all ages in
the home. | Same |
7
| Principle of
| operation | Measure temperature by reading infrared radiation emitting from the forehead when | Measure temperature by reading infrared radiation emitting from the forehead when | Same |
|---|---|---|---|
| the |
| | thermometer is placed within few
centimeters of forehead. | the thermometer is placed within few
centimeters of forehead. | |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------|
| target
population | people of all ages | people of all ages | Same |
| Measurement
site | forehead | forehead | Same |
| Material of
Patient contact
components | Probe: ABS
Cap: PS
Liquid crystal display (LCD): Glass
ON/Scan button: ABS
Battery Cover (shell has same material):
ABS
Memory button: Silica gel | Housing and battery cover material:
ABS707
Patient-Contact Button material: PMMA | Different
(Discussion is
indicated in D1) |
| Biocompability
testing | Meets ISO 10993- 5
ISO 10993-10 | Meets ISO 10993- 5
ISO 10993-10 | Same |
| Environment | home | home | Same |
| Design | Handheld | Handheld | Same |
| Measurement
method | Infrared radiation detection | Infrared radiation detection | Same |
| Display Type | LCD | LCD | Same |
| Measurement
Mode | Forehead mode | Forehead mode | Same |
| Reference site | Oral | Oral | Same |
| Key | Two buttons (ON/Scan button, Memory
button) | Two buttons (M-button, START I/O
button) | Same |
| Scale selection | °C/°F | °C/°F | Same |
| Display unit | °C/°F | °C/°F | Same |
| High
temperature
warning | Yes | Yes | Same |
| Low battery
indicator | Yes | Yes | Same |
| Sensor Type | Thermopile | Thermopile | Same |
| Performance
Testing | Meets ASTM E1965-98 and ISO 80601-2-
56 | Meets ASTM E1965-98 and ISO 80601-
2-56 | Same |
| Electrical Safety | ANSI AAMI ES60601-1 | ANSI AAMI ES60601-1 | Same |
| EMC Meets | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Measuring
Range | 34.0 to 42.0 °C (93.2 to 107.6 °F). | 32.0-43.0 °C (89.6-109.4 °F) | Different
(Discussion is
indicated in D2) |
| Display
resolution | 0.1°F (0.1ć) | 0.1°F (0.1ć) | Same |
| Measuring
accuracy | ±0.3°C (0.5°F): 34.0 to 42.0 °C (93.2 to
107.6 °F). | ±0.2 °C: 35.0 ~ 42.0 °C
±0.3 °C: 34.0 ~ 34.9 °C, 42.1 ~ 43.0 °C | Different
(Discussion is
indicated in D3) |
| Measuring
Distance |