(99 days)
Not Found
No
The summary describes an image-guided surgery system that uses electromagnetic tracking and pre-operative imaging for navigation. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The functionality described is based on traditional image processing and tracking techniques.
No
The device is an aid for precisely locating anatomical structures during ENT procedures, providing guidance for the surgeon but not directly treating a medical condition itself.
No
The device is described as a surgical guidance platform intended to aid in precisely locating anatomical structures during ENT procedures. While it uses images and provides positional information, its primary function is not to diagnose medical conditions but to guide surgeons during interventions.
No
The device description explicitly states that the StealthStation™ System is an Image Guided System (IGS) comprised of a platform (StealthStation FlexENT™ or StealthStation™ S8), clinical software, surgical instruments, and a referencing system (which includes patient and instrument trackers). This indicates it is a system with both hardware and software components, not software-only. Furthermore, the performance studies include "Hardware Verification testing".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The StealthStation FlexENT™ System is an Image Guided System (IGS) used during surgical procedures to help surgeons precisely locate anatomical structures based on pre-operative or intra-operative images. It tracks the position of instruments relative to the patient's anatomy.
- Intended Use: The intended use clearly states it's an "aid for precisely locating anatomical structures in either open or percutaneous ENT procedures." It does not involve the analysis of specimens taken from the body.
The device is a surgical navigation system, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The StealthStation FlexENT™ System, with the StealthStation™ ENT Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT 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 procedures:
- Functional Endoscopic Sinus Surgery (FESS)
- Endoscopic Skull Base procedures
- Lateral Skull Base procedures
The Medtronic SteathStation FlexENT™ computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT 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.
Product codes (comma separated list FDA assigned to the subject device)
PGW
Device Description
The StealthStation FlexENT™ is an electromagnetic based surgical guidance platform that supports use of special application software (StealthStation™ S8 ENT Software 1.3 and associated instruments.
The StealthStation™ S8 ENT Software 1.3 helps guide surgeons during ENT procedures such as functional endoscopic sinus surgery (FESS), endoscopic skull base procedures, and lateral skull base procedures. StealthStation™ S8 ENT Software 1.3 functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.
Patient images can be displayed by the StealthStation™ S8 ENT Software 1.3 from a variety of perspectives (axial, sagittal, coronal, oblique) and 3dimensional (3D) renderings of anatomical structures can also be displayed. During navigation, the system identifies the tip location and traiectory of the tracked instrument on images and models the user has selected to display. The surgeon may also create and store one or more surgical plan trajectories before surgery and simulate progression along these trajectories. During surgery, the software can display how the actual instrument tip position and trajectory relate to the plan, helping to guide the surgeon along the planned trajectory. While the surgeon's judgment remains the ultimate authority, realtime positional information obtained through the StealthStation™ System can serve to validate this judgment as well as guide. The StealthStation™ S8 ENT v1.3 Software can be run on both the StealthStation FlexENT™ and StealthStation™ S8 Platforms.
The StealthStation™ System is an Image Guided System (IGS), comprised of a platform (StealthStation FlexENT™ or StealthStation™ S8), clinical software, surgical instruments, and a referencing system (which includes patient and instrument trackers). The IGS tracks the position of instruments in relation to the surgical anatomy, known as localization, and then identifies this position on preoperative or intraoperative images of a patient.
Mentions image processing
Patient images can be displayed by the StealthStation™ S8 ENT Software 1.3 from a variety of perspectives (axial, sagittal, coronal, oblique) and 3dimensional (3D) renderings of anatomical structures can also be displayed.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray based, MR based, Nuclear Medicine based
Anatomical Site
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)
Study Type: Bench testing
Sample Size: Not specified
Key Results:
Under representative worst-case configuration, the StealthStation FlexENT™ and S8 Systems with StealthStation™ S8 ENT v1.3 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
Results of Software running on StealthStation FlexENT™:
Positional Error – 0.93mm
Trajectory Error – 0.55°
Results of Software running on StealthStation™ S8:
Positional Error – 1.04mm
Trajectory Error – 1.31°
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.
Study Type: Electrical Emissions and Immunity testing
Key Results: Confirmed that the StealthStation FlexENT™ platform conforms to AAMI/ANSI ES 60601-1:2012 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, MOD).
Study Type: Electrical, Mechanical, Thermal Safety testing
Key Results: Confirmed that the StealthStation FlexENT™ platform conforms to IEC 60601-1-2:2014 - Medical Electrical Equipment - Part 1-2: General requirements for safety; Electromagnetic Compatibility - Requirements and Tests.
Study Type: Software Verification and Validation testing
Key Results: Verified the operating system software requirements are met and software performs as intended. Integration tests are executed as part of development tasks for every code change. These tests are executed and must pass prior to merging into the production code branch for formal testing. Verification & validation tests are then executed, and evidence of final passing execution is documented in the Verification & Validation Plan-Summary.
Study Type: Hardware Verification testing
Key Results: Ensured the hardware requirements identified for the system are met and hardware performs as intended.
Study Type: Human Factors and Usability Engineering testing
Key Results: The StealthStation FlexENT™ platform and product labeling was tested for the intended user profiles, uses, and use environments in accordance to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices" demonstrating that the usability and human factors requirements were adequately met. The StealthStation FlexENT has been found to be adequately safe and effective for the intended users, uses and use environments.
Bench testing has shown that as navigation devices, the subject devices are as functional as the predicate. As such, there are no different questions of safety and effectiveness.
Clinical testing was not considered necessary prior to release as this is not new technology.
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 26, 2020
Medtronic Navigation Inc. Carey Brenner Sr. Regulatory Affairs Specialist 826 Coal Creek Circle Louisville. Colorado 80027
Re: K200723
Trade/Device Name: StealthStation S8 ENT Software 1.3, StealthStation FlexENT Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: March 18, 2020 Received: March 19, 2020
Dear Carey Brenner:
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, 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
1
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for 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 (QS) 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 (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,
for Michael J. Ryan Director DHT1C: Division of ENT. Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200723
Device Name StealthStation™ S8 ENT Software 1.3
Indications for Use (Describe)
The StealthStation FlexENT™ System, with the StealthStation™ ENT Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT 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 procedures:
- · Functional Endoscopic Sinus Surgery (FESS)
- · Endoscopic Skull Base procedures
- · Lateral Skull Base procedures
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K200723
Device Name StealthStation FlexENT™
Indications for Use (Describe)
The Medtronic SteathStation FlexENT™ computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT 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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
l. Company Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200 Fax Number: 720-890-3500
Contact
Carev Brenner Senior Regulatory Affairs Specialist 720-352-1146 carey.j.brenner@medtronic.com
K. Elizabeth Waite Requlatory Affairs Manager 720-890-2182 elizabeth.waite@medtronic.com
- II. Proprietary Trade Name: StealthStation™ S8 ENT Software 1.3 StealthStation FlexENT™
- III. Common Name: Stereotaxic Instrument
- IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- V. Classification: Class II (21 CFR 882.4560)
- VI. Product Code: PGW
VII. Product Description
The StealthStation FlexENT™ is an electromagnetic based surgical guidance platform that supports use of special application software (StealthStation™ S8 ENT Software 1.3 and associated instruments.
The StealthStation™ S8 ENT Software 1.3 helps guide surgeons during ENT procedures such as functional endoscopic sinus surgery (FESS), endoscopic skull base procedures, and lateral skull base procedures. StealthStation™ S8 ENT Software 1.3 functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.
5
Patient images can be displayed by the StealthStation™ S8 ENT Software 1.3 from a variety of perspectives (axial, sagittal, coronal, oblique) and 3dimensional (3D) renderings of anatomical structures can also be displayed. During navigation, the system identifies the tip location and traiectory of the tracked instrument on images and models the user has selected to display. The surgeon may also create and store one or more surgical plan trajectories before surgery and simulate progression along these trajectories. During surgery, the software can display how the actual instrument tip position and trajectory relate to the plan, helping to guide the surgeon along the planned trajectory. While the surgeon's judgment remains the ultimate authority, realtime positional information obtained through the StealthStation™ System can serve to validate this judgment as well as guide. The StealthStation™ S8 ENT v1.3 Software can be run on both the StealthStation FlexENT™ and StealthStation™ S8 Platforms.
The StealthStation™ System is an Image Guided System (IGS), comprised of a platform (StealthStation FlexENT™ or StealthStation™ S8), clinical software, surgical instruments, and a referencing system (which includes patient and instrument trackers). The IGS tracks the position of instruments in relation to the surgical anatomy, known as localization, and then identifies this position on preoperative or intraoperative images of a patient.
VIII. Indications for Use
StealthStation™ S8 ENT Software 1.3
The StealthStation FlexENT™ system with the StealthStation™ ENT software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT 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 procedures:
- Functional Endoscopic Sinus Surgery (FESS) .
- Endoscopic Skull Base procedures .
- . Lateral Skull Base procedures
StealthStation FlexENT™
The StealthStation FlexENT™ computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT 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.
6
- IX. Identification of Legally Marketed Devices (Predicate Devices) Primary Predicate: K170018 - StealthStation™ S8 ENT Software 1.0 Predicate: K153247 - FUSION™ Compact
X. Comparison of the Technological Characteristics
Refer to the tables within this section for a comparison of the technological features of the subject devices compared to the predicate devices. The S8 Software 1.3 has been updated to enable compatibility with the StealthStation FlexENT™ platform. The StealthStation™ S8 ENT software 1.3 running on the StealthStation™ S8 Platforms, including FlexENT™ is equivalent to the predicate devices in technological characteristics and indications for use.
The StealthStation FlexENT™ is a new platform that utilizes the latest Medtronic localization system (AxiEM III). The EM mounting apparatus has been updated from the Fusion™ Compact version in order to be compatible with the Medtronic AxiEM III localization system. The instruments that are compatible with the StealthStation FlexENT™ system are the same Medtronic instruments as those compatible with the Fusion™ Compact. The StealthStation FlexENT™ platform is equivalent to the predicate device in technological characteristics and indications for use.
Bench testing has shown that as navigation devices, the subject devices are as functional as the predicate. As such, there are no different questions of safety and effectiveness.
StealthStation™ S8 ENT Software Version 1.3 as Compared to Primary Predicate Device
| Feature/
Attribute | Subject Device
StealthStation™ S8 ENT
Software v1.3 | Primary Predicate
K170018, StealthStation™ S8
ENT Software v1.0 Running on
StealthStation™ S8 Platform |
|-----------------------|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Classification | Same | Class II |
| Product Code | Same | PGW |
7
| Feature/
| Attribute | Subject Device | Primary Predicate |
|---|---|---|
| StealthStationTM S8 ENT | ||
| Software v1.3 | K170018, StealthStationTM S8 | |
| ENT Software v1.0 Running on | ||
| StealthStationTM S8 Platform | ||
| Intended/ | ||
| Indications for | ||
| Use | StealthStationTM ENT Software | |
| v1.3, Running on StealthStation | ||
| FlexENTTM | ||
| The StealthStation FlexENTTM | ||
| System, with the StealthStationTM | ||
| ENT software, is intended as an | ||
| aid for precisely locating | ||
| anatomical structures in either | ||
| open or percutaneous ENT | ||
| 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 procedures: | ||
| Functional Endoscopic Sinus | ||
| Surgery (FESS)Endoscopic Skull Base | ||
| proceduresLateral Skull Base procedures | ||
| StealthStationTM S8 ENT | ||
| Software v1.3, Running on | ||
| StealthStationTM S8 Platform | ||
| Same | The StealthStationTM S8 | |
| System, with the | ||
| StealthStationTM ENT software, | ||
| is intended as an aid for | ||
| precisely locating anatomical | ||
| structures in either open or | ||
| percutaneous ENT 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 | ||
| procedures: | ||
| Functional Endoscopic | ||
| Sinus Surgery (FESS)Endoscopic Skull Base | ||
| proceduresLateral Skull Base | ||
| procedures | ||
| Feature/ | ||
| Attribute | Subject Device | Primary Predicate |
| StealthStation™ S8 ENT | ||
| Software v1.3 | K170018, StealthStation™ S8 | |
| ENT Software v1.0 Running on | ||
| StealthStation™ S8 Platform | ||
| Accuracy Testing | Under representative worst-case configuration, the StealthStation | |
| FlexENT™ and S8 Systems with | ||
| StealthStation™ S8 ENT v1.3 | ||
| 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 | ||
| Results of Software running on | ||
| StealthStation FlexENT™: | ||
| Positional Error – 0.93mm | ||
| Trajectory Error – 0.55° | ||
| Results of Software running on | ||
| StealthStation™ S8: | ||
| Positional Error – 1.04mm | ||
| Trajectory Error – 1.31° | Under representative | |
| worst-case configuration, the | ||
| StealthStation™ S8 System with | ||
| StealthStation™ ENT v1.0 | ||
| 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. | ||
| Specific Mean Accuracy Values | ||
| Results: | ||
| Positional Error – 0.88mm | ||
| Trajectory Error – 0.73° | ||
| Compatible | ||
| instrumentation | Same | Medtronic instruments tracked |
| via electromagnetic localization | ||
| technology located within the | ||
| instrument and patient trackers. | ||
| Imaging | ||
| Modalities | Same | X-Ray based MR based Nuclear |
| Medicine based | ||
| View (Display) | ||
| Features | Same | 3D, 2D Anatomic Orthogonal |
| (Coronal, Sagittal, Axial), Video | ||
| Input, Virtual Endoscopic, | ||
| Trajectory 1 and 2, Target | ||
| Guidance, Trajectory Guidance, | ||
| Probe's Eye, Look Ahead | ||
| Exam-to-Exam | ||
| Registration | ||
| Features | Same | Identity Merge Registration, |
| Manual Merge Registration and | ||
| Automatic Merge Registration | ||
| Patient | ||
| Registration | ||
| Features | Same | PointMerge® registration, |
| Tracer™ registration, Touch | ||
| registration (previously Touch-n- | ||
| Go™) | ||
| Feature/ | ||
| Attribute | Subject Device | Primary Predicate |
| StealthStation™ S8 ENT | ||
| Software v1.3 | K170018, StealthStation™ S8 | |
| ENT Software v1.0 Running on | ||
| StealthStation™ S8 Platform | ||
| Planning | ||
| Features | Same | Plan Entry and Target Selection, |
| 3D Model Building, Advanced | ||
| Visualization | ||
| Scanner Interface | ||
| Technology (to | ||
| imaging devices) | Same | Network Connectivity |
| CD, DVD, USB | ||
| DICOM Import | ||
| DICOM Export | ||
| Software | ||
| Interface (GUI) | Same | 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 | Same | C++ |
| Compatible | ||
| Platforms | StealthStation™ Platforms | |
| including S8, Planning Station, | ||
| FlexENT™ | StealthStation™ S8 Platforms |
8
9
StealthStation FlexENT™ Platform as compared to Predicate Device
| Item | Subject Device
StealthStation FlexENT™
Platform | Predicate
K153247, FUSION™ Compact
Platform |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Same | Class II |
| Product Code | Same | PGW |
| Item | Subject Device
StealthStation FlexENT™
Platform | Predicate
K153247, FUSION™ Compact
Platform |
| Intended/ Indications
for Use | Same | The Medtronic FUSION™
Compact computer-assisted
surgery system and its
associated applications are
intended as an aid for precisely
locating anatomical structures
in either open or percutaneous
ENT 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. |
| Operating Principle | Electromagnetic | Electromagnetic |
| (Tracking Method)
Electromagnetic | Manufacturer: Same
Localizer: AxiEM III | Manufacturer: Medtronic
Navigation, Inc. |
| Technology | Emitter Types: Side, Flat | Localizer: AxiEM II |
| including
Localization System | | Emitter Types: Side |
| Computer | Same | Intel-Based PC
Computer/Monitor all-in-one,
touch screen technology, video
capture |
| Operating System | Same | Linux-based: Ubuntu |
| Network
Connectivity | Same | Standard Ethernet |
| Instrument Tracking | Same | Receive Coils |
| Instrument ports | 4-coils per port, 6 ports in total | 4-coils per port, 8 ports in total |
| EM Mounting
apparatus | FlexENT Articulating Arm
mounted to FlexENT Cart,
FlexENT Floor Stand, or surgical
bed rail. | Emitter Stand and Emitter
Clamp |
| Compatible
instrumentation | Medtronic instruments tracked
via electromagnetic localization
technology located within the
instrument and patient trackers. | General instruments for ENT
procedures, navigated sinus
dilation instrumentation,
trackers, powered blades,
suctioning devices |
10
11
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 FlexENT™ Platform to establish substantial equivalence of the system and verify that the device will perform as intended meeting all the design inputs. The subject devices met all the performance testing requirements:
- . Electrical Emissions and Immunity 4th edition testing provided confirmation that the StealthStation FlexENT™ platform conforms to AAMI/ANSI ES 60601-1:2012 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, MOD).
- . Electrical, Mechanical, Thermal Safety testing confirmed that the StealthStation FlexENT™ platform conforms to IEC 60601-1-2:2014 -Medical Electrical Equipment - Part 1-2: General requirements for safety; Electromagnetic Compatibility - Requirements and Tests.
- ' Software Verification and Validation testing verified the operating system software requirements are met and software performs as intended
- l Hardware Verification testing ensuring the hardware requirements identified for the system are met and hardware performs as intended
- . The StealthStation FlexENT™ platform and product labeling was tested for the intended user profiles, uses, and use environments in accordance to FDA quidance "Applying Human Factors and Usability Engineering to Medical Devices" demonstrating that the usability and human factors requirements were adequately met. The StealthStation FlexENT has been found to be adequately safe and effective for the intended users, uses and use environments.
For the software, Integration tests are executed as part of development tasks for every code change. These tests are executed and must pass prior to merging into the production code branch for formal testing. Verification & validation tests are then executed, and evidence of final passing execution is documented in the Verification & Validation Plan-Summary
The following table summarizes the testing conducted on the StealthStation FlexENT™ and the StealthStation™ S8 platforms with StealthStation™ ENT v1.3 Software.
Description
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Testing was performed under the representative worst-case configuration, for the StealthStation™ S8 ENT 1.3 Software running on the StealthStation FlexENT™ and the StealthStation™ S8 platforms. Results 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 anatomically representative phantoms and utilizing a subset of system components and features that represent the worst-case combinations of all potential system components. The results show that the update to the StealthStation™ S8 ENT 1.3 Software running on the StealthStation FlexENT™ and the StealthStation™ S8 platforms do not impact overall system accuracy performance.
| | Subject
(StealthStation™ S8 ENT v1.3) | | Predicate
(StealthStation™
S8 ENT v1.0) |
|----------------------------|------------------------------------------|-----------------------|-----------------------------------------------|
| platform | StealthStation
FlexENT™ | StealthStation™
S8 | StealthStation™
S8 |
| | Positional Error (mm) | | |
| Mean | 0.93 | 1.04 | 0.88 |
| Standard
Deviation | 0.47 | 0.51 | 0.48 |
| 99% Confidence
Interval | 2.02 | 2.23 | 2.39 |
| | Trajectory Error (degree) | | |
| Mean | 0.55 | 1.31 | 0.73 |
| Standard
Deviation | 0.29 | 0.44 | 0.45 |
| 99% Confidence
Interval | 1.22 | 2.34 | 2.52 |
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 |
The results of testing support the safety and effectiveness of the StealthStation ENT v1.3 software running on the StealthStation FlexENT and StealthStation S8 platforms and demonstrate that the software should perform as intended in the specified use conditions.
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Bench testing has shown that as navigation devices, the subject devices are as functional as the predicate. As such, there are no different questions of safety and effectiveness.
Clinical testing was not considered necessary prior to release as this is not new technology.
XII. Conclusions
The StealthStation FlexENT™ Platform and StealthStation™ S8 ENT Software v1.3 have been shown through comparison and testing to be substantially equivalent to the identified predicate devices.