(120 days)
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 assessment of the patient's medical condition and requirements. The patient populations and many of the populations include all ages of the human body and internal images of the human body. This device is intended for use by qualified healthcare personnel who are trained in its 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. It provides for use with both laptop and desktop computers. The computer provides the user interface, image storage and display.
This is a 510(k) clearance letter and an Indications for Use statement, not a study report or clinical trial summary. Therefore, the detailed information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and study methodologies (MRMC, standalone) is not available in the provided text.
The documents indicate regulatory clearance for the Meditherm Med2000 thermal imaging system based on its substantial equivalence to predicate devices, but they do not describe a specific study proving the device meets particular acceptance criteria in the way a clinical trial report would.
Here's a breakdown of what can be extracted and what cannot:
What Can Be Extracted from the Provided Text:
- Device Name: Meditherm Med2000
- Regulatory Class: I (21 CFR §884.2980/Procode: 90 LHQ)
- Intended 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 where healthcare is provided. 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 assessment of the patient's medical condition and requirements. The patient populations include all ages of the human body for both external and internal images of the human body. This device is intended for use by qualified healthcare personnel who are trained in its use."
Information NOT Available in the Provided Text:
- A table of acceptance criteria and the reported device performance: The clearance letter states the device was found "substantially equivalent to legally marketed predicate devices," which is the regulatory acceptance criterion for 510(k) clearance, but it does not detail specific performance metrics (e.g., sensitivity, specificity, accuracy) or numerical thresholds.
- Sample size used for the test set and the data provenance: No information on a specific test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set study is detailed.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: No information on such a study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is described as a "thermal based imaging device" with a "computer provides the user interface, image storage and display," implying human interaction. No standalone algorithm performance is mentioned.
- The type of ground truth used: Not applicable, as no study is detailed.
- The sample size for the training set: Not applicable, as this is a 510(k) submission, not a machine learning algorithm development document.
- How the ground truth for the training set was established: Not applicable.
Summary:
The provided documents are a regulatory clearance for a medical device. They affirm its substantial equivalence to existing devices for its stated intended use. However, they do not contain the details of a clinical study or performance evaluation that would specify acceptance criteria and report device performance in the manner requested for an AI/device performance study. The 510(k) process primarily assesses substantial equivalence, not necessarily de novo clinical effectiveness against pre-defined performance metrics through a clinical trial.
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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)
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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)
§ 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.