(87 days)
Not Found
No
The summary describes a standard infrared thermometer and does not mention any AI or ML capabilities. The performance studies listed are standard safety and electromagnetic compatibility tests, not AI/ML performance metrics.
No
The device is a thermometer used for temperature detection, which is a diagnostic function, not a therapeutic intervention.
No
A diagnostic device identifies a disease or condition. This device measures body temperature, which is a vital sign, but it does not diagnose a specific illness.
No
The device description explicitly states it is an "electronic thermometer using an infrared sensor" and "utilizes infrared technology to measure infrared energy emitted from the skin surface," indicating it is a hardware device with an infrared sensor.
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: The TF1265, TF1267 Forehead Thermometer measures human body temperature from the surface of the skin using infrared technology. It does not analyze samples taken from the body.
- Intended Use: The intended use is to detect human body temperature from the surface of human skin, which is a direct measurement on the body, not an analysis of a sample.
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
TF1265, TF1267 Forehead Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature fro the surface of human skin without contact. It is for use by people of all ages in the homecare environment.
Product codes
FLL
Device Description
The Forehead Thermometer TF1265, TF1267 is characterized by measuring human body temperature from the surface of human skin. It utilizes infrared technology to measure infrared energy emitted from the skin surface when making a temperature measurement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surface of human skin
Indicated Patient Age Range
people of all ages
Intended User / Care Setting
homecare environment
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Tests: Safety Test: · IEC 60601-1 - Medical electrical equipment Part 1. General requirements for safety, 2005. Electromagnetic Compatibility Test: · EN/IEC 60601-1-2 - Medical electrical equipment, Part 2. Electromagnetic compatibility - Requirements and tests, 2007. In accordance with: EN12470, ASTME 1965-98, and ASTM E1112-00
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K122221, Nexus IR30 Thermometer, Model: TD-1265
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
KINGTECH ENTERPRISES LIMITED
ROOM 2016. 20F., BLOCK B. REGENT CENTER, 70 TA CHUEN PING ST., KWAJ CHUNG. N.T. HONG KONG TEL : 852-24810188 FAX : 852-24253939
510(K) SUMMARY
for KINGTECH Forehead Thermometer, TF1265, TF1267
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(K) number is:__K 133113
| Submission Date: | September 22, 2013 | |
|---|---|---|
| Submitter: | Kingtech Enterprises Limited | |
| Room 2016, 20/F., Block B, Regent Center 70 Ta Chunen Ping | ||
| Street, Kwai Chung, New Territories, HK | ||
| Tel: +852-24810188 Fax:+852-2423939 | ||
| Manufacturer: | Kingtech (Dong Guan) Enterprises Limited | |
| Farm Village, Da Ling Shan Town, DongGuan, China | ||
| Tel: +86-76985636260 Fax:+86-76985636350 | ||
| Establishment | ||
| Registration No.: | 3008808166 | |
| Official Contact: | Dr. Jen, Ke-Min | |
| Tel: +886-3-5208829 Fax:+886-3-5209783 | ||
| Email: ceirs.jen@msa.hinet.net | ||
| Common / | ||
| Usual Name: | Forehead Thermometer | |
| Trade Name: | KINGTECH Forehead Thermometer. Models: TF1265, TF1267 | |
| Classification | ||
| Code: | FLL, Class II, 21 CFR 880.2910 | |
| Intended Use: | TF1265, TF1267 Forehead Thermometer is an electronic | |
| thermometer using an infrared sensor to detect human body | ||
| temperature fro the surface of human skin without contact. | ||
| It is for use by people of all ages in the homecare environment | ||
| Predicated | ||
| Devices: | K122221, Nexus IR30 Thermometer, Model: TD-1265 | |
| TaiDoc Technology Corporation | ||
| Device Description: | The Forehead Thermometer TF1265, TF1267 is characterized by | |
| measuring human body temperature from the surface of human | ||
| skin. It utilizes infrared technology to measure infrared energy | ||
| emitted from the skin surface when making a temperature | ||
| measurement. | ||
| Test Principle: | The thermometer Measures temperature by reading infrared | |
| radiation emitting from the skin and converts it into a temperature | ||
| value. |
1
KINGTECH ENTERPRISES LIMITED
ROOM 2016, 20/P., BLOCK B, REGENT CENTER, 70 TA CHUEN PING ST., KWAI CHUNG, N.T. HONG KONG TEL : 852-24810188 FAX : 852-24253939
Performance Tests: Safety Test: · IEC 60601-1 - Medical electrical equipment Part 1. General requirements for safety, 2005. Electromagnetic Compatibility Test: · EN/IEC 60601-1-2 - Medical electrical equipment, Part 2. Electromagnetic compatibility - Requirements and tests, 2007. In accordance with: EN12470, ASTME 1965-98, and ASTM E1112-00 This 510k submission only need change the application name of the predicate K122221 from "Nexus IR30 Thermometer, Conclusion: TD-1265" to "KINGTECH Forehead Thermometer, TF1265" there is the entire identical specifications and only need to separate into different 510k. And all of the test reports and documentation for this 510k submission were prepared by the applicant of the predicate device: TaiDoc Technology Corporation. We, Kingtech Enterprises Limited, are authorized by BioCare Co., Ltd. who is a branch office of TaiDoc Technology Corporation. We also present the authorized "Statement" as the following page. In addition, another model TF1267 of the subject device, it is only minor difference to the exterior dimension for the TF1265. Thus the new device is substantially equivalent to the predicate devices in this aspect.
Clinical Tests:
Comparison and
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
December 26, 2013
Kingtech Enterprises Limited C/O Dr. Ke-Min Jen Official Correspondent Room 2016, 20/F., Block B, Regent Center 70 Ta Chunen Ping Street Kwai Chung, New Territories HONG KONG
Re: K133113
Trade/Device Name: KINGTECH Forehead Thermometer, Model: TF1265, TF1267 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: II . Product Code: FLL Dated: September 22, 2013 Received: September 30, 2013
Dear Dr. Jen:
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.
3
Page 2 - Dr. Jen
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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kwame O.
Ulmer-S
for
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133113
ﺒﻪ، "ﻧﺎﺀ
Device Name
KINGTECH Forehead Thermometer, Models: TF 1265, TF 1267
Indications for Use (Describe)
TF1265 and TF1267 Forehead Thermometer is an electronic thermometer using an infraced sensor to detect human body temperature fro the surface of human skin without contact. It is for use by people of all ages in the homecare environment.
Type of Use (Select one or both, as applicable)
[] Prescription Use (Part 21 CFR 801 Subpart D)
χ Over-The-Counter Use (21 CFR 801 Subpart C)
Please do not write below this line - continue on a separate page if needed.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | Digitally signed by Richard C. Chapman
Date: 2013.12.26 11:50:34 -05'00' |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| FORM FDA 3881 (9/13) | Page 1 of 2 |
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