(11 days)
The IMTEC Imaging ILUMA™ OrthoCat™ and DentalCat™ are x-ray devices (cone beam computed tomography) that acquire a single 360° rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support.
x-ray devices (cone beam computed tomography) that acquire a single 360° rotational sequence
The provided text is a 510(k) clearance letter from the FDA for the ILUMA OrthoCat/DentalCat device. This document primarily focuses on the regulatory approval process and does not contain the specific details about acceptance criteria, study design, or performance metrics that would typically be found in a study report or a more detailed section of a 510(k) submission.
Therefore, I cannot extract the requested information regarding acceptance criteria and the study proving the device meets those criteria from the provided text. The document confirms that the device is substantially equivalent to a predicate device but does not elaborate on the specific performance studies conducted to demonstrate this equivalence in terms of detailed metrics, sample sizes, ground truth establishment, or expert reviews.
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Image /page/0/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IMTEC CORP. % Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Service NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719
Re.: K053046
Trade/Device Name: ILUMA OrthoCat/ DentalCat Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 27, 2005
Received: October 28, 2005
Dear Mr. Lehtonen:
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 (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. 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 (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
NOV - 8 2005
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This letter will allow you to begin marketing your device as described in your Section 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:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Nancy L. hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Device Name: ILUMA™ OrthoCat™ / DentalCat™ Indications for Use:
The IMTEC Imaging ILUMA™ OrthoCat™ and DentalCat™ are x-ray devices (cone beam computed tomography) that acquire a single 360° rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Al and Radiological Devices 510(k) Number
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§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.