TOPOGRAPHIC IMAGING MARKER

K990242 · I.Z.I. Medical Products Corp. · KPR · Mar 3, 1999 · Radiology

Device Facts

• Record ID: K990242
• Device Name: TOPOGRAPHIC IMAGING MARKER
• Applicant: I.Z.I. Medical Products Corp.
• Product Code: KPR · Radiology
• Decision Date: Mar 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Topographic Imaging Marker is a radiopaque skin marker used to correlate external skin positions with internal anatomy or pathology. Device applied to patient skin prior to imaging; provides visible reference point on fluoroscopic or standard radiographic images. Enables physicians or technicians to pinpoint ailment locations relative to skin surface; facilitates biopsy guidance. Used in clinical imaging settings; operated by physicians or technicians. Benefits include improved accuracy in cross-referencing external skin markers with internal pathologic processes shown on radiographic studies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radiopaque skin marker; form factor designed for external application to patient skin; functions as a visual reference point in radiographic and fluoroscopic imaging modalities.

Indications for Use

Indicated for adult, child, and infant patients requiring localization of internal anatomy and pathology during fluoroscopic and standard radiographic procedures, including biopsy guidance.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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