MHS 7000

K030018 · Micro Health Systems, Inc. · LHQ · Mar 26, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K030018
• Device Name: MHS 7000
• Applicant: Micro Health Systems, Inc.
• Product Code: LHQ · Obstetrics/Gynecology
• Decision Date: Mar 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2980
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The MHS 7000 thermal imaging system is a thermal based imaging device intended for viewing and digitally storing thermal patterns generated by the human body in the clinical, hospital, acute care settings, surgery, healthcare practitioner facilities or in any environment where healthcare is provided by a qualified healthcare professional. The MHS 7000 provides for use with both laptop and desktop computers. The computer provides the user interface, image storage and display. Use of this device is determined by the healthcare professional and is based upon his or her assessment of the patient's medical condition and requirements. The patient populations include all age groups from adult to pediatric and neonatal. The device is for providing thermal images of the human body. This device is intended for use by qualified healthcare personnel who are trained in its use.

Device Story

MHS 7000 is a thermal imaging system capturing body heat patterns; inputs processed via connected laptop or desktop computer. Computer provides user interface, image storage, and display. Used in clinical, hospital, acute care, and surgical settings by trained healthcare professionals. Output consists of thermal images for clinical assessment; assists healthcare providers in evaluating patient medical conditions. Benefits include non-invasive visualization of thermal patterns for diagnostic support.

Clinical Evidence

No clinical data provided; substantial equivalence based on regulatory classification and intended use.

Technological Characteristics

Telethermographic system; thermal imaging sensor; connects to laptop or desktop computers for processing and display; software-based user interface for image storage and visualization.

Indications for Use

Indicated for viewing and digitally storing thermal patterns of the human body in clinical, hospital, acute care, surgical, or healthcare practitioner settings. Applicable to all patient populations, including adults, pediatric, and neonatal patients. Intended for use by trained, qualified healthcare personnel.

Regulatory Classification

Identification

A telethermographic system for adjunctive diagnostic screening for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 26 2003

Mr. Robert Barnes President Micro Health Systems, Inc. 7407 Dover Lane PARKLAND FL 33067

Re: K030018

Trade/Device Name: MHS 7000 Thermal Imaging System Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: 90 LHQ Dated: December 28, 2002 Received: January 2, 2003

Dear Mr. Barnes:

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 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.

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.

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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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

to proceed to the market.

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510(K) Number (if known):

Devise Name: MHS 7000

Indications For Use:

The MHS 7000 thermal imaging system is a thermal based imaging device intended for viewing and digitally storing thermal patterns generated by the human body in the clinical, hospital, acute care settings, surgery, healthcare practitioner facilities or in any environment where healthcare is provided by a qualified healthcare professional. The MHS 7000 provides for use with both laptop and desktop computers. The computer provides the user interface, image storage and display.

Use of this device is determined by the healthcare professional and is based upon his or her assessment of the patient's medical condition and requirements. The patient populations include all age groups from adult to pediatric and neonatal. The device is for providing thermal images of the human body.

This device is intended for use by qualified healthcare personnel who are trained in its use.

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Concurrence of CDHR of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
And Radiological Devices

510(k) Number **__**

Prescription Use ***_*** or Over-the-Counter Use **_**

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030018