MHS 5000

K011981 · Micro Health Systems, Inc. · LHQ · Sep 5, 2001 · Obstetrics/Gynecology

Device Facts

• Record ID: K011981
• Device Name: MHS 5000
• Applicant: Micro Health Systems, Inc.
• Product Code: LHQ · Obstetrics/Gynecology
• Decision Date: Sep 5, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2980
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The MHS 5000 thermal imaging system is a thermal based imaging device intended for the viewing and digitally storing of thermal patterns generated by the human body in clinical settings, surgery, healthcare practitioner facilities or in any environment where healthcare is provided by a qualified healthcare professional. The MHS 5000 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 device is for providing thermal images of the human body. The device is for use only by qualified healthcare personnel who are trained in its use.

Device Story

MHS 5000 is a thermal imaging system capturing infrared radiation patterns from the human body; transforms thermal data into digital images for display and storage on connected laptop or desktop computers. Operated by qualified healthcare professionals in clinical, surgical, or healthcare settings. Provides visual thermal maps to assist clinicians in assessing patient medical conditions. Benefits include non-invasive visualization of thermal patterns to support diagnostic or monitoring decisions.

Technological Characteristics

Thermal imaging system; interfaces with standard laptop or desktop computers for processing and display; intended for clinical use.

Indications for Use

Indicated for providing thermal images of the human body for clinical assessment by qualified healthcare professionals. Applicable to all patient populations, including pediatric and neonatal. No specific contraindications listed.

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)

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2001

Mr. Robert Barnes President Micro Health Systems, Inc. 7407 Dover Lane Parkland, Florida 33067

Re: K011981 MHS 5000 Thermal Imaging System Dated: June 6, 2001 Received: June 25, 2001 Regulatory Class: I 21 CFR 884.2980/Procode: 90 LHQ

Dear Mr. Barnes:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we in a marked in internets We have revelved your Section 10(k) notification of their to marketed precience devices maketed in interstate substantially equivated (for the macatolis to the Medical Device Amendments, or to devices madest the daying which the commerce prior to May 26, 1976, the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to accordance with the provisions of the Peteral controls provisions of the Act include requirements for annual registration, the general controls provisions of the Act. "The general one holds against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Prematet Approval), it may be subject to such If your device is classined (see alove) in (opedail Sales) it (opedia Social in the Code of Federal Regulations, Title 21, Partica poursepar additional controls. Existing major regulations articling your avvit the Current Cood Manufacturing Practice requirements, 800 to 895. A substantially equivaled delemination with are election (21 CFR Part 820) and that, through periodic as set form in the Quality System Regulation (QS) to Medical Derices Comply with the CMP Pegulation may QS Inspections, the Food and Drive (1 Dr.) vir versi possession your device in the Federal Register. Please result in regulator, action. In addition, closentialited and affect any obligation you might have under sections 31 through note: this response to your premation sommon as a not alleo any of the 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 of the part the I his letter will allow you to begilly 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 one of the following numbers, based on the regulation number at the top of this letter.

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4,xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance of Collied of Complete Also, please note the regulation and all the larges of premarket notification" (21 CFF 807.97). Other general Also, pease note the regulation entition, "Misotanding of research of Small Manufacturers, International and mormation on your responsibilities ander [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

{1}------------------------------------------------

510(K) Number (if known): K011981

K011981-A1

Devise Name: MHS 5000

Indications For Use:

The MHS 5000 thermal imaging system is a thermal based imaging device intended for The MITS 5000 thermal ming.ing by the mall patterns generated by the human body in the viewing and digitally storms are settings, surgery, healthcare practitioner facilities or in any environment where healthcare is provided by a qualified healthcare professional. The MHS 5000 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 ner assessment of the parters incured on only to pediatric and neonatal. The device is for providing thermal images of the human body.

providing theimal mages of the namalified healthcare personnel who are trained in its use.

## (PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)

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)

Toneve Broadon

(Division Sign-O
Drusion of Reproductive, Abdominal,
nical Devices K011981
(K) ivumoer

SKS-6