(114 days)
Infrared Ear/Forehead Thermometer DET-218 is 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/Forehead Thermometer is a hand-held, battery powered device designed to measure human body temperature from the auditory canal or forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or forehead.
The Infrared Ear/Forehead Thermometer use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a thermopile collect, the infrared energy emitted from the forehead.The results can be displayed on LCD. And, the results measured by DET-218 can also be transmitted to mobile device (i.e. iPhone) with Bluetooth and the application APP installed on a mobile device using the iOS system or the Android system. The thermometer is reusable for home use on people of all ages with adult supervision. The device can be used with as a stand-alone device or in conjunction with the App on a compatible BLE enabled smartphone.
The purpose of data transfer to a mobile device is convenient for users to view the measured data through the APP. The APP operating system is IOS 9.0+ system , Android 5.0+ system.
The name of APP is "Healthforyou",it adopts AES+RSA combination to encrypt and decrypt interface parameters and the data transmission between APP and server adopts HTTP+SSL mode to ensure the security of information.
The App only visualizes the Measurements from the device via. bluetooth to smart phone. The APP receives and records data, and displays measurement on smart phone in correspondence with DET-218 Measurement site (Ear/Forehead) set. The App has the following functions:
l. data recording;
II. curve display;
III. alarm functions.
The light bar of DET-218 turns on green light when the measurement is < 38.0 ℃ (100.4 °F ). The alarm function refers to the light bar of the device DET-218 turns on red light when the measurement is ≥38.0 ℃ (100.4 下 ), the APP will give an alarm when the measurement received simultaneously from DET-218 displays≥38.0℃.
Here's an analysis of the provided text to extract the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the infrared ear/forehead thermometerDET -218 are established by relevant international standards, particularly ASTM E1965-98 (2016) for clinical performance. The reported device performance is stated to comply with these requirements.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Accuracy (Ear/Forehead mode) | ASTM E1965-98 (2016) defines accuracy requirements for infrared thermometers. | ±0.2°C (0.4°F) during 35.5°C ~ 42.0°C (95.9°F ~ 107.6°F) at 15°C ~ 35°C (59.0°F ~ 95.0°F) operating temperature range.±0.3°C (0.5°F) for other measuring and operating temperature range. |
| Electrical Safety and Performance | AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 Medical Electrical EquipmentISO 80601-2-56:2017 Medical electrical equipment Part 2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurementASTM E 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature | Results of these tests demonstrate compliance to the requirements of the standards. |
| Home-Used Medical Equipment & Environmental | IEC 60601-1-11:2015 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 | Compliance demonstrated. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and testsEN300328:Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques;ETSI EN 301489-1: Electromagnetic compatibility and Radio spectrum Matters(ERM); ElectroMagnetic Compatibility (EMC)standard for radio equipment and services;Part 1:Common technical requirements;ETSI EN 301489-17: Electromagnetic compatibility and Radio spectrum Matters (ERM);ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions or Broadband Data Transmission Systems; | Compliance demonstrated; FCC, EN301489-1, EN301489-17, EN 300328 and wireless coexistence test passed for the Bluetooth transmission. |
| Biocompatibility | ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicityISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization | Compliance demonstrated. |
| Software/Firmware Verification and Validation | Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005. | Software Validation Passed (for memory set changes and lack of voice function). |
| Response Time | Implied functional requirement (not explicitly given as an acceptance criterion from a standard, but noted as a difference from the predicate). | Approx. 1s (shorter than predicate, and all tests passed, indicating this difference "does not raise new performance questions"). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Performance Test: 150 subjects.
- Data Provenance: The document does not explicitly state the country of origin for the clinical test data. It only mentions that "clinical tests were conducted on the DET-218." It is reasonable to assume it was a prospective study, as it was conducted to evaluate the device's performance against a standard. The study included three groups based on age:
- Infants: newborn to one year
- Children: greater than one to five years
- Adults: greater than five years old
3. Number of Experts Used to Establish 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 performance test. The ground truth method is described below.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method. The clinical performance test protocol and data analysis were conducted as per the requirements of ASTM E1965-98 (2016). This standard typically outlines the methods for comparison against a reference thermometer, implicitly defining the ground truth measurement process rather than an adjudication among multiple readings of the device under test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a thermometer, and its performance is evaluated against reference measurements rather than subjective human interpretation of cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The entire summary focuses on the device (Infrared Ear/Forehead Thermometer DET-218) and its conformance to standards. The "clinical tests" described are for the device itself, not for an algorithm where human input is part of the performance metric. The device also has an associated app, but the app's function is for data visualization, recording, and alarm, not for independent diagnostic or measurement capabilities requiring a human in the loop for its core function.
7. The Type of Ground Truth Used
The ground truth for the clinical performance test was established by a reference measurement method as defined by ASTM E1965-98 (2016). This typically involves comparing the device's readings against highly accurate reference thermometers or established clinical measurement techniques to determine accuracy. It is not expert consensus, pathology, or outcomes data in the usual sense for diagnostic imaging or similar devices.
8. The Sample Size for the Training Set
The document describes a clinical performance test, which is a test set evaluation. It does not mention a "training set" or any machine learning model training process for the core measurement functionality of the thermometer. The device's operation is based on physical principles (measuring thermal radiation), not a data-trained algorithm for its primary measurement.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned for the primary measurement function of the device, this question is not applicable based on the provided text.
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July 26, 2019
Joytech Healthcare Co., Ltd. Mr. Yunhua Ren General Manager No.365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Hangzhou, Zhejiang, 311100 China
Re: K190873
Trade/Device Name: Infrared Ear/Forehead Thermometer, DET-218 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 26, 2019 Received: July 1, 2019
Dear Mr. Yunhua Ren:
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/cfpmp/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
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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 (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 Alan Stevens 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190873
Device Name
Infrared Ear/Forehead Thermometer DET-218
Indications for Use (Describe)
Infrared Ear/Forehead Thermometer DET-218 is 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: K190873
1. Date Prepared: 2019.07.10
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 Name:Infrared Ear/Forehead Thermometer Trade Name:Infrared Ear/Forehead Thermometer Including models:DET-218 Classification name:Clinical Electronic Thermometer
4. Classification Information:
Product Code: FLL Device Class: II Panel: 80 Regulation number:880.2910
Predicate Device Information: 5.
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The Infrared Ear/Forehead Thermometer DET-218 is substantially equivalent to the following device:
| 510k number | model | Product code | manufacturer |
|---|---|---|---|
| K181239 | DET-215 | FLL | JOYTECH HEALTHCARE CO., LTD. |
6. Intended use / Indication for Use:
Infrared Ear/Forehead Thermometer DET-218 is 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:
The Infrared Ear/Forehead Thermometer is a hand-held, battery powered device designed to measure human body temperature from the auditory canal or forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or forehead.
The Infrared Ear/Forehead Thermometer use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a thermopile collect, the infrared energy emitted from the forehead.The results can be displayed on LCD. And, the results measured by DET-218 can also be transmitted to mobile device (i.e. iPhone) with Bluetooth and the application APP installed on a mobile device using the iOS system or the Android system. The thermometer is reusable for home use on people of all ages with adult supervision. The device can be used with as a stand-alone device or in conjunction with the App on a compatible BLE enabled smartphone.
The purpose of data transfer to a mobile device is convenient for users to view the measured data through the APP. The APP operating system is IOS 9.0+ system , Android 5.0+ system.
The name of APP is "Healthforyou",it adopts AES+RSA combination to encrypt and decrypt interface parameters and the data transmission between APP and server adopts HTTP+SSL mode to ensure the security of information.
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The App only visualizes the Measurements from the device via. bluetooth to smart phone. The APP receives and records data, and displays measurement on smart phone in correspondence with DET-218 Measurement site (Ear/Forehead) set. The App has the following functions:
l. data recording;
II. curve display;
III. alarm functions.
The light bar of DET-218 turns on green light when the measurement is < 38.0 ℃ (100.4 °F ). The alarm function refers to the light bar of the device DET-218 turns on red light when the measurement is ≥38.0 ℃ (100.4 下 ), the APP will give an alarm when the measurement received simultaneously from DET-218 displays≥38.0℃.
8.Substantial Equivalence Comparison:
| SE Comparison | Subject DeviceModel:DET-218 | Predicate DeviceModel:DET-215 | Note |
|---|---|---|---|
| 510k number | K190873 | K181239 | -- |
| Regulationnumber | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Product Code | FLL | FLL | Same |
| Intended Use/Indications for use | Infrared Ear/ForeheadThermometer DET-218 isintended for the intermittentmeasurement of human bodytemperature by people of allages. The devices are reusablefor home use only. | Thermometer DET seriesare intended for theintermittent measurement ofhuman body temperature bypeople of all ages. The devicesare reusable for home useonly. | Same |
| Measure Method | Infrared radiation detection | Infrared radiation detection | Same |
| MeasurementRange | Ear/Forehead mode: 34.0°C | Ear/Forehead mode: 34.0°C | Same |
| Accuracy | Ear/Forehead mode:±0.2°C (0.4°F) during 35.5°C | Ear/Forehead mode:±0.2°C (0.4°F) during 35.5°C | Same |
| Display | 0.1℃ (0.1℉) | 0.1℃ (0.1℉) | Same |
| Measurement | Forehead | Forehead | Same |
| Place | Ear | Ear | Same |
| Response Time | Approx. 1s | Ear mode/Object mode:Approx. 1sForehead: Approx. 3s | Different(Note3) |
| Sensor Type | Thermopile | Thermopile | Same |
| Scale Selection | ℃/℉ | ℃/℉ | Same |
| Signal processingand display | -Internal firmware and local LCD display-Also able to transfer transmitdata to mobile device forsecondary display | Internal firmware and local LCDdisplay | Different(Note1) |
| Wireless Interface | Bluetooth Low Energy (BLE) | None | Different(Note 1) |
| Memory | Ear/forehead/ objectmeasurements sharing 30memories | Each 10 sets memories forear,forehead and objectmeasurements | Different(Note 2) |
| Signaltransmission | Bluetooth 4.0 | / | Different(Note 1) |
| Receiver (mobileterminal) | iOS9.0 or above mobile deviceAndroid5.0 or above mobiledevice | / | Different(Note 1) |
| Auto power-offwhile no operation | Yes | Yes | Same |
| Buzzer | Yes | Yes | Same |
| Voice Function | No | Yes | Different(Note4) |
| Power Source | DC3V(2×AAA battery) | DC3V(2×AAA battery) | Same |
| Patient contactmaterials | Enclosure:ABS;Probe: Stainless steel&.ABS; | Enclosure:ABS;Probe: Stainless steel&.ABS; | Same |
| Biocompatibility | Cytotoxicity, Skin irritation,Skin sensitization | Cytotoxicity, Skin irritation,Skin sensitization | Same |
| Conformancestandard | ISO 80601-2-56(Performance)IEC 60601-1(Safety)IEC 60601-1-2(EMC)ASTM E1965-98ISO 10993-5 and ISO 10993-10(Biocompatibility) | ISO 80601-2-56(Performance)IEC 60601-1(Safety)IEC 60601-1-2(EMC)ASTM E1965-98ISO 10993-5 and ISO10993-10 (Biocompatibility) | Same |
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Analysis
From the comparison table, the subject device and predicate device have the same
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Intended use & Indications for Use, same measurement places, unit change, battery source& Auto power-off. There are several differences between the subject device and predicate device as follows:
| S/N. | Change from predicatedevice | Comments |
|---|---|---|
| Note1 | Add blue tooth datatransmission | FCC, EN301489-1, EN301489-17, EN 300328and wirelesscoexistence test passed. |
| Note2 | Memory set changes | Software Validation Passed. |
| Note3 | Response time changes | Our device has shorter response time tomeasure from 3s to 1s the temperature,and alltests passed,so this difference does not raisenew performance questions |
| Note4 | No voice function | Software Validation Passed. |
The differences between the subject device and predicate device have been analyzed and tests performed accordingly. It has been shown that the differences do not raise new questions of safety and effectiveness for DET-218.
9. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The following performance data were provided in support of the substantial equivalence determination:
Performance testing was conducted to validate and verify that Infrared Ear/Forehead Thermometer, DET-218 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.
Electrical Safety and performance requirements:
- AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 Medical Electrical Equipment
- · 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
- · ASTM E 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
Home-used medical equipment requirements and environmental test:
- · IEC 60601-1-11:2015 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
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Electromagnetic compatibility requirements:
- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- . EN300328:Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques;
- . ETSI EN 301489-1: Electromagnetic compatibilityand Radio spectrum Matters(ERM); ElectroMagnetic Compatibility (EMC)standard for radio equipment and services;Part 1:Common technical requirements;
- . ETSI EN 301489-17: Electromagnetic compatibility and Radio spectrum Matters (ERM);ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions or Broadband Data Transmission Systems;
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.
12. Discussion of Clinical Tests Performed:
Clinical tests were conducted on the DET-218.The clinical tests evaluated 150 of subjects. Each model was evaluated in three groups 1) infants-newborn to one year; 2) children-greater than one to five years; and 3) adults-greater than five years old. 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).
13. Conclusions:
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Based on the information provided in this submission, the submit Infrared
Ear/Forehead Thermometer DET-218 is substantially equivalent to the predicate device.
§ 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.