(50 days)
The SNN System is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head. It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations of the spine. The SNN System is contraindicated for patients suspected of having Creutzfeld-Jacob's disease if adequate sterilization of the instruments cannot be assured.
The SNN Fluoro Navigation Module is also indicated for situations where reference to a rigid anatomical structure such as the skull, a long bone or vertebra can be identified relative to a fluoroscopic image of the anatomy.
The SNN Fluoro Navigation System is a module of the SNN System to provide image-guided surgery based on an intra-operative fluoroscopic image of the patient anatomy.
The provided document describes the SNN Fluoro Navigation System (K993673), an image-guided surgical system that uses intra-operative fluoroscopic images for localization and navigation.
Unfortunately, the document does not contain any information regarding acceptance criteria, study details, performance data, or ground truth establishment.
The document primarily consists of:
- 510(k) Summary: This section provides a brief description of the device, its intended use, a comparison to predicate devices, and contact information for the submitter.
- FDA Clearance Letter: This letter from the FDA confirms the device's substantial equivalence to previously marketed devices and grants permission to market it.
- Indications for Use: This section outlines the medical conditions and scenarios for which the device is intended.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, and performance based on the provided text.
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DEC 2 1 1996
Image /page/0/Picture/2 description: The image shows a logo with the letters SNN in a stylized font. Below the letters, the text "THE NETWORK FOR IMAGE GUIDED SURGERY" is written in a smaller font. To the right of the letters, there is an image of a cursor.
510(k)_Premarket Notification
SNN Fluoro Navigation System Submitter Surgical Navigation Specialists Inc.
October26, 1999
510(k) Summary of Safety and Effectiveness
| Submitter: | Surgical Navigation Specialists Inc. |
|---|---|
| Address: | 6509 Airport RoadMississauga, OntarioCanada L4V 1S7 |
| Contact: | Dolores McGirr, Regulatory Scientist |
| Telephone: | (905) 672-2100 |
| Date: | October 26, 1999 |
| Trade Name: | SNN Fluoro Navigation System |
| Common Name: | Image-Guided Surgical System. |
| Classification Name: | Stereotaxic Device. |
| Predicate Devices: | SNN System K982570; the Stealth Station with FluoroNavModule by Surgical Navigation Technologies K990214. |
| Device Description: | The SNN Fluoro Navigation System is a module of the SNNSystem to provide image-guided surgery based on an intra-operative fluoroscopic image of the patient anatomy. |
| Intended Use: | The SNN Fluoro Navigation System, comprised of a medicalworkstation and an integrated position-sensing instrument, isintended to be used intra-operatively for localization andnavigation. |
| Comparison toPredicates: | The intended use and technological characteristics of the SNNFluoro Navigation system are substantially equivalent, in theopinion of SNS Inc., to those of the predicate devices and do notpose any new issues of safety and effectiveness. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a traditional symbol of medicine, with three lines representing the branches of government. The seal is black and white.
Public Health Service
DEC 2 1 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mrs. Dolores McGirr Regulatory Scientist Quality Engineering Support Team I.S.G. Technologies, Inc. 6509 Airport Road Mississauga, Ontario Canada L4V 1S7
Re: K993673
Trade Name: SNN Fluoro Navigation System Regulatory Class: II Product Code: HAW Dated: October 26, 1999 Received: November 1, 1999
Dear Mrs. McGirr:
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 (OS) 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.
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
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Page 2 - Mrs. Dolores McGirr
predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If vou 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.
Stephen Rhodes
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ _ 99 ≤ 6 7 3
Device Name: The SNN Fluoro Navigation System
Indications For Use :
The SNN System is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head. It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or The SNN System is contraindicated for malformations of the spine. patients suspected of having Creutzfeld-Jacob's disease if adequate sterilization of the instruments cannot be assured.
The SNN Fluoro Navigation Module is also indicated for situations where reference to a rigid anatomical structure such as the skull, a long bone or vertebra can be identified relative to a fluoroscopic image of the anatomy.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _____________
(Optional Format 1-2-96)
Het Eluolu
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K995673
§ 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).