(37 days)
The 121 Topographic Imaging Marker provides a location on the patient's skin to reference internal anatomy and pathology. Given any radiographic information thereby, a physician or technician can pinpoint the location of the patient's ailment on the skin surface in reference to an internal pathologic process. The subsequent radiographic study would enable one to cross reference the skin position indicated by the patient with the internally demonstrated pathologic process shown on the study.
The IZI Topographic Imaging Marker is used for all fluoroscopic procedures, all standard radiographic procedures, localization of internal anatomy and pathology, as well as being able to direct biopsy procedures.
Topographic Imaging Marker
The provided text is a 510(k) clearance letter from the FDA for a device called "Topographic Imaging Marker." This document does not contain any information regarding acceptance criteria, study data, sample sizes, expert qualifications, or ground truth establishment relevant to the device's performance.
The letter primarily confirms that the device has been found substantially equivalent to legally marketed predicate devices and outlines regulatory information for marketing the device. It identifies the device's intended use and target population but does not include any performance data or study details.
Therefore, I cannot answer your request with the input provided.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 3 1999
I.Z.I. Medical Products Corporation E J Smith C/O Smith Associates P.O. Box 4341 Crofton, MD 21114
Re:
K990242 Topographic Imaging Marker Dated: January 20, 1999 Received: January 25, 1999 -Regulatory class: II 21 CFR 892.1650/Procode: 90 KPR 21 CFR 892.1680/Procode: 90 JAA
Dear Mr. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 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,
J.J.T.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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$10(k) Number (if known):
Device Name: Topographic Imaging Marker
Indications for Use:
The 121 Topographic Imaging Marker provides a location on the patient's skin to reference internal anatomy and pathology. Given any radiographic information thereby, a physician or technician can pinpoint the location of the patient's ailment on the skin surface in reference to an internal pathologic process. The subsequent radiographic study would enable one to cross reference the skin position indicated by the patient with the internally demonstrated pathologic process shown on the study.
The IZI Topographic Imaging Marker is used for all fluoroscopic procedures, all standard radiographic procedures, localization of internal anatomy and pathology, as well as being able to direct biopsy procedures.
Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Target Population: Adult, Child, and Infant
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-the Counter Use
David C. Legum
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological De 510(k) Number
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.