(87 days)
Not Found
No
The device description details standard electronic components for temperature measurement and display, with no mention of AI/ML algorithms or data processing beyond basic calculation.
No
A therapeutic device is used to treat or cure a disease or condition. This device is a digital thermometer, which is used for measurement and diagnosis, not treatment.
No
This device is a digital thermometer, which measures body temperature. While temperature can be an indicator for various conditions, the device itself is only a measurement tool and does not provide a diagnosis.
No
The device description explicitly lists hardware components such as a thermistor, reference resistor, buzzer, ASIC, and LCD, indicating it is a physical device with embedded software, not a standalone software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure body temperature orally. This is a direct measurement of a physiological parameter within the body, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description: The description details how the device measures temperature using a thermistor and displays the result. It doesn't mention any components or processes related to analyzing biological samples.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body to provide information about a person's health. This device does not perform such tests.
Therefore, based on the provided information, the TT1001 Digital Thermometer is a medical device, but it falls under the category of a clinical thermometer, not an IVD.
N/A
Intended Use / Indications for Use
TT1001 Digital Thermometer is intended to measure the body temperature orally and to be used by medical professionals in clinical and hospital environments and consumers in a home environment. It is intended for use on people of all ages.
Product codes
FLL
Device Description
The Digital Thermometer TT1001 enables easy and accurate readings over the body temperature range. It must be used in conjunction with disposable probe cover when taking temperature. From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
all ages
Intended User / Care Setting
medical professionals in clinical and hospital environments and consumers in a home 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)
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.
Biocompatibility Tests:
• ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
• ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for in irritation and skin sensitization.
Clinical Tests: In accordance with: EN12470, ASTM E 1965-98, and ASTM E1112-00
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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KINGTECH ENTERPRISES LIMITED
ROOM 2016. 20F , BLOCK B, REGE:NT CENTER. 70 TA CHUEN PING ST., KWAI CHUNG, N.T. HONG KONG TEL : 852-24810188 FAX : 852-24253939
510(K) SUMMARY for KINGTECH Digital Thermometer, TT1001
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_133111
| Submission Date: | September 21, 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: | Digital Thermometer |
| Trade Name: | KINGTECH Digital Thermometer, TT1001 |
| Classification | |
| Code: | FLL, Class II, 21 CFR 880.2910 |
| Intended Use: | TT1001 Digital Thermometer is intended to measure the body |
| temperature orally and to be used by medical professionals in | |
| clinical and hospital environments and consumers in a home | |
| environment. It is intended for use on people of all ages. | |
| Predicated | |
| Devices: | K122520, TaiDoc Digital Thermometer, TD-1001 |
| TaiDoc Technology Corporation | |
| Device Description: | The Digital Thermometer TT1001 enables easy and accurate |
| readings over the body temperature range. It must be used in | |
| conjunction with disposable probe cover when taking temperature. | |
| From the construction point of view, the digital thermometer | |
| comprises of a thermistor for measuring sensor, a reference resistor | |
| for comparison of temperature, a buzzer for sounding effect, an | |
| ASIC for calculating, and LCD for displaying the measuring | |
| temperature digitally for which the thermistor contacts. |
1
KINGTECH ENTERPRISES LIMITED
ROOM 2016, 20/F, BLOCK B, REGENT CENTER, 70 TA CHUEN PING ST., KWAI CHUNG, N.T. HONG KONG TEL : 852-24810188 FAX : 852-24253939
| Test Principle: | The Digital thermometer TT1001 is the electronic thermometer
operated by a thermistor as the temperature sensor and an ASIC
(Application Specified IC) for signal processing. The basic
operation principle is that a change of thermistor, caused by
changes of temperature, provide signal to ASIC. ASIC gets the
sensor's signal then processes the signal and calculates the result,
after that displays the temperature result by a LCD. |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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.
Biocompatibility Tests:
• ISO 10993-5:2009, Biological evaluation of medical devices -
Part 5: Tests for in vitro cytotoxicity.
• ISO 10993-10:2010, Biological evaluation of medical devices -
Part 10: Tests for in irritation and skin sensitization. |
| Clinical Tests: | In accordance with:
EN12470, ASTM E 1965-98, and ASTM E1112-00 |
| Comparison and
Conclusion: | This 510k submission only need change the application name of
the predicate K122520 from "TaiDoc Digital Thermometer,
TD-1001" to "KINGTECH Digital Thermometer, TT1001"; 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 TaiDoc Technology
Corporation and BioCare Co., Ltd. who is a branch office of
TaiDoc Technology Corporation.
Thus the new device is substantially equivalent to the predicate
devices in this aspect. |
.
. .
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name arranged in a circular fashion around the department's emblem. The emblem is a stylized representation of an eagle with outstretched wings, symbolizing protection and care. The logo is printed in black ink.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 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: K133111
Trade/Device Name: KINGTECH Digital Thermometer TT1001 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: II Product Code: FLL Dated: September 21, 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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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.
Image /page/3/Picture/7 description: The image shows the name "Kwame O. Ulmer" in bold, black font. Below the name, there is a faded, illegible text. To the left of the faded text, there is a "-S".
for
Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133111
Device Name
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KINGTECH Digital Thermometer, TT1001
Indications for Use (Describe)
TT.1001 Digital Thermometer is intended to measure the body temperature orally and to be used by medical professionals in clinical and hospital environments and consumers in a home environment. It is intended for use on people of all ages.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Digitally signed by Richard C. Chapman Date: 2013.12.26 11:36:46 -05'00'
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
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