DIGITAL FOREHEAD THERMOMETER, MODEL FS-100

K043331 · Hubdic Co., Ltd. · FLL · Mar 4, 2005 · General Hospital

Device Facts

• Record ID: K043331
• Device Name: DIGITAL FOREHEAD THERMOMETER, MODEL FS-100
• Applicant: Hubdic Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Mar 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Digital Forehead Thermometer FS-100 is an infrared thermometer intended for the intermittent measurement of human body temperature of people of all ages.

Device Story

Hand-held, battery-operated infrared thermometer; measures natural thermal infrared radiation emitted from skin surface over temporal artery. Used for intermittent body temperature measurement in patients of all ages. Operated by clinicians or patients in clinical or home settings. Provides temperature reading to user to assist in clinical decision-making regarding patient health status.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design comparison to predicate.

Technological Characteristics

Hand-held, battery-operated infrared thermometer. Sensing principle: detection of natural thermal infrared radiation from the temporal artery. Form factor: portable electronic device. No specific materials or software algorithm class specified.

Indications for Use

Indicated for intermittent measurement of human body temperature in people of all ages using an infrared sensor to detect heat over the temporal artery on the forehead.

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

• Exergen Corporation Temporal Scanner Thermometer (K011291)

Submission Summary (Full Text)

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K093331

MAR 4 - 2005

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Image /page/0/Picture/3 description: The image shows the letters 'MTC' in a bold, serif font. The letters are large and black, contrasting with the white background. The letters are slightly slanted to the right, giving the image a dynamic feel. The overall impression is clean and professional.

Media Trade Corporation

11820 Red Hibiscus Drive -- Bonita Springs, FL 34135 Tel [phone] - Fax [phone] E-mail: mediatradecorplagmx.net

## 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: | May 7, 2004 |
| Trade Name: | Digital Forehead Thermometer FS-100 |
| Classification: | Thermometer, Clinical, Electronic<br>Product Code: FLL<br>Regulation Number: 880.2910<br>Class: II<br>Panel: 80 (General Hospital) |
| Predicate Devices: | Exergen Corporation<br>Temporal Scanner Thermometer<br>K 011291 (Predicate) |

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KC43331
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## The Digital Forehead Thermometer FS-100 is a Device Description: hand held, battery operated device that measures the skin temperature of the skin over the temporal artery. Operation is based on measuring the natural thermal infrared radiation emitted from the surface of the skin over the temporal artery. The Digital Forehead Thermometer FS-100 is an Intended Use: infrared thermometer intended for the intermittent measurement of human body temperature of people of all ages. The Digital Forehead Thermometer FS-100 has Technological Characteristics: the same general design and performance characteristics as the predicate device from Exergen Corpporation. The main difference is the physical size, shape and weight. The Digital Forehead Thermometer FS-100 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 Digital Forehead Thermometer FS-100 is therefore substantially equivalent to the predicate device from Exergen.

Page -2- (510k Summary)

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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right and is composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 4 - 2005

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

Re: K043331

Ro45531
Trade/Device Name: Digital Forehead Thermometer FS-100 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 2, 2005 Received: February 7, 2005

Dear Mr. Ginsberg:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becales as a see is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in Indications for use stated in the ensiblem 76, 1976, the enactment date of the Medical Device mierstate commerce pror to way been reclassified in accordance with the provisions of Amendinents, or to de rood also metic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the ristration, listing of devices, good manufacturing practice, requirements for animals against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III II your device is classified (see as other and controls. Existing major regulations affecting (PMA), it may be subject to back adata f Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the South no everning 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 Please be advised that FDA Sissuance of a substantar see complies with other requirements mean that FDA nas made a decemmandia had Jour winistered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by points of the posictroi of the Act or any Pederal statutes and regulations, but not limited to: registration
You must comply with all the Act's requirements and the You must comply with an the Act 3 requirements and 1); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Fall 807), labeling (21 OFF areas) /
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (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) I mis letter will anow you to begin marketing your alence of your device to a premarket notification. The PDF Intalling or 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), If you desire specific advice for your as at [phone]. Also, please note the regulation i picase contact the Office or Occipitalism promarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may other general meeting. International and Consumer Assistance at its toll-free Division of Six 2041 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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## Indications for Use

510(k) Number (if known): K043331

Hubdic Co. Ltd., Digital Forehead Thermometer FS-100 Device Name:

Indications For Use:

This device is an electronic clinical thermometer using an infrared sensor to detect body I mis device is an clock one entired wer the temporal artery on the forehead. It is intended for people of all ages.

Prescription Use (Part 21 CFR 801 Subpart D) AND/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)

Vick Husband for Anthony Weston

Salnay, General Hospital,

) [k] Number:

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