(87 days)
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.
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.
This document describes the regulatory submission for the KINGTECH Forehead Thermometer, Models TF1265 and TF1267. It is a 510(k) summary, indicating that the device is seeking clearance based on substantial equivalence to a legally marketed predicate device.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific numerical acceptance criteria for clinical performance (e.g., accuracy against a gold standard) for the subject device. Instead, it relies on a claim of "entire identical specifications" and a direct comparison to a predicate device, K122221, "Nexus IR30 Thermometer, Model: TD-1265."
The performance tests mentioned are safety and electromagnetic compatibility (EMC) standards:
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| IEC 60601-1 (Medical electrical equipment Part 1. General requirements for safety, 2005) | Compliant |
| EN/IEC 60601-1-2 (Medical electrical equipment, Part 2. Electromagnetic compatibility - Requirements and tests, 2007) | Compliant |
| EN12470 (Specific to clinical thermometers) | Compliant |
| ASTME 1965-98 (Standard Specification for Clinical Thermometers) | Compliant |
| ASTM E1112-00 (Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature) | Compliant |
Note: The document states, "This 510k submission only need change the application name of the predicate K122221 from 'Nexus IR30 Thermometer, TD-1265' to 'KINGTECH Forehead Thermometer, TF1265' there is the entire identical specifications and only need to separate into different 510k." This implies that the KINGTECH device's clinical performance is assumed to be identical to the predicate device's performance, as they share the same specifications. However, the performance metrics of the predicate device are not included in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide information on a specific clinical test set for the KINGTECH device, nor does it specify sample size or data provenance. It explicitly states under "Clinical Tests:" followed by a blank entry, suggesting no new clinical testing was conducted for this 510(k) submission. Instead, the submission relies on the "entire identical specifications" to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable or provided as no specific clinical test set for the KINGTECH device is described. The device's substantial equivalence is based on its identical specifications to the predicate device, not on new clinical data with an independent ground truth.
4. Adjudication Method for the Test Set
This information is not applicable or provided as no specific clinical test set requiring adjudication for the KINGTECH device is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance
This information is not applicable or provided. The device is an infrared thermometer, not an AI-assisted diagnostic tool requiring MRMC studies for human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable or provided. The device is a thermometer, not an algorithm. Its performance is measured directly, though the document defers to the predicate device's performance characteristics.
7. The Type of Ground Truth Used
This information is not applicable or provided for the subject device. For a thermometer, the "ground truth" for reported temperature accuracy would typically be a highly accurate reference thermometer measurement. However, since no new clinical testing is presented, the ground truth methodology for the predicate device is not detailed here.
8. The Sample Size for the Training Set
This information is not applicable or provided. The device is a hardware product (thermometer) and not a machine learning algorithm that requires a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided. Refer to point 8.
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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 PingStreet, Kwai Chung, New Territories, HK | ||
| Tel: +852-24810188 Fax:+852-2423939 | ||
| Manufacturer: | Kingtech (Dong Guan) Enterprises Limited | |
| Farm Village, Da Ling Shan Town, DongGuan, ChinaTel: +86-76985636260 Fax:+86-76985636350 | ||
| EstablishmentRegistration No.: | 3008808166 | |
| Official Contact: | Dr. Jen, Ke-MinTel: +886-3-5208829 Fax:+886-3-5209783Email: ceirs.jen@msa.hinet.net | |
| Common /Usual Name: | Forehead Thermometer | |
| Trade Name: | KINGTECH Forehead Thermometer. Models: TF1265, TF1267 | |
| ClassificationCode: | FLL, Class II, 21 CFR 880.2910 | |
| Intended Use: | TF1265, TF1267 Forehead Thermometer is an electronicthermometer using an infrared sensor to detect human bodytemperature fro the surface of human skin without contact.It is for use by people of all ages in the homecare environment | |
| PredicatedDevices: | K122221, Nexus IR30 Thermometer, Model: TD-1265TaiDoc Technology Corporation | |
| Device Description: | The Forehead Thermometer TF1265, TF1267 is characterized bymeasuring human body temperature from the surface of humanskin. It utilizes infrared technology to measure infrared energyemitted from the skin surface when making a temperaturemeasurement. | |
| Test Principle: | The thermometer Measures temperature by reading infraredradiation emitting from the skin and converts it into a temperaturevalue. |
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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
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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.
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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
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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. ChapmanDate: 2013.12.26 11:50:34 -05'00' |
|---|---|
| FORM FDA 3881 (9/13) | Page 1 of 2 |
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§ 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.