(161 days)
Not Found
No
The document describes a standard infrared ear thermometer and does not mention any AI or ML components or capabilities.
No.
The device is intended for measurement/diagnosis, not for treating a condition, disease, or injury.
No
The device is used for measuring body temperature, which is a vital sign, but it doesn't diagnose a specific disease or condition. It provides data that a healthcare professional might use as part of a diagnostic process, but it is not a diagnostic device itself.
No
The device description explicitly mentions hardware components such as an infrared detector, probe, plastic enclosure, display window, buttons, and battery cover.
No, 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: This device measures body temperature by detecting infrared radiation from the ear canal. It does not analyze a sample taken from the body. It measures a physical property of the body.
- Intended Use: The intended use is for "intermittent measurement of human body temperature," which is a direct measurement, not an analysis of a biological sample.
Therefore, based on the provided information, the Infrared Ear Thermometer is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Infrared Ear Thermometers are intended for the intermittent measurement of human body temperature by people of all ages. The devices are reusable for home use only.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Infrared Ear Thermometers are electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. It's operation is based on measuring the natural thermal radiation emanating from the tympanic membrane. DET-103 and DET-105 include probe cover that is optional. The Infrared Ear Thermometers include probe which used to measure ear canal temperature, plastic enclosed the display window, buttons and the battery cover.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
auditory canal / tympanic membrane / ear canal
Indicated Patient Age Range
all ages
Intended User / Care Setting
Home use only.
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
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 the requirement of ASTM E1965-98 (2016).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 the requirement of ASTM E1965-98 (2016).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 2, 2018
JOYTECH Healthcare Co., Ltd. Yunhua Ren General manager No.365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Zhejiang, 311100 China
Re: K181081
Trade/Device Name: Infrared Ear Thermometer, Model: DET-102, DET-102, DET-103, DET-105 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: August 25, 2018 Received: August 29, 2018
Dear Yunhua Ren:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181081
Device Name
Infrared Ear Thermometers DET-101,DET-102,DET-103,DET-105
Indications for Use (Describe)
Infrared Ear Thermometers are intended for the intermittent measurement of human body temperature by people of all ages. The devices are reusable for home use only.
| 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
The assigned 510(k) number is: K181081
Date Prepared: 2018.08.24 1.
Submitter's Identification: 2.
Name: JOYTECH Healthcare Co.,Ltd. Add.: No,365,Wuzhou Road,Yuhang Economic Development Zone, Hangzhou City,311100 Zhejiang,China
Contact Person: Yunhua Ren
Phone: +86-571-81957767
Fax: +86-571-81957750
Email: renyh@sejoy.com
3. Name of the Device:
| Device | Accessory | |
|---|---|---|
| Device Name | Infrared Ear Thermometer | |
| Models:DET-101,DET-102,DET-103,DET-105 | Probe Cover | |
| Trade Name | Infrared Ear Thermometer | |
| Models:DET-101,DET-102,DET-103,DET-105 | PC11 Probe Cover |
4. Classification Information:
Product Code: FLL
Device Class: II
Panel: 80
Regulation number:21 CFR 880.2910
Regulation Name: Clinical Electronic Thermometer
4
Predicate Device Information: 5.
Manufacturer: SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. Device: Infrared Ear Thermometer,Model ET-101H 510k number: K153146
6. Intended use / Indication for Use: _
Infrared Ear Thermometers are intended for the intermittent measurement of human body temperature by people of all ages. The devices are reusable for home use only.
7. Device Description:
Infrared Ear Thermometer:
The Infrared Ear Thermometers are electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. It's operation is based on measuring the natural thermal radiation emanating from the tympanic membrane.DET-103 and DET-105 include probe cover that is optional.
The Infrared Ear Thermometers include probe which used to measure ear canal temperature,plastic enclosed the display window,buttons and the battery cover.
Probe Cover:
The probe cover is used as a sanitary barrier between the infrared ear thermometer and the ear canal to prevent any secretions or particulates from being transferred between different people.
8. Comparing to Predicate Device:
5
| Comparisons | SUBJECT DEVICE:
Infrared Ear Thermometer
Model:DET-101,DET-102,DET-103,
DET-105
510k number:K181081 | PREDICATE DEVICE:
Infrared Ear Thermometer
Model:ET-101H
510k number:K153146 | Remark | |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|----------------------|
| Indications for
Use | Infrared Ear Thermometers are intended
for the intermittent measurement of
human body temperature by people of
all ages. The devices are reusable for
home use only. | Infrared Ear Thermometers are indicated
for the intermittent measurement and
monitoring of human body temperature
by consumers in a home use
environment. It's intended for use on
people of all ages. | Same | |
| Measurement
method | Infrared radiation detection | Infrared radiation detection | Same | |
| Measuring Site | Ear canal | Ear canal | Same | |
| Principle of
operation | The thermometer measures
temperature by reading infrared
radiation emitting from eardrum
tissue. The probe of the thermometer is
inserted into the ear canal, where
surrounding tissues give off heat. The
thermometer converts it into a
temperature value. | The thermometer measures temperature
by reading infrared radiation emitting
from eardrum tissue. The probe of the
thermometer is inserted into the ear
canal, where surrounding tissues give off
heat. The thermometer converts it into a
temperature value. | Same | |
| Display | $0.1°C (0.1°F)$ | $0.1°C (0.1°F)$ | Same | |
| Measurement
range | DET-101,
DET-102,
$32.0°C43.0°C$109.4°F)$ | Ear mode: $28.0°C
$(89.6°F43.0°C$109.4°F)$
$(82.4°F
Object mode: $-20°C100°C(-4°F212°F)$ | Similar
(Note1) | |
| | DET-103,
DET-105
Ear mode: $32.0°C43.0°C$109.4°F)$
$(89.6°F
Object mode:
$0°C100°C(32°F212°F)$ | Ear mode: $28.0°C43.0°C$109.4°F)$
$(82.4°F
Object mode: $-20°C100°C(-4°F212°F)$ | Similar
(Note1) | |
| Accuracy | DET-101,
DET-102
$±0.2°C (0.4°F)$ during
$35.0°C42.0°C (95.0°F$95.0°F)$ operating | Ear mode:
$107.6°F)$ at $15°C35°C$
$(59.0°F
$±0.2°C (0.4°F)$ during $35.5°C42.0°C$107.6°F)$ at $15°C~35°C (59.0°F$ | Similar
$(95.9°F
(Note1) | |
| | | temperature range | ~95.0°F) operating temperature range | |
| | | ±0.3℃ (0.5°F) for other
measuring and operating
temperature range | ±0.3℃ (0.5°F) for other measuring and
operating
temperature range | |
| | | Ear mode:
±0.2℃ (0.4°F) during
35.5℃~42.0℃ (95.9°F
~107.6°F) at 15℃35℃95.0°F) operating
(59.0°F
temperature range | Object mode: ±4% or ±2℃(4°F)
whichever is greater | |
| | DET-103,
DET-105 | ±0.3℃ (0.5°F) for other
measuring and operating
temperature range
Object mode: ±4% or ±
2°C(4°F) whichever is
greater | | |
| Operating
temperature
range | | 10℃40℃ (50°F104°F),
15%~85%RH, non-condensing
Atmospheric Pressure:
700hPa ~ 1060hPa | 10℃40℃ (50°F104°F), 15%~85%RH,
non-condensing
Atmospheric Pressure:
700hPa ~ 1060hPa | Same |
| Storage and
transport
environment | | -25℃55℃(-13°F131°F),
15%95%RH, non-condensing1060hPa | -25℃
Atmospheric Pressure:
700hPa55℃ (-13°F131°F),
15%95%RH, non-condensing1060hPa | Same |
Atmospheric Pressure:
700hPa
| Power Source | DET-101,
DET-102 | One CR2032 battery | Two AAA battery | Different
(Note2) |
| | DET-103,
DET-105 | Two AAA battery | Two AAA battery | Same |
| Accessory | DET-101,
DET-102 | No accessory | Probe cover | Different
(Note3) |
| | DET-103,
DET-105 | Probe cover | Probe cover | Same |
| Response Time | | Approx. One second | Approx. One second | Same |
| Material | | Enclosure;ABS
Probe:ABS & Glass
Probe Cover:PE | Enclosure;ABS
Probe:ABS & Glass
Probe Cover:PE | Same |
| Memory | | 10 memories | 10 memories | Same |
| Voice | DET-101,
DET-102,
DET-103 | No | No | Same |
| | DET-105 | Yes | NO | Different
(Note4) |
| Biocompatibility | Comply with ISO 10993-5 and ISO
10993-10 | | Comply with ISO 10993-5 and ISO
10993-10 | Same |
| Electrical
Safety | Complied with IEC 60601-1 | | Complied with IEC 60601-1 | Same |
| EMC | Complied with IEC 60601-1-2 | | Complied with IEC 60601-1-2 | Same |
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7
Analysis
From the comparison table, the subject devices and predicate devices have the same Intended use & Indications for Use, Measurement place, Scale selection, Display screen, Auto power-off while no operation & Conformance standard. There are slightly differences between the devices and predicate devices as follows and these differences do not raise new performance questions.
| Note1 | Measurement Range changes from 28.0 °C
43.0 °C to 32.0 °C43.0 °C & Accuracy changes
from ±0.2 °C (0.4 °F) during 35.5 °C42.0 °C107.6 °F) to ±0.2 °C (0.4 °F) during
(95.9 °F
35.0 °C42.0 °C (95.0 °F107.6 °F) | The changed measurement range and
accuracy of subject devices meet the
requirements of ISO80601-2-56 and
ASTM E1965-98. |
|-------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Note2 | DET-101, DET-102 Power Source changes from
Two AAA battery to CR2032 battery | Meet the requirement of IEC 60601-1. |
| Note3 | DET-101, DET-102 accessory changes from
have probe cover to no probe cover. | Meet the requirement of ASTM E1965-98. |
| Note4 | DET-105 add voice function | Software Validation passed. |
8
9. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Infrared Ear Thermometer conforms to applicable standards that include:
- ◆ ASTM E 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
- ◆ 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
- ◆ ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity,
- � ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- � 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
- ◆ ISO 80601-2-56: 2017 Medical electrical equipment - part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- � Software Validation:FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued on May 11, 2005
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10. 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 the requirement of ASTM E1965-98 (2016).
11. Conclusions:
Based on the information provided in this submission, we conclude that the submit Infrared Ear Thermometers, models: DET-101, DET-102,DET-103 and DET-105 are substantially equivalent to the predicate thermometer.