(126 days)
The Trajectory Guide is intended to provide stereotactic guidance for the placement and operation of neurological instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MRI imaging. The Trajectory Guide is intended as an aid in procedures that have traditionally used stereotactic methodology. These procedures include catheter placement and electrode implant. The device will provide accurate delivery of devices or instruments to target sites 3mm and larger.
Not Found
I am sorry, but the provided text from the FDA Pre-Market Notification does not contain information on the acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document is an approval letter for the Trajectory Guide (K983539), indicating that the FDA found it substantially equivalent to previously marketed devices. It outlines the regulatory classification and general controls applicable to the device but does not detail the technical performance or supporting studies.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 1999
Mr. Michael J. Renner Vice-President, Operations Image-Guided Neurologics, Inc. 570 Hale Avenue North Oakdale, Minnesota 55128
Re: K983539 Trade Name: Trajectory Guide Regulatory Class: II Product Code: HAW Dated: December 23, 1998 Received: January 13, 1999
Dear Mr. Renner:
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 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). 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 (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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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.
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Page 2 -- Mr. Michael J. Renner
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 vour 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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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Page _ of _
| 510(k) Number (if known): | K983539 |
|---|---|
| --------------------------- | --------- |
Device Nime: JEASECTORY 6005DE
Indication: For Use;
The Trajectory Guide is intended to provide stereotactic guidance for The Trajectory Gulde is intendents or devices during planning and the placement and operation orecedures within the MRI environment and in operation of nearological processions Guide is intended as an conjunction with MIC magang. In thave traditionally used stereotactic methodology. These procedures include catheter placement and electrode implant. The device will provide accurate delivery of devices or instruments to target sites 3mm
and larger.
(I'LEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off)Division of General Restorative Devices510(k) Number | K983539 | |
| Prescription Use(Per 21 CFR 801.109) | X OR | Over-The-Counter Use |
(Optional Format 1-2-96)
§ 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).