THERMOFLASH LX-26

K080759 · Jxb Co. Ltd Guangzhou (China) · FLL · May 12, 2008 · General Hospital

Device Facts

• Record ID: K080759
• Device Name: THERMOFLASH LX-26
• Applicant: Jxb Co. Ltd Guangzhou (China)
• Product Code: FLL · General Hospital
• Decision Date: May 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

ThermoFlash LX-26 is an infrared thermometer for body surface and forehead temperature measurement for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.

Device Story

ThermoFlash LX-26 is a handheld, battery-operated, non-contact infrared thermometer. It measures infrared energy emitted from the body surface or forehead. An internal infrared sensor detects thermal radiation, which is converted into a digital temperature value by an ASIC and displayed on an LCD screen. The device is intended for use by consumers in home environments or by clinicians in medical settings as a reference tool. It provides non-invasive temperature monitoring, reducing the risk of cross-contamination by eliminating physical contact with the patient.

Clinical Evidence

Bench testing only. The device conforms to ASTM E 1965-98(2003), IEC 60601-1, and IEC 60601-1-2 standards.

Technological Characteristics

Handheld infrared thermometer; battery-operated; infrared sensor technology; ASIC-based signal processing; LCD display. Complies with ASTM E 1965-98(2003) standard specification for infrared thermometers.

Indications for Use

Indicated for non-contact body surface and forehead temperature measurement in infants and adults.

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

• Infrared Thermometer, Model: FDIR-V1 (K052849)

Submission Summary (Full Text)

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K080759

# 510(K) SUMMARY

MAY 12 2008

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR § 807.92

1.0 Submitter's Information

| Name: | JXB Co, LTD Guangzhou (China) |
|----------|-------------------------------------------------------------|
| Address: | Nº 38 Huanzhen Xi Road, Dagang Town,Panuy, Guangzhou, China |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Tray Cui |
| Email: | [e-mail] |

### 2.0 Device Information

| Name: | Infrared Thermometer |
|-------------|----------------------|
| Trade Name: | ThermoFlash LX-26 |
| Model: | ThermoFlash LX-26 |

### Classification 3.0

| Product Code: | FLL---clinical electronic thermometer |
|-----------------|---------------------------------------|
| Regulation: | 880.2910 |
| Number: | |
| Classification: | II |
| Panel: | 80 |

### Predicate Device Information 4.0

| Sponsor: | Famidoc Technology Co., Ltd |
|----------------|--------------------------------------|
| Device: | Infrared Thermometer, Model: FDIR-V1 |
| 510(K) Number: | K052849 |

### 5.0 Device description

Infrared Thermometer ThermoFlash LX-26 is a hand held, reusable, battery operated, maximum device that can measure human body surface and forehead

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temperature measurement for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference. It is manufactured in accordance with the ASTM 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.

The operation principle is based on infrared sensor technology. IR Sensor can putout different signal when mcasuring different object temperature or in different ambient temperature. An ASIC can turn the signal from IR schsor to digital value and display it by LCD.

### 6.0 Intended Use

ThermoFlash LX-26 is an infrared thermometer for body surface and forehead temperature measurement for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.

### 7.0 Performance Summary

The device conforms to applicable standards included ASTM E 1965-98(2003). IEC 60601-1 and IEC 60601-1-2 requirements.

### Comparison to predicate device and conclusion 8.0

Our Infrared Thermometer ThermoFlash LX-26 is substantially equivalent to Infrared Thermometer, Model: FDIR-V1 whose 510(K) number is K052849.

The two devices are very similar in design principle, intended use, functions, material and the applicable standards. Only their outlook and some parameter such as measurement rang are different. However, the tests in this submission provide demonstration these small differences do not raise any new question of safety or effectiveness.

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The infrared thermometer ThermoFlash LX-26 is substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 12 2008

JXB Company, Limited Guangzhou C/O Mr. Casey Conry Responsible Third Party Official Underwriters Laboratories, Incorporated 1285 Walt Whitman Road Melville, New York 11747

Re: K080759

Trade/Device Name: ThermoFlash LX-26 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: April 25, 2008 Received: April 28, 2008

Dear Mr. Conry:

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. Conry

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/industry/support/index.html.

Sincerely yours,

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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K484759

## Statement of Indications for Use

510(k) Number (if known):

Device Name: ThermoFlash LX-26

Indications For Use:

ThermoFlash LX-26 is an infrared thermometer for body surface and forellead temperature measurement for infants and adults without contact to human body.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cim 200

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

510(k) Number:

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