(145 days)
Not Found.
Unknown
The summary mentions "automatic detection of leads in post-operative images" and "automatic and semi-automatic WayPoint anchor detection". While these could potentially be implemented using traditional image processing techniques, the term "automatic detection algorithm" for the anchors could also imply the use of AI/ML. Without further details on the implementation of these "automatic" features, it's not possible to definitively confirm or deny the presence of AI/ML. The lack of mention of training/test sets or performance metrics typically associated with AI/ML models also contributes to the uncertainty.
No
Explanation: This device is a software for planning surgical trajectories and creating coordinates and measurements for surgical intervention. It does not directly provide therapy.
No
Brief Explanation: The "Intended Use" section clearly states that the software is for "pre-, intra- and postoperative image-based planning and review" for neurosurgical procedures. It focuses on planning the "placement of instruments/devices" and identifying their position, not on diagnosing medical conditions. Diagnosis involves identifying the nature of a disease or problem, which is not the function described here.
Yes
The device description explicitly states it is "a software used to plan minimally invasive possible pathways". While it interacts with scanned images and potentially provides output for surgical intervention, the core function and description are centered around the software itself for planning and processing data. There is no mention of accompanying hardware that is part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for pre-, intra-, and postoperative image-based planning and review of neurosurgical procedures. This involves planning surgical trajectories and using imaging data to guide instrument placement within the body.
- Device Description: The device is software used to plan surgical pathways on scanned images and generate coordinates for surgical intervention. It processes and views anatomical images and planning content.
- Lack of IVD Characteristics: An IVD device is intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such analysis on biological specimens.
The device is clearly a surgical planning and navigation software, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
Brainlab Elements Trajectory Planning software is intended for pre-, intra- and postoperative image-based planning and review of either open or minimally invasive neurosurgical procedures. Its use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate for the placement of instruments/devices and where the position of the instrument/device can be identified relative to images of the anatomy.
This includes, but is not limited to, the following cranial procedures (including frame-based stereotaxy and frame alternative-based stereotaxy):
- · Catheter placement
- · Depth electrode placement (SEEG procedures)
- · Lead placement and detection (DBS procedures)
- · Probe placement
- · Cranial biopsies
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
Brainlab Elements Trajectory Planning is a software used to plan minimally invasive possible pathways ('Trajectories') for surgical instruments on scanned images. It is used for the processing and viewing of anatomical images (for example: axial, coronal and sagittal reconstructions, etc.) and corresponding planning contents (for example: co-registrations, seqmentations, fiber tracts created by compatible applications and stored as DICOM data) and the planning of trajectories based on this data. The device is also used for the creation of coordinates and measurements that can be used as input data for surgical intervention (e.g.: stereotactic arc settings or FHC STarFix platform settings). Depending on the workflow and available licenses, Brainlab Elements Trajectory Planning might be used in different roles where only specific application features are available.
The following roles are available for Trajectory Planning:
- · Trajectory (Element): allows the creation of trajectories
- · Stereotaxy (Element): allows the creation of trajectories and supports stereotactic procedures based on Stereotactic Arc Settings or FHC STarFix platform settings
- · Lead Localization (Element): allows the creation of trajectories and automatic detection of leads in post-operative images.
All roles are enabled to be used for cranial trajectory planning procedures after installation of Trajectory as well as the corresponding workflow files for Cranial Planning, Stereotactic Planning or Post-Op Review.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Scanned images, CT data.
Anatomical Site
Cranial
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
The target user group are healthcare professionals educated for the planning and execution of functional neurosurgery procedures. These include neurosurgeons and neurologists.
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)
Verification
Software verification was performed, verifying the software requirements through integration tests, and unit tests. Incremental test strategies have been set up after verification of the first release candidate for changes with limited scope. In this case, an impact analysis of the modifications is performed and tests to be performed are identified and planned correspondingly. That means, not all tests have to be performed but only a subset, as some of the previous tests are not affected by the change and remain therefore valid. Software verification verifies all specifications, including SOUP items and cybersecurity.
Bench Testing
FHC anchor detection: The objective of these validative tests is to verify for Trajectory Planning 2.6, that accuracy and robustness of the automatic and semi-automatic WayPoint anchor detection on CT data for FHC's 4 mm and 5 mm bone anchors are non-inferior to the SW application WayPoint™ Planner Software. The acceptance criteria specified in the test plan regarding the Brainlab automatic and semi-automatic anchor detection algorithm were fullfilled.
Summative Usability Evaluation: Within version 2.6 of Trajectory Planning (Subject Device) the support of STarFix plaforms for DBS procedures including detection of WayPoint bone anchors and platform planning was introduced and thus the whole workflow of planning a STarFix platform in Stereotaxy Element was subject to summative evaluation. In addition, locking of plans and overlay/blending of two fused images sets were added as features as well and were included in the summative evaluation. Additionally, the new interaction with the coordinates (e.g.AC/PC) caused by GUI changes was also evaluated.
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.
(K211544) Brainlab Elements Trajectory Planning (2.5), (K092192) Waypoint Stereotactic System
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 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.
April 19, 2023
Brainlab AG Sadwini Suresh QM Consultant Olof-Palme-Str.9 Munich, BY 81829 Germany
Re: K223552
Trade/Device Name: Brainlab Elements - Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: November 25, 2022 Received: November 25, 2022
Dear Sadwini Suresh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for "Adam D. Pierce -S". The date of the signature is 2023.04.19, and the time is 18:01:44 -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) K223552
Device Name
Brainlab Elements Trajectory Planning (2.6), Elements Lead Localization, Elements Trajectory Planning Cranial
Indications for Use (Describe)
Brainlab Elements Trajectory Planning software is intended for pre-, intra- and postoperative image-based planning and review of either open or minimally invasive neurosurgical procedures. Its use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate for the placement of instruments/devices and where the position of the instrument/device can be identified relative to images of the anatomy.
This includes, but is not limited to, the following cranial procedures (including frame-based stereotaxy and frame alternative-based stereotaxy):
- · Catheter placement
- · Depth electrode placement (SEEG procedures)
- · Lead placement and detection (DBS procedures)
- · Probe placement
- · Cranial biopsies
| 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
K223552 Page 1 of 9
| General Information | |
|---|---|
| Manufacturer | Brainlab AG; Olof-Palme Str.9; 81829, Munich, Germany |
| Establishment Registration | 8043933 |
| Trade Names | Brainlab Elements - Trajectory Planning (2.6) Elements Stereotaxy Elements Lead Localization Elements Trajectory Planning Cranial |
| Classification Name | Neurological Stereotaxic Instrument |
| Product Code | HAW |
| Regulation Number | 882.4560 |
| Regulatory Class | II |
| Panel | Neurology |
| Primary Predicate Device | (K211544) Brainlab Elements Trajectory Planning (2.5) |
| Additional Predicate Device | (K092192) Waypoint Stereotactic System |
| Contact Information | |
| Primary Contact | Sadwini Suresh |
| QM Consultant | |
| Regulatory Affairs | |
| Phone: +49 89 99 15 68 0 | |
| Email: regulatory.affairs@brainlab.com | |
| Alternate Contact | Chiara Cunico |
| Senior Manager Regulatory Affairs | |
| Phone: +49 89 99 15 68 0 | |
| Email: chiara.cunico@brainlab.com |
1. Indications for Use
Brainlab Elements - Trajectory Planning software is intended for pre-, intra- and postoperative image-based planning and review of either open or minimally invasive neurosurgical and neurological procedures.
lts use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate for the placement of instruments/devices and where the position of the instrument/ device can be identified relative to images of the anatomy.
This includes, but is not limited to, the following cranial procedures (including frame-based stereotaxy and frame alternative-based stereotaxy):
- o Catheter placement
- Depth electrode placement (SEEG procedures) o
- Lead placement and detection (DBS procedures) 0
- Probe placement ●
- Cranial biopsies
4
2. Device Description
Brainlab Elements Trajectory Planning is a software used to plan minimally invasive possible pathways (Trajectories') for surgical instruments on scanned images. It is used for the processing and viewing of anatomical images (for example: axial, coronal and sagittal reconstructions, etc.) and corresponding planning contents (for example: co-registrations, seqmentations, fiber tracts created by compatible applications and stored as DICOM data) and the planning of trajectories based on this data. The device is also used for the creation of coordinates and measurements that can be used as input data for surgical intervention (e.g.: stereotactic arc settings or FHC STarFix platform settings). Depending on the workflow and available licenses, Brainlab Elements Trajectory Planning might be used in different roles where only specific application features are available.
The following roles are available for Trajectory Planning:
- · Trajectory (Element): allows the creation of trajectories
· Stereotaxy (Element): allows the creation of trajectories and supports stereotactic procedures based on Stereotactic Arc Settings or FHC STarFix platform settings
· Lead Localization (Element): allows the creation of trajectories and automatic detection of leads in post-operative images.
All roles are enabled to be used for cranial trajectory planning procedures after installation of Trajectory as well as the corresponding workflow files for Cranial Planning, Stereotactic Planning or Post-Op Review.
3. Substantial Equivalence
The Subject Device has similar intended use and technological features as the predicate devices. An overview of the similarities and differences can be found in the tables below:
| Device | Name |
|---|---|
| Primary Predicate Device | (K211544) Brainlab Elements Trajectory Planning (2.5) |
| Additional Predicate device | (K092192) Waypoint Stereotactic System |
5
| Topic/ Feature | Primary Predicate:
(K211544) Brainlab Elements Trajectory
Planning (2.5) | Subject Device (Trajectory Planning 2.6) | Comment |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Brainlab Elements Trajectory Planning
software is intended for pre-, intra- and
postoperative image-based planning and review
of either open or minimally invasive
neurosurgical and neurological procedures.
Its use is indicated for any medical condition in
which the use of stereotactic surgery may be
appropriate for the placement of
instruments/devices and where the position of
the instrument/ device can be identified relative
to images of the anatomy.
This includes, but is not limited to, the following
Cranial procedures (including frame-based
stereotaxy and frame alternative-based
stereotaxy):
- Catheter placement
- Depth electrode placement (SEEG procedures)
- Lead placement and detection (DBS
procedures) - Probe placement
- Cranial biopsies | The Brainlab Elements Trajectory Planning
software is intended for pre-, intra- and
postoperative image-based planning and review
of either open or minimally invasive
neurosurgical and neurological procedures.
Its use is indicated for any medical condition in
which the use of stereotactic surgery may be
appropriate for the placement of
instruments/devices and where the position of
the instrument/ device can be identified relative
to images of the anatomy.
This includes, but is not limited to, the following
Cranial procedures (including frame-based
stereotaxy and frame alternative-based
stereotaxy): - Catheter placement
- Depth electrode placement (SEEG procedures)
- Lead placement and detection (DBS
procedures) - Probe placement
- Cranial biopsies | No Changes compared to the
primary predicate. |
| User Profile | The target user group are healthcare
professionals educated for the planning and | The target user group are healthcare
professionals educated for the planning and | No Changes compared to the
primary predicate. |
| Topic/ Feature | Primary Predicate: | Subject Device (Trajectory Planning 2.6) | Comment |
| | (K211544) Brainlab Elements Trajectory
Planning (2.5) | | |
| | execution of functional neurosurgery procedures.
These include neurosurgeons and neurologists. | execution of functional neurosurgery procedures.
These include neurosurgeons and neurologists. | |
| Hardware
requirements | Trajectory Planning can be used on computer
platforms that fulfill the defined minimum
requirements: - Operating System: Windows 7 64bit SP1
- Minimum 4 logical cores
- Minimum RAM: 6 GB
- Graphics: Direct X compatible
- Display Resolution: 1920 x 1080 (Full HD) | Trajectory Planning can be used on computer
platforms that fulfill the defined minimum
requirements: - Operating System: Windows 7 64bit SP1
- Minimum 4 logical cores
- Minimum RAM: 6 GB
- Graphics: Direct X compatible
- Display Resolution: 1920 x 1080 (Full HD) | No Changes compared to the
primary predicate. |
| View and Adjust | N/A | Adjust Windowing via dedicated windowing
parameter controls and presets | New GUI functionality added
to the Subject Device. Only
additional GUI options are
offered for adjusting the
windowing |
| Measurements | Make Measurements in the selected dataset with
different measurement tools: - Margin Measurement: Create a margin around a
trajectory - Distance Measurement: Measure the distance
between two points | Make Measurements in the selected dataset with
different measurement tools: - Point Measurement: Mark individual points
in the dataset and get additional information
such as the DICOM coordinates of the point,
the grey values of the image dataset at this
point or the AC/PC coordinates of the point - Angle Measurement: Measure the angle
between two lines | Only additional tool options for
measuring points, distances or
angles are offered . |
| Topic/ Feature | Primary Predicate:
(K211544) Brainlab Elements Trajectory
Planning (2.5) | Subject Device (Trajectory Planning 2.6) | Comment |
| Supported Non-
Brainlab
Stereotactic
Hardware | N/A | - Multiline Measurement: Measure the
distance between several points
Inomed SUSy Arc interfacing with Inomed
Titanium or Inomed Open Ceramic Headring | Additional stereotactic arc
system supported with the
subject device. |
| Stereotactic
Platform Support | N/A | FHC STARFIX Stereotactic Platform is supported | Added support of FHC STARFIX
Stereotactic Platforms |
6
7
8
| Topic/ Feature | Additional Predicate: | Subject Device (Trajectory Planning 2.6) | Comment |
|---|---|---|---|
| (K092192) Waypoint Stereotactic System | |||
| Indications for use | The WayPoint Stereotaxic System is intended | ||
| to be used with commercially available | |||
| stereotactic systems for neurosurgical | |||
| procedures which require the accurate | |||
| positioning of microelectrodes, stimulating | |||
| electrodes, implantable electrodes or other | |||
| instruments in the brain or nervous system. | The Brainlab Elements Trajectory Planning | ||
| software is intended for pre-, intra- and | |||
| postoperative image-based planning and | |||
| review of either open or minimally invasive | |||
| neurosurgical and neurological procedures. | |||
| Its use is indicated for any medical condition | |||
| in which the use of stereotactic surgery may | |||
| be appropriate for the placement of | |||
| instruments/devices and where the position of | |||
| the instrument/ device can be identified | |||
| relative to images of the anatomy. | |||
| This includes, but is not limited to, the | |||
| following Cranial procedures (including frame- | |||
| based stereotaxy and frame alternative-based | |||
| stereotaxy): |
- Catheter placement
- Depth electrode placement (SEEG
procedures) - Lead placement and detection (DBS
procedures) - Probe placement | Similar indications for use. |
| Topic/ Feature | Additional Predicate: | Subject Device (Trajectory Planning 2.6) | Comment |
| | (K092192) Waypoint Stereotactic System | | |
| | | - Cranial biopsies | |
| | The application allows the user to configure
and review trajectory planning results to be
realized using FHC STarFix Platforms. These
are patient/case specific frameless
stereotactic platforms manufactured and
delivered by FHC Inc. | The application allows the user to configure
and review trajectory planning results to be
realized using FHC STarFix Platforms. These
are patient/case specific frameless
stereotactic platforms manufactured and
delivered by FHC Inc. | No changes. |
| Anchor Detection | User can detect (FHC WayPoint) anchors on
CT scans that are used as interface to the
patients head (based on stereotactic
registration). | User can detect (FHC WayPoint) anchors on
CT scans that are used as interface to the
patients head (based on stereotactic
registration). | No changes. |
| Stereotactic
Platforms | The following FHC STarFix Stereotactic
Platforms can be used (as selected by the
user): - Four legged Unilateral Platforms
(2h2h) - Four legged Bilateral Platforms
(2h2h, 2b2b) - Three Legged Unilateral Platforms
(Unilateral) - Staged Bilateral Platforms (Epilepsy
Multi-Hub) | The following FHC STarFix Stereotactic
Platforms can be used (as selected by the
user): - Four legged Unilateral Platforms
(2h2h) - Four legged Bilateral Platforms (2h2h,
2b2b) - n/a
- n/a | Minor Difference
- Only four legged stereotactic
positioning platforms are supported
(reducing the number of options) - Provided options are similar
to the predicate. |
| Registration | The following registration constraints are
applied: | The following registration constraints are
applied: | - Supporting only 4 anchors
furthermore prevents wrong
mounting of the platform |
| Topic/ Feature | Additional Predicate:
(K092192) Waypoint Stereotactic System | Subject Device (Trajectory Planning 2.6) | Comment |
| | - One and the same anchor length (4 mm or 5 mm) is supported for the required set of anchors -
3 or 4 anchors are supported -
Anchor detections have to be accepted by the user | - One and the same anchor length (4 mm or 5 mm) is supported for the required set of anchors -
Only 4 anchors are supported -
Anchor detections have to be accepted by the user | Overall functionality is similar to the predicate. |
9
10
K223552
Page 8 of 9
11
4. Performance Data
Verification
Software Verification:
Software verification was performed, verifying the software requirements through integration tests, and unit tests. Incremental test strategies have been set up after verification of the first release candidate for changes with limited scope. In this case, an impact analysis of the modifications is performed and tests to be performed are identified and planned correspondingly. That means, not all tests have to be performed but only a subset, as some of the previous tests are not affected by the change and remain therefore valid. Software verification verifies all specifications, including SOUP items and cybersecurity.
Bench Testing
In addition to the routine verification tests, the following performance tests were carried out for the Subject Device.
FHC anchor detection:
The objective of these validative tests is to verify for Trajectory Planning 2.6, that accuracy and robustness of the automatic and semi-automatic WayPoint anchor detection on CT data for FHC's 4 mm and 5 mm bone anchors are non-inferior to the SW application WayPoint™ Planner Software. The acceptance criteria specified in the test plan regarding the Brainlab automatic and semi-automatic anchor detection algorithm were fullfilled.
Summative Usability Evaluation:
Within version 2.6 of Trajectory Planning (Subject Device) the support of STarFix plaforms for DBS procedures including detection of WayPoint bone anchors and platform planning was introduced and thus the whole workflow of planning a STarFix platform in Stereotaxy Element was subject to summative evaluation. In addition, locking of plans and overlay/blending of two fused images sets were added as features as well and were included in the summative evaluation.
Additionally, the new interaction with the coordinates (e.g.AC/PC) caused by GUI changes was also evaluated.
5. Conclusion
The performed verification and validation activities established that the set requirements were met and that the device performs as intended.
The Subject Devices' comparison with the Predicate Devices establishes that they have similar functionality, intended use and technological characteristics. Therefore, we consider that the Subject Device can be considered substantially equivalent to the predicate device.