← Product Code [HAW](/productcode/HAW) · K992457 # SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION (K992457) _Surgical Navigation Specialists, Inc. · HAW · Aug 27, 1999 · Neurology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K992457 ## Device Facts - **Applicant:** Surgical Navigation Specialists, Inc. - **Product Code:** [HAW](/productcode/HAW.md) - **Decision Date:** Aug 27, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.4560 - **Device Class:** Class 2 - **Review Panel:** Neurology ## Indications for Use The SNN image-guided surgical system (including cranial and spinal applications), comprised of a medical workstation and an integrated position sensing instrument and the Olivier Double-Chuck Support Arm option, is intended to be used pre-operatively and intra-operatively for various planning, localization, and navigation purposes. ## Device Story SNN image-guided surgical system includes medical workstation, position sensing instrument, and optional Olivier Double-Chuck Support Arm. Arm provides mechanical support/guidance for frameless stereotaxic procedures, tumor resections, biopsies, and endoscopies. Double-chuck head holds surgical instruments; one chuck secures instrument position, second chuck stabilizes arm against skull to prevent vertical movement. Used intra-operatively by surgeons for navigation and localization. System assists in surgical planning and instrument guidance, potentially improving precision during cranial and spinal interventions. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Mechanical support arm with double-chuck head for instrument stabilization. System includes medical workstation and position sensing instrumentation. Operates as an accessory to stereotaxic devices. ## Regulatory 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. ## Predicate Devices - SNN image-guided surgical system ([K992457](/device/K992457.md)) - Philips EasyTaxis option to the EasyGuide system - Radionics Optical Tracking System ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo for "The Network for Image Guided Surgery". The logo is in black and white and features the letters SNN in a stylized font. The text "THE NETWORK FOR IMAGE GUIDED SURGERY" is written below the letters. A cursor is pointing to the right of the text. | AUG 27 1999 | 510(k) Summary of Safety and Effectiveness | K992457 | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Submitter: | Surgical Navigation Specialists Inc. | | | Address: | 6509 Airport Road
Mississauga, Ontario
Canada L4V 1S7 | | | Contact: | Carol Nakagawa. | | | Telephone: | (905) 672-2100. | | | Date: | July 21, 1999. | | | Trade Name: | SNN image-guided surgical system with optional Olivier Double-
Chuck Support Arm. | | | Common Name: | Image-Guided Surgical System. | | | Classification Name: | Accessory to Stereotaxic Device. | | | Predicate Devices: | The SNN image-guided surgical system, the Philips EasyTaxis
option to the EasyGuide system, and the Radionics Optical
Tracking System with the frameless cranial biopsy indication. | | | Device Description: | The Olivier Double-Chuck Support Arm is an optional component
of the SNN image-guided surgical system. The arm itself can be
positioned and locked into place. The double-chuck head has one
chuck to firmly hold a surgical instrument in the desired location.
The instrument can also be moved up or down by sliding it through
the chuck. The second chuck is used to prevent excessive vertical
movement, by stabilizing the arm against the skull. | | | Intended Use: | The SNN image-guided surgical system (including cranial and
spinal applications), comprised of a medical workstation and an
integrated position sensing instrument and the Olivier Double-
Chuck Support Arm option, is intended to be used pre-operatively
and intra-operatively for various planning, localization, and
navigation purposes. | | | Comparison to
Predicate: | The intended use and technological characteristics of the SNN
image-guided surgical device including the Olivier Double-Chuck
Support Arm option, are substantially equivalent, in the opinion of
Surgical Navigation Specialists Inc., to those of the predicate
devices and do not pose any new issues of safety and effectiveness. | | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with three faces in profile, overlaid with three horizontal bars. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 27 1999 Surgical Navigation Specialists, Inc. c/o Ms. Carol Nakagawa Clinical Scientist Department of Clinical Development I.S.G. Technologies, Inc. 6509 Airport Road Mississauga, Ontario Canada L4V 187 K992457 Re: > Trade Name: The SNN System with the Olivier Double-Chuck Support Arm Option Regulatory Class: II Product Code: HAW Dated: July 21, 1999 Received: July 23, 1999 Dear Ms. Nakagawa: 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 {2}------------------------------------------------ ## Page 2 - Ms. Carol Nakagawa 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 your 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, Mark N. Milkeaser 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 {3}------------------------------------------------ ## Page 1 of 1 K992457 510(k) Number (if known): The SNN System with the Olivier Double-Chuck Support Arm Option Device Name: Indications For Use: The SNN system with the Olivier Double-Chuck Support Arm Option 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 Olivier Double-Chuck Support Arm Option can provide mechanical support and guidance for vanous frameless stereotaxic procedures, turnor resections, biopsies, and endoscopies. The SNN system is contraindicated for patients suspected of having Creutzfeld-Jacob's disease if adequate sterilization of the instruments cannot be assured. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mark N Mulkerson (Optional Format 3-10-98) (Division Sign-Off) Division of General Restorative Devices 510(k) Number --- **Source:** [https://fda-staging.innolitics.com/device/K992457](https://fda-staging.innolitics.com/device/K992457) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com