(42 days)
Not Found
Unknown
The device description mentions "predictive algorithm technology" but does not explicitly state that this algorithm uses AI or ML. It could be a simpler, non-AI/ML based algorithm.
No.
The device is described as an electronic thermometer intended to measure human body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
No
Explanation: The device is an electronic thermometer used to measure body temperature. While temperature can be an indicator of health, measuring it alone is not a diagnostic act in itself. Diagnosis involves identifying the nature of a disease or condition, which is beyond the function of this device.
No
The device description explicitly states it is an "electronic thermometer with a hinged probe and an LCD display," indicating it is a hardware device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The device described is an electronic thermometer that measures human body temperature directly from the body (orally, rectally, under the arm). It does not analyze specimens taken from the body.
Therefore, based on the provided information, this device falls under the category of a general medical device for measuring a physiological parameter, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The devices are intended to measurement the human body temperature, and specifically indicated to operate in either predictive mode or regular mode orally, rectally or under the arm.
The Digital Clinical Thermometer Model KD-193 is intended to measure the human body temperature and is specifically indicated to operate in either predictive mode or regular mode orally, rectally or under the arm.
Product codes
FLL
Device Description
The device is an electronic thermometer with a hinged probe and an LCD display. The device was designed to measure human body predictive temperature (fast mode) around four seconds with predictive algorithm technology. If the predictive temperature cannot be measured, the device will take actual temperature (regular mode) automatically.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orally, rectally or under the arm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The Digital Clinical Thermometer model KD-193 complies with EN 60601-1-2 (1996); EN 55011 (1991); IEC 801-2(1991); IEC 801-3(1984) and the ASTM E1112-00 Electronic Thermometer for Intermittent Determination of Patient Temperature standard.
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.
0
510(k) Summary
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Daniel Tseng K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien Taiwan Phone: + 886 2 22991378 Facsimile: + 886 2 22991386
Date Prepared: June 5, 2002
Name of Device and Name/Address of Sponsor
Digital Clinical Thermometer Model KD-193
K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien Taiwan Phone: + 886 2 22991378 Facsimile: + 886 2 22991386 Contact Person : Daniel Tseng
| Common or Usual Name | Digital Thermometer |
|---|---|
| Classification Name | Class II §880.2910 Clinical Electronic |
| Thermometer | |
| Predicate Device | I. K-jump Health Co., Ltd. K-jump |
| Digital Clinical Thermometer | |
| II. Advanced Bioresearch Assoc. | |
| SureTemp® Electronic Thermometer |
1
Intended Use/Indications for Use
The devices are intended to measurement the human body temperature, and specifically indicated to operate in either predictive mode or regular mode orally, rectally or under the arm.
Technology Characteristics
The device is an electronic thermometer with a hinged probe and an LCD display. The device was designed to measure human body predictive temperature (fast mode) around four seconds with predictive algorithm technology. If the predictive temperature cannot be measured, the device will take actual temperature (regular mode) automatically.
Performance Data
The Digital Clinical Thermometer model KD-193 complies with EN 60601-1-2 (1996); EN 55011 (1991); IEC 801-2(1991); IEC 801-3(1984) and the ASTM E1112-00 Electronic Thermometer for Intermittent Determination of Patient Temperature standard.
Substantial Equivalence
The device is substantially equivalent to K-jump's Digital Clinical Thermometer (K903590) and Advanced Bioresearch Assoc.'s SureTemp® Electronic Thermometer (K943695). The devices share the same intended use an indication for use and are technologically identical.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized lines forming the body and wings.
JUL 1 7 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
K-Jump Health Company Limited C/O Mr. Jonathan S. Kahan Hogan & Harton L.L.P. 555 Thirteen Street, N.W. Washington, D. C. 20004-1109
Re: K021851
Trade/Device Name: Digital Clinical Thermometer Model KD-193 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: June 5, 2002 Received: June 5, 2002
Dear Mr. Kahan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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.
3
Page 2 – Mr. Kahan
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Timo Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form
510(k) Number (if Known):
Device Name: Digital Clinical Thermometer Model KD-193
Indication for Use:
The Digital Clinical Thermometer Model KD-193 is intended to measure the human body temperature and is specifically indicated to operate in either predictive mode or regular mode orally, rectally or under the arm.
(PLEASE DO NOT WRITE BELOW THIS LINE----CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
Over-The-Counter Use________ (Per 21 C.F.R. 801.109)
Patura Crescent
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_ KO26851