(132 days)
Not Mentioned
No
The document describes an image-guided surgical navigation system that tracks instrument position relative to anatomical structures based on pre- or intra-operative images. It does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies. The performance metrics are based on positional and trajectory accuracy, typical for navigation systems, not AI/ML-driven analysis or prediction.
No
The device is an aid for precisely locating anatomical structures during neurosurgical procedures, guiding surgeons, rather than directly treating a medical condition.
No
The device is described as an "aid for precisely locating anatomical structures" and helps "guide surgeons during cranial surgical procedures." It uses image guidance to track instruments in relation to surgical anatomy. This functionality is for guiding intervention, not primarily for diagnosis. While it uses diagnostic images, its purpose is not to diagnose a condition itself.
No
The device description explicitly states that the Synergy 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 that the device is a system that includes hardware components, not just software.
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 precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. This describes a device used during a surgical procedure on a patient, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description reinforces this by explaining how the system helps guide surgeons during cranial surgical procedures by tracking instrument position in relation to the surgical anatomy and displaying it on images.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The system relies on imaging data of the patient's anatomy.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to provide surgical guidance based on imaging, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
The StealthStation System, with Synergy® Cranial software, is intended as an aid for 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:
- Cranial Biopsies
- Tumor Resections
- Craniotomies/Craniectomies
- Skull Base Procedures
- Transsphenoidal Procedures
- Thalamotomies/Pallidotomies
- Pituitary Tumor Removal
- CSF Leak Repair
- Pediatric Catheter Shunt Placement
- General Catheter Shunt Placement
Product codes
HAW
Device Description
The StealthStation System, with Synergy Cranial v2.2.7 software helps guide surqeons during cranial surgical procedures such as biopsies, tumor resections, and shunt placements. The Synergy Cranial v2.2.7 software works in conjunction with an Image Guided System (IGS) which consists of clinical software, surqical instruments, a referencing system and platform/computer hardware. Image quidance, 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. Synergy Cranial v2.2.7 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Under representative worst-case configuration, the StealthStation® System with Synergy Cranial Software, has demonstrated performance in 3D positional accuracy with a mean error
§ 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 seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract design featuring three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 11, 2015
Medtronic Navigation, Inc. Ms. Kaye E. Waite Senior Regulatory Specialist 826 Coal Creek Circle Louisville, Colorado 80027
Re: K150216
Trade/Device Name: StealthStation System with Synergy Cranial Software Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: May 11, 2015 Received: May 12, 2015
Dear Ms. Waite:
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
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
Sincerely yours,
Carlos L. Pena -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) K150216
Device Name
StealthStation System with Synergy Cranial Software
Indications for Use (Describe)
The StealthStation System, with Synergy® Cranial software, is intended as an aid for 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:
- Cranial Biopsies
- Tumor Resections
- Craniotomies/Craniectomies
- Skull Base Procedures
- Transsphenoidal Procedures
- Thalamotomies/Pallidotomies
- Pituitary Tumor Removal
- CSF Leak Repair
- Pediatric Catheter Shunt Placement
- General Catheter Shunt Placement
| 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
June 10, 2015
- Medtronic Navigation, Inc. l. Company: 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200 Fax Number: 720-890-3500
- Kaye E. Waite Contact: Senior Requlatory Affairs Specialist Telephone Number: 720-890-3200 Fax Number: 720-890-3500
- ll. Proprietary Trade Name: StealthStation System with Synergy Cranial Software
- .............................................................................................................................................................................. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- Classification: Class II, Stereotaxic Instrument IV.
- V. Product Code: HAW
VI. Product Description
The StealthStation System, with Synergy Cranial v2.2.7 software helps guide surqeons during cranial surgical procedures such as biopsies, tumor resections, and shunt placements. The Synergy Cranial v2.2.7 software works in conjunction with an Image Guided System (IGS) which consists of clinical software, surqical instruments, a referencing system and platform/computer hardware. Image quidance, 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. Synergy Cranial v2.2.7 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.
VII. Indications for Use
The StealthStation System, with Synergy Cranial software, is intended as an aid for 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.
4
This can include, but is not limited to, the following cranial procedures:
- Cranial Biopsies
- Tumor Resections
- Craniotomies/Craniectomies
- Skull Base Procedures
- Transsphenoidal Procedures
- Thalamotomies/Pallidotomies
- Pituitary Tumor Removal
- CSF Leak Repair
- Pediatric Catheter Shunt Placement
- General Catheter Shunt Placement
VIII. Summary of the Technological Characteristics
| Item | Subject Device (Synergy Cranial) | Predicate Device (Mach Cranial)
StealthStation System Update -
K050438 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The StealthStation® System, with Synergy®
Cranial software is designed as an aid for
precisely locating anatomical structures in
either open or percutaneous neurosurgical
procedures. | The StealthStation® System is intended as an
aid for precisely locating anatomical structures
in either open or percutaneous procedures. |
| Indications for
Use | The StealthStation System, with Synergy
Cranial software, is intended as an aid for
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:
- Cranial Biopsies
- Tumor Resections
- Craniotomies/Craniectomies
- Skull Base Procedures
- Transsphenoidal Procedures
- Thalamotomies/Pallidotomies
- Pituitary Tumor Removal
- CSF Leak Repair
- Pediatric Catheter Shunt Placement
- General Catheter Shunt Placement | The StealthStation® System is intended as an
aid for precisely locating anatomical structures
in either open or percutaneous procedures.
The StealthStation® System 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, a long bone, or
vertebra, can be identified relative to a CT or
MR based model, fluoroscopy images, or
digitized landmarks of the anatomy.
For the optical-based and EM-based system,
example procedures include, but are not
limited to: - Cranial Biopsies
- Tumor Resections
- Craniotomies/Craniectomies
- Skull Base Procedures
- Transsphenoidal Procedures
- Thalamotomies/Pallidotomies
- Pituitary Tumor Removal
- CSF Leak Repair
- Pediatric Catheter Shunt Placement
- General Catheter Shunt Placement |
| System
Accuracy
Requirement | The System has demonstrated accuracy with | The System has demonstrated accuracy with |
| | a mean positional error of 2mm and mean | a mean positional error of 2mm and mean |
| | trajectory error of 2 degrees | trajectory error of 2 degrees |
5
| Imaging Modalities | X-Ray based,
MR based
Nuclear Medicine based |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Features | Exam-to-Exam Registration
Patient Registration |
| Planning Features | Plan Entry and Target Selection
3D Model Building
Advanced Visualization |
| Medical Device Interfaces | Microscope Navigation: Zeiss, Leica
Ultrasound Navigation: Aloka and Sonosite
Medtronic O-arm |
| View (Display) Features | Ultrasound Video In, Ultrasound Overlay, 3D,
Anatomic Orthogonal, Trajectory 1 and 2,
Target Guidance, 2D 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. |
| Programming Language | C++ |
| Localization Technology | Optical (infra-red)
Electromagnetic |
IX. Identification of Legally Marketing Device (Predicate Device) StealthStation System Update (K050438)
Discussion of the Performance Testing X.
The following table summarizes the testing conducted on the StealthStation System with Synergy Cranial v2.2.7 software:
Description
Under representative worst-case configuration, the StealthStation® System with Synergy 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. This performance was determined using an anatomically representative phantom and utilizing a subset of system components and features that represent the worst-case combination of all potem components. The test configuration included CT images with slice spacing and thickness of 1.0 mm, and T1-weighted MR images with slice spacing and thickness of 1.5 mm.
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:
6
Description
Software Development Life Cycle
Software Risk Assessment
Software Configuration Management and Version Control
Design verification and validation was performed using the StealthStation System with Synerqy Cranial v2.2.7 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..
Clinical testing was not considered necessary prior to release as this is not new technology.
XI. Conclusions
The non-clinical data support the safety of the device and the software verification and validation demonstrate that the StealthStation System with Synergy Cranial v2.2.7 software should perform as intended in the specified use conditions. The non-clinical data demonstrate that the StealthStation System with Synergy Cranial 2.2.7 software performs comparably to the predicate device for the same intended use.