(294 days)
Not Found
No
The document describes a neuronavigation system that integrates ultrasound imaging with pre-operative MR/CT images for real-time navigation and brain shift compensation. It does not mention any AI or ML algorithms for image analysis, processing, or decision support. The focus is on image acquisition, registration, and display for navigation.
No.
The device is described as a neuronavigation system and ultrasound scanner used to aid in surgery and provide imaging, not to treat a condition or disease.
No
The device is intended for use as a tool for intraoperative ultrasound imaging and image-guided surgery, and as a standard neuronavigation system or stand-alone ultrasound scanner. Its primary functions are to show the position of tools or pointers relative to anatomical images (MR, CT, or Ultrasound) and to acquire ultrasound images during operation for navigation and comparison. While it provides imaging, its stated uses and functions revolve around guiding surgical procedures and updating navigational maps, rather than making a diagnosis.
No
The device description explicitly states that the system includes hardware components such as a navigation computer, ultrasound scanner, tracking system, trolley, power supply, probe interface, wiring, cabling, infrared camera, and touch screen. It is an integrated system with both software and hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "intraoperative ultrasound imaging and image guided surgery during neurosurgery," "a standard neuronavigation system," and "a stand-alone ultrasound scanner." These are all related to imaging and navigation within the body during a surgical procedure.
- Device Description: The description reinforces this by detailing its function as a neuronavigation system that uses ultrasound and other imaging modalities to guide surgical tools and visualize anatomy in real-time during surgery.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information. IVDs are specifically designed for testing samples in vitro.
The device is a surgical imaging and navigation system, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HAW, IYN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, MR, CT
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, Neurosurgery
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 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
1
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.
2
Comparison Table:
バ
| Element of
Comparison | Subject Device | Predicate
Device | Predicate
Device | Predicate
Device | Comments |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | K023651 | K061525 | K072365 | |
| | SonoWand
Invite | BrainLab
Vector Vision | GE Vivid-I | Siemens
Sequoia™
Plus system | |
| Common
Name | Intraoperative
3D ultrasound i
maging system
with
navigation for
neurosurgery | Image guided
surgery
system, CAS
/Stereotaxy
instrument | Diagnostic
ultrasound
system | Diagnostic
ultrasound
system | |
| Intended use | Intended for
use as a tool to
aid
intraoperative
ultrasound
imaging and
image guided
surgery during
neurosurgery.
The Invite is
intended for
use as a
standard
neuronavigatio
n system. The
Invite is
intended for
use as a stand-
alone
ultrasound
scanner. | The system is
indicated for
any medical
condition in
which the use
of stereotactic
surgery may
be appropriate
and where a
reference to a
rigid
anatomical
structure, such
as the skull, a
long bone, or
vertebra, can
be identified
relative to a
CT, CTA, X-
ray, MR, MRA
and ultrasound
based model of
the anatomy. | Intended for
use by a
qualified
physician for
ultrasound
evaluation of
Fetal;
Abdominal;
Pediatric;
Small Organ;
Neonatal
Cephalic;
Adult
Cephalic;
Cardiac;
Peripheral
vascular;
Musculoskelet
al
Conventional
and
Superficial;
Urology;
Transesophaga
l, Transrectal, | Intended for
the following
applications:
Cardiac,
neonatal
cardiac,
pediatric,
transesophagea
l, adult
cephalic,
peripheral
vessel,
intraoperative
neurological,
musculoskelet
al conventional
and
musculoskelet
al superficial
applications. | The intended
use of the
Invite as a
navigation tool
is the same as
for the Vector
Vison.
The Invite
intended use as
an ultrasound
evaluation tool
is the same as
for the GE
Vivid-i, but
limited to the
neurological
system.
The intended
use of the
Siemens
system
includes
intraoperative
neurological. |
| Element of
Comparison | Subject Device | Predicate
Device | Predicate
Device | Predicate
Device | Comments |
| Types of
Procedures | Medical
conditions
where
stereotactic
surgery can be
appropriate.
Identification is
relative to MR
or CT images
and/or to
intraoperative
ultrasound
images.
Ultrasound
images can be
compared with
the MR and/or
CT images | Cranial
procedures
Cranial
biopsies
Tumor
resections
Caniotomies/
craniectomies
Skull base
procedures
Thalamotomie
s
ENT
procedures | Transvaginal,
intraoperative | | The procedures
are the same as
to those used
for Vector
Vision and GE
Vivid-i. Invite
aids the
surgeon, but
does not make
any decisions
or in any way
controls the
operation. |
| Major
Components | Ultrasound
scanner
Navigation
computer
Tracking
system (passive
marker system)
Ultrasound
probe
Trolley
Appendant
support system | Freehand
probe
Navigation
computer
Passive marker
system | Ultrasound
scanner
Ultrasound
probe | | The
Ultrasound
scanner used in
Invite is the
GE Vivid-i
scanner.
The tracking
system is
similar to that
used in Vector
Vision. The
Invite system
with its
computer,
trolley and
appendant
support is
tested by
Nemko. |
| Power
Requirements | 5A/230V or
10A/110V
(Total power
demand | Unknown | 1.1A/240V to
2.3A/100V | | The electric
power system
is tested by
Nemko |
| Element of
Comparison | Subject Device | Predicate
Device | Predicate
Device | Predicate
Device | Comments |
| | including built
in Vivid-i) | | | | |
| Accessories | GE 12L-RS
linear array
probe, phased
array probe,
various
disposables | | Multiple
probes,
including the
12L-RS linear
array probe. | | Invite uses the
same probes
used for Vivid-i |
3
4
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.
5
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.
6
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
7
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