(72 days)
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.
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. The MHS 5000 provides for use with both laptop and desktop computers. The computer provides the user interface, image storage and display.
I am sorry, but the provided text does not contain detailed information about the acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter for the MHS 5000 Thermal Imaging System, indicating that the device has been found substantially equivalent to a predicate device.
The clearance letter primarily addresses regulatory aspects, such as:
- Device identification: MHS 5000 Thermal Imaging System.
- Intended Use: "a thermal based imaging device intended for viewing and digitally storing thermal patterns generated by the human body... for providing thermal images of the human body."
- Regulatory classification: Class I.
- General controls: Acknowledgment of general controls provisions of the Act, including annual registration, misbranding, and adulteration rules.
- Marketing permission: Granting permission to market the device.
There is no information within this document regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used in studies.
- Training set sample size.
- Ground truth establishment method for the training set.
To obtain this type of detailed performance data, one would typically need to refer to the premarket notification (510(k)) submission document itself, which details the studies and evidence provided to the FDA to demonstrate substantial equivalence, or publicly available literature related to the device's validation. This clearance letter is merely the FDA's decision based on that submission.
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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
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
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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
§ 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.