(153 days)
Infrared Ear Thermometers, models ET-101D and ET-101H 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.
The Infrared Ear Thermometers, models ET-101D and ET-101H are electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. The thermometer's operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient. Both thermometer models include probes, which are used to measure ear canal temperature, plastic enclosures enclosing the display window as well as buttons and a battery cover. The disposable probe cover of ET-101H is optional when measuring temperature while ET-101D does not utilize a disposable probe cover. The Infrared Ear Thermometers measure temperature by reading infrared radiation emitting from the eardrum tissue. The small cone-shape end of the thermometer is inserted into the ear canal, where the eardrum (tympanic membrane) and surrounding tissues give off heat. The thermometer converts the heat into a temperature value using software.
Here's a breakdown of the acceptance criteria and study information for the Infrared Ear Thermometer (models ET-101D and ET-101H) based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by the precision (laboratory accuracy) and clinical accuracy, which align with the ASTM E1965-98 standard.
| Acceptance Criteria (Standard / Predicate) | Infrared Ear Thermometer ET-101D Performance | Infrared Ear Thermometer ET-101H Performance |
|---|---|---|
| Precision (Laboratory Accuracy) | ||
| ASTM E1965-98 (Reapproved 2009) | ±0.2°C (0.4°F) during 35.0°C | Ear mode: ±0.2°C (0.4°F) during 35.5°C |
| Clinical Accuracy | ||
| Predicate (ET-101A): | Clinical bias: 0.07°C (0.1°F) | Clinical bias: 0.08°C (0.14°F) |
| Clinical repeatability: 0.12 (0.2°F) | Clinical repeatability: 0.11 (0.2°F) | Clinical repeatability: 0.13 (0.23°F) |
| Limits of agreement: 0.8°C (1.4°F) | Limits of agreement: 0.76°C (1.4°F) | Limits of agreement: 0.76°C (1.31°F) |
| Other Requirements | Compliance Status | |
| Electrical Safety (AAMI/ANSI ES60601-1) | Complied | Complied |
| Performance (ISO 80601-2-56) | Complied | Complied |
| EMC (IEC 60601-1-2) | Complied | Complied |
| Biocompatibility (ISO 10993-5, ISO10993-10) | Complied | Complied |
| Home-used medical equipment (IEC 60601-1-11) | Complied | Complied |
| Software Validation | Complied | Complied |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Clinical evaluation of Infrared Ear Thermometers was conducted by Sejoy Electronics & Instruments Co., Ltd in compliance with ISO 80601-2-56 and ASTME1965." However, specific sample sizes for the clinical test set are not provided in this document. The geographic provenance of the data (country of origin) is also not explicitly stated, but given the manufacturer is Sejoy Electronics & Instruments Co., Ltd. from China, it is highly probable the study was conducted there. The document does not specify if the study was retrospective or prospective, but clinical evaluations for device approvals are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical evaluation. For temperature measurement devices, the ground truth is typically assessed against a highly accurate reference thermometer (e.g., rectal thermometer in a controlled setting) rather than subjective expert opinion.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
The document does not specify any adjudication method for the clinical test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was mentioned or conducted. This device is a diagnostic tool (thermometer) and does not involve human readers interpreting images or data where AI assistance would be relevant in that context. The "readers" are the users of the thermometer, and the output is a direct temperature reading.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is an inherently standalone device in terms of its core function: the device measures temperature and provides a reading. The clinical accuracy and precision tests are essentially standalone performance evaluations in a clinical setting. There is no "human-in-the-loop" performance in the sense of a human interpreting the device's output and making a further diagnosis/decision that needs to be assessed for improvement with AI. The user reads the temperature; the device algorithm calculates it.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
For clinical accuracy, the ground truth for temperature measurement devices is typically established by simultaneous measurements using a highly accurate and calibrated reference thermometer (often a rectal thermometer in a controlled environment) to which the investigational device's readings are compared. The document mentions compliance with ISO 80601-2-56 and ASTM E1965, which both define rigorous methods for establishing clinical accuracy against reference standards. While not explicitly stated as "rectal thermometer readings," this is the industry standard for such evaluations.
8. The Sample Size for the Training Set
The document does not specify a training set sample size. For a device like an infrared ear thermometer, there typically isn't a "training set" in the machine learning sense. The device's algorithm for converting infrared radiation to temperature is based on established physical principles and calibrated during manufacturing, rather than learned from a large dataset. The "training" for such a device would be more analogous to calibration and validation against physical standards.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" in the machine learning context is not applicable here, the concept of establishing ground truth for it is also not relevant. The device's underlying physics and algorithms are validated through bench testing and calibration against known temperature standards in a laboratory setting, and then confirmed for clinical accuracy against reference thermometers in human subjects.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2016
Sejoy Electronics & Instruments Co., Ltd. Ren Yunhua General Manager Building 2, No. 202, Zhenzhong Road, West Lake Economy & Technology Zone Hangzhou, 310030 CHINA
Re: K153146
Trade/Device Name: Infrared Ear Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 25, 2016 Received: February 29, 2016
Dear Ren Yunhua:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153146
Device Name Infrared Ear Thermometers ET-101D,ET-101H
Indications for Use (Describe)
Infrared Ear Thermometers, models ET-101D and ET-101H 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.
Type of Use (Select one or both, as applicable)
| Research Use Only (21 CFR 201.128) and/or |
|---|
| Over-The-Counter Use (21 CFR 201.66) and/or |
__ 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: K153146 Date Prepared: 2015.11.22
I. Submitter:
Name: Sejoy Electronics & Instruments Co., Ltd. Add.: Building 2, No.202, Zhenzhong Road, West Lake Economy & Technology Zone, Hangzhou, China 310030 Contact Person: Yunhua Ren Phone: +86-571-81957767 Fax: +86-571-81957750 Email: renyh@sejoy.com
II. Device:
Trade Name: Infrared Ear Thermometer, Including models: ET-101D,ET-101H Common Name: Infrared Ear Thermometer Classification name: Clinical Electronic Thermometer
Classification Information: Product Code: FLL- Clinical Electronic Thermometer Device Class: II Panel: 80 Regulation number: 880.2910
III.Predicate Device Information:
Infrared Ear Thermometer ET-101A, K082192 The predicate device is manufactured by Sejoy Electronics & Instruments Co., Ltd.
IV. Device Description:
The Infrared Ear Thermometers, models ET-101D and ET-101H are electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. The thermometer's operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient.
Both thermometer models include probes, which are used to measure ear canal temperature, plastic enclosures enclosing the display window as well as buttons and a battery cover. The disposable probe cover of ET-101H is optional when measuring temperature while ET-101D does not utilize a disposable probe cover.
The Infrared Ear Thermometers measure temperature by reading infrared radiation emitting from the eardrum tissue. The small cone-shape end of the thermometer is inserted into the ear canal, where the eardrum (tympanic membrane) and surrounding tissues give off heat. The thermometer converts the heat into a temperature value using software.
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V. Intended use / Indication for Use:
Infrared Ear Thermometers, models ET-101D and ET-101H are indicated for the intermittent measurement and monitoring of human body temperature by consumers in a home use environment. It is intended for use on people of all ages.
| SE Comparisons | SUBJECT DEVICE : | PREDICATE DEVICE: | Comparison Result | Remark |
|---|---|---|---|---|
| Infrared Ear ThermometerModel:ET-101D、ET-101HManufacturer:SEJOY ELECTRONICS &INSTRUMENTS CO., LTD | Infrared Ear ThermometerET-101A (K082192)Manufacturer:SEJOY ELECTRONICS &INSTRUMENTS CO., LTD | Identical | / | |
| Thermometer type | Infrared Ear ThermometerProduct code: FLL | Identical | / | |
| Measuring Site: | Ear canal | Identical | / | |
| Reference BodySite: | Oral (This thermometer converts the ear temperature to displayits "oral equivalent") | Identical | / | |
| Intended use(s) | Indicated for the intermittent measurement and monitoring of human bodytemperature by consumers in a home use environment.It's intended for use onpeople of all ages. | Identical | / | |
| Operation mode | Ear mode(Adjusted mode) | Identical | / | |
| Components& Materials | ET-101HCase: ABSProbe: Stainless steel & ABSProbe Cover: PEET-101DCase: ABSProbe: Stainless steel & ABS | Case: ABSProbe: Stainless steel & ABSProbe Cover: PE | Identical | ET-101D donot haveprobe cover |
| Sensor | Infrared Sensor | Identical | / | |
| Signal processingand display | Transform the analog signals to digital signals, then displays on the LCD | Identical | / |
VI. Comparison of Technological Characteristics with the Predicate Device
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| Measurement range | ET-101D | $32.0°C | $32.0°C | Similar | Meet therequirementof ASTME1965-98 |
|---|---|---|---|---|---|
| Ear mode:$28.0°C | |||||
| ET-101H | Object mode:$-20°C | ||||
| Operatingtemperature range | ET-101D | $10°C | $10°C | Identical | |
| ET-101H | Ear/Object mode:$10°C | ||||
| Storage andtransportationenvironment | $-25°C | Identical | |||
| Precision(Laboratory accuracy) | ET-101D | $±0.2°C (0.4°F)$ during $35.0°C | $±0.2°C (0.4°F)$ during $35.0°C | ||
| ET-101H | Ear mode:$±0.2°C$ ( $0.4°F$ ) during operating temperature range$35.5°C | $15°C | Similar | / | |
| Biocompatibility | Complied with the biocompatible requirements of FDA. | Identical | / | ||
| ET-101D | No accessory | Storage Case,Probe Cover | Different | / | |
| Accessories | ET-101H | Storage Case, Probe Cover | Storage Case, Probe Cover | Identical | / |
| Response time | Approximately 1 Second | Identical | / | ||
| ET-101D | Approx. 1 year/3000 readings | Approx. 1 year/3000 readings | Identical | / | |
| Battery Life | ET-101H | Approx. 1 year/6000 readings | Approx. 1 year/3000 readings | Similar | / |
| Clinical Accuracy | ET-101D | Clinical bias: $0.07°C$ ( $0.1°F$ )Clinical repeatability: 0.11( $0.2°F$ )Limits of agreement: $0.76°C$ ( $1.4°F$ ) | Clinical bias: $0.12°C$ ( $0.2°F$ )Clinical repeatability:0.12( $0.2°F$ )Limits of agreement: $0.8°C$ ( $1.4°F$ ) | Similar | / |
| ET-101H | Clinical bias: $0.08°C$ ( $0.14°F$ )Clinical repeatability: 0.13( $0.23°F$ )Limits of agreement: $0.76°C$ ( $1.31°F$ ) | ||||
| ET-101D | One CR2032 battery | One CR2032 battery | Different | / | |
| Power Sources | ET-101H | Two AAA batteries | One CR2032 battery | Different | / |
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| Probe Cover | ET-101D | NO | YES | Different | / |
|---|---|---|---|---|---|
| ET-101H | Optional | YES | Similar | / | |
| Low Battery Detection | YES | Identical | / | ||
| Automatic Power-Off | YES | Identical | / | ||
| Beep Alarm | YES | Identical | / | ||
| °C/°F Switchable | YES | Identical | / | ||
| Object temperaturemode | ET-101D | NO | NO | Identical | / |
| ET-101H | YES | NO | Different | / | |
| Ambient temperaturemode | ET-101D | NO | NO | Identical | / |
| ET-101H | YES | NO | Different | / | |
| Real time clock | ET-101D | NO | NO | Identical | / |
| ET-101H | YES | NO | Different | / | |
| Room Temperature | ET-101D | NO | NO | Identical | / |
| ET-101H | YES | NO | Different | / | |
| Backlight function | ET-101D | One color | NO | Different | / |
| ET-101H | Three colors in ear mode and onecolor in object mode | NO | Different | / | |
| Memory | ET-101D | 10 sets | 10 sets | Identical | / |
| ET-101H | Each 10 sets memories for earand object measurements | 10 sets | Similar | / | |
| Probe coverautomatic detectionfunction | ET-101D | NO | NO | Identical | / |
| ET-101H | YES | NO | Different | / |
Summary of technological characteristics / performance
The Infrared Ear Thermometer, Model ET-101D, ET-101H have substantially equivalent indications for use and technological characteristics as the predicate device.
-
- ET-101D,ET-101H have the same intended use/indication for use as the predicate device.
-
- The same technologies and test principles are used in the ET-101D and ET-101H thermometers as the predicate device.
-
- The identified differences in technological characteristics do not raise new or different questions of safety and effectiveness than the predicate devices.
-
- Although some specifications are slightly different than the predicate device, ET-101A, changes have been verified and validated as part of performance testing and safety /EMC testing and are included as part of this submission. Performance information and evidence of compliance to recognized standards demonstrate the device is substantially equivalent to the predicate devices.
Based upon the intended use, and upon the similarity of materials, product configuration and administration, it can be concluded the Infrared Ear Thermometer, Model ET-101D and ET-110H devices are substantially equivalent to the identified predicate device.
VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination:
Performance testing was conducted to validate and verify that Infrared Electronic Thermometers, models ET-101D and ET-101H met all requirements of related international standards, including electrical safety, EMC, biocompatibility, software validation and product specifications. Results of these tests demonstrate compliance to the requirements of the below consensus standards.
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Electrical Safety and performance requirements:
- AAMI/ANSI ES60601-1:2055/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 Medical Electrical Equipment
- . ISO 80601-2-56:2099 Medical electrical equipment Part 2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- ASTM E1965-98(Reapproved 2009) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
- ASTM E1104-98(Reapproved 2009) Standard Specification for clinical thermometer probe . covers and sheaths
Home-used medical equipment requirements and environmental test:
-
IEC 60601-1-11:2010 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 requirements: -
IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements for basic ● safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
Biocompatibility Evaluation for patient contacting components: -
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro ● cytotoxicity
-
ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and . skin sensitization
Guidance Document:
- Guidance on the content of Premarket Notifications [510(k)] Submissions for clinical electronic ● thermometers
The software/firmware verification and validation was provided in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
Discussion of Animal Tests Performed: No animal testing was performed.
Discussion of Clinical Tests Performed:
Clinical evaluation of Infrared Ear Thermometers was conducted by Sejoy Electronics & Instruments Co., Ltd in compliance with ISO 80601-2-56 and ASTME1965.
VIII. Conclusions:
The non-clinical data support the safety of the device and the hardware and software verifications and validation demonstrate that the Infrared Ear Thermometers, models: ET-101D and ET-101H should perform as intended in the specified use conditions. Based on the information provided in this submission, the Infrared Ear Thermometers, models: ET-101H are substantially equivalent to the predicate thermometer ET-101A.
§ 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.