(30 days)
Thermal Imaging is a noninvasive diagnostic technique that allows a practitioner to quantify and visualize skin surface temperature changes. The Spectrum 9000 MB allows the user to graphically map the body temperature and display the image on a monitor. The Spectrum 9000MB will be used as an aid for diagnosis as well as to follow up therapy on such areas as orthopedics, pain management, neurology and diabetic foot care.
The intended use for the Spectrum 9000 MB is similar to what is being used currently on the Dorex DTI-16 thermal imager. Images are captured and stored on a computer that can be used to diagnose problem areas.
Not Found
This FDA 510(k) clearance letter dated November 14, 2002, for the Dorex Spectrum 9000MB Thermography System does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria.
The document is a clearance letter, indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It focuses on regulatory compliance and administrative details, not on a detailed performance study.
Therefore, I cannot provide the requested information based solely on the provided text.
Here's why and what's missing:
- No Acceptance Criteria: The letter does not list any specific performance metrics (e.g., sensitivity, specificity, accuracy, temperature measurement precision) that the device must meet.
- No Study Description: There is no mention of a specific study, its design, methodology, results, or statistical analysis. The letter just states equivalence to a predicate device.
- No Sample Sizes: Consequently, there are no details on sample sizes for test or training sets.
- No Information on Experts, Ground Truth, Adjudication, or MRMC Studies: These specific elements related to a performance study are absent.
- No Standalone Performance: While the device itself is standalone, the letter doesn't report its standalone performance metrics.
In summary, the provided document is a regulatory clearance and not a technical report or clinical study summary. To answer your questions, one would need access to the actual 510(k) submission itself or any associated clinical/technical reports that were part of that submission, which are not included in this extract.
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird-like shape. The profiles are connected and appear to be flowing or merging into one another.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2002
Mr. Mel Kutas President DOREX, Inc. 954 North Lemon St. ORANGE CA 92867 Re: K023434 Trade/Device Name: Dorex Spectrum 9000MB Thermography System Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: 90 LHQ Dated: October 15, 2002 Received: October 15, 2002
Dear Mr. Kutas:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 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 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, 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" (21 CFR Part 807.97). 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/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
Page 2
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INTENDED USE FOR SPECTRUM 9000 MB
Thermal Imaging is a noninvasive diagnostic technique that allows a practitioner to quantify and visualize skin surface temperature changes. The Spectrum 9000 MB allows the user to graphically map the body temperature and display the image on a monitor. The Spectrum 9000MB will be used as an aid for diagnosis as well as to follow up therapy on such areas as orthopedics, pain management, neurology and diabetic foot care.
The intended use for the Spectrum 9000 MB is similar to what is being used currently on the Dorex DTI-16 thermal imager. Images are captured and stored on a computer that can be used to diagnose problem areas.
Jamil h. hyson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
§ 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.