(154 days)
The FT-100A Electronic thermometer is an Infrared thermometer which uses an infrared sensor to detect human body temperature of patients of all ages. It is intended to detect body temperature. The FT-100A is intended for home use.
The Universal Infrared Forehead Thermometer, Model FT-100A is a non-contact thermometer which infers temperature from the blackbody radiation emitted from the patient. Temperature is calculated from the knowledge of the amount of infrared energy emitted from the human body. The design consists of a lens to focus the infrared thermal radiation on to a detector, which converts the radiant power to an electrical signal that can be displayed in units of temperature after being compensated for ambient temperature. This permits temperature measurement from a distance without contact with the object to be measured.
The provided text describes the 510(k) premarket notification for the Infrared Forehead Thermometer, FT-100A. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a standalone study for the device's performance against specific statistical targets commonly seen in AI/ML medical devices.
However, I can extract information related to the device's accuracy and the clinical investigation performed.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for accuracy are implicitly derived from the comparison to the predicate device and the standards met. The table below combines the stated accuracy for the new device and the predicate, implying that the new device aims to meet or exceed the predicate's accuracy.
| Characteristic | Acceptance Criteria (implied from predicate/standards) | Reported Device Performance (FT-100A) |
|---|---|---|
| Accuracy (Body Mode) | ±0.2°C (±0.36°F) from 36.0°C (96.8°F) to 39.0°C (102.2°F)±0.3°C (±0.54°F) from 32.0°C (89.6°F) to 35.9°C (96.6°F) and from 39.1°C (102.4°F) to 43.0°C (109.4°F) (From Predicate) | FOR BODY MODE:± 0.2°C (±0.4°F) from 36.0°C (96.8°F) to 39.0°C (102.2°F)± 0.3°C (±0.5°F) from 32.0°C (89.6°F) to 35.9°C (96.6°F) and from 39.1°C (102.4°F) to 43.0°C (109.4°F)Clinical investigation demonstrated: "bias less than predicate device when compared to reference." This implies the FT-100A met or exceeded the accuracy of the predicate against the reference."clinical repeatability... statistically and clinically acceptable (less than 0.3 deg C or 0.58 deg F)." |
| Accuracy (Object Mode) | ± 1°C (±2°F) from 0°C (32°F) to 100°C (212°F) (From Predicate) | FOR OBJECT MODE:± 4°C (±7.2°F) from 0°C (32°F) to 4.9°C (40.8°F)± 1°C (±2°F) from 5.0°C (32°F) to 60.0°C (140.0°F)± 4°C (±7.2°F) from 60.1°C (140.1°F) to 100°C (199.9°F) |
| Clinical Repeatability | Defined in ASTM E1965-98 (Reapproved 2009) as "clinical acceptability" (not explicitly quantified for predicate, but implied by standard compliance). | "statistically and clinically acceptable (less than 0.3 deg C or 0.58 deg F)." |
| Compliance with Standards | ISO 80601-2-56:2009, ASTM E1965-98(Reapproved 2009) (and others for biocompatibility, electrical safety, EMC) | Passed all listed standards (ISO 10993-5, ISO 10993-10, ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 80601-2-56, ASTM E1965-98). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The text states, "A clinical investigation was performed to evaluate the clinical accuracy and clinical repeatability on the following three age groups: 0-12 months- <5 years, and 5 years and older." However, the exact number of subjects or measurements in the test set for this clinical investigation is not specified.
- Data Provenance: The document does not explicitly state the country of origin of the clinical data. It is a submission by a company in Hangzhou, China, but the location of the clinical trial is not mentioned. It is a prospective study, as it describes a "clinical investigation" that was "performed."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a thermometer, and "ground truth" for temperature is established by a reference thermometer, not by expert interpretation. The reference was the "Reference SureTemp Plus Oral/Rectal and Axillary Contact Thermometer in the monitoring mode (K030580)."
4. Adjudication method for the test set
Not applicable, as ground truth is established by a reference thermometer, not by expert consensus where adjudication would be necessary.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device for measuring temperature, not an AI/ML diagnostic tool that involves human readers interpreting output.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence. The device (infrared thermometer FT-100A) measures temperature directly. The clinical investigation compared its readings to a reference thermometer. This is a "device only" performance evaluation, as there is no human-in-the-loop component for reading the thermometer itself.
7. The type of ground truth used
The ground truth for the clinical accuracy and repeatability study was established by a reference clinical thermometer: "Reference SureTemp Plus Oral/Rectal and Axillary Contact Thermometer in the monitoring mode (K030580)."
8. The sample size for the training set
Not applicable. This device is an infrared thermometer, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its function is based on physical principles of infrared radiation detection, not on machine learning from a dataset.
9. How the ground truth for the training set was established
Not applicable (see point 8).
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected and appear to be part of a single, flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 24, 2016
Hangzhou Universal Electronic Co., Ltd. c/o Mr. Charlie Mack IRC 7808 Rush Creek Drive Pasco. Washington 99301
Re: K160802
Trade/Device Name: Infrared Forehead Thermometer, FT-100A Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: July 16, 2016 Received: July 20, 2016
Dear Mr. Mack:
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.
{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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K160802
Device Name Infrared forehead thermometer, FT-100A
Indications for Use (Describe)
The FT-100A Electronic thermometer is an Infrared thermometer which uses an infrared sensor to detect human body temperature of patients of all ages. It is intended to detect body temperature. The FT-100A is intended for home use.
| 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)
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 K160802
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: March 5, 2016
- Company and Correspondent making the submission:
Name - Hangzhou Universal Electronic Co., Ltd. Address – 38 Yangjiatang, Sandun, Westlake District, Hangzhou City Zhejiang Province, China 310030 Tel: 86-755-86213939 Fax: 86-571-89905288 Contact - Mr. Jiaqiang Wan General Manager Email - charliemack@irc-us.com
2. Device :
Trade/proprietary name: FT-100a Common Name : Clinical electronic thermometer Classification Name : thermometer, electronic, clinical
3. Predicate Devices :
| Manufacturer | Predicate Device | 510(k)Number | Submitted Device |
|---|---|---|---|
| TaiDocTechnologyCorporation | NEXUS IR30 NON-CONTACT INFRAREDFOREHEADTHERMOMETER | K122221 | Infrared ForeheadThermometer, FT-100A |
4. Classifications Names & Citations :
21CFR 880.2910, FLL, Clinical electronic thermometer
{4}------------------------------------------------
5. Description :
The Universal Infrared Forehead Thermometer, Model FT-100A is a non-contact thermometer which infers temperature from the blackbody radiation emitted from the patient. Temperature is calculated from the knowledge of the amount of infrared energy emitted from the human body.
The design consists of a lens to focus the infrared thermal radiation on to a detector, which converts the radiant power to an electrical signal that can be displayed in units of temperature after being compensated for ambient temperature. This permits temperature measurement from a distance without contact with the object to be measured.
There are some specific limitations to the use of the FT-100A.
It is suggested that a control measurement using a conventional thermometer is recommended in the following cases if the reading is surprisingly low, for new-born infants up to 100 days old or for children under three years of age who have a weakened immune system or who react unusually in the presence or absence of fever
6. Indication for use:
The FT-100A Electronic thermometer is an Infrared thermometer which uses an infrared sensor to detect human body temperature of patients of all ages. It is intended to be used on forehead to detect body temperature. The FT-100A is intended for home use.
- Comparison with predicate device:
Hangzhou Universal Electronic Co., Ltd. believes that the Infrared Forehead Thermometer, FT-100A is substantially equivalent to the (K122221) Nexus Ir30 Non-Contact Infrared Forehead Thermometer (TaiDoc Technology Corporation).
There are differences between the Indications For Use between the predicate TaiDoc Technology Corporation device and the submitted Hangzhou FT-100A device. The difference is simply different grammatical approaches to state that the same point. Both Indication For Use statements state the intended use is to take body temperature from an Infrared device on the same patient population in the same environment.
{5}------------------------------------------------
| Content | New Device | Predict Device |
|---|---|---|
| Device Name | Infrared forehead thermometer, FT-100A | Nexus IR30 Thermometer (TD-1265) |
| Manufacturer | Hangzhou Universal Electronic Co., Ltd. | TaiDoc Technology Corporation |
| 510(K) | N/A | K122221 |
| Indication for Use | The FT-100A Electronic thermometer is anInfrared thermometer which uses an infraredsensor to detect human body temperature ofpatients of all ages. It is intended to be used onforehead to detect body temperature. TheFT-100A is intended for home use. | Nexus IR30 Thermometer is an electronicthermometer using an infrared sensor todetect human body temperature from thesurface of human skin without contact. It isfor use on people of all ages (infants,children, adolescents, and adults) in thehomecare environment. |
| Temperature unit | Same | °C or °F |
| Measurement range | Same | Forehead:32.0°C to 43.0°C (89.6°F to 109.4°F)Object:0°C to 100°C (32°F to 212°F) |
| Operating temperature | Same | 16°C to 40°C (60.8°F to 104°F) |
| Operating humidity | 85% RH or less | 95% RH or less |
| Storage temperature | Same | -25°C to 55°C (-13°F to 131°F) |
| Storage humidity | Same | 95% RH or less |
| Accuracy | FOR BODY MODE: Same as predict device± 0.2°C (±0.4°F) from 36.0°C (96.8°F) to39.0°C (102.2°F)± 0.3°C (±0.5°F) from 32.0°C (89.6°F) to35.9°C (96.6°F) and from 39.1°C (102.4°F) to43.0°C ( 109.4°F)FOR OBJECT MODE:± 4°C (±7.2°F) from 0°C (32°F) to 4.9°C(40.8°F)± 1°C (±2°F) from 5.0°C (32°F) to 60.0°C(140.0°F)± 4°C (±7.2°F) from 60.1°C (140.1°F) to100°C (199.9°F) | FOR BODY MODE:±0.2°C (±0.36°F) from 36.0°C (96.8°F) to39.0°C (102.2°F)±0.3°C (±0.54°F) from 32.0°C (89.6°F) to35.9°C (96.6°F) and from 39.1°C(102.4°F) to 43.0°C (109.4°F)FOR OBJECT MODE:± 1°C (±2°F) from 0°C (32°F) to 100°C(212°F) |
| Memory capacity | Same | 20 measurements |
| Power down time | 1 min | 15 seconds |
| Battery type | 1.5V AAA×2 | 1.5V AAA x 2 |
| LCD Backlight | Available | Available |
| Fundamental scientific technology | Infrared technology | Infrared technology |
| Display resolution | 0.1°C/0.1 °F | 0.1°C/0.1 °F |
{6}------------------------------------------------
8. Safety and Performance Data:
| Test Report FileNo. | Test | Standards | Result |
|---|---|---|---|
| SDWH-M201502527-1 | In vitro cytotoxicity with 10%FBS | ISO 10993-5:2009 | Pass |
| SDWH-M201502527-2 | Skin sensitization 0.9%SC | ISO 10993-10:2010 | Pass |
| SDWH-M201502527-3 | Skin sensitization sesame oil | ISO 10993-10:2010 | Pass |
| SDWH-M201502527-4 | Skin irritation 0.9%SC | ISO 10993-10:2010 | Pass |
| SDWH-M201502527-5 | Skin irritation sesame oil | ISO 10993-10:2010 | Pass |
| EED33H000003-2 | General requirements forbasic safety and essentialperformance | ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012and A2:2010/(R)2012 | Pass |
| EED32H000003 | EMC TEST | IEC 60601-1-2:2007 | Pass |
| GF20150815001 | Particular requirement forbasic safety and essentialperformance ofclinical thermometers forbody temperatureMeasurement | ISO 80601-2-56:2009 | Pass |
| GF20150518001 | Standard specification forinfrared thermometers forintermittent determination ofpatient temperature | ASTM E1965-98(Reapproved 2009) | Pass |
{7}------------------------------------------------
-
- Clinical: A clinical investigation was performed to evaluate the clinical accuracy and clinical repeatability on the following three age groups: 0-12 months- <5 years, and 5 years and older in accordance with ASTM E1965-98 (Reapproved 2009) to compare the Infrared Forehead Thermometer, FT-100A (test thermometer) with the predicate Nexus IR30 Thermometer (TD-1265) (K122221).
This clinical investigation demonstrated that the Infrared Forehead Thermometer, FT-100A is as safe and effective as predicate device, Nexus IR30 Thermometer, TD-1265 (K122221) in all age groups with respect to the bias and standard deviation in comparison to the Reference SureTemp Plus Oral/Rectal and Axillary Contact Thermometer in the monitoring mode (K030580). The temperatures obtained with the test Infrared Forehead Thermometer were equivalent when compared to the predicate device, where temperatures were measured in the oral mode (for children above 5 years) and axillary mode (for children under 5 years). The clinical bias with stated uncertainty and clinical repeatability as defined in the ASTM E1965-98 (Reapproved 2009) standard were within clinical acceptability (bias less than predicate device when compared to reference). The clinical repeatability of the Infrared Forehead Thermometer, FT-100A was statistically and clinically acceptable (less than 0.3 deg C or 0.58 deg F).
- Clinical: A clinical investigation was performed to evaluate the clinical accuracy and clinical repeatability on the following three age groups: 0-12 months- <5 years, and 5 years and older in accordance with ASTM E1965-98 (Reapproved 2009) to compare the Infrared Forehead Thermometer, FT-100A (test thermometer) with the predicate Nexus IR30 Thermometer (TD-1265) (K122221).
The design of the submitted device specifications is substantially the same as the predicate, with minor differences in the storage humidity range.
All the labeling and characteristics of the submitted OTC Infrared Forehead Thermometer, FT-100A are the same as the predicate devices and most typical OTC Infrared Forehead Thermometers currently on the market. The submitted device and predicate both are used for measuring patient temperatures and also to measure object temperatures.
-
- Conclusions:
In accordance with the Federal Food. Drug and Cosmetic Act. 21 CFR Part 807 and based on the information provided in this premarket notification Hangzhou Universal Electronic Co., Ltd. concludes that the Infrared Forehead Thermometer, FT-100A are substantially equivalent to predicate devices as described herein.
- Conclusions:
-
- Hangzhou Universal Electronic Co., Ltd. will update and include in a summary any other information deemed seasonably necessary by the FDA.
END
- Hangzhou Universal Electronic Co., Ltd. will update and include in a summary any other information deemed seasonably necessary by the FDA.
{8}------------------------------------------------
§ 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.