(35 days)
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No
The document describes a mechanical support arm for surgical instruments and does not mention any computational or algorithmic functions, let alone AI/ML.
No
Explanation: The device is described as a mechanical support and guidance system for surgical procedures, not as something that directly treats or heals a condition itself. Its function is to assist in surgical operations rather than providing therapy.
No
The device is described as a surgical system component, providing support and guidance for procedures, rather than diagnosing conditions.
No
The device description explicitly details a physical support arm with mechanical components (chucks) used to hold and guide surgical instruments, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a system used for surgical procedures (tumor resections, biopsies, endoscopies) on patients with lesions or malformations in the head and spine. This is a therapeutic and surgical guidance application, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a mechanical support arm designed to hold surgical instruments and stabilize against the skull during surgery. This is a surgical tool, not a device used to analyze biological samples for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
HAW
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
head, spine
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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
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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
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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