(108 days)
No
The description focuses on standard electronic components and compliance with established thermometer standards, with no mention of AI or ML.
No
The device is a thermometer, which measures temperature for diagnostic or monitoring purposes, but it does not directly treat or prevent a disease or condition.
No
Explanation: A diagnostic device is used to identify or determine the cause of a disease or condition. This device is a thermometer used to measure and monitor body temperature, which is a measurement of a physiological parameter, not a diagnosis.
No
The device description explicitly details hardware components including a wireless LCD reader with PCBs, LEDs, a buzzer, a battery compartment, and batteries, as well as a patch with a plastic body, thermister sensor, and a TAG printed circuit board.
Based on the provided information, the Digital Thermometer with Battery-Less Patch, Model KD-2100, is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device directly measures human body temperature. It does not analyze any biological samples.
The device description and intended use clearly indicate it's a thermometer for measuring temperature in vivo (within the living body), specifically in the ear and mouth. This is a standard medical device function, not an in vitro diagnostic function.
N/A
Intended Use / Indications for Use
The Digital Thermometer with Battery-Less Patch, Model KD-2100, is intended to measure and monitor human body temperature with a wireless digital LCD reader and a sensor coupled patch. The device is reusable and intended for ear and mouth measurement of adults and pediatric patients.
Product codes
FLL
Device Description
The Digital Thermometer with Battery Less Patch, Model KD -2100, consists of a DC battery powered wireless LCD reader and a battery less patch. The LCD reader part consists mainly of a plastic body, four keys (ON/OFF power, memory, read and LED on), two printed circuit boards (CPU and RFID), and and CD assembly with four backlight LEDs, a buzzer, a battery compartment and four AAA type batteries. The patch part includes a plastic body, a thermister sensor, and a TAG printed circuit board.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear and mouth
Indicated Patient Age Range
adults and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness.
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
Exhibit #1
1 0 2002
Barren Barren Barren
510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K060240
1. Submitter's Identification:
K-Jump Health Co., Ltd.
No. 56 Wu Kung 5* Rd. Wu Ku Industrial Park Taipei Hsien, Taiwan 248 Tel: 886 2 22991378 Fax: 886 2 22991386
Contact: Mr. Danny Wang
Date Summary Prepared: January 27, 2006
2. Name of the Device:
K-Jump Digital Thermometer with Battery-Less Patch, Model KD-2100
3. Common or Usual Name:
Clinical Electronic Thermometer
4. Predicate Device Information:
K003326, Funet Amy Mama Body Thermometer, Funai Radio & Communications Corporation
5. Device Description:
The Digital Thermometer with Battery Less Patch, Model KD -2100, consists of a DC battery powered wireless LCD reader and a battery less patch. The LCD reader part consists mainly of a plastic body, four keys (ON/OFF power, memory, read and LED on), two printed circuit boards (CPU and RFID), and and CD assembly with four backlight LEDs, a buzzer, a battery compartment and four AAA type batteries. The patch part includes a plastic body, a thermister sensor, and a TAG printed circuit board.
1
060240
હ. Intended Use:
The Digital Thermometer with Battery-Less Patch, Model KD-2100, is intended to measure and monitor human body temperature with a wireless digital LCD reader and a sensor coupled patch. The device is reusable and intended for ear and mouth measurement of adults and pediatric patients.
7. Comparison to Predicate Devices:
The subject device is substantially equivalent to the predicate device, the Funet Amy Mama Body Thermometer, K#003326. The two devices share the same intended use and indications for use with the exception of small differences in their temperature measurement ranges, transmission frequency, minimum operational temperature and humidity, minimum storage temperature and humidity. These minor technological differences do not raise new issues of safety or effectiveness.
Discussion of Non-Clinical Tests Performed for Determination of 8. Substantial Equivalence are as follows:
The Digital Thermometer with Battery Less Patch, Model KD-2100 complies with EN 60601-1-2 (2001) and ASTM E112-00 "Electronic Thermometer for Intermittent Determination of Patient Temperature" standard. The conformity of harmonized standards for electronic safety ruled by FCC Part 15 is also included.
ರು. Discussion of Clinical Tests Performed:
Not Applicable
10. Conclusions:
The subject device and predicate devices share the same intended use and similar characteristics. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Digital Thermometer with Battery-Less Patch, Model KD-2100, is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, representing medicine and health.
Public Health Servic
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
MAY 19 2006
K-Jump Health Company Limited C/O Ms. Susan D. Goldstein-Falk MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K060240
Trade/Device Name: The Digital Thermometer with Battery-Less Patch, KD-2100 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: April 28, 2006 Received: May 1, 2006
Dear Ms. Goldstein-Falk:
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.
3
Page 2 - Ms. Goldstein-Falk
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 vour 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 (301) 443-6597 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
4
Indications for Use Statement
Page 1 of
510(k) Number (if known): _ K (6 Ox 4 O
Device Name: The Digital Thermometer with Battery-Less Patch, Model KD-2100
Indications for Use:
The Digital Thermometer with Battery-Less Patch, Model KD-2100, is intended to measure and monitor human body temperature with a wireless digital LCD reader and a sensor coupled patch. The device is reusable and intended for ear and mouth measurement of adults and pediatric patients.
Prescription Use (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Euth
OF.
: Dign-Off) of Anesthesiology, General Hospital, Con Control, Dental Devices
Number. k@by44