MEDITHERM MED2000

K003332 · Meditherm, Inc. · LHQ · Feb 21, 2001 · Obstetrics/Gynecology

Device Facts

• Record ID: K003332
• Device Name: MEDITHERM MED2000
• Applicant: Meditherm, Inc.
• Product Code: LHQ · Obstetrics/Gynecology
• Decision Date: Feb 21, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2980
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The Meditherm med2000 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, or in any environment when healthcare practitioner facilities or healthcare practices are used. The Meditherm med2000 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 ages of the human body and internal images of the human body. This device is intended for use by qualified healthcare personnel who are trained in its use.

Device Story

Meditherm Med2000 is a thermal imaging system; captures infrared thermal patterns generated by human body; transforms thermal data into digital images for display and storage. Device connects to laptop or desktop computers; computer provides user interface, image processing, and storage. Used by qualified healthcare personnel in clinical, hospital, or acute care settings. Healthcare provider views thermal images on computer screen; assists in assessment of patient medical condition and requirements. Benefits include non-invasive visualization of thermal patterns for diagnostic support.

Clinical Evidence

No clinical data provided; device is a Class I thermal imaging system.

Technological Characteristics

Thermal imaging system; interfaces with standard laptop or desktop computers for processing and display. Operates as a digital imaging device for thermal patterns.

Indications for Use

Indicated for thermal imaging of human body surface and internal thermal patterns for patients of all ages. Intended for use by trained healthcare personnel in clinical, hospital, or acute care settings.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2001

Dr. Peter Leando President Meditherm, Inc. 7407 Dover Lane PARKLAND FL 33067 Re: K003332

. Meditherm Med2000 Dated: November 14, 2000 Received: November 27, 2000 Regulatory Class: I 21 CFR §884.2980/Procode: 90 LHQ

Dear Dr. Leando:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have we liave reviewed your socion 110kg notications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate comment for and more 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the may, ulerelor, inalist the do not, suche stating 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 (Premarket Approval, it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, to such additional controls. Listing major regulations assumes compliance with the Current Good Manufacturing I tite 21, Paus 600 to 673. A subsantany ogar accemation (QS) for Medical Devices: General regulation (21 CFR Part Fractive requirements, as scroun in the Quality Drissan on Drug Administration (FDA) will verify such assumptions. Failure ozon and under the GMP regulation are gulatory action. In addition, FDA may publish further announcements to comply with the Federal Register. Please note: this response to your premarket notification submission does not concenting your device in alle Podera Registerions 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding I fills letter will and 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 and additionally 809.10 for in vitn If you desire specific dovice to your do rea. saliance of [phone]. Additionally, for questions on the promotion diagnosite devices), prour device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.
Captain, USPHS

Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure (s)

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## 510(K) Number (if known): K003332

Devise Name: Meditherm Med2000

Indications For Use :

The Meditherm med2000 thermal imaging system is a thermal based imaging device intended for I he Meditherm med2000 themal patterns generated by the human body in the clinical, hospital, viewing and digitally storing themal pactitioner facilities or in any environment when healthcares were with acute care settings, surgery, nealthcare pracations. The Meditherm med2000 provides for use with both laptop and desktop computers.

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Doth 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 assess-Use of this device is delemined by the neather professional and many of the populations include all ages of the lux ment of the patient's medical condition and requirements. The patent populations and internal images of the human body.

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

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Concurrence of CDRH of Device Evaluation (ODE)

David A. Segura

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

510(k) Number K003332

Prescription Use

or

Over-the-Counter Use _

(Optional Format 1-2-96)