(308 days)
Not Found
No
The description focuses on basic infrared detection and data transmission via Bluetooth, with no mention of AI/ML algorithms for temperature interpretation or other functions.
No
The device is a non-contact infrared thermometer, which is used for measuring body temperature. It is not described as providing treatment or therapy for any medical condition.
No
The device is a non-contact infrared thermometer intended for measuring human body temperature. While temperature can be an indicator of health, the device itself is not described as providing a diagnosis, but rather a measurement for 'reference'.
No
The device is a non-contact infrared thermometer, which is a hardware device that measures temperature by detecting infrared radiation. While it has a companion app, the core medical device function is performed by the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device measures human body temperature by detecting infrared heat emitted from the forehead. It does not analyze samples taken from the body.
- Intended Use: The intended use is for measuring body temperature, which is a physiological measurement, not a diagnostic test performed on a sample.
Therefore, while it is a medical device, it falls under the category of a non-IVD medical device.
N/A
Intended Use / Indications for Use
Non-contact Infrared 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 two months and above of people by detecting infrared heat from the center of the forehead.
Product codes
FLL
Device Description
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 at the center of the forehead or the object with a distance of 15mm-50mm and the radiation sensor is activated, the measurement will be taken instantly by detection of the infrared heat.
The thermometer AET-R161 can be connected with FOND APP through Bluetooth. The FOND APP applies to mobile phones which systems are Android 4.3 and above, or IOS 8.0 and above, and can be downloaded from Google store (for Android 4.3 and above) or iPhone APP Store (for IOS 8.0 and above). The data measured with AET-R161 can be transmitted to the FOND APP, where data can be recorded, saved and shared.
The device principle of operation is described as below:
All object, solid, liquid or gas, emit energy by radiation. The intensity of this energy depends on the temperature of the object. The Infrared Thermometer is therefore able to measure the temperature of a person by the energy the person emits. This measurement can be taken by an external temperature probe on the device for analysis and register the ambient temperature. Therefore, as soon as the operator holds the thermometer near forehead and activates the radiation sensor, the measurement is taken instantly by detection of the infrared heat generated by the arterial blood flow. Body heat can therefore be measured without any interference from the heat of the surrounding environment.
The thermometer includes four models: AET-R161, AET-R171, AET-R1D2, AET-R1B1. They all have the following basic functions:
- Sound alarm if the temperature exceeds 37.8°C.
- LCD back-lighted digital screen.
- Data displayed in Celsius or Fahrenheit.
- Automatic stop (energy saver).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
center of the forehead
Indicated Patient Age Range
two months and above of people
Intended User / Care Setting
consumers in homecare environment and doctors in clinic as reference
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The clinical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2009).
In this clinical study for the clinical accuracy validation, we conduct tests with Infrared Thermometer (model: AET-R161) and the RCT (model: WDJ-001) on the presentative patient populations, which include three age groups, i.e. Infants (two months to 1 year old), Children (1 up to 5 years old) and Adults (older than 5 years), and the number of subjects is 38 for Infants, 36 for Children and 42 for Adults.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests:
- Electric Safety: IEC 60601-1:2005+A1:2012, IEC 60601-1-11: 2015. Results: Pass
- EMC: IEC 60601-1-2:2014. Results: Pass
- Bench performance: ISO 80601-2-56 First Edition 2009-10-01. Results: Pass
- Clinical accuracy: ASTM E1965-98 (Reapproved 2009). Results: Pass
- Biological Evaluation: AAMI ANSI ISO 10993-1:2009/(R)2013. Results: Pass
- In vitro Cytotoxicity: ISO 10993-5:2009. Results: Pass
- Irritation and Skin sensitization: ISO 10993-10: 2010. Results: Pass
- QoS testing: 47 CFR PART 15 Subpart C. Results: Pass
- Wireless coexistence: 47 CFR PART 15 Subpart C. Results: Pass
- Software validation and verification test: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on: May 11, 2005; Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices issued on: September 9, 1999. Results: Pass
Clinical tests:
- Study type: Clinical accuracy validation.
- Sample size: 38 Infants (two months to 1 year old), 36 Children (1 up to 5 years old), and 42 Adults (older than 5 years).
- Key results: The test report showed the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2009). Therefore, the subject device is able to measure patients' temperatures as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Summary of Performance Studies states:
- Measurement accuracy: ±0.2°C (0.4°F)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 28, 2018
Alicn Medical (Shenzhen), Inc % Reanny Wang Medical Device Consultant Shenzhen Reanny Medical Devices Management Consulting Co, Ltd Room 2012 of Gebu commercial building, Hongxing community, Songgang street Baoan District Shenzhen, Guangdong 518000 China
Re: K180207
Trade/Device Name: Non-contact Infrared Thermometer, Model: AET-R161, AET-R171, AET-R1D2, AET-R1B1 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: September 9, 2018 Received: October 19, 2018
Dear Reanny 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
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 mediation-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
2
Indications for Use
510(k) Number (if known) K180207
Device Name
Non-contact Infrared Thermometer (Model: AET-R161, AET-R171, AET-R1B2, AET-R1B1)
Indications for Use (Describe)
Non-contact Infrared 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 two months and above of people by detecting infrared heat from the center of the forehead.
| 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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3
510(k) Summary K180207
1 Administrative Information
| Date of Summary
| prepared | Nov. 28, 2018 |
|---|---|
| Manufacturer | |
| information | Submitter's Name: Alicn Medical (Shenzhen), Inc. |
| Address: | |
| 4/F, B Building, Shenfubao Modern Optical Factory, | |
| Kengzi Street, Pingshan District, Shenzhen City, China | |
| Contact person: Meisong Fang | |
| Phone: +86-755-26501548 | |
| Fax: +86-755-26504849 | |
| E-mail: hans.fang@alicn.com.hk | |
| Submission | |
| Correspondent | Name: Reanny Wang |
| Address: Room 2012 of Gebu commercial building, | |
| Hongxing community, Songgang street, Baoan district, | |
| Shenzhen City, Guangdong Province, China | |
| Contact person: Reanny Wang | |
| E-Mail: cefdacfda@163.com |
2 Device Information
| Type of 510(k)
| submission: | Traditional |
|---|---|
| Trade Name: | Non-contact Infrared Thermometer |
| Model: | AET-R161, AET-R171, AET-R1D2, AET-R1B1 |
| Regulation Name: | Clinical electronic thermometer |
| Review Panel: | General Hospital |
| Product Code: | FLL |
| Device Class: | II |
| Regulation Number: | 880.2910 |
3 Predicate Device Information
Sponsor:
KAZ USA, Inc.
4
| Device: | No Touch + Forehead Thermometer |
|---|---|
| 510(K) Number: | K134043 |
4 Device Description
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 at the center of the forehead or the object with a distance of 15mm-50mm and the radiation sensor is activated, the measurement will be taken instantly by detection of the infrared heat.
The thermometer AET-R161 can be connected with FOND APP through Bluetooth. The FOND APP applies to mobile phones which systems are Android 4.3 and above, or IOS 8.0 and above, and can be downloaded from Google store (for Android 4.3 and above) or iPhone APP Store (for IOS 8.0 and above). The data measured with AET-R161 can be transmitted to the FOND APP, where data can be recorded, saved and shared.
The device principle of operation is described as below:
All object, solid, liquid or gas, emit energy by radiation. The intensity of this energy depends on the temperature of the object. The Infrared Thermometer is therefore able to measure the temperature of a person by the energy the person emits. This measurement can be taken by an external temperature probe on the device for analysis and register the ambient temperature. Therefore, as soon as the operator holds the thermometer near forehead and activates the radiation sensor, the measurement is taken instantly by detection of the infrared heat generated by the arterial blood flow. Body heat can therefore be measured without any interference from the heat of the surrounding environment.
The thermometer includes four models: AET-R161, AET-R171, AET-R1D2, AET-R1B1. They all have the following basic functions:
- Sound alarm if the temperature exceeds 37.8℃.
- LCD back-lighted digital screen.
- Data displayed in Celsius or Fahrenheit.
- Automatic stop (energy saver).
Their detailed functions see below table:
5
Alicn Medical (Shenzhen), Inc.
| Functions | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Models | Memory | C/F | LCD | Buzzer | High | ||||
| temperat- | |||||||||
| ure | |||||||||
| indicator | Power | ||||||||
| off/ | |||||||||
| Auto | |||||||||
| Off | Back | ||||||||
| light | Low | ||||||||
| battery | DATA | ||||||||
| AET- | |||||||||
| R161 | ● | ● | ● | ● | ● | ● | ● | ● | ● |
| AET- | |||||||||
| R171 | ● | ● | ● | ● | ○ | ● | ● | ● | ○ |
| AET- | |||||||||
| R1D2 | ● | ● | ● | ● | ● | ● | ● | ● | ○ |
| AET- | |||||||||
| R1B1 | ● | ● | ● | ● | ● | ● | ● | ● | ○ |
Note 1:
"●" means "with the function"; "○" means "without the function".
Note 2:
Details of the functions are listed below:
-
Memory: The thermometers can memorize 32 sets of readings;
-
C/F: The thermometer can shift the temperature units between ℃ and F;
-
LCD: The readings will be showed on the LCD;
-
Buzzer: At the start-up or during the measurement, the thermometers will emit beeping sounds:
-
High temperature indicating: If the thermometer detects a temperature ≥37.8℃ (or 100.0°F) under Forehead mode, the LCD display will be lit by a "Red" light;
-
Power off/Auto Off: Device will automatically power off left idle for more than 60 seconds to extend battery life;
-
Backlight: There are three backlight colors: green, orange and red. The LCD will display different color according to the temperature measurement;
-
Low battery: When the battery voltage is less than 2.55V, a low battery capacity sign will be shown on the LCD.
-
DATA: The temperature data can be transferred to cell phone via Bluetooth technique.
6
5 Intended Use/ Indications for Use
Non-contact Infrared 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 two months and above of people by detecting infrared heat from the center of the forehead.
| Items | Predicate Device (K134043),
KAZ | Subject Device (K180207) | Remarks |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Indications for
use | The No Touch + Forehead
Thermometer (Model
NTF3000US) is a non-sterile,
reusable clinical thermometer
intended for the intermittent
determination of human body
temperature in a touch and no
touch on the centre of the
forehead as the measurement
site on people of all ages. | Non-contact Infrared
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
two months and above of
people by detecting infrared
heat from the center of the
forehead. | Similar
(Note 12) |
| Measurement
method | Infrared radiation detection | Infrared radiation detection | Same |
| Measurement
mode | Forehead measure mode | Forehead measurement mode/
Body mode, which is same
with Forehead measure mode | Same |
| Measuring
range | Forehead temperature mode:
$34.4°C$ - $42.2°C$ ( $93.9°F$ -
$108°F$ ) | Forehead measurement mode/
Body mode: $32.0°C$ to $42.2°C$
( $89.6°F$ to $108°F$ ) | Similar
(Note 01) |
| Display
resolution | $0.1°C$ ( $0.1°F$ ) | $0.1°C$ / $0.1°F$ | Same |
| C/F switchable | Yes | Yes | Same |
| Measuring
accuracy | Forehead temperature mode:
$±0.2°C$ ( $0.4°F$ ) | Forehead measurement mode/
Body mode: $±0.2°C$ ( $0.4°F$ ) | Same |
| Display | LCD display | LCD display | Same |
| Measurement
distance | 0-5cm | 1.5-5.0cm | Similar
(Note 02) |
| Memory | Not available. | 32 sets. | Note 03 |
| Power source | Two AA batteries | Two 1.5V AAA battery | Similar
(Note 04) |
6 Technological characteristics of the subject device compared to the predicate device
7
| Alicn Medical (Shenzhen), Inc. |
|---|
| -------------------------------- |
| Items | Predicate Device (K134043),
KAZ | Subject Device (K180207) | Remarks |
|------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Low battery
indication | Yes | Yes | Same |
| Waterproof | No, IP20 | No, IP22 | Similar
(Note 05) |
| Operating
condition | 15 °C – 40 °C (59 °F –
104 °F), 15–95% non
condensing | 10-40°C (50-104°F), 10%-
85%RH | Similar
(Note 06) |
| Patient contact
materials | metals and resins | ABS | Different
(Note 07) |
| Cleaning/
disinfection | The thermometer casing and
the measuring probe are
cleaned and disinfected by
alcohol (70% Isopropyl). | The surface of the device is
cleaned and disinfected by
70% alcohol. | Different
(Note 08) |
| Biocompatibility | Comply with ISO 10993-
5:2009, ISO 10993-10:2010 | Comply with ISO 10993-
5:2009, ISO 10993-10:2010 | Same |
| Electric Safety
and 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), IEC
60601-1-2: 2014, IEC 60601-
1-11: 2010, ISO 80601-2-56:
2009. | Similar
(Note 09) |
| Performance | ASTM E1965-98 (2009) | ASTM E1965-98 (2009), ISO
80601-2-56: 2009. | Similar
(Note 10) |
| Bluetooth | No | AET-R171, AET-R1D2, AET-
R1B1: These three models do
not have a Bluetooth module.
AET-R161: This model has a
Bluetooth module. | AET-
R171,
AET-
R1D2,
AET-
R1B1:
Same
with
predicate
device
AET-
R161
(Note 11) |
Note 01:
The measuring range of subject device meets the minimum rated output range of clinical thermometer requirement, from 35°C to 42°C, which is stated in standard ISO 80601-2-56.
8
Note 02:
The measurement distance of the subject device is within that of the predicate device. Because the both compliance with ISO 80601-2-56 and ASTM E 1965 standards, the measurement accuracy were meet the requirements of performance standards.
Note 03:
The memory is just for storage of measurement data and viewing by users and it will not affect the performance 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 performance. Furthermore, the electric safety of the battery has been validated with the subject device according to the IEC 60601-1.
Note 05:
The difference in waterproof will not affect the performance of the subject device, which has passed IEC 60601-1 and IEC 60601-1-11 safety test.
Note 06:
The operating condition of subject device has passed the performance test, and the Instructions for Use provides the operating condition.
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.
Note 08:
The cleaning has been validated according to the standards ASTM E2314 -03(2014).
Note 09:
The electrical safety of the subject device has passed the IEC 60601-1, IEC 60601-1-11 and ISO 80601-2-56 tests, and the EMC has passed the IEC 60601-1-2 test.
Note 10:
The performance of the subject device meets the requirements of ASTM E1965-98 (2009), ISO 80601-2-56: 2009.
9
Note 11:
Many legally marketed thermometers contain Bluetooth function to contact an APP. For the Bluetooth function, the subject device (model: AET-R161) has passed the IEC 60601-1, IEC 60601-1-2, 47 CFR PART 15 Subpart C tests, and the hazards, risks have been identified and the risks are controlled.
Note 12:
Although the description of "Indications for use" of subject device is few difference with predicate device. But the patients ages range (all ages) of predicate device covered the patients ages rang (two months and above) of subject device, and the subject device had performed the clinical accuracy test according to the ASTM E 1965-98 and ISO 80601-2-56 standards.
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. The differences noted above between the subject device and the predicate device do not raise new or different performance concerns. Thus, the subject device is substantially equivalent to the predicate device.
7 Brief discussion of nonclinical tests
Nonclinical tests of the Non-contact Infrared Thermometer are listed as below table:
| Tests | Test Standards | Results |
|---|---|---|
| Electric Safety | IEC 60601-1:2005+A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; | Pass |
| 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 | ||
| Tests | Test Standards | Results |
| EMC | IEC 60601-1-2:2014, Medical electrical equipment - | |
| Part 1-2: General requirements for basic safety and | ||
| essential performance - Collateral Standard: | ||
| Electromagnetic compatibility - Requirements and | ||
| tests | Pass | |
| Bench | ||
| performance | ISO 80601-2-56 First Edition 2009-10-01, Medical | |
| electrical equipment - Part 2-56: Particular | ||
| requirements for basic safety and essential | ||
| performance of clinical thermometers for body | ||
| temperature measurement | Pass | |
| Clinical | ||
| accuracy | ASTM E1965-98 (Reapproved 2009): Standard | |
| Specification for Infrared Thermometers for | ||
| Intermittent 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 management process | Pass | |
| In vitro | ||
| Cytotoxicity | ISO 10993-5:2009, Biological evaluation of medical | |
| devices - Part 5: Tests for in vitro cytotoxicity | Pass | |
| Irritation and | ||
| Skin | ||
| sensitization | ISO 10993-10: 2010, Biological evaluation of medical | |
| devices - Part 10: Tests for irritation and skin | ||
| sensitization | Pass | |
| QoS testing | 47 CFR PART 15 Subpart C, Radio Frequency | |
| Devices Subpart C – Intentional Radiators | Pass | |
| Wireless | ||
| coexistence | 47 CFR PART 15 Subpart C, Radio Frequency | |
| Devices Subpart C – Intentional Radiators | Pass | |
| Software | ||
| validation and | ||
| verification test | Guidance for the Content of Premarket Submissions | |
| for Software Contained in Medical Devices issued on: | ||
| May 11, 2005; | ||
| Guidance for Industry, FDA Reviewers and | ||
| Compliance on Off-The-Shelf Software Use | Pass | |
| Tests | Test Standards | Results |
| in Medical Devices issued on: September 9, 1999 |
10
11
8 Brief discussion of clinical tests
The clinical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2009).
In this clinical study for the clinical accuracy validation, we conduct tests with Infrared Thermometer (model: AET-R161) and the RCT (model: WDJ-001) on the presentative patient populations, which include three age groups, i.e. Infants (two months to 1 year old), Children (1 up to 5 years old) and Adults (older than 5 years), and the number of subjects is 38 for Infants, 36 for Children and 42 for Adults.
The test report showed the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2009). Therefore, the subject device is able to measure patients' temperatures as intended.
9 Conclusions
Based on the above information, we conclude that the subject device, Non-contact Infrared Thermometer, is substantially equivalent to the predicate device.