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

The intended use of a localizer is to enable navigation by showing the position of surgical instruments or pointers relative to MR, CT or Ultrasound images

The General purpose localizers with adapters are intended to be used to attach surgical tools manufactured by other vendors. SonoWand Invite System will display position and orientation of the tools in the medical images on the screen.

Device Description

The 510(k) cleared SonoWand Invite System is a neuronavigation system with intraoperative imaging capabilities. An ultrasound scanner is physically integrated with a neuronavigation system in a single rack of equipment.

SonoWand Invite can be used as a conventional neuronavigation system based on preoperative MR or CT-images, or as a stand-alone ultrasound scanner for real-time 2D imaging or as a combined system where 3D ultrasound data can be transferred to the navigation system for direct navigation.

SonoWand Invite has basically two functionalities. It supports the surgeon by showing the position of tools or pointers relative to MR, CT or Ultrasound images. 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. The secondary control is by a footswitch.

The new accessories, General purpose localizers with adapters, shall be used to attach surgical tools manufactured by other vendors. SonoWand Invite will then display position and orientation of the tools in the medical images on the screen in the same way as the previous 510(k) cleared Navigator tool.

The localizers with adapters are designed to fit surgical tools normally used in the operating room.

There are no changes to the Intended use, function or technological aspects including software of the SonoWand Invite. The additional accessories are being added to increase usability of the SonoWand Invite system.

AI/ML Overview

The provided text describes a 510(k) submission for new accessories (general purpose localizers and adapters) for the SonoWand Invite System. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive de novo clinical study data.

Therefore, the information you've requested regarding acceptance criteria, specifics of a study proving those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment is largely not present in this 510(k) summary.

The summary states that the new accessories have been tested to comply with standards and requirements, and that "Results of the tests performed show the General purpose localizers and adapters are as safe and effective as the accessories of the predicate device." However, it does not detail the specific performance metrics or the study design with the granularity you've requested.

Here's what can be extracted and inferred from the provided text, while also explicitly stating what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

No specific numerical acceptance criteria (e.g., accuracy thresholds, precision ranges) are reported in a quantifiable manner, nor are specific performance values provided for the new device or the predicate. The "performance" described is qualitative, stating equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with cleaning and sterilization standards	Complies with all applicable cleaning and sterilization standards
Software module function in cleared SonoWand Invite System	Software module in cleared SonoWand Invite System supports function and complies
Requirements of SonoWand Invite System Test (for Localizers)	Localizers comply with requirements of SonoWand Invite System Test
Fit, calibration, and accuracy (for Adapters)	Adapters were tested for fit, calibration and accuracy
Safety and effectiveness equivalence to predicate devices	"as safe and effective as the accessories of the predicate device"
Does not affect intended use of connected device	Connecting a localizer to the device does not affect the intended use of the connected device

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document states "The Localizers have been tested..." and "The Adapters were tested...", but does not provide the number of localizers, adapters, or test scenarios.
Data Provenance: Not specified. The submitter is from Norway, but the location where the tests were conducted or the origin of any data (if human subjects were involved, which is not indicated) is not mentioned. The testing is internal to the manufacturer's validation activities for demonstrating substantial equivalence.
Retrospective/Prospective: Not applicable, as this is a device accessory validation (likely bench testing/engineering validation), not a clinical study involving patients being followed over time.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. The testing described appears to be technical/engineering validation, not a study where expert interpretations are compared to establish ground truth for image analysis or diagnostic performance.

4. Adjudication Method for the Test Set

Not applicable/Not specified. This type of information is typically relevant for clinical studies involving multiple readers and often conflicting interpretations, which is not the case described here.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence of new accessories through technical validation, not on comparing reader performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable in the context of these accessories. The SonoWand Invite System itself has software, and the document states: "The devices subject to this submission do not contain software module in the cleared SonoWand Invite System that supports the function of the subject devices has been tested to and complies with requirements." This implies the existing system's software was evaluated, but not these passive localizers/adapters as standalone algorithms.

7. The Type of Ground Truth Used

For the tests mentioned (cleaning/sterilization, SonoWand Invite System test, fit/calibration/accuracy), the ground truth would be established by engineering specifications, regulatory standards, and measurement references. For example, calibration accuracy would be measured against known precise standards, and fit would be verified against design specifications. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. These accessories are passive mechanical components (localizers and adapters) that enable the tracking of surgical tools. There is no AI model or algorithm being "trained" with data for these specific components. The SonoWand Invite System itself is a neuronavigation system, but the submission is for its accessories.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for these accessories, there is no ground truth establishment for such a set.

Summary

{0}------------------------------------------------

510(k) Summarv

KII 2469

510(k) Number:

Device Trade Name:	General purpose localizers and adapters - new accessories for SonoWand Invite System
Device Common Name:	Diagnostic ultrasound neuronavigation intraoperative imaging system
Device Regulation Name:	Sterotaxic instrument (21 CFR 882.4560, Class II, Code: HAW,IYN)
Submitter:	SONOWAND ASNedre lla 397018 TrondheimNORWAYPhone number: 0047 73805900
Contact Information:	Constance G. BundyC. G. Bundy Associates, Inc.435 Rice Creek Terrace NEFridley, MN 55432763-574-1976Fax: 763-571-2437cgbundy@live.com
Submission Date:	August 24, 2011

Equivalent Device Identification:

The purpose of this submission is to add additional accessories to the SonoWand Invite System. The additional accessories are general purpose localizers with adapters. These accessories are equivalent in function and intended use to the Navigator tool which was cleared in the original 510(k), K083597.

Device Description:

The localizers with adapters are designed to fit surgical tools normally used in the operating room.

{1}------------------------------------------------

K112469

Intended Use:

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

The intended use of a localizer is to enable navigation by showing the position of surgical instruments or pointers relative to MR, CT or Ultrasound images

Comparison Chart:

Element ofComparison	Subject	Predicate Device	Comment
	SonoWand Invite newaccessories	K083597SonoWand Inviteaccessories
Commonname	Generalpurposelocalizers,small andlarge	User tooladapters (*)Bracket &Clamp adapter	Navigator,intraoperative	Probelocalizersfor variablesizeultrasoundprobes
Pictures	Image: General purpose localizers	Image: User tool adapters	Image: Navigator	Image: Probe localizers	Accessories arebiocompatible andsterilizable.
	Image: General purpose localizers	Image: User tool adapters	Image: Navigator	Image: Probe localizers
Intendeduse ofaccessories	The intendeduse of alocalizer is toenablenavigation byshowing theposition ofsurgicalinstruments orpointers relativeto MR, CT orUltrasoundimages	The adapter isintended toconnect thegeneral purposelocalizer with avariety ofsurgicalinstruments	The intended useof a localizer is toenable navigationby showing theposition of theNavigator (pointer)relative to MR, CTor Ultrasoundimages	The intendeduse of a probelocalizer is toenableaccurateimaging duringsurgery bytracking theprobeslocationrelative to thepatient.	No changes tointended use or thefunctionality ofSonoWand Invite(**).The adapted surgicalinstruments are giventhe same functionalityas the Navigator(pointer).Connecting a localizerto the device does notaffect the intended useof the connecteddevice.
Materials	316 L Stainlesssteel,6082 AluminiumDLC Coating	316 L Stainlesssteel,Plastic RadelPPSU (PEEK)	316 L Stainlesssteel,6082 AluminiumDLC Coating	316 LStainlesssteel,6082AluminiumDLC Coating	New material; PlasticRadel PPSU (PEEK)are widely used forsurgical instruments.The material is incompliance with bothUnited StatesPharmacopeias (USP)and ISO 10993-1guideline requirementsfor BiocompatibilityTesting of Materials.

{2}------------------------------------------------

K112469

(*) Images show adapters attached to localizers

(**) SonoWand Invite has basically two functionalities. It supports the surgeon by showing the position of tools or pointers relative to MR, CT or Ultrasound images. 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 surgeon by showing the position of tools and pointers.

Intended use:

There are no changes to the Intended use of the SonoWand Invite.

The additional accessories (localizers and adapters) will facilitate the commonly used surgical instruments with the same functionality as the Navigator (pointer).

Connecting a localizer to the device does not affect the intended use of the connected device.

Technological and performance characteristics:

Technological characteristics of the localizers and adapters, including device design and performance, are substantially equivalent to the accessories of the predicate device SonoWand Invite. K083597.

Summary of Testing:

The new localizers and adapters have been tested to and comply with all applicable cleaning and sterilization standards.

The devices subject to this submission do not contain software module in the cleared SonoWand Invite System that supports the function of the subject devices has been tested to and complies with requirements.

The Localizers have been tested to and comply with requirements of the SonoWand Invite System Test. The Adapters were tested for fit, calibration and accuracy.

Results of the tests performed show the General purpose localizers and adapters are as safe and effective as the accessories of the predicate device.

Conclusion:

The conclusion drawn from the testing is that the localizers and adapters can be used for supporting the surgeon by showing the position of surgical tools.

Connecting a localizer to the device does not affect the intended use of the connected device. Results of the tests performed show the new accessories (localizers and adapters) to SonoWand Invite

are as safe and effective as the predicate devices.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.

Public Health Service

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

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

Re: K112469

Trade/Device Name: General purpose localizers and adapters - new accessories for SonoWand Invite System

Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW, IYN Dated: March 14, 2012 Received: March 20, 2012

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

MAR 2 3 2012

{4}------------------------------------------------

Page 2 - Ms. Constance G. Bundy

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erinl Keith

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

Enclosure

{5}------------------------------------------------

wand

Indications for Use

K112469 510(k) Number (if known):

Device Name: General purpose localizers and adapters - new accessories for SonoWand Invite System

Indications For Use:

The intended use of a localizer is to enable navigation by showing the position of surgical instruments or pointers relative to MR, CT or Ultrasound images

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogle for mx
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112469

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).