(388 days)
Not Found
Not Found
No
The summary describes a standard infrared ear thermometer and does not mention any AI or ML components or capabilities.
No
The device is described as a clinical thermometer for determining human temperature, which is a diagnostic function, not a therapeutic one.
No
The device is described as a clinical thermometer intended for the determination of human temperature. This is a measurement of a physiological parameter, not a diagnosis of a disease or condition.
No
The device description explicitly states it is a "clinical thermometer" and conforms to a standard for "Electronic Thermometer," indicating it is a physical hardware device that measures temperature.
No, 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. They are used to examine these samples outside of the body.
- Device Function: The Infrared Ear Thermometer measures temperature by detecting radiation emitted from the ear. This is a direct measurement of a physiological parameter within the body, not an analysis of a sample taken from the body.
Therefore, based on the provided information, the Infrared Ear Thermometer is a clinical thermometer used for measuring body temperature, which falls under the category of medical devices, but not specifically IVDs.
N/A
Intended Use / Indications for Use
The Infared Ear Thermometer is a clinical thermometer intended for the determination of human temperature by radiation emitted via the human ear (tympanic temperature).
The Infared Ear Thermometer is a non-sterile, reusable clinical thermometer intended for the determination of human temperature by radiation emitted via the ear (tympanic temperature).
Product codes
FLL
Device Description
The Infared Ear Thermometer is a clinical thermometer intended for the determination of human temperature by radiation emitted via the human ear (tympanic temperature).
In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear (tympanic)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Becton Dickinson's Assure Ear Thermometer
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) Infrared Ear Thermometer K-Jump Health Co., Ltd.
510(k) Summary
| Proprietary Name: | Infared Ear Thermometer | |
|---|---|---|
| Common Name: | Radiation Thermometer (Tympanic Temperature) | |
| Classification: | Class II | |
| Submitter Details: | Polygreen Company, Ltd. | |
| a subsidiary of K-Jump Health Co. Ltd. | ||
| 136 Wu Kung Road, Wu Ku Industrial Park | ||
| Taipei, Hsien | ||
| Taiwan, R.O.C. | ||
| Tele.: | ||
| Fax: | ||
| Contact: | 001-886-2-2991378-82 | |
| 001-886-2-2991386 | ||
| Mr. Tseng Chao Man (Daniel) |
The Infared Ear Thermometer is a clinical thermometer intended for the determination of human temperature by radiation emitted via the human ear (tympanic temperature).
In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature."
The Infared Ear Thermometer is substantially equivalent to Becton Dickinson's Assure Ear Thermometer.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 2000
Jonathan S. Kahan, Esquire Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street N.W. Washington, D.C. 20004-1109
Re: K984551 K-Jump Health Co., Ltd.'s Infrared Ear Trade Name: Thermometer, Model KI-8120 Requlatory Class: II Product Code: FLL November 5, 1999 Dated: November 5, 1999 Received:
Dear Mr. Kahan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
2
Page 2 - Mr. Kahan
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
.
imothy A. Ulatowski
Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Infrared Ear Thermometer K-Jump Health Co., Ltd.
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
| 510(K) Number: | Unassigned
K-Jump Health Co., Ltd. |
| ---------------- | --------------------------------------- |
|---|
Infared Ear Thermometer Device Name:
- The Infared Ear Thermometer is a non-sterile, reusable Indications for Use: clinical thermometer intended for the determination of human temperature by radiation emitted via the ear (tympanic temperature).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRS, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1.2.96)
(Optional Format 1-2-96)
Palaccio Cucenti
(Division Sign-Off)
Division of Dental, Infection Contr and General Hospital I 510(k) Number
Page 61