NPAC MULTI-USE EAR THERMOMETER, MODELS TP 700,TP 702

K051835 · Norm Pacific Automation Corp. · FLL · Sep 23, 2005 · General Hospital

Device Facts

• Record ID: K051835
• Device Name: NPAC MULTI-USE EAR THERMOMETER, MODELS TP 700,TP 702
• Applicant: Norm Pacific Automation Corp.
• Product Code: FLL · General Hospital
• Decision Date: Sep 23, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

For intermittent measurement of body temperature in patients of all ages in home environment

Device Story

NPAC Multi-Use Ear Thermometer (Models TP700, TP702) is an electronic clinical thermometer for home use. Device measures infrared energy emitted from ear canal/eardrum; converts thermal radiation into digital temperature reading. Operated by patient or caregiver; provides intermittent temperature monitoring. Output displayed on device screen to assist in fever detection and health monitoring. Benefits include non-invasive, rapid temperature assessment.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Electronic infrared ear thermometer; handheld form factor; battery-powered. Measures infrared thermal radiation from the tympanic membrane/ear canal. Intended for home use.

Indications for Use

Indicated for intermittent body temperature measurement in patients of all ages in home settings.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.

Public Health Service

SEP 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Norm Pacific Automation Corporation C/O Dr. Chi-Chu Wu Chen Regulatory Consultant New Century Technology 3F, No. 31, Hu-Pin Road #1 SBIP, HSIN-CHU TAIWAN

Re: K051835

Trade/Device Name: NPAC Multi-Use Ear Thermometer, Models TP 700, TP 702 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: August 26, 2005 Received: September 1, 2005

Dear Dr. Chi-Chu Wu Chen:

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 – Dr. Chi-Chu Wu Chen

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 (OS) 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 vours,

Chiu Lin, Ph.D.

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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Letter to Mr. Chapman Special 510(k) K051835

Exhibit #1

## Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: NPaC Multi-Use Ear Thermometers TP700 series Models TP700, TP702

Indications For Use: For intermittent measurement of body temperature in patients of all ages in home environment

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ × (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton D. mwe

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device

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510(k) Number:__