TOPOGRAPHIC IMAGING MARKER by I.Z.I. MEDICAL PRODUCTS CORP.

The IZI 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.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "Topographic Imaging Marker". It is a regulatory document and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information based on the input text. The input text is a regulatory clearance letter, not a device performance study or clinical trial report. It confirms that the device is "substantially equivalent" to legally marketed predicate devices, but it does not detail performance metrics, study designs, sample sizes, or ground truth establishment.

Summary

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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 features the department's name arranged in a circular fashion around a central emblem. The emblem consists of a stylized caduceus, with three human profiles facing right, representing health and human services. The logo is presented in black and white.

Public Health Service

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:

K990298 Topographic Imaging Marker Dated: February 1, 1999 Received: February 1, 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 (Act). 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 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 regulation (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 notfication"(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 vours,

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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S 10(k) Number (if known):

Device Name: Topographic Imaging Marker

Indications for Use:

Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Adult, Child, and Infant Target Population:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-the-Counter Use Prescription Use (Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological De 510(k) Number

Regulation Number and Section

N/A