SPHERZ

K022074 · I.Z.I. Corp. · HAW · Aug 13, 2002 · Neurology

Device Facts

• Record ID: K022074
• Device Name: SPHERZ
• Applicant: I.Z.I. Corp.
• Product Code: HAW · Neurology
• Decision Date: Aug 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

For use as a stereotactic system accessory to aid in auto-registration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgery. It is indicated for any medical condition in which the use of sterotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure can be identified relative to a CT or MR-based model of the anatomy. Federal (U.S.A.) law restricts this device to sale by, or on the order of a physician.

Device Story

Spherz is a stereotactic system accessory used in open or percutaneous image-guided surgery. It functions as a fiducial or registration marker to aid in the auto-registration and localization of rigid patient anatomical structures. The device is used in clinical settings by physicians. By providing a reference point relative to CT or MR-based anatomical models, it facilitates precise surgical navigation. This assists the surgeon in accurately correlating the patient's physical anatomy with pre-operative imaging, potentially improving surgical accuracy and patient outcomes during stereotactic procedures.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Stereotactic system accessory; designed for auto-registration and localization of rigid anatomical structures; compatible with CT and MR-based imaging models.

Indications for Use

Indicated for adult, child, and infant patients undergoing stereotactic surgery where rigid anatomical structures can be referenced to CT or MR-based anatomical models for auto-registration and localization.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Submission Summary (Full Text)

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 3 2002

Ms. Helen Zinreich Chief Executive Officer I.Z.I. Corporation 7020 Tudsbury Road Baltimore, Maryland 21244

Re: K022074

Trade/Device Name: SpherzTM Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: June 17, 2002 Received: June 26, 2002

Dear Ms. Zinreich:

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 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 (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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Page 2 – Ms. Helen Zinreich

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 and additionally 21 CFR Part 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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html

Sincerely yours,

L. Supt Rhodes

2 Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(K) Number (if known):

Spherz™ Product Name:

Indications for Use.

For use as a stereotactic system accessory to aid in auto-registration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgery. It is indicated for any medical condition in which the use of sterotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure can be identified relative to a CT or MR-based model of the anatomy.

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)

Stuart Rurka

× Prescription Use

DRof General, Restorative Counter Use and Neurological Devices

510(k) Number k022074

SK-33

FD/01

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