(83 days)
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No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on basic thermal imaging, storage, and display without mentioning any advanced analytical or interpretive capabilities that would typically involve AI/ML.
No.
The document states the device is an imaging system for viewing and storing thermal patterns, not for treating or diagnosing a medical condition.
No
The "Intended Use" states that the device is "intended for viewing and digitally storing thermal patterns generated by the human body." It does not mention using these thermal patterns to diagnose a disease or condition, but rather for healthcare professionals to assess a patient's medical condition and requirements.
No
The device description explicitly states it is a "thermal based imaging device" and a "thermal imaging system," implying the presence of hardware components for capturing thermal images, not just software for processing or displaying them.
Based on the provided information, the MHS 7000 thermal imaging system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- MHS 7000 Function: The MHS 7000 is described as a thermal imaging system that views and stores thermal patterns generated by the human body. It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use focuses on providing thermal images of the human body for viewing and storage, to be used by healthcare professionals in their assessment of a patient's condition. This is a form of in vivo imaging (imaging within the living body), not in vitro diagnostics.
Therefore, the MHS 7000 falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / 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.
Product codes
90 LHQ
Device Description
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. The MHS 7000 provides for use with both laptop and desktop computers. The computer provides the user interface, image storage and display.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Thermal imaging
Anatomical Site
Human body
Indicated Patient Age Range
all age groups from adult to pediatric and neonatal
Intended User / Care Setting
qualified healthcare personnel who are trained in its use.
clinical, hospital, acute care settings, surgery, healthcare practitioner facilities or in any environment where healthcare is provided by a qualified healthcare professional.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 884.2980 Telethermographic system.
(a)
Telethermographic system intended for adjunctive diagnostic screening for detection of breast cancer or other uses —(1)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.(2)
Classification. Class I (general controls).(b)
Telethermographic system intended for use alone in diagnostic screening for detection of breast cancer or other uses —(1)Identification. A telethermographic system for use as the sole diagnostic screening tool 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.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 884.3.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services.
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.
1
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.
2
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.
(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)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030018