(121 days)
K#032362
K#032362
No
The device description details standard electronic components and a thermister sensor, with no mention of AI or ML algorithms for temperature determination or any other function.
No
The device is a thermometer, intended for measuring body temperature, which is a diagnostic tool, not a therapeutic intervention.
No
The device is a thermometer used to measure body temperature, which is a vital sign. While changes in body temperature can be indicators of illness, the device itself simply measures a physiological parameter and does not provide a diagnosis or interpret the measurement in the context of disease.
No
The device description explicitly lists hardware components such as a probe with thermister sensor, PC board with ASIC circuits, LCD display, plastic main body, power key, buzzer, and batteries.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "measure the human body temperature using the forehead as measurement site." This is a direct measurement of a physiological parameter of the patient, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description: The description details components for sensing and displaying temperature, which aligns with a standard medical device for measuring body temperature. There is no mention of reagents, assays, or analysis of biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, etc.)
- Detection or measurement of substances within those samples
- Use of reagents or assays
Therefore, the Digital Forehead Thermometer, Model KD-2200, is a medical device for measuring body temperature, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The devices are intended to measure the human body temperature using the forehead as measurement site. It can be used with adult or pediatric patients.
The Digital Forehead Thermometer, Model KD-2200 is intended to measure the human body temperature using the forehead as measurement site. It can be used with adult or pediatric patients.
Product codes
FLL
Device Description
The Digital Forehead Thermometer, Model KD -2200, consists of a probe with thermister sensor and stainless steel plate, a PC board with ASIC circuits, a LCD display, a plastic main body, an ON/OFF power key, a buzzer and two AAA type batteries for the determination of human body temperature. The tip of probe is made with a thermister sensor and stainless steel plate which may sense the temperature changing. The electronic signal was transferred to ASIC circuit on PC board through sensor of probe. The LCD displays the predictive temperature or last temperature recorded and warning information during measurement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
adult or pediatric patients.
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
The Digital Forehead Thermometer, Model KD-2200 complies with the ASTM E1112-00(Reapproved 2006) "Electronic Thermometer for Intermittent Determination of Patient Temperature" standard, EN 60601-1-2 (2001) and EN 60601-1(1997).
Key Metrics
Not Found
Predicate Device(s)
K#032362
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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K07 0491
page 1 of 1
JUN 2 1 2007
EXHIBIT 11
510(k) Summary
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Daniel Tsenq K-jump Health Co., Ltd. No. 56 Wu Kung 500 Road Wu Ku Industrial Park Taipei Hsien Taiwan Phone: + 886 2 22991378 Facsimile: + 886 2 22991386
Date Prepared: Feb. 14, 2007
Name of Device and Name/Address of Sponsor
Digital Forehead Thermometer, Model KD-2200
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 : Danny Wanq
| Common or Usual Name | Clinic Thermometer |
|---|---|
| Classification Name | Class II §880.2910 Clinical Electronic |
| Thermometer | |
| Predicate Device | Up-grade Forehead Thermometer, |
| K#032362, Medisim Ltd. |
Intended Use/Indications for Use
The devices are intended to measure the human body
1
temperature using the forehead as measurement site. It can be used with adult or pediatric patients.
Technology Characteristics
The Digital Forehead Thermometer, Model KD -2200, consists of a probe with thermister sensor and stainless steel plate, a PC board with ASIC circuits, a LCD display, a plastic main body, an ON/OFF power key, a buzzer and two AAA type batteries for the determination of human body temperature. The tip of probe is made with a thermister sensor and stainless steel plate which may sense the temperature changing. The electronic signal was transferred to ASIC circuit on PC board through sensor of probe. The LCD displays the predictive temperature or last temperature recorded and warning information during measurement.
Performance Data
The Digital Forehead Thermometer, Model KD-2200 complies with the ASTM E1112-00(Reapproved 2006) "Electronic Thermometer for Intermittent Determination of Patient Temperature" standard, EN 60601-1-2 (2001) and EN 60601-1(1997).
Substantial Equivalence
The device is substantially equivalent to Up-grade Forehead Thermometer, K#032362. The device is share the same intended use an indication for use with the exception of small differences in their temperature measurement ranges, minimum operational temperature and humidity, minimum storage temperature and humidity, both devices are technologically identical.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Danny Wang Quality Representative K-jump Health Company, Limited No. 56 Wu Kung 5th Road Wu Ku Industrial Park, Taipei Hsien TAIWAN 248
JUN 2 1 2007
Re: K070491
Trade/Device Name: Digital Forehead Thermometer, Model KD-2200 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermoter Regulatory Class: II Product Code: FLL Dated: June 15, 2007 Received: June 18, 2007
Dear Mr. Wang:
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.
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Page 2 -- Mr. Wang
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); 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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EXHIBIT A
Indications for Use
510(k) Number (if Known):
Device Name: Digital Forehead Thermometer, Model KD-2200
Indication for Use:
The Diqital Forehead Thermometer, Model KD-2200 is intended to measure the human body temperature using the forehead as measurement site. It can be used with adult or pediatric patients.
(PLEASE DO NOT WRITE BELOW THIS LINE----CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 C.F.R. 801.109)
OR Over-The-Counter Use_ v
C
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number Kony 41