SONOWAND INVITE

K083597 · Sonowand AS · HAW · Sep 25, 2009 · Neurology

Device Facts

• Record ID: K083597
• Device Name: SONOWAND INVITE
• Applicant: Sonowand AS
• Product Code: HAW · Neurology
• Decision Date: Sep 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Sonowand is intended for use as a tool to aid intraoperative ultrasound imaging and image guided surgery during neurosurgery. The Sonowand is intended for use as a standard neuronavigation system. The Sonowand is intended for use as a stand-alone ultrasound scanner.

Device Story

Integrated neuronavigation system with intraoperative imaging; combines navigation computer, ultrasound scanner, and tracking system on a mobile trolley. Inputs: preoperative MR/CT images and real-time 2D/3D intraoperative ultrasound data. Operation: surgeon uses infrared camera (NDI Polaris Spectra) to track tools relative to imported preoperative maps or updated intraoperative ultrasound maps; updates navigation map 5-10 times during surgery to mitigate brain shift. Output: visual display on touch screen showing tool position relative to anatomy. Used in OR by neurosurgeons. Benefits: provides real-time anatomical visualization, reducing impact of brain shift during resection. Surgeon controls system via touch screen or footswitch; snapshots stored for documentation.

Clinical Evidence

Bench testing only. System verified and validated against specification requirements. Compliance with EMC/EMI standards confirmed. Ultrasound components tested to international standards. No clinical trial data presented.

Technological Characteristics

Mobile trolley with industrial PC, GE Vivid-i ultrasound unit, NDI Polaris Spectra infrared tracking camera, and touch screen interface. Passive marker tracking system. Connectivity via network and USB ports. Power: 5A/230V or 10A/110V. Software-based integration of ultrasound and navigation data.

Indications for Use

Indicated for use in neurosurgery as a tool for intraoperative ultrasound imaging, image-guided surgery, and as a standard neuronavigation system or stand-alone ultrasound scanner. Applicable to medical conditions where stereotactic surgery is appropriate.

Regulatory Classification

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

• BrainLab Vector Vision (K023651)
• GE Vivid-I (K061525)
• Siemens Sequoia™ Plus (K072365)

Submission Summary (Full Text)

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K083597

# 510(k) Summary (Revised 6/7/10)

Submitter: SonoWand AS Nedre lla 39 N-7018 Trondheim Norway [phone]

Contact Information: C. G. Bundy Associates, Inc. 435 Rice Creek Terrace Fridley. MN 55432 763-574-1976

Submission Date: December 3, 2008

Device Name and Classification: SonoWand® Invite, Class II 21 CFR 882.4560, 892.1550 Product Code HAW, IYN

Equivalent Device Identification: BrainLab Vector Vision (K023651), GE Vivid-I (K061525), Seimens Sequoia™ Plus (K072365)

#### Device Description:

Invite is an integrated neuronavigation system with intraoperative imaging capabilities. The main components of the system are a navigation computer running the Invite software application, an ultrasound scanner and a tracking system in a single rack of equipment.

Invite can be used as a conventional neuronavigation system based on preoperative MR or CTimages, or as a stand-alone ultrasound scanner for real-time 2D imaging. It can also be used as a combined system where high-quality 3D ultrasound data can be transferred to the navigation system for direct navigation. Thus, the surgeon can navigate not only on a preoperative 3D map (MR or CT), but also on an intraoperative 3D ultrasound map which is only a few seconds old. The acquisition time is less than one minute, which means that the surgeon can typically update the navigation map 5-10 times during the surgery. The problem with brain shift is therefore practically eliminated.

The system is contained on a trolley with lockable wheels. This trolley contains power supply, power restrictor, on/off main switch, network and USB ports, an industrial standard PC (navigation computer), the ultrasound unit (GE Vivid-i), probe interface, wiring and cabling. Attached to the trolley is a steel tube column which supports two pendant arms. One of these arms supports an infrared camera (NDI Polaris Spectra). The other arm supports a touch screen. which is the primary user interface.

Invite has two functions. It supports the surgeon by showing the position of tools or pointers relative to MR, CT or Ultrasound images (which will normally show features such as brain

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tumors). It also makes it possible for the surgeon to acquire ultrasound images during operation which can be compared with other images (such as MR or CT) and can be used for supporting the surgeon by showing the position of tools and pointers. The control is primarily by a graphical touch screen (which can be draped). The secondary control is by a footswitch.

Data sets (preoperative MR/CT and intraoperative 3D ultrasound) can be used for planning the surgery as well as to navigate in the brain. As the surgery progresses, the accuracy and value of the preoperative images will normally decrease, while ultrasound images will maintain a more precise representation of the true anatomy if these images are updated regularly.

Digital snapshots of the screen can easily be stored during surgery for documentation purposes. It is also possible to review the data sets and to store images after surgery.

#### Intended Use:

The Sonowand is intended for use as a tool to aid intraoperative ultrasound imaging and image guided surgery during neurosurgery. The Sonowand is intended for use as a standard neuronavigation system. The Sonowand is intended for use as a stand-alone ultrasound scanner.

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# Comparison Table:

バ

| Element of<br>Comparison | Subject Device | Predicate<br>Device | Predicate<br>Device | Predicate<br>Device | Comments |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | K023651 | K061525 | K072365 | |
| | SonoWand<br>Invite | BrainLab<br>Vector Vision | GE Vivid-I | Siemens<br>Sequoia™<br>Plus system | |
| Common<br>Name | Intraoperative<br>3D ultrasound i<br>maging system<br>with<br>navigation for<br>neurosurgery | Image guided<br>surgery<br>system, CAS<br>/Stereotaxy<br>instrument | Diagnostic<br>ultrasound<br>system | Diagnostic<br>ultrasound<br>system | |
| Intended use | Intended for<br>use as a tool to<br>aid<br>intraoperative<br>ultrasound<br>imaging and<br>image guided<br>surgery during<br>neurosurgery.<br>The Invite is<br>intended for<br>use as a<br>standard<br>neuronavigatio<br>n system. The<br>Invite is<br>intended for<br>use as a stand-<br>alone<br>ultrasound<br>scanner. | The system is<br>indicated for<br>any medical<br>condition in<br>which the use<br>of stereotactic<br>surgery may<br>be appropriate<br>and where a<br>reference to a<br>rigid<br>anatomical<br>structure, such<br>as the skull, a<br>long bone, or<br>vertebra, can<br>be identified<br>relative to a<br>CT, CTA, X-<br>ray, MR, MRA<br>and ultrasound<br>based model of<br>the anatomy. | Intended for<br>use by a<br>qualified<br>physician for<br>ultrasound<br>evaluation of<br>Fetal;<br>Abdominal;<br>Pediatric;<br>Small Organ;<br>Neonatal<br>Cephalic;<br>Adult<br>Cephalic;<br>Cardiac;<br>Peripheral<br>vascular;<br>Musculoskelet<br>al<br>Conventional<br>and<br>Superficial;<br>Urology;<br>Transesophaga<br>l, Transrectal, | Intended for<br>the following<br>applications:<br>Cardiac,<br>neonatal<br>cardiac,<br>pediatric,<br>transesophagea<br>l, adult<br>cephalic,<br>peripheral<br>vessel,<br>intraoperative<br>neurological,<br>musculoskelet<br>al conventional<br>and<br>musculoskelet<br>al superficial<br>applications. | The intended<br>use of the<br>Invite as a<br>navigation tool<br>is the same as<br>for the Vector<br>Vison.<br>The Invite<br>intended use as<br>an ultrasound<br>evaluation tool<br>is the same as<br>for the GE<br>Vivid-i, but<br>limited to the<br>neurological<br>system.<br>The intended<br>use of the<br>Siemens<br>system<br>includes<br>intraoperative<br>neurological. |
| Element of<br>Comparison | Subject Device | Predicate<br>Device | Predicate<br>Device | Predicate<br>Device | Comments |
| Types of<br>Procedures | Medical<br>conditions<br>where<br>stereotactic<br>surgery can be<br>appropriate.<br>Identification is<br>relative to MR<br>or CT images<br>and/or to<br>intraoperative<br>ultrasound<br>images.<br>Ultrasound<br>images can be<br>compared with<br>the MR and/or<br>CT images | Cranial<br>procedures<br>Cranial<br>biopsies<br>Tumor<br>resections<br>Caniotomies/<br>craniectomies<br>Skull base<br>procedures<br>Thalamotomie<br>s<br>ENT<br>procedures | Transvaginal,<br>intraoperative | | The procedures<br>are the same as<br>to those used<br>for Vector<br>Vision and GE<br>Vivid-i. Invite<br>aids the<br>surgeon, but<br>does not make<br>any decisions<br>or in any way<br>controls the<br>operation. |
| Major<br>Components | Ultrasound<br>scanner<br>Navigation<br>computer<br>Tracking<br>system (passive<br>marker system)<br>Ultrasound<br>probe<br>Trolley<br>Appendant<br>support system | Freehand<br>probe<br>Navigation<br>computer<br>Passive marker<br>system | Ultrasound<br>scanner<br>Ultrasound<br>probe | | The<br>Ultrasound<br>scanner used in<br>Invite is the<br>GE Vivid-i<br>scanner.<br>The tracking<br>system is<br>similar to that<br>used in Vector<br>Vision. The<br>Invite system<br>with its<br>computer,<br>trolley and<br>appendant<br>support is<br>tested by<br>Nemko. |
| Power<br>Requirements | 5A/230V or<br>10A/110V<br>(Total power<br>demand | Unknown | 1.1A/240V to<br>2.3A/100V | | The electric<br>power system<br>is tested by<br>Nemko |
| Element of<br>Comparison | Subject Device | Predicate<br>Device | Predicate<br>Device | Predicate<br>Device | Comments |
| | including built<br>in Vivid-i) | | | | |
| Accessories | GE 12L-RS<br>linear array<br>probe, phased<br>array probe,<br>various<br>disposables | | Multiple<br>probes,<br>including the<br>12L-RS linear<br>array probe. | | Invite uses the<br>same probes<br>used for Vivid-i |

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# Conclusion:

The Sono Wand Invite is substantially equivalent to the predicate devices regarding intended use, function and technology. The Invite simply combines the functions of the predicate devices into one system.

#### Intended Use:

The intended use of Invite as a navigation tool is equivalent to the Vector Vision and to the Seimens system incorporating use in the neurological system. The Invite is equivalent to the GE Vivid-I regarding use as an ultrasound evaluation tool.

#### Function/Technology:

The procedures used with Invite are the same as those used for Vector Vision and Vivid-i. The Invite performs the same type of neuronavigation as the Vector Vision using a similar passive marker system and navigation computer.

The ultrasound scanner and probes are the same as those used with the Vivid-i. Slight modifications were made to the Vivid-i software to enable integration into the Invite software application. These changes do not affect the safe operation of the Vivid-I components confirmed by appropriate ultrasound output testing according to accepted international standards.

### Summary of Testing:

The SonoWand Invite system has been verified and validated according to specification requirements. The system has been also been tested to and complies with all applicable EMC/EMI standards. Applicable testing of the ultrasound components has been performed. Results of the tests performed show the SonoWand Invite is as safe and effective as the predicate devices.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an abstract human figure or a caduceus. The symbol is positioned to the right of the text, which is arranged in a circular fashion around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

SonoWand AS % C. G. Bundy Associates, Inc. Ms. Constance G. Bundy 435 Rice Creek Terrace Fridley, Minnesota 55432

Re: K083597

Trade/Device Name: SONOWand® Invite Regulation Number: 21 CFR 882.4560 : Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW, IYN Dated: August 24, 2009 Received: August 27, 2009

SEP 2 5 2009

Dear Ms. Bundy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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. Ilsting 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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#### Page 2 - Ms. Constance G. Bundy

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Barbara Brelund

Mark N. Melkerso Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### SONOWAND AS Trondheim, Norway

## Indications for Use

510(k) Number (if known): K08 3597

Device Name: SonoWand® Invite

Indications For Use:

The Sonowand is intended for use as a tool to aid intraoperative ultrasound imaging and image guided surgery during neurosurgery. The Sonowand is intended for use as a standard neuronavigation system. The Sonowand is intended for use as a stand-alone ultrasound scanner.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Vorlave Buelum Hofman

cleal. Orthopedic. and Restorative Device

510(k) Number K083597

4.