(56 days)
The SNN Stereotactic Planning Application module is intended to be used as an accessory for planning stereotactic frame-based procedures such as biopsies, functional stereotaxy, turnor resections, vascular malformation surgeries, thalamotomies and pallidotomies.
The SNN Stereotactic Planning Application software is an optional module of the SNN System software. The SNN Stereotactic Planning Application module registers medical scan images with stereotactic frame space and calculates frame and arc system coordinates.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary and an FDA clearance letter for the SNN Stereotactic Planning Application. It primarily focuses on:
- Device Identification: Trade name, common name, classification, and intended use.
- Predicate Devices: Comparison to existing legally marketed devices to establish substantial equivalence.
- Regulatory Information: FDA contact information, clearance date, and general regulatory requirements.
It does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample size, data provenance, expert qualifications, or adjudication methods for a test set.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Data on standalone (algorithm only) performance.
- The type of ground truth used in any study.
- Sample size for a training set or how its ground truth was established.
The text states that the device is "substantially equivalent" to predicate devices and "do not pose any new issues of safety and effectiveness," implying that extensive new performance studies (especially clinical ones) were likely not required beyond validation that it functions as intended and safely. However, the details of such validation are not provided in this document.
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Image /page/0/Picture/0 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 a cursor pointing towards the logo.
ﺎﺀ ﻣﺤﻤﺪ ﺍ
FEB 2 3 2000
SIO(K) Premarket Notification
Submitter Siteroolactic Planning Application
Submitter: Surgical Navigation Siceliation Inc.
Submitter: Surgical Navigation Inc. And
510(k) Summary of Safety and Effectiveness
K99442|
| Submitter: | Surgical Navigation Specialists Inc. |
|---|---|
| Address: | 6509 Airport RoadMississauga, OntarioCanada LAV 1S7 |
| Contact: | Carol Nakagawa. |
| Telephone: | (905) 672-2100. |
| Date: | February 18, 2000. |
| Trade Names: | SNN Stereotactic Planning Application; SNN StereotacticApplication. |
| Common Name: | Stereotactic Head Frame software accessory. |
| Classification Name: | Accessory to Stereotaxic Instrument. |
| Predicate Devices: | StereoPlan and AtlasPlan software from Radionics, and @Targetsoftware from Brainlab. |
| Device Description: | The SNN Stereotactic Planning Application software is an optionalmodule of the SNN System software. The SNN StereotacticPlanning Application module registers medical scan images withstereotactic frame space and calculates frame and arc systemcoordinates. |
| Intended Use: | The SNN Stereotactic Planning Application module is intended tobe used as an accessory for planning stereotactic frame-basedprocedures such as biopsies, functional stereotaxy, tumorresections, vascular malformation surgeries, thalamotomies andpallidotomies. |
| Comparison toPredicate: | The intended use and technological characteristics of the SNNimage-guided surgical device including the SNN StereotacticPlanning Application software module is substantially equivalent,in the opinion of Surgical Navigation Specialists Inc., to those ofthe predicate devices and do not pose any new issues of safety andeffectiveness. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three wavy lines above a shape resembling an eagle's head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 2000
Surgical Navigation Specialists, Inc. c/o Ms. Carol Nakagawa Regulatory Scientist Cedara Software Corporation 6509 Airport Road Mississauga, Ontario Canada L4V 1S7 T
K994421 Re:
Trade Name: SNN Stereotaxic Planning Application Regulatory Class: II Product Code: HAW Dated: December 28, 1999 Received: December 29, 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 (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.
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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,
Stipt Plurle
1 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): K994421
SNN Stereotactic Planning Application Device Name:
Indications For Use :
The SNN Stereotactic Planning Application module is intended to be used as an accessory for planning stereotactic frame-based procedures such as biopsies, functional stereotaxy, turnor resections, vascular malformation surgeries, thalamotomies and pallidotomies.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use d (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K994421
§ 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).