(64 days)
Intended Use: The Navigus Passive Probe (BL) is intended to be used for trajectory navigation in conjunction with the Navigus family of Image-Guided Systems. The device is provided sterile and for single use.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study design, or ground truth establishment. The document is an FDA 510(k) clearance letter for a medical device (Navigus Passive Probe (BL)) and primarily focuses on regulatory approval based on substantial equivalence to predicate devices. It confirms the device can be legally marketed but does not include the detailed study information required to answer your request.
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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 an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 2004
Mr. David M. Lee Director of Regulatory Affairs Image-Guided Neurologics, Inc. 2290 W. Eau Gallie Boulevard Melbourne, Florida 32935
Re: K040834
IC04005 Tice Name: Navigus Passive Probe (BL) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: IIAW Dated: March 30, 2004 Received: April 2, 2004
Dear Mr. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premained in substantially equivalent (for the indications
referenced above and have determined the device marketed in interstate referenced above and nave determined the devices marketed predicate devices marketed in interstate for use stated in the encrosule) to regally mance of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Enderal Food Drug commerce prior to May 28, 1978, the exceence with the provisions of the Federal Food, Drug, devices that have been reclassified in accession which approval applications (PMA).
and Cosmetic Act (Act) that do not require approval of a previous of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The You may, merelore, market mo device, basjon to views of registrator, listing of the prod general controls provisions of the Feet Interest and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) mis existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation UPA may be subject to such adultional controller Entisting may on 898. In addition, FDA may be found in the Code of Posterial England In the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled on a buccessions with other requirements of the Act
that FDA has made a determination that your device complies with other requirements that FDA has made a decermination that Jour Jose Jose Federal agencies. You must or any Pederal statutes and regulations daministers be of not limited to: registration and listing (21 let comply with an the Act s requirements, mercesses annufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 800), good and frapplicable, the electronic forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
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Page 2 - Mr. David M. Lee
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin mailteing of substantial equivalence of your device to a legally premarket notheadon. The PDA midning of backannal vir
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 If you desire specific advice for Jour ac (301) 594-4659. Also, please note the regulation entitled, Comact the Office of Computers in (set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general Miorination on your response 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): Passive Probe Naviques Device Name: Indications For Use:
Intended Use: The Navigus Passive Probe (BL) is intended to be used Intended Use. The Navigus I assn of the Navigus family of trajectory 101 havigation in confunential ton the Guided System. The device is provided sterile and for single use.
Prescription Use (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)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number K040834
§ 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).