K-JUMP DIGITAL THERMOMETER WITH BATTERY-LESS PATCH, MODEL KD-2100

K060240 · K-Jump Health Co., Ltd. · FLL · May 19, 2006 · General Hospital

Device Facts

• Record ID: K060240
• Device Name: K-JUMP DIGITAL THERMOMETER WITH BATTERY-LESS PATCH, MODEL KD-2100
• Applicant: K-Jump Health Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: May 19, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Device consists of battery-powered wireless LCD reader and battery-less patch. Patch contains thermistor sensor and RFID tag; reader contains CPU, RFID circuitry, LCD, and buzzer. System measures body temperature; data transmitted wirelessly from patch to reader. Used by patients or clinicians in clinical or home settings. Reader displays temperature; provides audible/visual feedback. Enables temperature monitoring for clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only, including compliance with EN 60601-1-2 (2001) and ASTM E112-00.

Technological Characteristics

System comprises wireless LCD reader and battery-less patch. Materials include plastic housing. Sensing via thermistor. Connectivity via RFID. Powered by 4 AAA batteries (reader). Complies with ASTM E112-00 and EN 60601-1-2. FCC Part 15 compliant.

Indications for Use

Indicated for measurement and monitoring of human body temperature in adult and pediatric patients via ear or mouth.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• Funet Amy Mama Body Thermometer (K003326)

Submission Summary (Full Text)

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### 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: [phone] Fax: [phone]

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.

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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.

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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.

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## 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 [phone]. 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 [phone] or [phone] 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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# 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