(120 days)
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No
The document describes a thermal imaging system for viewing and storing thermal patterns. There is no mention of AI, ML, or any advanced image processing that would suggest the use of these technologies. The computer is described as providing the user interface, image storage, and display, not analysis or interpretation using AI/ML.
No The device is an imaging system intended for viewing and storing thermal patterns, not for treating or providing therapy.
No
The "Intended Use / Indications for Use" section 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 diseases or conditions, but rather for providing images for a healthcare professional to assess.
No
The device description explicitly states it is a "thermal based imaging device" and mentions "viewing and digitally storing thermal patterns generated by the human body," which implies the presence of a hardware component (a thermal camera or sensor) to capture these patterns. The computer is described as providing the user interface, storage, and display, not the primary image acquisition.
Based on the provided information, the Meditherm med2000 thermal imaging system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that the Meditherm med2000 is used for "viewing and digitally storing thermal patterns generated by the human body." This involves imaging the body directly, not analyzing samples taken from the body (like blood, urine, tissue, etc.).
- The input modality is thermal imaging. IVD devices typically involve methods like chemical analysis, immunological assays, or molecular diagnostics performed on biological samples.
The Meditherm med2000 is a medical imaging device that captures thermal information from the body's surface.
N/A
Intended Use / Indications for 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, healthcare practitioner facilities or in any environment when healthcares were with acute care settings, surgery, healthcare applications. 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 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.
This device is intended for use by qualified healthcare personnel who are trained in its use.
Product codes
90 LHQ
Device Description
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. It 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 (thermal patterns generated by the human body and internal images of the human body)
Indicated Patient Age Range
all ages
Intended User / Care Setting
Qualified healthcare personnel who are trained in its use. Clinical, hospital, healthcare practitioner facilities or in any environment when healthcares were with acute care settings, surgery, healthcare applications.
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The emblem is black, and the text is also in black.
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 (301) 594-4639. Additionally, for questions on the promotion diagnosite devices), prour device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)
1
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.
7
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.
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
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)