A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER

K993116 · A&D Engineering, Inc. · FLL · Apr 12, 2000 · General Hospital

Device Facts

• Record ID: K993116
• Device Name: A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER
• Applicant: A&D Engineering, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Apr 12, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

A&D Medical UT-101 LifeSource Digital Ear Thermometer is intended for the intermittent measurement and monitoring of human body temperature by consumers in the home. It is intended for use on people of all ages.

Device Story

Digital ear thermometer; measures infrared energy emitted from tympanic membrane/ear canal; converts thermal radiation to digital temperature reading; intended for home use by consumers of all ages; provides rapid temperature assessment; aids in monitoring health status; non-invasive measurement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infrared sensing technology; digital display; handheld form factor; battery-powered; intended for home use.

Indications for Use

Indicated for intermittent measurement and monitoring of human body temperature in patients of all ages in a home setting.

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)

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 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 an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 8 2000

Mr. Jerry Wang Director of Engineering & QA A&D Engineering, Incorporated 1555 McCandless Drive Milpitas, California 95025

Re : K993116 Trade Name: A&D Medical UT-101 LifeSource Digital Ear Thermometer Regulatory Class: II Product Code: FLL Dated: January 31, 2000 Received: February 1, 2000

Dear Mr. Wang:

This letter corrects our substantially equivalent letter of April 12, 2000, regarding the Indication for Use Statement.

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 obligation you might have under sections 531 through 542 of

{1}------------------------------------------------

Page 2 - Mr. Wang

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] oc al its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Pastora Casanova ffa.

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## 510(k) Number (if known): צו 1993 צו (נ

Device Name: A&D Medical UT-101 LifeSource Digital Ear Thermometer

## Indications for Use:

A&D Medical UT-101 LifeSource Digital Ear Thermometer is intended for the intermittent measurement and monitoring of human body temperature by consumers in the home. It is intended for use on people of all ages.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricio Cicceretti

(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control, Division of General Hospital I 510(k) Number -

Prescription Use _

ог

. .

.

Over-The-Counter Use X

(Optional Format 1-2-96)