(108 days)
No
The summary describes a traditional image-guided surgery system that tracks instrument position relative to images. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The testing focuses on accuracy and software functionality, not on AI/ML model performance.
No.
The device is a surgical navigation system that aids in precisely locating anatomical structures during neurosurgical procedures. It does not directly treat a disease or condition.
No
The device is intended to aid in precisely locating anatomical structures during neurosurgical procedures and guides surgeons during these procedures. It does not diagnose medical conditions.
No
The device description explicitly states that the StealthStation Cranial 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 system that includes hardware components, not a standalone software-only device.
Based on the provided information, the StealthStation System, with StealthStation Cranial software, is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- StealthStation's Function: The StealthStation System is an Image Guided System (IGS) used during surgical procedures. It helps surgeons navigate and precisely locate anatomical structures within the patient's body based on pre-operative or intraoperative images. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states its purpose is to "aid in precisely locating anatomical structures in either open or percutaneous neurosurgical procedures." This is a surgical navigation tool, not a diagnostic test performed on a sample.
Therefore, the StealthStation System falls under the category of a surgical navigation or guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The StealthStation System, with SteathStation Cranial software, is intended to aid in precisely 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
Product codes
HAW
Device Description
The StealthStation System, with StealthStation Cranial software helps guide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation Cranial Software 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. StealthStation 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.
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
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
Testing conducted demonstrates the product will perform as intended according to the outlined design requirements. The following testing was conducted on the StealthStation Cranial Software to establish substantial equivalence of the system and verify that the device will perform as intended meeting all of the design inputs:
- Verification corrective testing to verify the software changes addressed the Biopsy Depth Gauge Graphic and the Distance to/past Target Text anomalies.
- Verification regression testing to confirm that changes introduced to the software do not adversely affect the functionality of the software.
- Verify the new software version will install and upgrade properly.
- Verify the changes to the instructions for use (IFU).
- User exploratory testing to explore clinical workflows, including standard and unusual clinically relevant workflows. This testing will include subject matter experts, internal and field support personnel.
- System accuracy validation testing to demonstrate that the modified software meets the accuracy acceptance criteria of
§ 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
October 19, 2023
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Medtronic Navigation, Inc. Rishi Mehta Senior Regulatory Affairs Specialist 200 Medtronic Drive Lafayette, Colorado 80026
Re: K231976
Trade/Device Name: StealthStation Cranial Software, v3.1.5 (9735585) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: September 19, 2023 Received: September 19, 2023
Dear Rishi Mehta:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Image /page/1/Picture/6 description: The image shows a digital signature. The signature is for Adam D. Pierce -S. The date of the signature is 2023.10.19, and the time is 11:31:58 -04'00'.
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known)
Device Name
StealthStation Cranial Software Version 3.1.5 (9735585)
Indications for Use (Describe)
StealthStation Cranial Software Version 3.1.5
The StealthStation System, with SteathStation Cranial software, is intended to aid in precisely 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
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
October 19, 2023
- l. Company: Medtronic Navigation, Inc. 200 Medtronic Drive Lafayette, CO, 80026 Telephone Number: 720-890-2462 Fax Number: 720-890-3500
- Contact: Rishi Mehta Senior Regulatory Affairs Specialist Telephone Number: 720-890-2462
Kyle Hoefling Senior Regulatory Affairs Manager Telephone Number: 720-890-2462
- II. Proprietary Trade Name: StealthStation™ Cranial Software v3.1.5
- lll. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- IV. Classification: Class II, Stereotaxic Instrument
- V. Product Codes: HAW
- VI. Predicate: Medtronic Navigation, Inc. manufactured software;
- K221087 StealthStation Cranial Software v3.1.4
VII. Product Description
The StealthStation System, with StealthStation Cranial software helps guide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation Cranial Software 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. StealthStation 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.
5
VIII. Indications for Use
StealthStation Cranial Software Version 3.1.5
The StealthStation System, with StealthStation Cranial Software, is intended to aid in precisely 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 י
- -Pediatric Ventricular Catheter Placement
- General Ventricular Catheter Placement -
IX. Summary of the Technological Characteristics
StealthStation Cranial Software Version 3.1.5 as compared to Predicate Device
| Item | Subject Device | Predicate Device |
|---|---|---|
| StealthStation System with Cranial | ||
| Software Version 3.1.5 | StealthStation System with | |
| StealthStation Cranial Software | ||
| Version 3.1.4 (K221087) | ||
| Intended Use | The StealthStation System, with | |
| StealthStation 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. | ||
| Indications for Use | 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 | 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 | ||
| Item | Subject Device | Predicate Device |
| StealthStation System with Cranial | ||
| Software Version 3.1.5 | StealthStation System with | |
| StealthStation Cranial Software | ||
| Version 3.1.4 (K221087) | ||
| structure can be identified relative to | ||
| images of the anatomy. | 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
- 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 | This can include, but is not limited to,
the following cranial procedures
(including stereotactic frame-based
and stereotactic frame alternatives-
based procedures): - Cranial Biopsies
- 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 user should consult the
"Navigational Accuracy" section of the
User Manual to assess if the accuracy
of the system is suitable to their
needs. | The user should consult the
"Navigational Accuracy" section of the
User Manual to assess if the accuracy
of the system is suitable to their needs. |
| | | |
| System Accuracy
Requirement | Under representative worst-case
configuration, the StealthStation®
System with StealthStation Cranial
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. | Under representative worst-case
configuration, the
StealthStation® System with
StealthStation® Cranial 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. |
| | | |
| | Specific Mean Accuracy Values | Specific Mean Accuracy Values |
| | | |
| | Positional Error - 0.824 mm | Positional Error - 1.27 mm |
| | Trajectory Error - 0.615 degrees | Trajectory Error – 1.02 degrees |
| Item | Subject Device | Predicate Device |
| | StealthStation System with Cranial
Software Version 3.1.5 | StealthStation System with
StealthStation Cranial Software
Version 3.1.4 (K221087) |
| Imaging
Modalities | X-Ray based,
MR based
Nuclear Medicine based | X-Ray based,
MR based
Nuclear Medicine based |
| Registration
Features | Exam-to-Exam Registration: Identity
Merge Registration, Manual Merge
Registration and Automatic Merge
Registration. | Exam-to-Exam Registration: Identity
Merge Registration, Manual Merge
Registration and Automatic Merge
Registration. |
| | Patient Registration: PointMerge
registration, Tracer registration,
Touch-N-Go registration, StealthAiR
registration, O-arm registration,
Stereotactic Localizer Registration and
StarFix Bone Anchor Registration | Patient Registration: PointMerge
registration, Tracer registration,
Touch-N-Go registration, StealthAiR
registration, O-arm registration,
Stereotactic Localizer Registration and
StarFix 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
STarFix 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
STarFix Designer
Annotations |
| Medical Device
Interfaces | Microscope Navigation: Zeiss, Leica
Ultrasound Navigation: Aloka and
Sonosite
Medtronic O-arm
Stereotactic Frame Systems: Fischer
ZD, Fischer RM, Integra CRW and
Leksell
Nexframe® Stereotactic System
STarFix™Platform | Microscope Navigation: Zeiss, Leica
Ultrasound Navigation: Aloka and
Sonosite
Medtronic O-arm
Stereotactic Frame Systems: Fischer
ZD, Fischer RM, Integra CRW and
Leksell
Nexframe® Stereotactic System
STarFix™Platform |
| 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 | 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 |
| Software Interface
(GUI) | Blue style with chronological next/back
task flow at the top of the screen.
Image controls on the left. Planning
information on the right | Blue style with chronological next/back
task flow at the top of the screen.
Image controls on the left. Planning
information on the right |
| Item | Subject Device | Predicate Device |
| 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 |
| Localization
Technology | Optical (infra-red)
Electromagnetic
Mechanical based stereotactic | Optical (infra-red)
Electromagnetic
Mechanical based stereotactic |
| | StealthStation System with Cranial
Software Version 3.1.5 | StealthStation System with
StealthStation Cranial Software
Version 3.1.4 (K221087) |
6
7
8
X. Identification of Legally Marketing Devices
XI. Discussion of the Performance Testing
Testing conducted demonstrates the product will perform as intended according to the outlined design requirements. The following testing was conducted on the StealthStation Cranial Software to establish substantial equivalence of the system and verify that the device will perform as intended meeting all of the design inputs:
- Verification corrective testing to verify the software changes addressed the Biopsy Depth Gauge Graphic and the Distance to/past Target Text anomalies.
- Verification regression testing to confirm that changes introduced to the software do not adversely affect the functionality of the software.
- Verify the new software version will install and upgrade properly.
- Verify the changes to the instructions for use (IFU).
- . User exploratory testing to explore clinical workflows, including standard and unusual clinically relevant workflows. This testing will include subject matter experts, internal and field support personnel.
- . System accuracy validation testing to demonstrate that the modified software meets the accuracy acceptance criteria of ≤2.0mm and ≤2.0 degrees, established in previous 510(k) submissions for the predicate device, the StealthStation S7 System.
The following table summarizes the quality assurance 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
9
XII. Conclusions
The StealthStation Cranial Software has been shown through testing and comparison to be substantially equivalent to the identified predicate device.