(210 days)
Not Found
No
The document describes a system for remote access, viewing, planning, and collaboration using existing surgical planning software. It mentions image processing but does not contain any terms or descriptions indicative of AI or ML technology being used for analysis, prediction, or decision support. The performance studies focus on usability, software verification/validation, accuracy of planning components, and display effectiveness, not on AI/ML model performance metrics.
No
The device is described as web-based software for viewing, planning, and collaborating on stereotactic surgery, functioning as an accessory to a surgical navigation system. Its primary functions are related to imaging and planning, not direct therapeutic intervention.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The StealthConnect® system has not been validated for primary diagnostic reading of Digital Imaging and Communications in Medicine (DICOM) images." Its primary function is for viewing, planning, and collaborating on surgical procedures.
Yes
The device is described as "web-based software" and a "web-based client interface" that interacts with existing software running on a cloud-based server. While it relies on user-supplied general-purpose computers for access, the core medical device functionality is presented as software. The description focuses on software features like secure access, image handling, and planning capabilities, without mentioning specific hardware components included with the device itself.
Based on the provided information, the StealthConnect® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "viewing, stereotactic surgery planning and collaborating" by trained professionals. It is explicitly stated that it has "not been validated for primary diagnostic reading of Digital Imaging and Communications in Medicine (DICOM) images." IVD devices are specifically intended for the examination of specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description focuses on providing remote access to surgical planning software and image viewing, not on analyzing biological samples.
- Input Data: While it uses medical images (CT, MRI), it's for planning and viewing, not for analyzing the images to diagnose a condition based on biological markers or characteristics within the images themselves.
- Performance Studies: The performance studies focus on usability, software verification/validation, accuracy of planning components, and display effectiveness for surgical planning. There are no studies related to the diagnostic accuracy of analyzing biological samples or image features for diagnostic purposes.
In summary, the StealthConnect® System is a software accessory for a surgical navigation system, designed to facilitate remote access, viewing, and planning for surgical procedures. It does not perform any tests on biological specimens or provide diagnostic information based on the analysis of such specimens, which are the defining characteristics of an IVD device.
N/A
Intended Use / Indications for Use
The StealthConnect® System is web-based software to remotely access the StealthStation® Cranial software for viewing, stereotactic surgery planning and collaborating by trained professionals such as physicians, technologists and nurses.
The StealthConnect® system has not been validated for primary diagnostic reading of Digital Imaging and Communications in Medicine (DICOM) images.
The StealthConnect® Remote Viewing, Planning and Collaboration System is an accessory to the StealthStation® System. It provides a web- based client interface to securely access encrypted storage of DICOM-compliant images via a LAN, and/or the internet using general-purpose computers, and by one or more authorized people. It provides for communication, storage, reformating, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. In addition, the system provides access to the surgical planning aspects of StealthStation® software, and can be used to set or review surgical plans for stereotactic surgeries that are compatible with and can be transferred to a StealthStation® System or any DICOM-compliant PACS system.
StealthConnect® is not to be used for mammography.
Product codes
HAW, LLZ
Device Description
The StealthConnect™ System enables web clients on users' computers to interact with a version of the existing StealthStation Cranial planning software that is running on a cloud-based server. The StealthConnect System enables
- Secure remote access for one or more authorized users simultaneously, with each accessing different patients (multi-user concurrent planning sessions) via the server-based cranial software using a web browser on user-supplied, general-purpose client computers.
- A safe environment to access, control, and share images on a secure Health Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical Health Act (HITECH) compliance-ready infrastructure.
- Authorization and access control, which is provided by integration with the user facility's Lightweight Directory Access Protocol (LDAP) or Windows Active Directory (AD) credentialing system (single sign on).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray based, MR based, Nuclear Medicine based
Anatomical Site
Cranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained Professionals (physicians, technologists and nurses) / Anywhere the end user can establish a secure connection to the hospital network (remote use).
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: Usability Testing, Software Verification and Validation testing, Functional Testing, Accuracy Testing, Display Effectiveness testing
Sample Size: Not specified
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results:
- Usability Testing was conducted in accordance to IEC 62366 demonstrating that the usability and human factors requirements were adequately met.
- Software Verification and Validation testing verifying the software and hardware requirements are met and software performs as intended. Design verification and validation was performed using the StealthConnect server and software in laboratory and simulated use settings. The results support the safety of the device and demonstrate that the software should perform as intended in the specified use conditions.
- Functional testing of the PureWeb component, a primary component of the predicate, ResolutionMD product demonstrated the functionality of the device is equivalent to the predicate.
- Accuracy testing for planning components was conducted to ensure that the StealthConnect™ System met the prescribed requirement for accuracy as compared to the predicate, StealthStation Cranial v 3.0.
- Display Effectiveness testing was performed to show that the images provided by the StealthConnect™ System, via the client applications, are sufficient to allow for the same level of stereotaxic surgical planning as provided by the predicate, Stealth Station with Cranial v 3.0 software.
Key Metrics
Mean Accuracy Values for subject device: Positional Error - 1.60mm, Trajectory Error - 0.95 degrees
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other to create a sense of depth and unity. The profiles are rendered in a dark color, contrasting with the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2017
Medtronic Navigation, Inc. Monica Montanez Principal Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027
Re: K162655
Trade/Device Name: StealthConnect Remote Viewing. Planning and Collaboration System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW, LLZ Dated: March 21, 2017 Received: March 22, 2017
Dear Ms. Montanez:
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 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 devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely yours,
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162655
Device Name
StealthConnect Remote Viewing, Planning and Collaboration System
Indications for Use (Describe)
The StealthConnect® System is web-based software to remotely access the StealthStation® Cranial software for viewing, stereotactic surgery planning and collaborating by trained professionals such as physicians, technologists and nurses.
The StealthConnect® system has not been validated for primary diagnostic reading of Digital Imaging and Communications in Medicine (DICOM) images.
The StealthConnect® Remote Viewing, Planning and Collaboration System is an accessory to the StealthStation® System. It provides a web- based client interface to securely access encrypted storage of DICOM-compliant images via a LAN, and/or the internet using general-purpose computers, and by one or more authorized people. It provides for communication, storage, reformating, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. In addition, the system provides access to the surgical planning aspects of StealthStation® software, and can be used to set or review surgical plans for stereotactic surgeries that are compatible with and can be transferred to a StealthStation® System or any DICOM-compliant PACS system.
StealthConnect® is not to be used for mammography.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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3
510(k) Summary
- Submitter: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, CO 80027
- Contact Person: Monica Montanez (Primary) Principal Regulatory Affairs Specialist Phone: (720) 890-2149 Fax: (763) 367-2076 E-mail: monica.r.montanez@medtronic.com
Paul Smolenski (Alternate) Sr Manager Regulatory Affairs Phone: (978)698-6065 Fax: (978) 698-6069 E-mail: paul.d.smolenski@medtronic.com
Date Summary Prepared:March 19, 2017
| Device Trade Name: | StealthConnect Remote Viewing, Planning and Collaboration
System |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Stereotaxic Instrument (21 CFR 882.4560) |
| Device Classification: | Class II |
| Product Code: | HAW (Stereotaxic Instrument)
LLZ (Image Processing System) |
| Classification Name: | 21 CFR 882.4560 – Stereotaxic Instrument (HAW) |
| | 21 CFR 892.2050 – Picture Archiving and
Communications System (LLZ) |
| Predicate Device: | K153660 – StealthStation Cranial v 3.0 (Primary)
K984000 - StealthSERVER Image Storage and
Communication System (Secondary)
K161130 - ResolutionMD (Secondary) |
| Device Description: | The StealthConnect™ System enables web clients on users'
computers to interact with a version of the existing
StealthStation Cranial planning software that is running on a
cloud-based server. The StealthConnect System enables |
4
- Secure remote access for one or more authorized users simultaneously, with each accessing different patients (multi-user concurrent planning sessions) via the server-based cranial software using a web browser on user-supplied, general-purpose client computers. ●
- A safe environment to access, control, and share images on a secure Health Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical Health Act (HITECH) compliance-ready infrastructure.
- Authorization and access control, which is provided ● by integration with the user facility's Lightweight Directory Access Protocol (LDAP) or Windows Active Directory (AD) credentialing system (single sign on).
Indications for Use:
The StealthConnect™ System is web-based software to remotely access the StealthStation™ Cranial software for viewing, stereotactic surgery planning and collaborating by trained professionals such as physicians, technologists and nurses.
The StealthConnect™ system has not been validated for primary diagnostic reading of Digital Imaging and Communications in Medicine (DICOM) images.
The StealthConnect™ Remote Viewing, Planning and Collaboration System is an accessory to the StealthStation™ System. It provides a web- based client interface to securely access encrypted storage of DICOM-compliant images via a LAN, and/or the internet using general-purpose computers, and by one or more authorized people. It provides for communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. In addition, the system provides access to the surgical planning aspects of StealthStation® software, and can be used to set or review surgical plans for stereotactic surgeries that are compatible with and can be transferred to a StealthStation '10 System or any DICOM-compliant PACS system.
StealthConnect™ is not to be used for mammography.
5
Substantial Equivalence: The application of Medtronic StealthConnect™ System is substantially equivalent to the predicate(s) StealthStation with StealthStation Cranial v 3.0 (K153660); StealthSERVER Image Storage and Communication System (K984000) and ResolutionMD (K161130) in intended use, technology, design and physician use.
The Indications for Use for the subject Medtronic StealthConnect™ System are similar as the predicate(s). StealthConnect System is considered an accessory to the StealthStation with Cranial v3.0. Both devices are stereotactic planning devices. Calgary Scientific ResolutionMD is considered a secondary predicate since they share the underlying technology that enables the remote access, collaboration and concurrent use features.
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K162655 Page 4 of 10
Table 1: StealthConnect Predicate Device Comparison Table
| Predicate
Devices for
510(k)Feature/
Attribute | Subject Device
StealthConnect®
System (K162655) | (Primary) Predicate:
StealthStation® System with
StealthStation Cranial v 3.0
Software (K153660) | (Secondary)Predicate:
StealthSERVER™ Image
Storage and
Communication System
(K984000) | (Secondary) Predicate:
Calgary Scientific's
ResolutionMD™ (K161130) |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The StealthConnect™
System is web- based
software to remotely access
the StealthStation Cranial
software for viewing,
stereotactic surgery
planning and collaborating
by trained professionals
such as physicians,
technologists and nurses.
The StealthConnect™
System has not been
validated for primary
diagnostic reading of
DICOM images.
The StealthConnect™
Remote Viewing, Planning
and Collaboration System is
an accessory to the
StealthStation™ System. It
provides a web- based client
interface to securely access
encrypted storage of
DICOM-compliant images
via a LAN, and/or the
internet using general-
purpose computers, and by
one or more authorized
people. It provides for
communication, storage, | The StealthStation™ System with
StealthStation™ Cranial software is
intended to aid in locating
anatomical structures in either open
or percutaneous neurosurgical
procedures. The system is
indicated for any medical condition
in which reference to a rigid
anatomical structure can be
identified relative to images of the
anatomy. This can include, but is
not limited to, the following cranial
procedures (including stereotactic
Frame-based and stereotactic frame
alternatives-based procedures):
-Cranial Biopsies (Including
Stereotactic)
-Deep Brain Stimulation (DBS) lead
placement
-Depth Electrode Placement
-Tumor Resections
Craniotomies/Craniectomies
-Skull Base Procedures
-Transsphenoidal Procedures
Thalamotomies/Pallidotomies
-Pituitary Tumor Removal
-CSF Leak Repair
-Pediatric Ventricular Catheter
Placement
-General Ventricular Catheter
Placement | The StealthServer™ Image
Storage and Communication
System is used to store and
provide remote viewing
access to diagnostic images
via a LAN, the internet or
modem. In addition, the
system can be used to
remotely set surgical plan for
stereotactic surgeries that are
compatible with and can be
accessed by the
StealthStation® Treatment
Guidance Platform. | The ResolutionMD™ Web 2.9
software-based is intended for
use as a diagnostic, review, and
analysis tool by trained
professionals such as
physicians, technologists and
nurses. When interpreted by a
trained physician, reviewed
images may be used as an
element for diagnosis. It is the
user's responsibility to ensure
that the software is installed on
appropriate hardware and that
the image quality is suitable for
the clinical application. Calgary
Scientific recommends that the
users of the ResolutionMD
software consult the appropriate
American College of Radiology
Practice Guidelines pertaining to
the anatomy and pathology
being studied. The
ResolutionMD™ is a software-
based Picture Archiving and
Communication System (PACS)
used with general purpose
computing hardware for the
display and 3D visualization of
medical image data. It provides
for communication, storage,
reformatting, rendering, and
display of DICOM 3.0 compliant |
| Predicate
Devices for
510(k)Feature/
Attribute | Subject Device
StealthConnect®
System (K162655) | (Primary) Predicate:
StealthStation® System with
StealthStation Cranial v 3.0
Software (K153660) | (Secondary)Predicate:
StealthSERVER™ Image
Storage and
Communication System
(K984000) | (Secondary) Predicate:
Calgary Scientific's
ResolutionMD™ (K161130) |
| | reformatting, rendering, and
display of DICOM 3.0
compliant image data
derived from various
sources including CT and
MRI. In addition, the system
provides access to the
surgical planning aspects of
StealthStation™ software,
and can be used to set or
review surgical plans for
stereotactic surgeries that
are compatible with and can
be transferred to a
StealthStation™ System or
any DICOM-compliant
PACS system.
StealthConnect™ is not to
be used for mammography. | The user should consult the
"Navigational Accuracy" section of
the User Manual to assess if the
accuracy of the system is suitable
for their needs. | | image data derived from various
sources including CT and MRI.
ResolutionMD is not to be used
for mammography. |
| Prescription Use | Yes | Yes | Yes | Yes |
| Intended Users | Trained Professionals | Trained Professionals | Trained Professionals | Trained Professionals |
| Remote Use | Yes: Anywhere the end user
can establish a secure
connection to the hospital
network | No: Hospital only | Yes: Anywhere the end user
can establish a secure
connection to the
StealthSERVER Network
Planning system inside and
outside hospital. | Yes: By using the web browser
over a network connection using
a user supplied computer. |
| Predicate
Devices for
510(k)Feature/
Attribute | Subject Device
StealthConnect®
System (K162655) | (Primary) Predicate:
StealthStation® System with
StealthStation Cranial v 3.0
Software (K153660) | (Secondary)Predicate:
StealthSERVER™ Image
Storage and
Communication System
(K984000) | (Secondary) Predicate:
Calgary Scientific's
ResolutionMD™ (K161130) |
| On Line
Collaboration | Yes: Using PureWeb to
share medical image data | No: Gather around the
StealthStation System in hospital
setting only | No: Only simultaneous
access | Yes: The feature "Collaboration"
is provided in ResolutionMD |
| Concurrent User
Sessions | Yes: StealthConnect
enables 5 users to
simultaneously log on and
access multiple patient data
for stereotactic planning. | No: Single planning/navigating
session | Yes: StealthSERVER allows
up to 4 concurrent user
sessions. | Yes: ResolutionMD allows
multiple concurrent users |
| DICOM
Import/Export via
Query/Receive
and Unattended | Yes: Import/Export DICOM
images to/from its Cloud
based patient database.
Can receive DICOM
transfers at any time
(Unattended) | Yes: DICOM
Import/Export/Query/Retrieve
to/from its local patient database,
and can receive DICOM transfers at
any time if StealthStation is turned
on and networked (Unattended). | Yes: DICOM Import/Export to
its local patient database at
any time | Yes: Import/Export DICOM
images to its local database |
| Planning Features | StealthConnect provides:
Plan Entry and Target
Selection
3D Model Building
Advanced Visualization
Create Patient Based
Anatomical Coordinate
Space
Stereotactic Frame Settings
Brain Atlas:Schaltenbrand-
Wahren Atlas with Talairach
Grid
STarFix Designer
Annotations | Yes: The device is intended for
detailed planning and treatment of
patients: Plan Entry and Target
Selection
3D Model Building
Advanced Visualization
Create Patient Based Anatomical
Coordinate Space
Stereotactic Frame Settings
Brain Atlas:Schaltenbrand-Wahren
Atlas with Talairach Grid
STarFix Designer
Annotations | Yes: Setting the target point
and the entry point for a
surgical procedure.
3D Model Building
For Cranial and Spine
procedures | No: The device is used for
viewing images rather than
stereotactic planning. However,
when images are interpreted by
a trained physician, the reviewed
images may be used as an
element for diagnosis and
planning of treatment. |
| Predicate
Devices for
510(k)Feature/
Attribute | Subject Device
StealthConnect®
System (K162655) | (Primary) Predicate:
StealthStation® System with
StealthStation Cranial v 3.0
Software (K153660) | (Secondary)Predicate:
StealthSERVER™ Image
Storage and
Communication System
(K984000) | (Secondary) Predicate:
Calgary Scientific's
ResolutionMD™ (K161130) |
| User
Authorization and
Authentication | Yes: Device requires user
authentication and log on
capabilities. StealthConnect
ties into the hospital
credentialing system. | No: Optional password protection | Yes: Device requires
password protection using at
the time C2 Security features
based upon the requirements
outlined in the U.S.
Department of Defense
Trusted Computer Systems | Yes: Device requires user
authentication and provides log
on capabilities. |
| 2D Viewing | Yes: StealthConnect
provides the same features
Cranial v 3.0 offers for 2D
standard viewing. | Yes: Utilizes StealthStation Cranial
Software viewer for standard
viewing to include tools for
window/level, pan, zoom. Anatomic
Orthogonal; Trajectory 1 and 2;
Probes Eye, Look Ahead | Yes: 2 D Standard viewing | Yes: Subject device and
predicates all have 2D
Viewing features. |
| 3D Viewing | Yes: StealthConnect
provides the same features
available in Cranial v 3.0 for
3 D volume rendering of the
data set. | Yes: 3 D Volume rendering of the
data set. Interactive controls lasso,
wand threshold, annotations and
segmentations tools. | Yes: 3D volume rendering of
the data set and viewing | Yes: 3 D Volume rendering of
the data set. Interactive controls
for zoom, pan, rotate and
window/level via mouse and
keyboard controls. |
| Programming
Language | C++/Javascript/HTML5 | C++ | Java | C++/Javascript/HTML |
| Imaging
Modalities | X-Ray based,
MR based
Nuclear Medicine based | X-Ray based,
MR based
Nuclear Medicine based | X-Ray based,
MR based | X-Ray based,
MR based
Nuclear Medicine based |
| System Accuracy
Requirement | Mean Accuracy Values:
Positional Error - 1.60mm
Trajectory Error - 0.95
degrees | Mean Accuracy Values:
Positional Error - 1.65mm
Trajectory Error - 0.68 degrees | No: Navigational Accuracy
was not required at the time | No: Device does not offer
Stereotactic Planning |
| Predicate
Devices for
510(k)Feature/
Attribute | Subject Device
StealthConnect®
System (K162655) | (Primary) Predicate:
StealthStation® System with
StealthStation Cranial v 3.0
Software (K153660) | (Secondary)Predicate:
StealthSERVER™ Image
Storage and
Communication System
(K984000) | (Secondary) Predicate:
Calgary Scientific's
ResolutionMD™ (K161130) |
| Scanner Interface
Technology (to
imaging devices) | Network Connectivity
CD, DVD, USB
DICOM Import
DICOM Export | Network Connectivity
CD, DVD, USB
DICOM Import
DICOM Export | DICOM Import/Export (from
PACS, scanners and
StealthStation) | Network Connectivity DICOM
Import
DICOM Export |
| "Cybersecurity"
Encryption of
Patient Data | Yes: StealthConnect
encrypts data in transit
using TLS 1.2, and at rest
using AES-256 with
dedicated hardware key
storage. | No: Data is not encrypted however
the StealthStation running the
software is located in a controlled
access hospital environment | No: Data was not encrypted
however security measures
were addressed in the IFU. | Yes: ResolutionMD is typically
secured using SSL. |
| Registration
Features | StealthConnect provides
Exam-to-Exam Registration:
Identity Merge Registration,
Manual Merge Registration
and Automatic Merge
Registration, Stereotactic
Localizer Registration and
StarFix Bone Anchor
Registration. Other patient
registration features in
Cranial v 3.0 are not
provided since they are for
navigation. | Yes: Exam-to-Exam Registration:
Identity Merge Registration, Manual
Merge Registration and Automatic
Merge Registration.
Stereotactic Localizer Registration
and StarFix Bone Anchor
Registration.
Patient Registration: PointMerge
registration, Tracer registration,
Touch-N-Go registration, StealthAiR
registration, O-Arm registration | No: None needed to be
provided for the planning
purposes in effect at that
time. | No: ResolutionMD does not offer
registration features. |
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- Performance Testing: Testing conducted demonstrates the product will perform as intended according to the outlined design requirements. The following testing was conducted on the StealthConnect™ System to establish substantial equivalence of the system and verify that the device will perform as intended, meeting all of the design inputs:
- . Usability Testing was conducted in accordance to IEC 62366 demonstrating that the usability and human factors requirements were adequately met.
- Software Verification and Validation testing verifying the . software and hardware requirements are met and software performs as intended. Design verification and validation was performed using the StealthConnect server and software in laboratory and simulated use settings. The results support the safety of the device and demonstrate that the software should perform as intended in the specified use conditions. This includes the following:
- Functional testing of the PureWeb component, O a primary component of the predicate, ResolutionMD product demonstrated the functionality of the device is equivalent to the predicate.
- Accuracy testing for planning components was o conducted to ensure that the StealthConnect™ System met the prescribed requirement for accuracy as compared to the predicate, StealthStation Cranial v 3.0.
- o Display Effectiveness testing was performed to show that the images provided by the StealthConnect™ System, via the client applications, are sufficient to allow for the same level of stereotaxic surgical planning as provided by the predicate. Stealth Station with Cranial v 3.0 software.
The following table summarizes the quality assurance measures that were applied during the development of the software component of the system:
Description
Software Development Life Cycle
Software Risk Assessment
12
Software Configuration Management and Version Control
Clinical testing was not considered necessary since this is not considered new technology.
Conclusion: The non-clinical data support the safety of the device and the software verification and validation demonstrate that the StealthConnect™ Systemv1.0 should perform as intended in the specified use conditions. The non-clinical data demonstrate that the StealthConnect™ System is substantially equivalent to the predicate(s) StealthStation™ Cranial v 3.0; StealthSERVER™ and ResolutionMD.