THERMO BUDDY, MODELS TB-100, TB-110, TB-120

K023412 · Hubdic Co., Ltd. · FLL · Apr 9, 2003 · General Hospital

Device Facts

• Record ID: K023412
• Device Name: THERMO BUDDY, MODELS TB-100, TB-110, TB-120
• Applicant: Hubdic Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Apr 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Thermo Buddy Ear Thermometer is intended for the intermittent measurement and monitoring of human body temperature in the home. It is intended for use on people of all ages.

Device Story

Hand-held electronic clinical thermometer; measures natural thermal radiation from tympanic membrane and adjacent auditory canal surfaces via infrared sensor. Used in home setting by patients of all ages or caregivers. Provides body temperature measurement to assist in health monitoring. Device design, materials, and performance characteristics are similar to predicate ear thermometers.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and performance characteristics compared to predicate devices.

Technological Characteristics

Hand-held electronic thermometer; infrared sensor for thermal radiation detection; intended for auditory canal measurement. Design and materials are similar to predicate devices.

Indications for Use

Indicated for intermittent measurement and monitoring of human body temperature in neonatal, pediatric, and adult populations in a home setting via the auditory canal.

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

• Braun Thermoscan IRT3020
• Omron Gentletemp Instant Ear Thermometer MC-509

Submission Summary (Full Text)

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APR 0 9 2003

K0234/2

## MTC

Media Trade Corporation

11820 Red Hibiscus Drive - Bonita Springs, FL 34135 Tel [phone] -- Fax [phone] E-mail: mediatradecorpla gmx.net Web: www.mediatradecorp.com

## 510(k) Summary

| Submitter's Name: | Guenter Ginsberg<br>Media Trade Corporation | |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------|--|
| Address: | 11820 Red Hibiscus Drive<br>Bonita Springs, FL 34135 | |
| Phone: | [phone] | |
| Fax: | [phone] | |
| E-mail: | [e-mail] | |
| Contact: | Guenter Ginsberg | |
| Date of Summary: | October 04, 2002 | |
| Trade Name: | Thermo Buddy, Ear Thermometer, Model TB-100 | |
| Classification: | Thermometer, Clinical, Electronic<br>Product Code: FLL<br>Regulation No. 880.2910<br>Class: Il<br>Panel: 80 (General Hospital) | |

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Page -2- (510k Summary) The Thermo Buddy Ear Thermometer is a hand Device Description: held instrument that measures body temperature through the opening of the auditory canal. Operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces. The Thermo Buddy Ear Thermometer is intended Intended Use: for the intermittent measurement and monitoring of human body temperature in the home. It is intended for use on people of all ages. The Thermo Buddy Ear Thermometer has the Technological Characteristics: same general design and performance characteristics as the predicate devices from Braun and Omron. The main difference is the physical size, shape and weight. The Thermo Buddy Ear Thermometer has the same intended use, general design and incorporates similar materials and components, hence should therefore raise no new questions of safety and effectiveness. This submitter concludes that the Thermo Buddy Thermometer is therefore substantially equivalent to the predicate devices "Braun Thermoscan IRT3020"and the "Omron Gentletemp Instant Ear Thermometer MC-509".

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Image /page/2/Picture/1 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 symbol that resembles three abstract human profiles or bird-like shapes, stacked on top of each other.

APR 0 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hubdic Company, Limited C/O Mr. Guenter Ginsberg Media Trade Corporation 11820 Red Hibiscus Drive Bonita Springs, Florida 34135

Re: K023412

Trade/Device Name: Thermo Buddy Ear Thermometer Model TB-100 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: January 21, 2003 Received: January 24, 2003

Dear Mr. Ginsberg:

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. Ginsberg

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 [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/dsma/dsmamain.html

Sincerely yours,

Susan Runge

Susan Runner, DDS, MA Interim 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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Page / of /

510(k) Number (if known): K023412
Hubdis Co Ltd
Thonmo Rudo

Hubdic Co. Ltd., Thermo Buddy Ear Thermometer Model TB-100 Device Name:_

Indications For Use:

This device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used at home.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|----------------------|------------------------|
| (Per 21 CFR 801.109) | <i>Patrice Lucente</i> |
| (Division Sign-Off) | |

OR

| Over-The-Counter Use | ✓ |
|----------------------|--------------------------|
| | (Optional Format 1-2-96) |

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

510(k) Number: K023412