STarFix Designer Software C0265

K231141 · FHC, Inc. · QRI · Sep 8, 2023 · Neurology

Device Facts

• Record ID: K231141
• Device Name: STarFix Designer Software C0265
• Applicant: FHC, Inc.
• Product Code: QRI · Neurology
• Decision Date: Sep 8, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for 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.

Device Story

STarFix Designer is image-based neurosurgical planning software for generating patient-specific frames (FHC Platform) for DBS and SEEG procedures. Inputs: CT and MR images. Processing: rigid registration between CT/MR; manual/automatic localizer extraction; 2D/3D visualization of anatomical landmarks (AC, PC, MP); trajectory planning; platform frame modeling. Output: surgical plan data for frame construction. Used in clinical settings by neurosurgeons, neurologists, or neurophysiologists. Software guides user through numbered menus and toolbar-based operations to verify planning elements before platform model generation. Benefits: enables accurate, efficient planning for electrode implantation.

Clinical Evidence

Bench testing only. Software regression testing performed iteratively per IEC 62304. All major software functions verified against predicate device workflows. No clinical data presented.

Technological Characteristics

Image-based planning software; rigid intensity-based registration; 2D/3D volume reconstruction; thresholding; distance/angle measurement tools. Connectivity: data import/export for planning transfer. Software lifecycle management per IEC 62304.

Indications for Use

Indicated for use with commercially available stereotactic systems for neurosurgical procedures requiring accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.

Regulatory Classification

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.

Predicate Devices

• Voxim (K092192)
• WayPoint™ Planning Software (K092192)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) | |
|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| <div> <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# K231141 Page 1 of 7

# 510(K) Summary

1. 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: [phone] Fax: [phone]

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.

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# 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.

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#### 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<br>Section | Feature | Subject Device:<br>STarFix™ Designer | Predicate:<br>Waypoint™ Planner | Predicate:<br>Voxim | |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------|
| Imaging<br>Load images, preview | CT loading | Yes | Yes | Yes, load<br>patient<br>datasets. | |
| | MRI loading | Yes | Yes | Yes, load<br>patient<br>datasets. | |
| Aligning images | Manual pre-align:<br>Align/Rotate | Yes | Yes | Yes | |
| | Automatic<br>Registration | Rigid<br>Registration by<br>Intensity | Rigid Registration<br>by Intensity,<br>Registration<br>by points,<br>Registration<br>by device | Yes,<br>automatic<br>matching,<br>imaging<br>device<br>referential, or<br>frame<br>registrations. | |
| | Incremental<br>registration – use<br>previous<br>registration step as<br>a base for a new<br>registration step | Yes | Yes | No | |
| Viewing Images -2D | Checkerboard, Lens<br>to check accurate<br>alignment | Yes | Same | Yes, shade<br>feature | |
| | Brightness/Contrast | Yes | Same | Yes, grayscale<br>tool. | |
| | Measurement | Yes, distance and<br>angles | Same | Yes, distance,<br>angles,<br>surface | |
| Viewing Images -3D | 3D volume<br>reconstruction | Yes | Yes | Yes | |
| | Thresholding | Yes, lower and<br>upper limit | Yes, lower<br>limit | Yes, lower<br>and upper<br>limit | |
| | Solid/ Slice views | Yes | Yes | Yes, solid and<br>surface cut | |
| | Distance<br>measurement | Yes | Same | Yes | |
| Fiducials<br>Anchor Detection | Automatic Anchor<br>detection | Yes | Same | Yes | |
| | Seed and search<br>(semi-automatic<br>search) | Yes | Same | No | |
| | Manual placement | Yes | Same | Yes | |
| Anatomy | AC, PC, MP manual<br>point placement | Yes | Same | Yes | |
| Point Selection | Display of AC-PC<br>Length | Yes | Yes | Yes | |
| Trajectories<br>Adding trajectories | Editing of trajectory<br>name, entry and<br>target coordinates | Yes | Yes | Yes,<br>trajectory<br>parameter<br>panel | |
| | Mirroring an<br>existing trajectory<br>with respect to the<br>mid-plane | Yes | Same | Yes | |
| | Using templates to<br>add trajectories | Yes | Same | No | |
| | Displaying distance<br>to target | Yes | No | Yes | |
| | Surgeon's eye view<br>(trajectory view) | Yes | Same | Yes | |
| Platform<br>STarFix™ Platform –<br>Unilateral or Bilateral | Select platform<br>model | Yes | Same | Yes | |
| | Automatically sort<br>anchors | Yes | Yes | Yes | |
| | Automatically sort<br>trajectories | Yes | Yes | Yes | |
| | Specifying Platform<br>height | Yes | Same | Yes | |
| | Building the<br>platform | Yes | Same | Yes | |
| Multi-Oblique Platform | Select platform<br>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™

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## 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<br>regression<br>testing | The internally created<br>software regression test<br>protocol is based on the<br>workflow established in the<br>Usability specification of the<br>predicate device. It is<br>performed iteratively at each<br>software release per IEC<br>62304. | All major areas of software<br>functionality were confirmed for the<br>subject device. No remaining bugs<br>had a risk level of greater than<br>Acceptable as defined by risk<br>management plan. |
| | All major and minor software<br>functions were tested<br>iteratively prior to each | Over the course of its life-cycle, the<br>predicate device received similar<br>treatment with respect to bug fixes,<br>bug risk acceptance, software |

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K231141 Page 7 of 7

| release of a new software<br>revision. Additionally, bugs<br>fixed since the previous round<br>of regression testing were<br>assessed for effectiveness and<br>risk. | releases, and regression testing. As<br>such, substantive equivalence is<br>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.