(70 days)
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.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Northern Digital Incorporated regarding their NDI Passive Spheres™ device. It primarily discusses the regulatory classification of the device and its indications for use.
Crucially, this document does not contain any information regarding acceptance criteria, reported device performance, study designs, sample sizes, ground truth establishment, or expert qualifications for a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information based on the given text. The document confirms that the device is substantially equivalent to legally marketed predicate devices for the stated indications for use, but it does not detail the testing or studies conducted to demonstrate this equivalence or establish performance metrics.
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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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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)
§ 882.4560 Stereotaxic instrument.
(a)
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.(b)
Classification. Class II (performance standards).