(140 days)
Not Found
No
The description focuses on image processing, registration, and manual/automatic extraction of localizers, but does not mention AI or ML. The "Automatic localizer extraction" feature could potentially use ML, but the description doesn't specify this, and the overall focus is on user-guided planning.
No
This device is a software for planning neurological procedures, specifically deep brain stimulation (DBS) and stereo-electroencephalography (SEEG), not a device that directly administers therapy.
No
The device is described as neurosurgical planning software used for generating patient-specific frames and for surgical planning, including image import, registration, and trajectory planning. It helps in the accurate positioning of instruments but does not perform diagnostic functions like analyzing images to identify diseases or abnormalities.
Yes
The device description explicitly states it is a "software application" and details its features related to image processing, planning, and modeling, without mentioning any accompanying hardware components that are part of the device itself. While it is part of a larger "WayPoint Stereotactic System" and is used with "commercially available stereotactic system," the description of the STarFix Designer Software focuses solely on its software functionalities.
Based on the provided information, the STarFix Designer Software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for planning and guiding neurological procedures that require accurate positioning of instruments in the brain or nervous system. This is a surgical planning and navigation tool, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The software's core features revolve around image processing, registration, trajectory planning, and modeling of patient-specific frames for surgical procedures like DBS and SEEG. These are all related to surgical planning and execution, not in vitro testing.
- Anatomical Site: The device is used for procedures on the brain or nervous system, which is an in vivo application, not an in vitro one.
- Intended User: The intended users are neurosurgeons, neurologists, or clinical neurophysiologists, who are involved in surgical and clinical procedures, not laboratory testing.
IVD devices are typically used in a laboratory setting to analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information. The STarFix Designer Software's function is entirely focused on assisting with surgical procedures performed directly on the patient.
N/A
Intended Use / Indications for Use
The STarFix Designer Software is part of the WayPoint Stereotactic System. The WayPoint Stereotactic System is intended to be used with commercially available stereotactic system for neurological procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.
Product codes (comma separated list FDA assigned to the subject device)
QRI, HAW
Device Description
FHC, Inc. STarFix Designer software is an advanced image-based neurosurgical planning software application designed for generating patient specific frames (FHC, Platform) primarily for Deep Brain Stimulation (DBS) Proedures and stereo-electroencephalography (SEEG) by means of the WayPoint Stereotactic platforms.
The STarFix Designer offers the following core features:
- Image import and registration
- Open and manipulate CT and MR images for surgical planning
- Rigid registration between CT and MR images, with user-selected reference scan of either modality.
- Automatic localizer extraction
- Extract localizers from preoperative CT manually or automatically
- Manually place localizers on MR scans
- Manual refinement of localizer position
- Patient specific 2D and 3D visualization of anatomical landmarks: AC, PC, MP
- Trajectory planning
- DBS STarFix Platform frame modeling
- Multi-Oblique STarFix Platform frame modeling
- Export and import planning data, including images, for transfer on another computer or to be saved for easy reference during the surgery
- Save the plan any time during the planning session
The STarFix Designer provides a modern design, built to ease user interaction, and allow fast and efficient planning for the WayPoint Platforms and ultimately, the implantation of DBS electrodes. With safety as a primary concern, all planning elements need to be verified and marked explicitly before a platform model can be built. The user interface is guiding the necessary planning steps, by using numbered menus and intuitive labeling, along with a minimum of application settings and common actions arranged in the form of a toolbar dedicated to either 2D or 3D operations.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR
Anatomical Site
brain or nervous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
neurosurgeon, neurologist or clinical neurophysiologist
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 regression testing was performed. The internally created software regression test protocol is based on the workflow established in the Usability specification of the predicate device. It is performed iteratively at each software release per IEC 62304. Results: All major areas of software functionality were confirmed for the subject device. No remaining bugs had a risk level of greater than Acceptable as defined by risk management plan. All major and minor software functions were tested iteratively prior to each release of a new software revision. Additionally, bugs fixed since the previous round of regression testing were assessed for effectiveness and risk. Over the course of its life-cycle, the predicate device received similar treatment with respect to bug fixes, bug risk acceptance, software releases, and regression testing. As such, substantive equivalence is established.
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
September 8, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
FHC, Inc. Kelly Moeykens QSO & Quality/Regulatory Manager 1201 Main Street Bowdoin, Maine 04287
Re: K231141
Trade/Device Name: STarFix Designer Software (C0265) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: QRI, HAW Dated: August 9, 2023 Received: August 10, 2023
Dear Kelly Moeykens:
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
1
801); medical device 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 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).
Sincerelv.
Image /page/1/Picture/5 description: The image shows a digital signature. The signature includes the name "Adam D. Pierce - S". The signature indicates that the document was digitally signed on September 8, 2023, at 11:37:42 -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 Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231141
Device Name STarFix Designer Software (C0265)
Indications for Use (Describe)
The STarFix Designer Software is part of the WayPoint Stereotactic System. The WayPoint Stereotactic System is intended to be used with commercially available stereotactic system for neurological procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.
| 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
K231141 Page 1 of 7
510(K) Summary
- Submitter's name, address, telephone number, a contact person, and the date the summary was prepared:
FHC, Inc. 1201 Main Street Bowdoin, ME-04287 Tel: 207-666-5651 Fax: 207-666-8292
Contact: Kelly Moeykens Date: 04/20/2023
2. Name(s) of the Device:
| Proprietary/Trade Name: | STarFix™Designer |
|---|---|
| STarFix™Designer, SFD or C0265 or Stereotaxis | |
| Common Name: | Planning Software |
| Regulation Number | |
| Regulation Name: | Neurological Stereotaxic Instrument |
| Classification Panel | Neurology |
| Product Code: | QRI |
| Regulatory Class: | II |
3. Legally Marked Predicate Device to which the submitter claims substantial equivalence:
The STarFix™Designer is substantially equivalent to FHC, Inc.'s Voxim and WayPoint™ Planning Software, part of the WayPoint™ Stereotactic System (K092192); decision date: February 12™ 2010, product code: HAW
4. Description of device:
FHC, Inc. STarFix™ Designer software is an advanced image-based neurosurgical planning software application designed for generating patient specific frames (FHC, Platform) primarily for Deep Brain Stimulation (DBS) Proedures and stereo-electroencephalography (SEEG) by means of the WayPoint™ Stereotactic platforms.
The STarFix™ Designer offers the following core features:
- Image import and registration
- Open and manipulate CT and MR images for surgical planning
- . Rigid registration between CT and MR images, with user-selected reference scan of either modality.
4
K231141
Page 2 of 7
- Automatic localizer extraction
- Extract localizers from preoperative CT manually or automatically
- I Manually place localizers on MR scans
- Manual refinement of localizer position
- Patient specific 2D and 3D visualization of anatomical landmarks: AC, PC, MP
- Trajectory planning ●
●
- DBS STarFix™ Platform frame modeling ●
- . Multi-Oblique STarFix™ Platform frame modeling
- . Export and import planning data, including images, for transfer on another computer or to be saved for easy reference during the surgery
- Save the plan any time during the planning session
The STarFix™ Designer provides a modern design, built to ease user interaction, and allow fast and efficient planning for the WayPoint™ Platforms and ultimately, the implantation of DBS electrodes. With safety as a primary concern, all planning elements need to be verified and marked explicitly before a platform model can be built. The user interface is guiding the necessary planning steps, by using numbered menus and intuitive labeling, along with a minimum of application settings and common actions arranged in the form of a toolbar dedicated to either 2D or 3D operations.
Image /page/4/Figure/13 description: The image shows a medical imaging interface with multiple views of a brain scan. The interface is divided into sections for imaging, fiducials, anatomy, trajectories, and platform. The brain scans are displayed in 2D and 3D views, with green lines indicating trajectories or points of interest. The display orientation is set to 'Original' with L: 2.75, P: 0.82, and S: -1.93.
Figure 1 : DBS planning session using the bilateral platform.
5
5. Statement of Intended Use:
STarFix™Designer software is intended to be used by a neurosurgeon, neurologist or clinical neurophysiologist to plan and monitor positioning of microelectrodes, stimulating electrodes, or other instruments in specific anatomical structures in brain or nervous system.
Statement of Indications for Use:
The STarFix™Designer is part of the WayPoint™ Stereotactic System. The WayPoint™ Stereotactic System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.
6. Comparison of Technological Characteristics to Predicate Device
The technological characteristics of the STarFix™ Designer are the same as those in the predicate device. There is no new technology, materials or method of manufacture introduced. A summary of similarities in the specifications between the STarFix™ Designer and its predecessor is provided below.
| Component
Section | Feature | Subject Device:
STarFix™ Designer | Predicate:
Waypoint™ Planner | Predicate:
Voxim | |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------|
| Imaging
Load images, preview | CT loading | Yes | Yes | Yes, load
patient
datasets. | |
| | MRI loading | Yes | Yes | Yes, load
patient
datasets. | |
| Aligning images | Manual pre-align:
Align/Rotate | Yes | Yes | Yes | |
| | Automatic
Registration | Rigid
Registration by
Intensity | Rigid Registration
by Intensity,
Registration
by points,
Registration
by device | Yes,
automatic
matching,
imaging
device
referential, or
frame
registrations. | |
| | Incremental
registration – use
previous
registration step as
a base for a new
registration step | Yes | Yes | No | |
| Viewing Images -2D | Checkerboard, Lens
to check accurate
alignment | Yes | Same | Yes, shade
feature | |
| | Brightness/Contrast | Yes | Same | Yes, grayscale
tool. | |
| | Measurement | Yes, distance and
angles | Same | Yes, distance,
angles,
surface | |
| Viewing Images -3D | 3D volume
reconstruction | Yes | Yes | Yes | |
| | Thresholding | Yes, lower and
upper limit | Yes, lower
limit | Yes, lower
and upper
limit | |
| | Solid/ Slice views | Yes | Yes | Yes, solid and
surface cut | |
| | Distance
measurement | Yes | Same | Yes | |
| Fiducials
Anchor Detection | Automatic Anchor
detection | Yes | Same | Yes | |
| | Seed and search
(semi-automatic
search) | Yes | Same | No | |
| | Manual placement | Yes | Same | Yes | |
| Anatomy | AC, PC, MP manual
point placement | Yes | Same | Yes | |
| Point Selection | Display of AC-PC
Length | Yes | Yes | Yes | |
| Trajectories
Adding trajectories | Editing of trajectory
name, entry and
target coordinates | Yes | Yes | Yes,
trajectory
parameter
panel | |
| | Mirroring an
existing trajectory
with respect to the
mid-plane | Yes | Same | Yes | |
| | Using templates to
add trajectories | Yes | Same | No | |
| | Displaying distance
to target | Yes | No | Yes | |
| | Surgeon's eye view
(trajectory view) | Yes | Same | Yes | |
| Platform
STarFix™ Platform –
Unilateral or Bilateral | Select platform
model | Yes | Same | Yes | |
| | Automatically sort
anchors | Yes | Yes | Yes | |
| | Automatically sort
trajectories | Yes | Yes | Yes | |
| | Specifying Platform
height | Yes | Same | Yes | |
| | Building the
platform | Yes | Same | Yes | |
| Multi-Oblique Platform | Select platform
model | Yes | Same | No | |
| | Edit connections | Yes | Yes | No | |
| | | Specifying hub height | Yes | Yes | No |
| | | Building the platform | Yes | Same | No |
| Data Export | Exporting the production file | Edit the patient details and save the file to disk | Yes | Same | Yes |
| | Plan files | Save the current plan to disk | Yes | Yes. | Yes. |
Table 2: Similarities between STarFix™Designer, Waypoint Planner and Voxim microTargeting™
6
7
8
8. Substantial Equivalence statement:
The STarFix™ Designer Software System is substantially equivalent in design, construction, materials, intended use and performance characteristics to its predicative devices, FHC, Inc.'s Voxim and WayPoint™ Planner Planning Software, part of the WayPoint™ Stereotactic System (K092192); decision date: February 12th 2010.
9. Performance Data:
Performance data of the STarFix™Designer Software System is documented in the verification and validation reports. Software regression test results show the system to be the equivalent to the predicate system.
| Test | Test Method Summary | Results |
|---|---|---|
| Software | ||
| regression | ||
| testing | The internally created | |
| software regression test | ||
| protocol is based on the | ||
| workflow established in the | ||
| Usability specification of the | ||
| predicate device. It is | ||
| performed iteratively at each | ||
| software release per IEC |
- | All major areas of software
functionality were confirmed for the
subject device. No remaining bugs
had a risk level of greater than
Acceptable as defined by risk
management plan. |
| | All major and minor software
functions were tested
iteratively prior to each | Over the course of its life-cycle, the
predicate device received similar
treatment with respect to bug fixes,
bug risk acceptance, software |
9
K231141 Page 7 of 7
| release of a new software
revision. Additionally, bugs
fixed since the previous round
of regression testing were
assessed for effectiveness and
risk. | releases, and regression testing. As
such, substantive equivalence is
established. |
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------ |
|---|
10. Conclusion
Based on the non-clinical performance data performed comparing the STarFix™ Designer software to the predicate device (Voxim and WayPoint Planning Software), it is concluded that the subject device is as safe and effective as the predicate device.