(257 days)
The Infrared thermometer is intended to measure human body temperature of people over three months old from the eardrum or forehead. It is indicated to be used in homecare and healthcare environments.
The AOJ-20 series Infrared thermometer is a handheld device, which can measure human body's temperature either via the eardrum or the forehead, for clinical or home use. The results can be displayed on LCD. The device operates in adjusted mode, and the reference body site of output temperature is oral. The measurement distance for forehead mode is 0 cm ~ 3 cm. The thermometers are powered by AAA 1.5V×2 alkaline batteries. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum or the surface of the skin of forehead, which is converted to the equivalent oral temperature with the unit of °C or ºF. All the models share the similar design and the same critical components. The major differences include: - Mechanical changes and the corresponding hardware adjustment happened to AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y - In the measurement function, two measurement modes are distinguished between children and adults for AOJ-20B and AOJ-20E.
The provided text describes the regulatory clearance of an Infrared Thermometer (AOJ-20 series) and includes detailed performance testing against acceptance criteria. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is an Infrared Thermometer, and its primary performance criterion is accuracy. The relevant standard for accuracy is ISO 80601-2-56.
| Acceptance Criteria (from ISO 80601-2-56) | Reported Device Performance |
|---|---|
| Accuracy: ±0.2°C (±0.4°F) | ±0.2°C (±0.4°F) |
| Biocompatibility: No cytotoxicity | No potential cytotoxicity |
| Biocompatibility: No sensitization | No sensitization observed |
| Biocompatibility: No irritation | Negligible irritation |
| Electrical Safety & EMC: Compliance with specific IEC standards (60601-1, 60601-1-11, 60601-1-2) | Device complies with specified IEC standards |
| Software Verification & Validation: Software functions meet requirements | Test results demonstrated software functions met requirements |
| Minimum Subject Numbers for Clinical Accuracy Validation (ISO 80601-2-56 Section 201.102) | All models met minimum subject number requirements for each age group (refer to table in source for specific counts) |
The text explicitly states: "The system complies with the 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 for performance effectiveness." and "Clinical accuracy validation was carried out on people over three month indicated in the instructions for use. The number of subjects in each age group met the minimum number requirements."
2. Sample Size Used for the Test Set and Data Provenance
The "test set" in this context refers to the clinical study subjects for accuracy validation.
- Sample Size: The sample sizes vary per model, but generally around 135-138 subjects per model. The specific breakdown is provided in the table:
- AOJ-20A: 138 subjects
- AOJ-20B: 136 subjects
- AOJ-20C: 137 subjects
- AOJ-20D: 138 subjects
- AOJ-20E: 137 subjects
- AOJ-20F: 137 subjects
- AOJ-20H: 135 subjects
- AOJ-20M: 137 subjects
- AOJ-20T: 137 subjects
- AOJ-20R: 137 subjects
- AOJ-20Y: 137 subjects
- Data Provenance: The document does not specify the country of origin for the clinical data. It also does not explicitly state whether the study was retrospective or prospective, but clinical accuracy validation per ISO standards is typically done in a prospective manner.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given document. For clinical thermometers, ground truth for body temperature is typically established using a highly accurate reference thermometer (e.g., rectal or oral thermometer depending on the standard's requirements for reference body site), not necessarily by human experts.
4. Adjudication Method for the Test Set
This information is not provided in the given document. Adjudication methods like 2+1 or 3+1 are more common in studies involving subjective assessments (e.g., image interpretation by radiologists), which is not directly applicable to a thermometer's clinical accuracy validation where objective measurements against a reference are typically performed.
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 explicitly mentioned or performed. This type of study is more relevant for diagnostic aids where human interpretation is involved. The document describes clinical accuracy validation of the device itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is an Infrared Thermometer, which is a standalone measurement device. Its performance is inherently standalone. There is no "algorithm only" component separate from human interaction, as a human user operates the device to take a temperature reading. The clinical and bench testing described assess this standalone performance.
7. The Type of Ground Truth Used
The ground truth used for clinical accuracy validation of a thermometer is typically based on a reference body temperature measurement obtained by a highly accurate, calibrated reference thermometer (e.g., a specific type of oral or rectal thermometer). The document states the device "operates in adjusted mode, and the reference body site of output temperature is oral," implying oral temperature is the reference for adjusted readings. The study was conducted "per Section 201.102 of ISO 80601-2-56," which would define the exact method for establishing ground truth.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. Infrared thermometers are hardware devices with embedded algorithms, but they are not typically "trained" on large datasets of temperature readings in the way AI/ML models are. The device relies on physical principles of infrared detection and calibrated conversion algorithms, not a training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a "training set" in the context of this infrared thermometer. The device's internal algorithms and calibrations are developed and verified through engineering principles and bench testing, not machine learning training on a ground truth dataset.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows 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.
December 20, 2022
Shenzhen AOJ Medical Technology Co., Ltd. Jack Wang Deputy Chief Room 301&4F, Blk A, Building A, Jingfa IM Park, Xiaweiyuan, Gushu Community, Xixiang, Baoan Shenzhen, Guangdong 518126 China
Re: K221039
Trade/Device Name: Infrared Thermometer, models AOJ-20A, AOJ-20C, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 17, 2022 Received: November 28, 2022
Dear Jack Wang:
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}------------------------------------------------
ce determination does not mean that FDA
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/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 mediation-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.
Joyce M. Whang -S
Joyce M. Whang, Ph.D. Deputy Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K221039
Device Name
Infrared Thermometer, models AOJ-20A. AOJ-20C. AOJ-20C. AOJ-20E. AOJ-20F. AOJ-20F. AOJ-20M. AOJ-20M. AOJ-20T. AOJ-20R and AOJ-20Y
Indications for Use (Describe)
The Infrared thermometer is intended to measure human body temperature of people over three months old from the eardrum or forehead. It is indicated to be used in homecare and healthcare environments.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter: | Shenzhen AOJ Medical Technology Co., Ltd. Room 301&4F, Block A, Building A, Jingfa Intelligent Manufacturing Park, Xiaweiyuan, Gushu Community, Xixiang Street, Bao'an District, 518126, Shenzhen, China TEL: 86 755-27786026 |
|---|---|
| Contact Person: | Jack Wang |
| Prepare date: | December 20, 2022 |
| 2. Device name and classification: | Device Name: Infrared Thermometer Models: AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y Classification Name: 21 CFR 880.2910 Clinical Electronic Thermometers Product code: FLL Regulatory Class: Class II |
| 3. Predicate Device: | Shenzhen AOJ Medical Technology Co., Ltd. AOJ-20A cleared under K182133. The predicate has not been subject to any recall. |
| 4. Device Description: | The AOJ-20 series Infrared thermometer is a handheld device, which can measure human body's temperature either via the eardrum or the forehead, for clinical or home use. The results can be displayed on LCD. The device operates in adjusted mode, and the reference body site of output temperature is oral. The measurement distance for forehead mode is 0 cm ~ 3 cm. The thermometers are powered by AAA 1.5V×2 alkaline batteries. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum or the surface of the skin of forehead, which is converted to the equivalent oral temperature with the unit of °C or ºF. All the models share the similar design and the same critical components. The major differences include: - Mechanical changes and the corresponding hardware adjustment happened to AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y - In the measurement function, two measurement modes are distinguished between children and adults for AOJ-20B and AOJ-20E. |
| 6. Indications for Use: | The Infrared thermometer is intended to measure human body temperature of people over three months old from the eardrum or forehead. It is indicated to be used in homecare and healthcare environments. |
{4}------------------------------------------------
7. Predicate Device Comparison
| ITEM | Proposed DeviceAOJ-20 series/K221039 | Predicate DeviceAOJ-20A/K182133 | ComparisonResult |
|---|---|---|---|
| Manufacture | Shenzhen AOJ MedicalTechnology Co., Ltd. | Shenzhen AOJ MedicalTechnology Co., Ltd. | Same |
| Indications forUse | The Infrared thermometer isintended to measure humanbody temperature of people overthree months old from theeardrum or forehead. It isindicated to be used in homecareand healthcare environments. | The Infrared thermometers(AOJ-20Aand AOJ-20B) takehuman body temperature via theeardrum or forehead. They applyto all age groups except forbabies under three months. Bothdevices apply to bothprofessional use and home use. | Different 1 |
| Operational Specifications | |||
| OperationalPrinciple | Infrared radiation detection | Infrared radiation detection | Same |
| Measuring Mode | Forehead and ear | Forehead and ear | Same |
| MeasurementRange | 32.0°C | 32.0°C | Same |
| MeasurementDistance | 0 cm for ear mode0~3 cm for forehead mode | 0 cm for ear mode0~3 cm for forehead mode | Same |
| Accuracy | ±0.2°C(0.4°F) | ±0.2°C(0.4°F) | Same |
| Memory DataLimit | The last 40 values (exceptAOJ-20A is 10 values) | The last 20 values | Different 2 |
| Productconfiguration | It is mainly composed withinfrared sensor, signal receivingprocessor, buttons, buzzer, LCDdisplay, battery and etc. | It is mainly composed withinfrared sensor, signal receivingprocessor, buttons, buzzer, LCDdisplay, battery and etc. | Same |
| Operation Mode | Adjusted Mode | Adjusted Mode | Same |
| Age toggleswitch | Used for sub-mode switch forchildren forehead measurement,available for AOJ-20B andAOJ-20E only | Not available | Different 3 |
| Sub-modeselection | Button for sub-mode selectionof children foreheadmeasurement, available forAOJ-20M only | Not available | Different 3 |
| Toggle Switchfor unit switch | Available for all models exceptAOJ-20Y, switch the unit bytoggle switch | Not available, unit switch isrealized by button operation | Different 4 |
| Touch function | Realize the mode switch bytouching, available for AOJ-20Yonly | Not available | Different 5 |
| Temperature unitand conversion | Dual temperature units "°C" and"°F" optional, and the two unitscan convert by the conversion | Dual temperature units "°C" and"°F" optional, and the two unitscan convert by the conversion | Same |
| Display | 0.1°C/°F, LCD(except AOJ-20Y) | 0.1°C/°F, LCD | Same |
| OperatingEnvironment | Temperature: 5°C~40°C(50°F-104°F)Humidity: 15%-95% RH,non-condensingAtmospheric pressure: 70-106kPa | Temperature: 10°C~40°C(50°F-104°F)Humidity: 15%-95% RH,non-condensingAtmospheric pressure: 70–106kPa | Different 6 |
| StorageEnvironment | Ambient Temperature: -20°C to55°C (-4°F-131°F)Relative Humidity: <95% RH,non-condensingAtmospheric pressure: 50kPa to106kPa | Ambient Temperature: -20°C to55°C (-4°F-131°F)Relative Humidity: <95% RH,non-condensingAtmospheric pressure: 50kPa to106kPa | Same |
| Power supply | 2 X 1.5V AAA Alkaline battery | 2 X 1.5V AAA Alkaline battery | Same |
| Physical Specifications | |||
| Weight | AOJ-20A: 60g (without battery)AOJ-20B: 75g (without battery)AOJ-20C: 60g (without battery)AOJ-20D: 73g (without battery)AOJ-20E: 80g (without battery)AOJ-20F: 73g (without battery)AOJ-20H: 73g (without battery)AOJ-20M: 76g (without battery)AOJ-20T: 98g (with battery)AOJ-20R: 80g (with battery)AOJ-20Y: 93g (with battery) | 90g (battery included) | Different 7 |
| Dimensions(mm×mm×mm) | AOJ-20A: 143×35×41AOJ-20B: 163.5×40×41AOJ-20C: 143×35×41AOJ-20D: 163.5×40×41AOJ-20E: 143×35×41AOJ-20F: 163.5×40×41AOJ-20H: 163.5×40×41AOJ-20M: 162×43×35AOJ-20T: 162×43×35AOJ-20R: 143×35×41AOJ-20Y: 166×38×40 | 146mm *52 mm *40 mm | |
| Biological Specifications | |||
| PatientContactingMaterials | PC+ABS | PC+ABS | Same |
| PatientContacting | Skin surface contacting,Less than 24 h | Skin surface contacting,Less than 24 h | Same |
| BiocompatibilityStandard | ISO 10993-5,ISO 10993-10 | ISO 10993-5,ISO 10993-10 | Same |
| BiocompatibilityTesting Items | In vitro CytotoxicitySkin SensitizationIrritation | In vitro CytotoxicitySkin SensitizationIrritation | Same |
Table 1 Comparison between the predicate AOJ-20A and the subject devices
{5}------------------------------------------------
Justification for the differences:
-
- Different Indications for Use
{6}------------------------------------------------
As indicated in the comparison table, the application scenario of the subject device and the predicate device can be used both in hospital and home, they have same intended use, they are just some language description differences. The difference does not raise new safety and effectiveness issues.
-
- Different memory capacity
The predicate device can store up to 20 values, while the subject device has the capacity to store 40 memories(except AOJ-20A is 10 values), this memory function has been verified during the design and development process. The test results met the requirements.
- Different memory capacity
The difference does not raise new safety and effectiveness issues.
-
- Different sub-mode design
AOJ-20B and AOJ-20E can switch between 3M to 6Y, 6Y to 12Y and greater than 12Y by Age toggle, and AOJ-20M can also realize the sub-mode selection of children forehead measurement by button operation, while the predicate device does not have the sub-mode selection. This function has been well verified and validated before product release. The difference does not raise any new safety and effective issues.
- Different sub-mode design
-
- Different Unit Switch Method
The unit toggle switch function is available for all models except AOJ-20Y, but this is not available for the predicate device. This function has been well verified and validated before product release. The difference does not raise any new safety and effective issues.
- Different Unit Switch Method
-
- Different Touch Function
The AOJ-20Y is designed to be performed by touch operation, which is different from the button operation of the predicate device, and all the functions of this model have been well demonstrated to be safety and effectiveness after the verification and validation data. The difference does not raise any new safety and effective issues.
- Different Touch Function
-
- Different Operation Environments
Minor difference to operation environments between the subject device and the predicate device. but the system has been proved to be safe and effective since the performance testing was conducted under the suggested environment per ISO 80601-2-56: 2017and the results met the requirements. The difference does not raise new safety and effectiveness issues.
- Different Operation Environments
-
- Different Physical Specifications
The weight and size of the subject device and predicate are different. The performance testing was conducted in accordance with standards. The test results met requirements. The differences do not raise new safety and effectiveness issues.
- Different Physical Specifications
8. Performance Testing:
Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.
Non-Clinical Data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the thermometer were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered surface-contacting, limited exposure (-less than 24 hours). And the evaluation of testing is summarized as below.
{7}------------------------------------------------
| Test name | Test standard | Evaluation endpoint | Summary results |
|---|---|---|---|
| In vitroCytotoxicity | ISO 10993-5 | No potentialcytotoxicity is allowed | No potential cytotoxicity |
| Skin Sensitization | ISO 10993-10 | No sensitizationshould be observed | No sensitization observed (testsample score 0) |
| Skin Irritation | ISO 10993-10 | No irritation shouldbe observed | Negligible (no observed primaryirritation, test sample score 0). |
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the thermometer device. The device complies with the IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety, IEC 60601-1-11 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, and the IEC 60601-1-2 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests standard for EMC.
Bench Testing
Bench testing was conducted on the thermometer device, consisting of all the accessories in the system. The system complies with the 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 for performance effectiveness.
Software Verification and Validation Testing
Software verification and validation testing were conducted and the test results demonstrated the software function met the requirements. The documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software in Medical Devices." The software for this device was considered as a "moderate" level of concern.
Clinical data:
The clinical testing was conducted per Section 201.102 of ISO 80601-2-56 on all the models. Clinical accuracy validation was carried out on people over three month indicated in the instructions for use. The number of subjects in each age group met the minimum number requirements. The specific number of tested subjects, age groups and test results are described as below.
| Item | Age group | Subject number in total for ear mode | Subject number in total for forehead mode | ||
|---|---|---|---|---|---|
| Model | Ear mode | Forehead mode | |||
| AOJ-20A | A2, B, C | A2, B, C0, C3 | 138 | 138 | |
| AOJ-20B | A2, B, C | A2, B, C1, C2, C3 | 136 | 136 | |
| AOJ-20C | A2, B, C | A2, B, C0, C3 | 137 | 137 | |
| AOJ-20D | A2, B, C | A2, B, C0, C3 | 138 | 138 | |
| AOJ-20E | A2, B, C | A2, B, C1, C2, C3 | 137 | 137 | |
| AOJ-20F | A2, B, C | A2, B, C0, C3 | 137 | 137 | |
| AOJ-20H | A2, B, C | A2, B, C0, C3 | 135 | 135 | |
| AOJ-20M | A2, B, C | A2, B, C1, C2, C3 | 137 | 137 | |
| AOJ-20T | A2, B, C | A2, B, C0, C3 | 137 | 137 | |
| AOJ-20R | A2, B, C | A2, B, C0, C3 | 137 | 137 | |
| AOJ-20Y | A2, B, C | A2, B, C0, C3 | 137 | 137 |
Age group is defined as below:
- A1 1 month up to 3 months -
A2 3 months up to one year -
{8}------------------------------------------------
- B older than one and younger than five years -
- C older than five years -
- -C1 older than five and younger than six years
- -C2 older than six and younger than 12 years
- -C3 older than 12 years
9. Conclusion:
Verification and validation testing was conducted on the subject device and all testing passed pre-specified criteria. Based on the performance testing, comparison and analysis above, the subject A OJ-20 series Infrared Thermometer 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.