(264 days)
Non Contact Infrared Forehead Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead.
The thermometer measures the temperatures of people by detecting the energy. The external probe plays an important role in the measuring process. As soon as the thermometer is placed near the body and the radiation sensor is activated, the measurement will be taken instantly by detection of the infrared heat. The thermometer includes two models: TVT-200, TVT-200 PLUS. The TVT-200 model includes four colors: pink, grey, orange and purple. While TVT-200 PLUS has only orange color. The Non Contact Infrared Forehead Thermometer is composed by an IR sensor, a Human temperature measurement button, an object temperature button, Battery compartment, Buzzer, °C /°F button, a LCD and an enclosure. The functions of TVT-200 and TVT-200 PLUS are the same, except the Back Light.
The provided text describes the acceptance criteria and the study conducted for the Non Contact Infrared Forehead Thermometer (Models: TVT-200, TVT-200 PLUS).
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the standards the device claims to meet, specifically ASTM E1965-98 (2009) and ISO 80601-2-56: 2009. The reported device performance indicates that the device passed all tests against these standards.
| Acceptance Criteria / Specification | Reported Device Performance (Compliance) |
|---|---|
| Measuring Accuracy | ±0.2°C (0.4°F) |
| Measuring Range (Forehead mode) | 32° to 43°C (89.6°F to 109.4°F). Meets minimum rated output range of clinical thermometer requirement from 35°C to 42°C (ISO 80601-2-56). |
| Display Resolution | 0.1°C / 0.1°F |
| Biocompatibility | Complies with ISO 10993-5:2009, ISO 10993-10:2010. Patient contact materials (ABS with colorants, Glass and Metal) passed ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010 Biocompatibility Test. |
| Electrical Safety | Passed IEC 60601-1:2005+A1:2012, IEC 60601-1-11:2010, IEC 60601-1 (for battery) |
| EMC | Passed IEC 60601-1-2:2014 |
| Bench Performance | Passed ISO 80601-2-56 First Edition 2009-10-01, ASTM E1965-98 (Reapproved 2009) |
| Clinical Accuracy | Passed ASTM E1965-98 (Reapproved 2009) |
| Cleaning/Disinfection | Cleaning has been validated according to ASTM E2314-03(2014). |
2. Sample Size Used for the Test Set and Data Provenance
The document states:
- Sample Size: Not explicitly mentioned in terms of number of subjects or measurements. It only states that the "[c]linical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2009)." This standard typically specifies requirements for clinical accuracy testing, which involves a certain number of subjects and repeated measurements.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, clinical accuracy tests for medical devices are generally prospective.
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 document. For a thermometer, "ground truth" for temperature is typically established by reference thermometers (e.g., rectal or oral thermometers) measured by trained personnel, not necessarily by "experts" in the sense of radiologists.
4. Adjudication Method for the Test Set
This information is not provided in the document.
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
This is not applicable to this device. The device is a non-contact infrared thermometer, which is a standalone measurement device, not an AI-assisted diagnostic tool that aids human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance assessment was done. The entire testing listed under "Nonclinical tests" and "Clinical accuracy" (bench performance, clinical accuracy) evaluates the device's performance without human interpretation or intervention in the temperature measurement itself. The device is intended for direct measurement.
7. The Type of Ground Truth Used
For the clinical accuracy testing, based on the reference to ASTM E1965-98 (2009), the ground truth would be measurements from a clinically accepted reference thermometer (e.g., a rectal or oral thermometer whose accuracy is established) taken concurrently with the non-contact forehead thermometer.
8. The Sample Size for the Training Set
This information is not applicable. The device is an infrared thermometer, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is based on its physical design and calibration, which are verified through the outlined tests.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as in point 8.
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Image /page/0/Picture/0 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
November 22, 2017
Intrinity Global Limited % Elly Xu Consultant Shenzhen Joyantech Consulting Co., Ltd NO. 55 Shizhou middle road, Nanshan District Shenzhen, 518000 China
Re: K170662
Trade/Device Name: Non Contact Infrared Forehead Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: October 15, 2017 Received: October 26, 2017
Dear Elly Xu:
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 of medical device-related 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.
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.
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.
Tina Kiang
-s
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) K170662
Device Name
Non Contact Infrared Forehead Thermometer
Indications for Use (Describe)
Non Contact Infrared Forehead Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead.
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Version:A/0
VOL_05: 001 510(k) Summary
5.1 Administrative Information
| Date of Summaryprepared | Nov, 14, 2017 |
|---|---|
| Manufacturerinformation | Intrinity Global LimitedUnit 1707, Floor 17, Westley Square, 48 Hoi YuenRoad, Kwun Tong, Hong Kong |
| Contact person: Alex KwokPhone: 852-35231874Fax: 852-37484128E-mail: alex.kwok@intrinity.com.hk | |
| SubmissionCorrespondentImage: logo卓远天成 | Shenzhen Joyantech Consulting Co., Ltd.Address: Room 1122, International MayorsCommunication Centre, NO. 55 Shizhou middle roadNanshan District, ShenzhenContact person: Ms. Elly Xu; Mr. Field FuE-Mail: elly@cefda.com; cefda13485@163.com |
| Establishment |
5.2 Device Information
registration number
| Type of 510(k)submission: | Traditional |
|---|---|
| Trade Name: | Non Contact Infrared Forehead Thermometer |
| Model: | TVT-200, TVT-200 PLUS |
| Classification name: | thermometer, electronic, clinical |
| Review Panel: | General Hospital |
| Product Code: | FLL |
| Device Class: | II |
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Subject product: Non Contact Infrared forehead Thermometer
880.2910 Requlation Number:
5.3 Predicate Device Information
KAZ USA, Inc. Sponsor: No Touch + Forehead Thermometer Device: K134043 510(K) Number:
5.4 Device Description
Intrinity Global Limited
The thermometer measures the temperatures of people by detecting the energy.
The external probe plays an important role in the measuring process.
As soon as the thermometer is placed near the body and the radiation sensor is activated, the measurement will be taken instantly by detection of the infrared heat.
The thermometer includes two models: TVT-200, TVT-200 PLUS. The TVT-200 model includes four colors: pink, grey, orange and purple. While TVT-200 PLUS has only orange color.
The Non Contact Infrared Forehead Thermometer is composed by an IR sensor, a Human temperature measurement button, an object temperature button, Battery compartment, Buzzer, ℃ /°F button, a LCD and an enclosure.
The functions of TVT-200 and TVT-200 PLUS are the same, except the Back
Light. The detailed functions see below table:
| Functions | ||||||||
|---|---|---|---|---|---|---|---|---|
| Models | Memory | °C/°F | Scan Mode | LCD | Buzzer | Fever alert | Power off/Auto Off | Back Light |
| TVT-200 | ● | ● | ● | ● | ● | ● | ● | ● |
| TVT-200PLUS | ● | ● | ● | ● | ● | ● | ● | ○ |
5.5 Intended Use/ Indications for Use
Non Contact Infrared Forehead Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in
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clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead.
5.6 Technological characteristics of the subject device compared to the predicate device
| Items | Predicate Device(K134043), KAZ | Subject Device | Remarks |
|---|---|---|---|
| Indications foruse | The No Touch + ForeheadThermometer (ModelNTF3000US) is a non-sterile, reusable clinicalthermometer intended forthe intermittentdetermination of humanbody temperature in a touchand no touch on the centreof the forehead as themeasurement site on peopleof all ages. | Non Contact InfraredForehead Thermometer is anon-sterile, reusable,handheld device. It can beused by consumers inhomecare environment anddoctors in clinic as reference.It is intended for measuringhuman body temperature ofall ranges of people bydetecting infrared heat fromthe forehead. | Equivalent:intendeduseremainsunchanged |
| Measurementmethod | Infrared radiation detection | Infrared radiation detection | Same |
| Measurementmode | Forehead measure mode | Forehead measurementmode | Same |
| Measuringrange | Forehead temperaturemode:34.4°C - 42.2°C (93.9°F -108°F) | Forehead measurementmode:32° to 43°C (89.6°F to109.4°F) | Similar(Note01) |
| Displayresolution | 0.1°C (0.1°F) | 0.1°C/0.1°F | Same |
| C/F switchable | Yes | Yes | Same |
| Measuringaccuracy | Forehead temperaturemode: ±0.2°C (0.4°F) | Forehead measurementmode:±0.2°C (0.4°F) | Same |
| Display | LCD display | LCD display | Same |
| Measurementdistance | 0-5cm | 1cm | Similar(Note02) |
| Memory | Not available. | 16 sets. | (Note03) |
| Items | Predicate Device(K134043), KAZ | Subject Device | Remarks |
| Power source | Two AA batteries | One 1.5V AAA alkalinebattery | Similar(Note04) |
| Low batteryindication | Yes | Yes | Same |
| Waterproof | No, IP20 | No, IP22 | Similar(Note05) |
| Operatingcondition | 15 °C – 40 °C (59 °F –104 °F), 15–95% noncondensing | 15°C~ 40°C (59°F~ 104°F);≤95% RH | Similar(Note06) |
| Patient contactmaterials | metals and resins | ABS with colorants (pink,grey, orange and purple),Glass and Metal | Different(Note07) |
| Cleaning/disinfection | The thermometer casingand the measuring probeare cleaned and disinfectedby alcohol (70% Isopropyl). | The thermometer casing andthe measuring probe arecleaned and disinfected by70% alcohol. | Different(Note08) |
| Biocompatibility | Comply with ISO 10993-5:2009, ISO 10993-10:2010 | Comply with ISO 10993-5:2009, ISO 10993-10:2010 | Same |
| Electric Safetyand EMC | IEC 60601-1 3rd edition:2005, IEC 60601-1-2: 2007,IEC 60601-1-11: 2010 | IEC 60601-1: 2005+CORR.1(2006)+ CORR.2 (2007), IEC60601-1-2: 2014, IEC 60601-1-11: 2010, ISO 80601-2-56:2009. | Similar |
| Performance | ASTM E1965-98 (2009) | ASTM E1965-98 (2009), ISO80601-2-56: 2009 | Similar |
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Subject product: Non Contact Infrared forehead Thermometer
Version:A/0
Note 01:
The measuring range of subject device meet the minimum rated output range of clinical thermometer requirement, from 35°C to 42°C, which is stated in standard ISO 80601-2-56. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
Note 02:
The difference in measurement distance will not affect the safety and effectiveness of the subject device. And the use method are described detailed in IFU.
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Note 03:
The memory capacity will not affect the safety and effectiveness of the subject device.
Note 04:
The main difference between the batteries of the Predicate and the subject device is the size, which will not affect the safety and effectiveness. Furthermore, the electric safety of the battery has been validated with the subject device according to the IEC 60601-1. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
Note 05:
The difference in waterproof will not affect the safety and effectiveness of the subject device, which has passed IEC 60601-1 and IEC 60601-1-11 safety test. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
Note 06:
The operating condition of subject device has passed the safety test, and the Instructions for Use in VOL 13 Labeling provides the operating condition, so the difference between the operating conditions of subject device and predicate device will not affect the safety and effectiveness of subject device.
Note 07:
The patient contact materials including colorants (pink, grey, orange and purple) have passed the ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010 Biocompatibility Test. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
Note 08:
The cleaning has been validated according to the standards ASTM E2314 -03(2014). The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
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The subject device and the predicate device have the same intended use and similar technological characteristics, they both use infrared radiation detection method to detect human body forehead temperature. Their design is compact, small and light-weight. They are same in measuring accuracy, and similar in measuring range. Thus, the subject device is substantially equivalent to the predicate devices.
5.7 Brief discussion of nonclinical tests
| Tests | Test Standards | Results |
|---|---|---|
| Electric Safety | IEC 60601-1:2005+A1:2012, Medical electricalequipment - Part 1: General requirements forbasic safety and essential performance;IEC 60601-1-11: 2010, Medical electricalequipment –Part 1-11: General requirements forbasic safety and essential performance –Collateral Standard: Requirements for medicalelectrical equipment and medical electricalsystems used in the home healthcareenvironment | Pass |
| EMC | IEC 60601-1-2:2014, Medical electricalequipment - Part 1-2: General requirements forbasic safety and essential performance -Collateral Standard: Electromagnetic compatibility- Requirements and tests; | Pass |
| Bench performance | ISO 80601-2-56 First Edition 2009-10-01, Medicalelectrical equipment - Part 2-56: Particularrequirements for basic safety and essentialperformance of clinical thermometers for bodytemperature measurement | Pass |
Nonclinical tests of the Infrared Thermometer are listed as below table:
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Subject product: Non Contact Infrared forehead Thermometer
Version:A/0
| Tests | Test Standards | Results |
|---|---|---|
| ASTM E1965-98 (Reapproved 2009): StandardSpecification for Infrared Thermometers forIntermittent Determination of Patient Temperature | ||
| Clinical accuracy | ASTM E1965-98 (Reapproved 2009): StandardSpecification for Infrared Thermometers forIntermittent Determination of Patient Temperature | Pass |
| Biological Evaluation | AAMI ANSI ISO 10993-1:2009/(R)2013,Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk managementprocess | Pass |
| In vitro Cytotoxicity | ISO 10993-5:2009, Biological evaluation ofmedical devices - Part 5: Tests for in vitrocytotoxicity | Pass |
| irritation and skin sensitization | ISO 10993-10: 2010, Biological evaluation ofmedical devices - Part 10: Tests for irritation andskin sensitization | Pass |
5.8 Brief discussion of clinical tests
The clinical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2009). The test report showed the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2009).
5.9 Conclusions
Based on the above information, we conclude that the subject device, Non Contact Infrared Forehead 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.