(30 days)
Not Found
No
The summary describes a traditional image-guided surgery system for neurosurgical procedures, focusing on tracking instruments relative to anatomical structures using pre-operative or intra-operative images. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or performance studies. The software functionalities are described in terms of standard image guidance features like registration, planning, and tracking.
No
The device aids in locating anatomical structures and tracking surgical instruments, which falls under diagnostic and guidance functions rather than directly treating or preventing a disease.
No
The device is described as an "aid for locating anatomical structures" during neurosurgical procedures, functioning as an "Image Guided System." Its primary purpose is to assist surgeons by tracking instrument positions relative to surgical anatomy, rather than to diagnose medical conditions or interpret clinical signs.
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/software 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 is an "aid for locating anatomical structures in either open or percutaneous neurosurgical procedures." It is used during surgery to guide instruments based on images of the patient's anatomy.
- Device Description: The description explains that it's an "Image Guided System (IGS)" that tracks the position of surgical instruments in relation to the surgical anatomy.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health status, diagnose conditions, or monitor treatment. This device does not perform any such analysis of biological specimens.
The StealthStation System is a surgical navigation system, which is a type of medical device used to assist surgeons during procedures by providing real-time guidance based on pre-operative or intra-operative imaging.
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 v1.3.2 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.
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)
Software verification testing for each requirement specification.
Design verification was performed using the StealthStation™ System with Station™ Cranial Software v1.3.2 in laboratory. The results support the safety of the device and demonstrate that the software should perform as intended in the specified use conditions.
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).
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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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
January 13, 2021
Medtronic Navigation, Inc. Taylor West, MBA Senior Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027
Re: K203639
Trade/Device Name: StealthStation Cranial Software v1.3.2 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: December 11, 2020 Received: December 14, 2020
Dear Taylor West:
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, Ph.D. 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) K203639
Device Name StealthStation Cranial v1.3.2
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 indical 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) | Exempt Activities Part 286 Subpart D On-Site Combustion (40 CFR 98 Subpart C) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------- |
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
11 December 2020
- I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville. Colorado 80027 USA Telephone Number: 720-890-3200
- Contact: Taylor Gold West, MBA (Primary) Senior Regulatory Affairs Specialist Telephone Number: 720.890.2322 Fax Number: 720.890.3500 Email: taylor.c.goldwest@medtronic.com
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 v1.3.2 II.
- III. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- IV. Classification: Class II, Stereotaxic Instrument
- V. Product Codes: HAW
VI. Primary Predicate Device
510(k): K201175 Device name: StealthStation™ Cranial Software v1.3.0 Manufacturer: Medtronic Navigation, Inc.
VII. Product Description
The StealthStation™ Cranial Software v1.3.2 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.
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VIII. Indications for Use
The StealthStation™ System, with Station™ 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
v1.3.2 (Subject Device) | StealthStation™ Cranial Software
v1.3.0 (Primary Predicate, K201175) |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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 | 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 |
| Feature | StealthStation™ Cranial Software
v1.3.2 (Subject Device) | StealthStation™ Cranial Software
v1.3.0 (Primary Predicate, K201175) |
| System Accuracy
Requirements | Identical; no changes made to the
StealthStation™ Cranial Software that
would require System Accuracy testing
for v1.3.2 | Under representative worst-case
configuration, the StealthStation™
System with StealthStation™ Cranial
Software v1.3.0, has demonstrated
performance in 3D positional accuracy
with a mean error $\leq$ 2.0 mm and in
trajectory angle accuracy with a mean
error $\leq$ 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 |
| 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 | PointMerge™ registration (referred to
as Landmark registrations), Tracer™
registration, Touch registration
(previously Touch-N-Go™),
StealthAiR™ registration, O-arm™
registration, Mechanical based
registrations (Stereotactic Localizer
Registration and StarFix™ Bone
Anchor Registration) | PointMerge™ registration (referred to
as Landmark registrations), Tracer™
registration, Touch registration
(previously Touch-N-Go™),
StealthAiR™ registration, O-arm™
registration, Mechanical based
registrations (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 |
| Feature | StealthStation™ Cranial Software
v1.3.2 (Subject Device) | StealthStation™ Cranial Software
v1.3.0 (Primary Predicate, K201175) |
| 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 Elekta Leksell
Nexframe™ Stereotactic System
STarFix™Platform 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
STarFix™Platform System
Stealth Midas Rex MR8
StealthStation Autoguide |
| 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 |
| 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 Tunes: Side, Flat | Manufacturer: Medtronic Navigation, Inc.
Localizer: AxiEM III
Emitter Tunes: Side, Flat |
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6
X. Discussion of Performance Testing
The following table summarizes the testing conducted for the StealthStation™ Cranial Software v1.3.2.
Description
Software verification testing for each requirement specification.
7
Design verification was performed using the StealthStation™ System with Station™ Cranial Software v1.3.2 in laboratory. 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.
XI. Conclusions
The StealthStation™ Cranial Software v1.3.2 has been shown through testing and comparison to be substantially equivalent to the identified predicate device.