(33 days)
Not Found
No
The document describes an image-guided surgical system that tracks instrument position relative to anatomical structures using optical or electromagnetic tracking and displays this on pre-operative or intra-operative images. The changes described are minor software updates related to image display and protocol support. There is no mention of AI or ML in the intended use, device description, or performance studies. The performance metrics are related to positional and trajectory accuracy, not typical AI/ML performance metrics like sensitivity or specificity.
No.
The device is an aid for locating anatomical structures and tracking surgical instruments, which fall under Image Guided Surgery (IGS) systems for navigation, not direct therapeutic intervention.
No
Explanation: The device is described as an "aid for locating anatomical structures" and "tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of the patient." Its purpose is to guide surgical procedures, not to diagnose a medical condition.
No
The device description explicitly states that the software works in conjunction with an Image Guided System (IGS) which consists of clinical software, surgical instruments, a referencing system, and platform/computer hardware. This indicates it is part of a larger hardware system, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the StealthStation™ System with Cranial Software is an aid for locating anatomical structures in vivo (within the body) during surgical procedures. It helps guide surgical instruments based on images of the patient's anatomy.
- Device Description: The description details an Image Guided System (IGS) that tracks the position of surgical instruments in relation to the patient's anatomy using imaging data. This is a surgical navigation system, not a device that performs tests on biological samples in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.) or providing diagnostic information based on such analysis. The system's function is to provide spatial guidance during surgery.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is entirely focused on surgical guidance during a procedure.
N/A
Intended Use / Indications for Use
The StealthStation™ System, with StealthStation™ Cranial Software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, 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):
- Tumor resections
- General ventricular catheter placement
- Pediatric ventricular catheter placement
- Depth electrode, lead, and probe placement
- Cranial biopsies
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The StealthStation™ Cranial Software v1.3.0 works in conjunction with an Image Guided System (IGS) which consists of clinical software, surgical instruments, a referencing system and platform/computer hardware. Image guidance, also called navigation, tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of the patient. During surgery, positions of specialized surgical instruments are continuously updated on these images either by optical tracking or electromagnetic tracking.
Cranial software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.
The changes to the currently cleared StealthStation S8 Cranial Software are as follows:
- Addition of an optional image display that allows the user to see through outer layers to increase the visibility of other models.
- Update the imaging protocol to support overlapping slices.
- Minor changes to the software were made to address user preferences and to fix minor anomalies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray based, MR based, Nuclear Medicine based
Anatomical Site
Cranial / Skull
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 StealthStation S8 System with StealthStation Cranial Software v1.3.0 has demonstrated performance in 3D positional accuracy with a mean error ≤ 2.0 mm and in trajectory angle accuracy with a mean error of ≤ 2.0 degrees. This performance was determined using anatomically representative phantoms and utilizing a subset of system components and features that represent the worst-case combinations of all potential system components. Software verification and validation testing for each requirement specification. System integration performance testing for cranial surgical procedures using anatomical phantoms.
Design verification and validation was performed using the StealthStation S8 System with StealthStation Cranial Software v1.3.0 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.
Clinical testing was not considered necessary prior to release as this is not new technology.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
System Accuracy Requirements: mean error ≤ 2.0 mm (3D positional accuracy), mean error ≤ 2.0 degrees (trajectory angle accuracy).
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 3, 2020
Medtronic Navigation Inc. Amelia Striegel Senior Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027
Re: K201175
Trade/Device Name: StealthStation Cranial Software v1.3.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: April 30, 2020 Received: May 1, 2020
Dear Amelia Striegel:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Adam D. Pierce Acting Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K201175
Device Name StealthStation™ Cranial Software v1.3.0
Indications for Use (Describe)
The StealthStation™ System, with StealthStation™ Cranial Software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, 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):
- · Tumor resections
- General ventricular catheter placement
- · Pediatric ventricular catheter placement
- · Depth electrode, lead, and probe placement
- · Cranial biopsies
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) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
cription 65c (Part 21 CFR 601 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
30 April 2020
- l. Company: Medtronic Navigation. Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200
- Amelia Striegel (Primary) Contact: Senior Regulatory Affairs Specialist Telephone Number: 720.890.2528 Fax Number: 720.890.3500
K. Elizabeth Waite Regulatory Affairs Manager Telephone number: 720.890.2182 Fax: 720.890.3500 Email: elizabeth.waite@medtronic.com
- Proprietary Trade Name: StealthStation™ Cranial Software v1.3.0 II.
- lll. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- IV. Classification: Class II, Stereotaxic Instrument
- V. Product Codes: HAW
- VI. Predicate Device
510(k): K162309 Device name: StealthStation S8 Cranial Software v1.0.0 Manufacturer: Medtronic Navigation, Inc.
VII. Product Description
The StealthStation™ Cranial Software v1.3.0 works in conjunction with an Image Guided System (IGS) which consists of clinical software, surgical instruments, a referencing system and platform/computer hardware. Image guidance, also called navigation, tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of the patient. During surgery, positions of specialized surgical instruments are continuously updated on these images either by optical tracking or electromagnetic tracking.
Cranial software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.
The changes to the currently cleared StealthStation S8 Cranial Software are as follows:
- . Addition of an optional image display that allows the user to see through outer layers to increase the visibility of other models.
4
- . Update the imaging protocol to support overlapping slices.
- . Minor changes to the software were made to address user preferences and to fix minor anomalies.
VIII. Indications for Use
The StealthStation™ System, with StealthStation™ Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, 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):
- · Tumor resections
- General ventricular catheter placement
- Pediatric ventricular catheter placement
- · Depth electrode, lead, and probe placement
- · Cranial biopsies
IX. Comparison of the Technological Characteristics
| Feature | StealthStation Cranial
Software v1.3.0 (Subject
Device) | StealthStation S8 Cranial
software v1.0.0 (Predicate
Device; K162309) |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The StealthStationTM System, with
StealthStationTM Cranial Software is
designed as an aid for locating
anatomical structures in either open
or percutaneous neurosurgical
procedures. | The StealthStation® System, with
StealthStation® Cranial software is
designed as an aid for locating
anatomical structures in either open
or percutaneous neurosurgical
procedures. |
| Feature | StealthStation Cranial
Software v1.3.0 (Subject
Device) | StealthStation S8 Cranial
software v1.0.0 (Predicate
Device; K162309) |
| Indications for
Use | The StealthStation™ System, with
StealthStation™ Cranial Software,
is intended as an aid for locating
anatomical structures in either open
or percutaneous neurosurgical
procedures. Their use is indicated
for any medical condition in which
the use of stereotactic surgery may
be appropriate, and where
reference to a rigid anatomical
structure, such as the skull, can be
identified relative to images of the
anatomy. | The StealthStation™ System, with
StealthStation™ Cranial software, is
intended as an aid for locating
anatomical structures in either open
or percutaneous neurosurgical
procedures. Their use is indicated
for any medical condition in which
the use of stereotactic surgery may
be appropriate, and where
reference to a rigid anatomical
structure, such as the skull, 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):
• Tumor resections
• General ventricular catheter
placement
• Pediatric ventricular catheter
placement
• Depth electrode, lead, and probe
placement
• Cranial biopsies | This can include, but is not limited
to, the following cranial procedures
(including stereotactic frame-based
and stereotactic frame alternatives-
based procedures):
• Tumor resections
• General ventricular catheter
placement
• Pediatric ventricular catheter
placement
• Depth electrode, lead, and probe
placement
• Cranial biopsies |
| System
Accuracy
Requirements | Under representative worst-case
configuration, the StealthStation S8
System with StealthStation Cranial
Software v1.3.0, has demonstrated
performance in 3D positional
accuracy with a mean error ≤ 2.0
mm and in trajectory angle
accuracy with a mean error ≤ 2.0
degrees. | Under representative worst-case
configuration, the StealthStation S8
System with StealthStation Cranial
v1.0.0 Software, has demonstrated
performance in 3D positional
accuracy with a mean error ≤ 2.0
mm and in trajectory angle
accuracy with a mean error ≤ 2.0
degrees. |
| Imaging
Modalities | X-Ray based, MR based,
Nuclear Medicine based | X-Ray based, MR based,
Nuclear Medicine based |
| View (Display)
Features | Ultrasound Video In, Ultrasound
Overlay, 3D, 2D Anatomic
Orthogonal, Trajectory 1 and 2,
Target Guidance, Trajectory
Guidance, Probes Eye, Look
Ahead, Microscope Injection, Video
Input, Endoscopic | Ultrasound Video In, Ultrasound
Overlay, 3D, 2D Anatomic
Orthogonal, Trajectory 1 and 2,
Target Guidance, Trajectory
Guidance, Probes Eye, Look
Ahead, Microscope Injection, Video
Input, Endoscopic |
| Feature | StealthStation Cranial
Software v1.3.0 (Subject
Device) | StealthStation S8 Cranial
software v1.0.0 (Predicate
Device; K162309) |
| Exam-to-Exam
Registration
Features | Identity Merge Registration, Manual
Merge Registration and Automatic
Merge Registration | Identity Merge Registration, Manual
Merge Registration and Automatic
Merge Registration |
| Patient
Registration
Features | PointMergeTM registration (referred
to as Landmark registrations),
TracerTM registration, Touch
registration (previously Touch-N-
GoTM), StealthAiRTM registration, O-
armTM registration, Mechanical
based registrations (Stereotactic
Localizer Registration and StarFixTM
Bone Anchor Registration) | PointMerge® registration (referred
to as Landmark registrations),
TracerTM registration, Touch
registration (previously Touch-N-
GoTM), StealthAiR® registration, O-
arm® registration, Mechanical
based registrations (Stereotactic
Localizer Registration and StarFixTM
Bone Anchor Registration) |
| Planning
Features | 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
STarFixTM Designer
Annotations | 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
STarFixTM Designer
Annotations |
| Medical Device
Interfaces | Microscope Navigation: Zeiss, Leica
Ultrasound Navigation: Aloka and
Sonosite
Medtronic O-armTM
Stereotactic Frame Systems:
Fischer ZD, Fischer RM, Integra
CRW and Elekta Leksell
NexframeTM Stereotactic System
STarFixTMPlatform System
Stealth Midas Rex MR8
StealthStation Autoguide | Microscope Navigation: Zeiss, Leica
Ultrasound Navigation: Aloka and
Sonosite
Medtronic O-arm®
Stereotactic Frame Systems:
Fischer ZD, Fischer RM, Integra
CRW and Elekta Leksell
Nexframe® Stereotactic System
STarFixTMPlatform System |
| Compatible
Medtronic
Optical
Instrumentation | Medtronic instruments tracked via
optical markers or LEDs located on
instrument and patient trackers via
the optical localizing system. | Medtronic instruments tracked via
optical markers or LEDs located on
instrument and patient trackers via
the optical localizing system. |
| Compatible
Medtronic EM
Instrumentation | Medtronic instruments tracked via
electromagnetic localization
technology located within the
instrument and patient trackers | Medtronic instruments tracked via
electromagnetic localization
technology located within the
instrument and patient trackers |
| Feature | StealthStation Cranial
Software v1.3.0 (Subject
Device) | StealthStation S8 Cranial
software v1.0.0 (Predicate
Device; K162309) |
| Software
Interface
(GUI) | Black and gray style with procedure
task overview in left menu option
and next/back task flow at bottom of
the screen. Software controls for
images, planning and instrument
management are contained in a
right side bar. | Black and gray style with procedure
task overview in left menu option
and next/back task flow at bottom of
the screen. Software controls for
images, planning and instrument
management are contained in a
right side bar. |
| Programming
Language | C++ | C++ |
| Scanner
Interface
Technology (to
imaging
devices) | Network Connectivity
CD, DVD, USB
DICOM Import
DICOM Export | Network Connectivity
CD, DVD, USB
DICOM Import
DICOM Export |
| Optical
Technology | Manufacturer: Northern Digital Inc.
Localizer: Vega | Manufacturer: Northern Digital Inc.
Localizer: Vega |
| Electromagnetic
Technology | Manufacturer: Medtronic
Navigation, Inc.
Localizer: AxiEM III
Emitter Types: Side, Flat | Manufacturer: Medtronic
Navigation, Inc.
Localizer: AxiEM III
Emitter Types: Side, Flat |
5
6
7
Identification of Legally Marketed Devices X.
StealthStation S8 Cranial Software v1.0.0 (K162309)
XI. Discussion of the Performance Testing
The following table summarizes the testing conducted on the StealthStation Cranial Software v1.3.0
Description
Under representative worst-case configuration, the StealthStation S8 System with StealthStation Cranial Software v1.3.0 has demonstrated performance in 3D positional accuracy with a mean error ≤ 2.0 mm and in trajectory angle accuracy with a mean error of ≤ 2.0 degrees. This performance was determined using anatomically representative phantoms and utilizing a subset of system components and features that represent the worst-case combinations of all potential system components. Software verification and validation testing for each requirement specification. System integration performance testing for cranial surgical procedures using anatomical phantoms.
The following table summarizes the quality assurance measures that were applied during development of the software component of the system:
| Description |
|---|
| Software Development Life Cycle |
| Software Risk Assessment |
| Software Configuration Management and Version Control |
8
Design verification and validation was performed using the StealthStation S8 System with StealthStation Cranial Software v1.3.0 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.
Clinical testing was not considered necessary prior to release as this is not new technology.
XII. Conclusions
The StealthStation Cranial Software v1.3.0 has been shown through testing and comparison to be substantially equivalent to the identified predicate device.