K112929 · Visiomed Group SA · FLL · Oct 18, 2011 · General Hospital
Device Facts
Record ID
K112929
Device Name
THERMOFLASH(TM) INFRARED THERMOMETER
Applicant
Visiomed Group SA
Product Code
FLL · General Hospital
Decision Date
Oct 18, 2011
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.2910
Device Class
Class 2
Attributes
Pediatric, 3rd-Party Reviewed
Indications for Use
ThermoFlash™ is an infrared thermometer for body surface and forehead temperature measurement for infants and adults without contacting to human body. It can be used by consumers in household environment and doctor in clinic as reference.
Device Story
Handheld electronic infrared thermometer (models LX-26, LX-261, LX-260, LX-260T) measures body temperature via infrared radiation emitted from forehead. Infrared sensor detects emissions; AD module converts analog signal to digital; temperature displayed on LCD. Used in home or clinic by patients or clinicians. Advanced models include additional selection keys (LX-260), rechargeable base/battery (LX-261), and voice temperature indication (LX-260T). Provides non-contact temperature monitoring to assist clinical decision-making.
Clinical Evidence
Bench testing only. Compliance verified with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and ASTM E1965-98 (R2009) (infrared thermometer performance).
Indicated for non-contact body surface and forehead temperature measurement in infants and adults. Suitable for use by consumers in household settings and by clinicians in clinical 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.
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Premarket Notification 510(k) Submission
K112929
Section III 510(k) Summary
# OCT 1 8 2011
III-I
#### Section III 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: _
1. Date of Submission: July 26, 2011
2. Sponsor
Visiomed Group SA 21, avenue Victor Huge, 75116, Paris, France
Establishment Registration Number: Not yet registered
Contact Person: Mr. Eric Sebban Position: President TEL: +33 1 40 67 06 50 FAX: +33 1 44 17 93 10 Email: eric@visiomed-lab.com
### 3. Proposed Device Identification
Proposed Device Name: ThermoFlash™ Infrared Thermometer Proposed Device Model: LX-26, LX-261, LX-260 and LX-260T
Classification: Class II Product Code: FLL Regulation Number: 21 CFR 880.2910 Review Panel: General Hospital
#### Intended Use Statement:
ThermoFlash™ is an infrared thermometer for body surface and forehead temperature measurement for infants and adults without contacting to human body. It can be used by consumers in household environment and doctor in clinic as reference.
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#### 4. Predicate Device Identification
510(k) Number: K090361 Product Name: Remote Infrared Thermometer, RC002 Manufacturer: Rycom Electron Technology Limited
- 5. Device Description
ThermoFlash™, including LX-26, LX-261, LX-260 and LX-260T, are handheld electronic thermometer that measures the body temperature based on the infrared sensor technology.
All objects emit energy by radiation. The intensity of this energy depends on the temperature of the object. ThermoFlash™ is, therefore, able to measure the temperature of a person by the energy the person emits. Infrared sensor can sense the infrared emissions from the human body (forehead) and environment; then the electronic signal will be transferred by AD module to the digital signal and displayed on the LCD screen.
- A LX-26 is a thermometer with basic temperature measurement functions.
- A LX-260 is an advanced model to LX-26, which provides three additional keys which allow user to select the measurement directly;
- ア LX-261 is an advanced model to LX-260, which provides a rechargeable station base and inner Li rechargeable battery which can be recharged;
- LX-260T is an advanced model, which provides voice indicating of measured temperature. A
- 6. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ア IEC 60601-1, Mcdical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995. (General);
- A IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests +Amendment 1: 2004;
- ASTM E1965-98 (R2009): Standard Specification for Infrared Thermometers for Intermittent A Determination of Patient Temperature. (General Plastic Surgery/General Hospital).
III-2
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### 7. Substantially Equivalent Conclusion
Compared with the predicate device, ThermoFlash™ Infrared Thermometers have some additional features of voice indicator and rechargeable battery, and different specifications of power supply. Based the on the comparison and analysis in Section 7 Substantially Discussion, these differences were determined not to affect the performance and effectiveness.
The proposed device, ThermoFlash™ Infrared Thermometer, is determined to be Substantially Equivalent (SE) to the predicate device, Remote Infrared Thermometer, RC002, K090361 in respect of safety and effectiveness.
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III-3
Concern Comments
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 1 8 2011
Visiomed Group SA C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 NW Lake Road Camas, Washington 98607
Re: K112929
Trade/Device Name: ThermoFlash™ Infrared Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: September 21, 2011 Received: October 3, 2011
" Dear Mr. Mouser:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Mouser
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthony O. n
Unthony D. Watson, B.S., M.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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## Section II Indications for Use
510(k) Number:
Device Name: ThermoFlash™ Infrared Thermometer Models: LX-26, LX-261, LX-260 and LX-260T
Indications for Use:
ThermoFlash™ is an infrared thermometer for body surface and forehead temperature measurement for infants and adults without contacting to human body. It can be used by consumers in household environment and doctor in clinic as reference.
[ ]PRESCRIPTION USE (Part 21 CFR 801 Subpart D)
## & OVER-THE-COUNTER USE (21 CFR 801 Subpart C)
FDA CDRH DMC
OCT 3 2011
Received
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Rld C. Ch
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112929
