(161 days)
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.
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.
The provided text describes the 510(k) premarket notification for an Infrared Ear Thermometer. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed acceptance criteria and studies in the same way one might for a novel AI/ML device or a device requiring a PMA.
Therefore, many of the requested details about acceptance criteria, study design (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), and training set information are not available in this document. The document primarily focuses on explaining how the new device is similar to an existing one (the predicate device).
However, I can extract the safety and performance standards the device is stated to conform to, which serve as the "acceptance criteria" for this type of device based on regulatory standards.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like a thermometer, "acceptance criteria" refer to the performance specifications defined by recognized standards.
| Acceptance Criteria (from conformity to standards) | Reported Device Performance (from comparison table) |
|---|---|
| Measurement Range: | |
| Per ISO 80601-2-56 and ASTM E1965-98 | DET-101, DET-102: 32.0°C |
| DET-103, DET-105: Ear mode:32.0°C | |
| Accuracy: | |
| Per ISO 80601-2-56 and ASTM E1965-98 | DET-101, DET-102: ±0.2°C (0.4°F) during 35.0°C |
| DET-103, DET-105: ±0.2°C (0.4°F) during 35.5°C | |
| Operating Temperature Range: | 10°C |
| Per IEC 60601-1-11 | |
| Biocompatibility: | Comply with ISO 10993-5 and ISO 10993-10 |
| Per ISO 10993-5, ISO 10993-10 | |
| Electrical Safety: | Complied with IEC 60601-1 |
| Per IEC 60601-1 | |
| EMC: | Complied with IEC 60601-1-2 |
| Per IEC 60601-1-2 | |
| Software Validation: | Software Validation passed. |
| Per 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 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions that "The clinical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2016)." However, it does not state the specific sample size used in this test, nor the country of origin of the data or whether it was retrospective or prospective. For a 510(k) for a thermometer, the clinical test usually involves human subjects to demonstrate accuracy against a reference method (e.g., oral/rectal mercury thermometer or a highly accurate electronic thermometer).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. For a thermometer, "ground truth" for temperature is typically established by comparing the device's reading to a laboratory-calibrated reference thermometer or medical device known for its accuracy in measuring body temperature (e.g., a rectal thermometer in a clinical setting). It does not involve expert readers like radiologists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like "2+1" are relevant for subjective image interpretation tasks, not for objective measurements like temperature.
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
Not applicable. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a traditional, non-AI medical device. Its "standalone" performance is its direct measurement output, as evaluated against the stated standards. The clinical test confirms its performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a clinical thermometer, the ground truth for temperature measurement is typically derived from a reference standard thermometer (e.g., a highly accurate, calibrated electronic thermometer or sometimes a rectal mercury thermometer in a controlled clinical study).
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this traditional 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). 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.
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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/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
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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 ThermometerModels:DET-101,DET-102,DET-103,DET-105 | Probe Cover |
| Trade Name | Infrared Ear ThermometerModels: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
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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:
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| Comparisons | SUBJECT DEVICE:Infrared Ear ThermometerModel:DET-101,DET-102,DET-103,DET-105510k number:K181081 | PREDICATE DEVICE:Infrared Ear ThermometerModel:ET-101H510k number:K153146 | Remark | |
|---|---|---|---|---|
| Indications forUse | Infrared Ear Thermometers are intendedfor the intermittent measurement ofhuman body temperature by people ofall ages. The devices are reusable forhome use only. | Infrared Ear Thermometers are indicatedfor the intermittent measurement andmonitoring of human body temperatureby consumers in a home useenvironment. It's intended for use onpeople of all ages. | Same | |
| Measurementmethod | Infrared radiation detection | Infrared radiation detection | Same | |
| Measuring Site | Ear canal | Ear canal | Same | |
| Principle ofoperation | The thermometer measurestemperature by reading infraredradiation emitting from eardrumtissue. The probe of the thermometer isinserted into the ear canal, wheresurrounding tissues give off heat. Thethermometer converts it into atemperature value. | The thermometer measures temperatureby reading infrared radiation emittingfrom eardrum tissue. The probe of thethermometer is inserted into the earcanal, where surrounding tissues give offheat. The thermometer converts it into atemperature value. | Same | |
| Display | $0.1°C (0.1°F)$ | $0.1°C (0.1°F)$ | Same | |
| Measurementrange | DET-101,DET-102,$32.0°C | Ear mode: $28.0°C | Similar(Note1) | |
| DET-103,DET-105Ear mode: $32.0°C | Ear mode: $28.0°C | Similar(Note1) | ||
| Accuracy | DET-101,DET-102$±0.2°C (0.4°F)$ during$35.0°C | Ear mode:$±0.2°C (0.4°F)$ during $35.5°C | Similar(Note1) | |
| temperature range | ~95.0°F) operating temperature range | |||
| ±0.3℃ (0.5°F) for othermeasuring and operatingtemperature range | ±0.3℃ (0.5°F) for other measuring andoperatingtemperature range | |||
| Ear mode:±0.2℃ (0.4°F) during35.5℃~42.0℃ (95.9°F~107.6°F) at 15℃ | Object mode: ±4% or ±2℃(4°F)whichever is greater | |||
| DET-103,DET-105 | ±0.3℃ (0.5°F) for othermeasuring and operatingtemperature rangeObject mode: ±4% or ±2°C(4°F) whichever isgreater | |||
| Operatingtemperaturerange | 10℃ | 10℃ | Same | |
| Storage andtransportenvironment | -25℃ | -25℃ | Same | |
| 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;ABSProbe:ABS & GlassProbe Cover:PE | Enclosure;ABSProbe:ABS & GlassProbe 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 ISO10993-10 | Comply with ISO 10993-5 and ISO10993-10 | Same | |
| ElectricalSafety | 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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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 | The changed measurement range andaccuracy of subject devices meet therequirements of ISO80601-2-56 andASTM E1965-98. |
|---|---|---|
| Note2 | DET-101, DET-102 Power Source changes fromTwo AAA battery to CR2032 battery | Meet the requirement of IEC 60601-1. |
| Note3 | DET-101, DET-102 accessory changes fromhave probe cover to no probe cover. | Meet the requirement of ASTM E1965-98. |
| Note4 | DET-105 add voice function | Software Validation passed. |
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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.
§ 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.