(35 days)
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.
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.
This 510(k) summary does not contain the detailed study information needed to fully address your request in the specified format. The document focuses on establishing substantial equivalence to predicate devices rather than presenting a standalone study with acceptance criteria and performance data.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in the provided text. Because this is a 510(k) summary, the "acceptance criteria" for the device's market clearance are primarily based on demonstrating substantial equivalence to predicate devices, rather than meeting specific quantitative performance metrics from a formal study.
- Reported Device Performance: Not detailed in the provided text. The document states that the intended use and technological characteristics of the SNN image-guided surgical device, including the Olivier Double-Chuck Support Arm option, are substantially equivalent to predicate devices and "do not pose any new issues of safety and effectiveness." This is a general claim of equivalence, not specific performance data.
Missing Information (Not available in the provided text):
Since the document is a 510(k) summary focused on substantial equivalence, it does not include the detailed results of a dedicated study with specific performance metrics. Therefore, the following cannot be answered from the provided text:
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not available. The device is an image-guided surgical system, not an AI diagnostic tool that assists human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not available. The device is a surgical system that requires human interaction.
- The type of ground truth used: Not available.
- The sample size for the training set: Not available.
- How the ground truth for the training set was established: Not available.
Summary of available information related to acceptance and study:
The acceptance for market clearance (510(k) clearance) was based on the claim of substantial equivalence to existing predicate devices:
- The SNN image-guided surgical system.
- The Philips EasyTaxis option to the EasyGuide system.
- The Radionics Optical Tracking System with the frameless cranial biopsy indication.
The determination of substantial equivalence was made by Surgical Navigation Specialists Inc. and accepted by the FDA. The FDA's letter (K992457) confirms this substantial equivalence based on the provided information, allowing the device to be marketed. The specific "study" referenced in the 510(k) summary is the comparison made by the manufacturer to predicate devices, focusing on intended use and technological characteristics to demonstrate no new safety or effectiveness concerns.
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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 RoadMississauga, OntarioCanada 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 EasyTaxisoption to the EasyGuide system, and the Radionics OpticalTracking System with the frameless cranial biopsy indication. | |
| Device Description: | The Olivier Double-Chuck Support Arm is an optional componentof the SNN image-guided surgical system. The arm itself can bepositioned and locked into place. The double-chuck head has onechuck to firmly hold a surgical instrument in the desired location.The instrument can also be moved up or down by sliding it throughthe chuck. The second chuck is used to prevent excessive verticalmovement, by stabilizing the arm against the skull. | |
| Intended Use: | The SNN image-guided surgical system (including cranial andspinal applications), comprised of a medical workstation and anintegrated position sensing instrument and the Olivier Double-Chuck Support Arm option, is intended to be used pre-operativelyand intra-operatively for various planning, localization, andnavigation purposes. | |
| Comparison toPredicate: | The intended use and technological characteristics of the SNNimage-guided surgical device including the Olivier Double-ChuckSupport Arm option, are substantially equivalent, in the opinion ofSurgical Navigation Specialists Inc., to those of the predicatedevices and do not pose any new issues of safety and effectiveness. |
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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
§ 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).