(72 days)
None
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on basic thermal imaging and storage without mentioning any advanced analytical or learning capabilities.
No
The device is described as an "imaging device" for "viewing and digitally storing thermal patterns generated by the human body," indicating it is for diagnosis or monitoring, not treatment.
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 any function for diagnosing or detecting a disease or condition, but rather for providing images. The statement "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" further indicates that the device assists the healthcare professional but doesn't perform the diagnosis itself.
No
The device description explicitly states it is a "thermal imaging system" and a "thermal based imaging device," implying the presence of hardware (a thermal sensor/camera) to capture the thermal patterns, in addition to the software for viewing, storing, and displaying the images.
Based on the provided information, the MHS 5000 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 about a person's health.
- MHS 5000 Function: The MHS 5000 is described as a thermal imaging device 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 is for viewing thermal images of the human body in a clinical setting, not for analyzing biological samples.
Therefore, the MHS 5000 falls under the category of an in vivo diagnostic or imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MHS 5000 thermal imaging system is a thermal based imaging device intended for viewing and digitally storing thermal patterns generated by the human body in the 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 population is not limited to pediatric and neonatal. The device is for providing thermal images of the human body.
Product codes
90 LHQ
Device Description
The MHS 5000 thermal imaging system is a thermal based imaging device. It provides for use with both laptop and desktop computers. The computer provides the user interface, image storage and display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Thermal imaging
Anatomical Site
Human body
Indicated Patient Age Range
Not limited to pediatric and neonatal.
Intended User / Care Setting
Qualified healthcare professional / healthcare practitioner facilities, surgery, or any environment where healthcare is provided by a qualified healthcare professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4,xxx, 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 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 (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
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