NDI PASSIVE SPHERES

K033621 · Northern Digital, Inc. · HAW · Jan 27, 2004 · Neurology

Device Facts

• Record ID: K033621
• Device Name: NDI PASSIVE SPHERES
• Applicant: Northern Digital, Inc.
• Product Code: HAW · Neurology
• Decision Date: Jan 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

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

Device Story

NDI Passive Spheres are stereotactic system accessories used in image-guided surgery. Spheres serve as markers for tracking rigid anatomical structures; they are detected by optical tracking systems to facilitate auto-registration and localization. Used in OR settings by surgeons or clinical staff; spheres provide spatial reference points relative to pre-operative CT or MR-based anatomical models. By enabling precise alignment between physical anatomy and digital imaging, the device assists in surgical navigation, potentially improving accuracy in targeting during open or percutaneous procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Passive reflective spheres designed for optical tracking in stereotactic surgical environments. Function as fiducial markers for registration and localization. Compatible with standard optical tracking stereotactic systems. Non-powered, passive components.

Indications for Use

Indicated for patients undergoing stereotactic surgery where rigid anatomical structures can be referenced against CT or MR-based models for auto-registration and localization in open or percutaneous image-guided procedures.

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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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 stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is facing left and the text is in all caps.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 7 2004

Northern Digital Incorporated C/o Ms. Nancy Ruth Manager, Regulatory Scrvices CanReg Incorporated 4 Innovation Drive Dundas Ontario, Canada L9II 7P3

Re: K033621

K035621
Trade/Device Name: NDI Passive Spheres™ Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: November 17, 2003 Received: November 18, 2003

Dear Ms. Ruth:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained in substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices markets in interstant for use stated in the enclosure for legally manoles for the Medical Device American County of the May commerce prior to May 28, 1770, the enterment adde at the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the U devices that have been reclassified in accordance what approval approval application (PMA) a and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The r ou may, merciole, market the dorres, belyer and and registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classificd (see above) into either class II (Special Controls) or class III (PMA). and IT your device is classified (300 above) major regulations affecting your device can
may be subject to such additional controls. Existing major and live a life and the may be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition. I'DA may be found in the Occoncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease of advised that 1171 3 155danted or our device complies with other requirements of the Act that I Dri has made a aod regulations administered by other Federal agencies. You must or any I cacal stutures and regenants, including, but not limited to: registration and listing (21 Comply with an the 70€ 31€ 31€ Part 801); good manufacturing practice requirements as set CITY an 607), adomig (21 CFR Part 820); and if applicable, the electronic forth in all quality systems (Sections 531-542 of the Act): 21 CFR 1000-1050.

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Page 2 – Ms. Nancy Ruth

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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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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## Indications for Use

510(k) Number (if known):

Device Name:

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

Muriami C. Provost

vision Sign-Off) Division of General, Restorative and Neurological Devices

Number K03362/

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)