(60 days)
Not Found
Yes
The document explicitly states that "Landmarks (used for pre-registration) are delivered by an AI/ML based model." and "There have been no changes to the AI/ML algorithm."
No.
The device is an image-guided surgery system intended to assist surgeons in planning and achieving trajectories for surgical instruments during cranial stereotactic procedures; it does not directly treat or diagnose a disease.
No
Explanation: The device is an image-guided surgery system described as an "Alignment System Cranial" intended to "plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures." Its indications for use are "biopsy of intracranial lesions, placement of stereoelectroencephalography (SEEG) electrodes and placement of anchor bolts for laser interstitial thermal therapy (LITT)." All these uses involve guiding surgical instruments for treatment or sampling, not diagnosing a condition. While a biopsy sample might be used for diagnosis, the device itself is a tool for obtaining the sample, not for performing the diagnosis.
No
The device description explicitly states that the Alignment System Cranial consists of a "combination of hardware and software" and lists several hardware components including an IGS platform (computer unit, touch display, infrared tracking camera), active and passive positioning devices (articulated arms), and indication-specific instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Alignment System Cranial is an image-guided surgery system. Its purpose is to assist surgeons in planning and executing surgical trajectories during cranial procedures. It uses optical tracking to guide instruments in relation to patient anatomy based on medical images.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. It interacts with the patient's anatomy and surgical instruments directly or indirectly through imaging and tracking technology.
The device is clearly a surgical navigation and guidance system, which falls under the category of medical devices used during surgical procedures, not for in vitro diagnostic testing of biological samples.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device; PCCP is listed as "Not Found" in the relevant section.
Intended Use / Indications for Use
Alignment System Cranial is intended to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures.
The indications for use are biopsy of intracranial lesions, placement of stereoelectroencephalography (SEEG) electrodes and placement of anchor bolts for laser interstitial thermal therapy (LITT).
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The subject device Alignment System Cranial is an image guided surgery system intended to support the surgeon to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures using optical tracking technology.
For this purpose, the Alignment System Cranial consists of a combination of hardware and software. The Alignment Software Cranial with LITT 2.1 is installed on an Image Guided Surgery (IGS) platform (Curve, Curve Navigation 17700, Kick 2 Navigation Station or Buzz Navigation) consisting of a computer unit, a touch display and an infrared tracking camera. During surgery, the software tracks the position of instruments in relation to the patient anatomy and identifies this position on pre- or intraoperative images. The position of the surgical instruments is continuously updated on these images by optical tracking. This position information is used by the software to align either passive or active positioning devices to a planned trajectory for subsequent surgical steps.
The Alignment System Cranial has different configurations of hardware devices depending on which positioning device is used and which indication is performed. The Alignment Software Cranial with LITT 2.1 supports the active positioning devices Surgical Base System 1.4 and Cirq Arm System 2.0 (+ Cirq Robotic Alignment Module + Cirq Robotic Disposable Kinematic Unit) as well as the passive positioning device VarioGuide. Both types of positioning devices consist of articulated arms with different joints where additional devices and surgical instruments can be attached to for further manual or robotic alignment to a defined trajectory.
In addition, the subject device offers a set of indication specific instruments to support biopsy, sEEG and LITT procedures. This instrumentation consists of instrument holders, tracking arrays, guide tubes, reduction tube, bone anchors, drill bits and depth stops. None of the instruments is delivered sterile. All patient contacting materials consist of different alloys of stainless steel.
The Alignment Software Cranial with LITT has the following accessories:
- Automatic Registration providing an automatic registration for subsequent use.
- Automatic Registration iMRI providing an automatic image registration for intraoperatively . acquired MR images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Yes - Surface matching: Landmarks (used for pre-registration) are delivered by an AI/ML based model.
There have been no changes to the AI/ML algorithm.
Input Imaging Modality
Not Found
Anatomical Site
Cranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Neurosurgeons / Hospital operating room
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 Verification and Validation Testing:
Documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Device Software Functions". These include successful implementation of product specifications, incremental testing for different release candidates, testing of risk control measures, compatibility testing or cybersecurity tests.
Usability Evaluation:
Formative usability was carried out according to the standard IEC 62366-1 "Medical devices – Part 1: Application of usability engineering to medical devices" in a simulated clinical environment to validate the LITT workflow with the Cirq Arm System positioning device. This covered aspects such as the quidance provided by the software, the assembly of the arm, handling of different instruments, etc. with focus on the main differences implemented for LITT. The results confirmed that the LITT workflow is comparable in terms of user interaction to the biopsy and SEEG workflows, already present in the secondary predicate.
System accuracy testing:
Study type: Positional and angular navigation accuracy testing.
N of registrations: 6
Total N of samples: 37 (Positional and Angular)
Results:
- Mean Positional Error: 1.19 mm (SD: 0.50 mm, 95th perc: 1.83 mm, 99th perc: 1.90 mm, 99% upper CI: 1.40 mm)
- Mean Angular Error: 0.86 degrees (SD: 0.39 degrees, 95th perc: 1.52 degrees, 99th perc: 1.57 degrees, 99% upper CI: 1.03 degrees)
Key results: The acceptance criteria were fulfilled: Mean Positional Error of the placed instrument's tip
§ 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
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January 28, 2025
Brainlab AG Esther Moreno Garcia Manager Regulatory Affairs Olof-Palme Str.9 Munich, 81829 Germany
Re: K243698
Trade/Device Name: Alignment System Cranial, with Alignment Software Cranial with LITT; Circ Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG: VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: November 29, 2024 Received: November 29, 2024
Dear Esther Moreno Garcia:
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 (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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Digitally signed Adam D. by Adam D. Pierce -S Pierce -S Date: 2025.01.28 17:39:20 -05'00' 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
3
Indications for Use
510(k) Number (if known) K243698
Device Name
Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG;
Indications for Use (Describe)
Alignment System Cranial is intended to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures.
The indications for use are biopsy of intracranial lesions, placement of stereoelectroencephalography (SEEG) electrodes and placement of anchor bolts for laser interstitial thermal therapy (LITT).
| 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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4
510(k) Summary
January 28th, 2025
| General Information | |
|---|---|
| Manufacturer | Brainlab AG; Olof-Palme-Str.9, 81829, Munich, Germany |
| Establishment Registration | 8043933 |
| Trade Name | Alignment System Cranial, with Alignment Software Cranial with LITT |
| Cirq Alignment Software Cranial Biopsy | |
| Cirq Alignment Software Cranial sEEG | |
| VarioGuide Alignment Software Cranial | |
| Cirq Alignment Software Cranial LITT | |
| Classification Name | Neurological Stereotaxic Instrument |
| Product Code | HAW |
| Regulation Number | 882.4560 |
| Regulatory Class | Class II |
| Panel | Neurology |
| Predicate Device(s) | Primary Predicate: K191597 Stealth Autoguide System |
| Secondary Predicate: K223864 Alignment System Cranial | |
| Contact Information | |
| Primary Contact | Alternate Contact |
| Esther Moreno Garcia | |
| Manager Regulatory Affairs | |
| Phone: +49 89 99 15 68 0 | |
| Email: regulatory.affairs@brainlab.com | Chiara Cunico |
| Senior Manager Regulatory Affairs | |
| Phone: +49 89 99 15 68 0 | |
| Email: chiara.cunico@brainlab.com |
1. Indication for Use
Alignment System Cranial is intended to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures.
The indications for use are biopsy of intracranial lesions, placement of stereoelectroencephalography (SEEG) electrodes and placement of anchor bolts for laser interstitial thermal therapy (LITT).
2. Device Description
The subject device Alignment System Cranial is an image guided surgery system intended to support the surgeon to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures using optical tracking technology.
5
For this purpose, the Alignment System Cranial consists of a combination of hardware and software. The Alignment Software Cranial with LITT 2.1 is installed on an Image Guided Surgery (IGS) platform (Curve, Curve Navigation 17700, Kick 2 Navigation Station or Buzz Navigation) consisting of a computer unit, a touch display and an infrared tracking camera. During surgery, the software tracks the position of instruments in relation to the patient anatomy and identifies this position on pre- or intraoperative images. The position of the surgical instruments is continuously updated on these images by optical tracking. This position information is used by the software to align either passive or active positioning devices to a planned trajectory for subsequent surgical steps.
The Alignment System Cranial has different configurations of hardware devices depending on which positioning device is used and which indication is performed. The Alignment Software Cranial with LITT 2.1 supports the active positioning devices Surgical Base System 1.4 and Cirq Arm System 2.0 (+ Cirq Robotic Alignment Module + Cirq Robotic Disposable Kinematic Unit) as well as the passive positioning device VarioGuide. Both types of positioning devices consist of articulated arms with different joints where additional devices and surgical instruments can be attached to for further manual or robotic alignment to a defined trajectory.
In addition, the subject device offers a set of indication specific instruments to support biopsy, sEEG and LITT procedures. This instrumentation consists of instrument holders, tracking arrays, guide tubes, reduction tube, bone anchors, drill bits and depth stops. None of the instruments is delivered sterile. All patient contacting materials consist of different alloys of stainless steel.
The Alignment Software Cranial with LITT has the following accessories:
- Automatic Registration providing an automatic registration for subsequent use. ●
- Automatic Registration iMRI providing an automatic image registration for intraoperatively . acquired MR images.
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3. Substantial Equivalence
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Characteristic | Primary Predicate
K191597 | Secondary Predicate K223864 | Subject device |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Stealth Autoguide System is a
positioning and guidance system
intended for the spatial positioning and
orientation of instrument holders or
tool guides to be used by
neurosurgeons to guide standard
neurosurgical instruments, based on a
pre-operative plan and feedback from
an image-guided navigation system
with three-dimensional imaging
software.
The Stealth Autoguide System is a
remotely-operated positioning and
guidance system, indicated for any
neurological condition in which the use
of stereotactic surgery may be
appropriate (for example, stereotactic
biopsy, stereotactic EEG, laser tissue
ablation, etc.). | Alignment System Cranial is intended to
support the surgeon to plan and to
achieve a trajectory with surgical
instruments during cranial stereotactic
procedures.
The indications for use are biopsy of
intracranial lesions and placement of
stereoelectroencephalography
(SEEG) electrodes. | Alignment System Cranial is intended to
plan and to
achieve a trajectory with surgical
instruments during cranial stereotactic
procedures.
The indications for use are
biopsy of intracranial lesions,
placement of
stereoelectroencephalography (SEEG)
electrodes and placement of anchor
bolts for laser interstitial thermal
therapy (LITT).
New indication LITT is equivalent to
primary predicate, biopsy and SEEG are
equivalent to both predicates. |
| Localization technique | Optical markers on tool holder | Infrared tracking camera is recognizing
infrared passive markers
Instrument tracking in relation to the
patients anatomy. | Same as both predicates |
| System accuracy | Under representative worst case
configuration: Mean navigation
accuracy of $\pm$ 2 mm and angular axis
displacement of $\pm$ 2° | Under representative worst case
configuration: Mean navigation
accuracy of $\pm$ 2 mm and angular axis
displacement of $\pm$ 2° | Same as both predicates |
| Operating principle | Preoperative images (StealthStation)
Surgical planning (StealthStation)
Patient registration
Guidance of instruments
Trajectory alignment | Preoperative images
Surgical planning
Patient registration
Guidance of instruments
Trajectory alignment with Cirq Arm
System plus Cirq Robotic Alignment
Module or with the Varioguide | Same as secondary predicate and
similar to primary predicate. |
| Planning software | Compatible with:
S8 Cranial v1.1
Synergy Cranial v.3.1 | Compatible with:
Cranial 3.1
Trajectory Planning 2.5 and 2.6 | Similar to secondary predicate. The
Cranial 3.1 software is no longer
needed as the Subject Device includes a
new component Cranial Instrument
Setup 3.0, providing the features for
instrument handling. |
| Alignment
Instrumentation | Navigated Trajectory Guide
Tool Holders (Drill Guides, Reducing
Tubes)
Height Guides
Tapping Tube | Alignment Guide Tubes
Instrument Holders, Tracking Arrays
Cranial Drill Bits + Depth Stops
Bone Anchors
(for biopsy and sEEG) | Similar to both predicates
Alignment instrumentation is generally
used in all devices with a combination
of holders, guides and tubes. Compared
to secondary predicate,
instrumentation has been extended to
support new LITT indication. |
| Instrument fixation | Special tool holders for different
applications mounted to the Stealth
AutoGuide | With Cirq Arm System: Cirq Robotic
Disposable Kinematic Unit to which the
instrument holder is attached. | Mechanical connection is used in all
devices for instrument fixation.
Identical to secondary predicate. |
| | | With Varioguide: Different Disc sets are
mechanically connected depending on
guiding diameter. | |
| Alignment process | Fine alignment robotically performed
by Autoguide | With Cirq Arm System:
-Rough alignment:
Manual positioning of Cirq Arm System
with Autopilot feature (Alignment
Software) close to final position
-Fine alignment:
Robotic movement of Cirq Robotic
Alignment Module
With Varioguide:
Rough and fine alignment by manual
positioning of VarioGuide along
planned trajectory with Autopilot
feature (Cranial Navigation) | Similar alignment process as Predicate
1 and identical to Predicates 2. |
| Patient Registration | Optical Registration Device (via StealthStation) | Optical registration done with
Registration 3.6.
Methods: Surface matching and
landmark registration
Surface matching: Landmarks (used for
pre-registration) are delivered by an
AI/ML based model. | Same registration methods as in
secondary predicate. There have been
no changes to the AI/ML algorithm. |
| IGS Platforms | StealthStation surgical navigation
platform consisting of computer, touch
monitor and stereotactic camera. | Curve, Curve Navigation, Kick and Buzz
Navigation models are used, consisting
of computer, touch monitor and IR
camera. | Similar to predicates. A new platform
model (Curve Navigation 17700
#17701) was released but with overall
same components and operating
principle. |
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4. Performance Data
The following testing was conducted on the Subject Device to establish substantial equivalence with the predicate devices:
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Device Software Functions". These include successful implementation of product specifications, incremental testing for different release candidates, testing of risk control measures, compatibility testing or cybersecurity tests. The documentation level for this software is enhanced.
Usability Evaluation
Formative usability was carried out according to the standard IEC 62366-1 "Medical devices – Part 1: Application of usability engineering to medical devices" in a simulated clinical environment to validate the LITT workflow with the Cirq Arm System positioning device. This covered aspects such as the quidance provided by the software, the assembly of the arm, handling of different instruments, etc. with focus on the main differences implemented for LITT. The results confirmed that the LITT workflow is comparable in terms of user interaction to the biopsy and SEEG workflows, already present in the secondary predicate.
System accuracy testing
The positional and angular navigation accuracy for placement of anchor bolts in LITT procedures of the Subject Device including the software, the platforms and the instruments was evaluated considering a realistic clinical setup and representative worst case scenarios.
| N of
registrations | Total N
of
samples | Error Type | Mean
Error | SD | 95th perc. | 99th perc | 99%
upper CI |
|-----------------------|--------------------------|-----------------|---------------|------|------------|-----------|-----------------|
| 6 | 37 | Positional [mm] | 1.19 | 0.50 | 1.83 | 1.90 | 1.40 |
| | | Angular [°] | 0.86 | 0.39 | 1.52 | 1.57 | 1.03 |
The above results show the following acceptance criteria are fulfilled:
- Mean Positional Error of the placed instrument's tip ≤ 2 mm
- Mean Anqular Error of the placed instrument's axis ≤ 2º
Therefore, the Subject Device achieves the same accuracy performance as both predicate devices.
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Electrical safety and electromagnetic compatibility (EMC)
Compliance to electrical safety, RFID and EMC was evaluated on the Subject device according to the standards: IEC 60601-1, AIM 7351731 and IEC 60601-1-2. The tests have shown that the subject device performs as intended.
Instruments
- . Biocompatibility assessment acc. ISO 10993-1 considered the materials used in the devices, manufacturing process, processing, bioloqical and chemical test data, and the history of safety and effectiveness of the device materials in contact with the human body.
- . Cleaning, disinfection and sterilization was carried out for instruments and sterilization trays considering the FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".
- Mechanical properties of instruments were assessed by performing life cycle simulations and verification of clearance fits, material fatigue, functionality, etc.
No clinical testing was needed for the Subject Device since optical tracking technology in the scope of image guided surgery for the included indications for use is well established in the market.
5. Conclusion
The comparison of the Subject Device with the predicate devices shows that the Alignment System Cranial, with Alignment Software Cranial with LITT has similar functionality, intended use and technological characteristics as the predicate devices. Based on the comparison to the predicates and the performance testing conducted, the Subject Device is considered substantially equivalent to the predicate devices.