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 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 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.

AI/ML Overview

The provided 510(k) summary for the SonoWand Invite does not contain the detailed study information typically requested for acceptance criteria and device performance.

This document describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. It confirms that the system has been "verified and validated according to specification requirements" and "tested to and complies with all applicable EMC/EMI standards," but does not provide any specific quantitative performance metrics, clinical study design, or results related to efficacy (e.g., accuracy, sensitivity, specificity, or improvement in human reader performance).

Therefore, I cannot fulfill your request for the following information based on the provided text:

A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics (e.g., accuracy, precision) are mentioned.
Sample size used for the test set and the data provenance: No test set or clinical data is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set with ground truth is described.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not mentioned, and the device is described as "a tool to aid" rather than a standalone diagnostic.
The type of ground truth used: Not applicable.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

What the document does state regarding testing:

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."

This broadly states that internal validation and verification processes were completed, and that the device meets safety standards, but it does not provide the specific performance data or study details you are asking for. This is common for 510(k) submissions focusing on substantial equivalence to predicate devices, where extensive new clinical performance data might not be required if the device's technology and intended use are similar to already cleared devices.

Summary

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K083597

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

Submitter: SonoWand AS Nedre lla 39 N-7018 Trondheim Norway +47 73805900

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 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:

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Comparison Table:

バ

Element ofComparison	Subject Device	PredicateDevice	PredicateDevice	PredicateDevice	Comments
		K023651	K061525	K072365
	SonoWandInvite	BrainLabVector Vision	GE Vivid-I	SiemensSequoia™Plus system
CommonName	Intraoperative3D ultrasound imaging systemwithnavigation forneurosurgery	Image guidedsurgerysystem, CAS/Stereotaxyinstrument	Diagnosticultrasoundsystem	Diagnosticultrasoundsystem
Intended use	Intended foruse as a tool toaidintraoperativeultrasoundimaging andimage guidedsurgery duringneurosurgery.The Invite isintended foruse as astandardneuronavigation system. TheInvite isintended foruse as a stand-aloneultrasoundscanner.	The system isindicated forany medicalcondition inwhich the useof stereotacticsurgery maybe appropriateand where areference to arigidanatomicalstructure, suchas the skull, along bone, orvertebra, canbe identifiedrelative to aCT, CTA, X-ray, MR, MRAand ultrasoundbased model ofthe anatomy.	Intended foruse by aqualifiedphysician forultrasoundevaluation ofFetal;Abdominal;Pediatric;Small Organ;NeonatalCephalic;AdultCephalic;Cardiac;Peripheralvascular;MusculoskeletalConventionalandSuperficial;Urology;Transesophagal, Transrectal,	Intended forthe followingapplications:Cardiac,neonatalcardiac,pediatric,transesophageal, adultcephalic,peripheralvessel,intraoperativeneurological,musculoskeletal conventionalandmusculoskeletal superficialapplications.	The intendeduse of theInvite as anavigation toolis the same asfor the VectorVison.The Inviteintended use asan ultrasoundevaluation toolis the same asfor the GEVivid-i, butlimited to theneurologicalsystem.The intendeduse of theSiemenssystemincludesintraoperativeneurological.
Element ofComparison	Subject Device	PredicateDevice	PredicateDevice	PredicateDevice	Comments
Types ofProcedures	Medicalconditionswherestereotacticsurgery can beappropriate.Identification isrelative to MRor CT imagesand/or tointraoperativeultrasoundimages.Ultrasoundimages can becompared withthe MR and/orCT images	CranialproceduresCranialbiopsiesTumorresectionsCaniotomies/craniectomiesSkull baseproceduresThalamotomiesENTprocedures	Transvaginal,intraoperative		The proceduresare the same asto those usedfor VectorVision and GEVivid-i. Inviteaids thesurgeon, butdoes not makeany decisionsor in any waycontrols theoperation.
MajorComponents	UltrasoundscannerNavigationcomputerTrackingsystem (passivemarker system)UltrasoundprobeTrolleyAppendantsupport system	FreehandprobeNavigationcomputerPassive markersystem	UltrasoundscannerUltrasoundprobe		TheUltrasoundscanner used inInvite is theGE Vivid-iscanner.The trackingsystem issimilar to thatused in VectorVision. TheInvite systemwith itscomputer,trolley andappendantsupport istested byNemko.
PowerRequirements	5A/230V or10A/110V(Total powerdemand	Unknown	1.1A/240V to2.3A/100V		The electricpower systemis tested byNemko
Element ofComparison	Subject Device	PredicateDevice	PredicateDevice	PredicateDevice	Comments
	including builtin Vivid-i)
Accessories	GE 12L-RSlinear arrayprobe, phasedarray probe,variousdisposables		Multipleprobes,including the12L-RS lineararray probe.		Invite uses thesame probesused 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 (800) 638-2041 or (240) 276-3150 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:

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

Regulation Number and Section

§ 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).