(267 days)
Stereotaxic Guiding Surgical Devices, NaoTrac S is intended for the spatial positioning and orientation of instrument holder or instrument tool to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
Stereotaxic Guiding Surgical Devices, NaoTrac S is a robotized platform for the guidance of neurosurgical instruments compatible with the diameter of instrument adaptor provided by Brain Navi Biotechnology Co., Ltd.
Stereotaxic Guiding Surgical Devices, NaoTrac S is composed of a compact robotic arm and display screen mounted on a wheeled trolley. Different types of instruments may be attached to the end of the arm and changed according to the requirements of the procedure to be completed.
The display screen permits to ensure the communication between NaoTrac S and its user by indicating the realizable actions as well as by proposing various commands. NaoTrac S is an aid for locating anatomical structures in either open or percutaneous procedures.
The provided FDA 510(k) Clearance Letter for the Stereotaxic Guiding Surgical Devices, NaoTrac S (K242575) includes details on acceptance criteria and supporting studies.
Here's an analysis of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (NaoTrac S) |
|---|---|
| Positional Error (Euclidean distance) < 2 mm | Mean: 1.13 mm |
| Standard Deviation: 0.38 mm | |
| 99% Confidence Interval: 1.31 mm | |
| Trajectory Angle Error < 2 degrees | Mean: 0.64 degrees |
| Standard Deviation: 0.37 degrees | |
| 99% Confidence Interval: 0.82 degrees | |
| Electrical Safety | Complies with IEC 60601-1 and ANSI AAMI ES 60601-1 |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 |
| Software Verification & Validation | Complies with FDA guidance for Software in Medical Devices and IEC 62304 Standard |
| Cleaning Validation (re-use accessories) | Complies with FDA Guidance, AAMI TIR30, and AAMI TIR12 |
| Sterilization Validation (re-use accessories) | Complies with ISO 17665-1, ISO 17664, ISO 11737-1, ISO 11737-2, and AAMI TIR12 (two cycles) |
| Sterilization Validation (single-use accessories) | Complies with ISO 11137-1 |
| Shelf-life & Packaging (single-use accessories) | Complies with ASTM F1980 and ISO 11607-1 |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "Accuracy Testing" which includes "systematic accuracy," but it does not specify the sample size for this test set (e.g., number of measurements, number of trajectories).
The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of a medical device accuracy test, it is typically conducted in a controlled environment (e.g., lab setting) rather than with patient data.
3. Number of Experts Used and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for the "Accuracy Testing." This type of accuracy evaluation for a stereotaxic device typically relies on metrology (precise measurement instruments and setups) to define the true position and angle, not human expert interpretation.
4. Adjudication Method for the Test Set
Since the ground truth for accuracy testing is established through metrological measurements rather than human interpretation, an adjudication method like 2+1 or 3+1 is not applicable and not mentioned in the document.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi Reader Multi Case (MRMC) comparative effectiveness study was done. The NaoTrac S is a robotic guiding surgical device, not an imaging diagnostic tool that typically involves human reader interpretation for comparative effectiveness studies. The primary evaluation focuses on the device's accuracy in guidance.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)
The "Accuracy Testing" results (Positional Error and Trajectory Angle Error) represent the standalone performance of the NaoTrac S device. These metrics evaluate how accurately the robotic arm positions and orientates instruments without direct human intervention in the final positioning step that is being measured. The device's function is to guide the neurosurgeon, but its intrinsic accuracy is a standalone measure.
7. Type of Ground Truth Used
For the accuracy testing, the ground truth was metrological measurements. The document states that the tests were conducted "according to internally defined methods" for "systematic accuracy," comprising "position accuracy and angular accuracy." This implies the use of highly precise measurement tools and techniques to determine the true position and angle against which the device's performance was compared.
8. Sample Size for the Training Set
The document does not specify a sample size for a training set. The NaoTrac S is a robotic guidance system, and its accuracy is primarily determined by its mechanical design, control algorithms, and calibration, rather than a machine learning model trained on a dataset in the way a diagnostic AI would be. While there are software components, the "Software Verification and Validation" section refers to standard software development lifecycle processes, not specifically to training a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Since a machine learning training set is not explicitly mentioned or implied for the core function of the NaoTrac S in its accuracy evaluation, the method for establishing its ground truth is not applicable and not discussed in the document.
FDA 510(k) Clearance Letter - K242575
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 23, 2025
Brain Navi Biotechnology Co., Ltd.
℅ Feng-Yu Lee
Principal Regulatory Consultant
Elite BioMedical Consulting, Inc.
29122 Rancho Viejo Road, Suite 212
San Juan Capistrano, California 92675
Re: K242575
Trade/Device Name: Stereotaxic Guiding Surgical Devices, NaoTrac S
Regulation Number: 21 CFR 882.4560
Regulation Name: Stereotaxic Instrument
Regulatory Class: Class II
Product Code: HAW
Dated: April 25, 2025
Received: April 25, 2025
Dear Feng-Yu Lee:
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 (the 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.
Page 2
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 (QS) 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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
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,
Adam D. Pierce -S [Digitally signed by Adam D. Pierce -S Date: 2025.05.23 13:23:26 -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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known)
K242575
Device Name
Stereotaxic Guiding Surgical Devices (NaoTrac S)
Indications for Use (Describe)
Stereotaxic Guiding Surgical Devices, NaoTrac S is intended for the spatial positioning and orientation of instrument holder or instrument tool to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
Sec 8-1 (Rev. 2025/5/23)
Brain Navi NaoTrac S
Brain Navi Biotechnology
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K242575
1. Submitter's Identification:
Brain Navi Biotechnology
No. 66-1, Shengyi 5th Rd., Zhubei City, Hsinchu County 302041, Taiwan
Contact Person: Shally Lu
Phone Number: +886-3-6579438
c/o Elite BioMedical Consulting, Inc.
29122 Rancho Viejo Road, Suite 212
San Juan Capistrano, CA 92675 (US Branch)
Contact Person: Feng-Yu Lee
Phone Number: 1-949-218-0929
Fax Number: 1-949-218-0928
Date Summary Prepared: May 23, 2025
2. Name of the Device:
Stereotaxic Guiding Surgical Devices, NaoTrac S
3. Common or Usual Name: Neurological Stereotaxic Instrument
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| HAW; Neurological Stereotaxic Instrument | Class II | 21 CFR 882.4560 | Neurology |
4. Device Description:
Stereotaxic Guiding Surgical Devices, NaoTrac S is a robotized platform for the guidance of neurosurgical instruments compatible with the diameter of instrument adaptor provided by Brain Navi Biotechnology Co., Ltd.
Stereotaxic Guiding Surgical Devices, NaoTrac S is composed of a compact robotic arm and display screen mounted on a wheeled trolley. Different types of instruments may be attached to the end of the arm and changed according to the requirements of the procedure to be completed.
K242575
Page 1 of 7
Page 6
The display screen permits to ensure the communication between NaoTrac S and its user by indicating the realizable actions as well as by proposing various commands. NaoTrac S is an aid for locating anatomical structures in either open or percutaneous procedures.
5. Indications for Use:
Stereotaxic Guiding Surgical Devices, NaoTrac S is intended for the spatial positioning and orientation of instrument holder or instrument tool to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
6. Predicate Device Information:
Stereotaxic Guiding Surgical Devices, NaoTrac S is substantially equivalent to the brand of ROSA ONE Brain Application noted as 6.1.
6.1
Name: ROSA ONE Brain Application
Device Company: Medtech S.A
510(K) Number: K182417
7. Comparison to Predicate Devices:
| Device | ROSA ONE® Brain Application v 3.1 (Predicate Device: K182417) | Stereotaxic Guiding Surgical Devices, NaoTrac S (Subject device) | Comparison Analysis |
|---|---|---|---|
| Device description and indications for use | |||
| General device description | Computer controlled electromechanical arm providing guidance of neurosurgical instruments | Computer controlled electromechanical arm providing guidance of neurosurgical instruments | Identical |
| Indications For Use | The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate. | Stereotaxic Guiding Surgical Devices, NaoTrac S is intended for the spatial positioning and orientation of instrument holder or instrument tool to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate. | Similar with the deletion of with endoscope |
| Where used | Neurosurgical operating room | Neurosurgical operating room | Identical |
| User | Neurosurgeon | Neurosurgeon | Identical |
| Anatomical site | Head | Head | Identical |
Sec 8-2 (Rev. 2025/5/23)
Brain Navi NaoTrac S
K242575
Page 2 of 7
Page 7
| Device | ROSA ONE® Brain Application v 3.1 (Predicate Device: K182417) | Stereotaxic Guiding Surgical Devices, NaoTrac S (Subject device) | Comparison Analysis |
|---|---|---|---|
| Principle of Operation | |||
| - | Pre & intraoperative images- Surgical planning- Patient registration- Guidance of instruments | - Planning- Patient Registration- Surgical operation | Similar operating procedures with different name of the procedures |
| Preoperative images and Surgical planning | |||
| Images type | 3D MRI / CT | 3D MRI / CT | Identical |
| DICOM compliance | Yes | Yes | Identical |
| Merge images (multimodality image fusion capability) | Yes | No | Different, but not affect safety and effectiveness |
| Integrated planning software | ROSANNA BRAIN (Medtech) | NaoTrac S Software (Brain Navi) | Different software |
| Define regions of interest (ROI) | Yes | No | Different, but not affect safety and effectiveness |
| Trajectory planning parameters | Entry point, target point, length of the instrument, diameter, name, color | Entry point, target point, length of the trajectory, diameter, name, color. | Identical |
| Trajectory definition (Endoscopy module) | Parameters for planning trajectories: entry point, target point, length of the instrument, diameter, name, security radius (10mm by default), security aperture (10° by default) | No | Different, but not affect safety and effectiveness |
| Save/load planning | Yes | Yes | Identical |
| Patient registration | |||
| Localization means | Robotic Arm absolute encoders | Robotic Arm absolute encoders | Identical |
| Controller | Axis controller for each joint Kinematic transformation between the Cartesian space and joint space Supervisor module | Axis controller for each joint Kinematic transformation between the Cartesian space and joint space Supervisor module | Identical |
| Head holder | - Required (MAYFIELD/DORO head holder is recommended).- The robotic stand is rigidly secured to the head holder or to the stereotactic frame, providing a fixed reference between the registration phase and the surgical phase to avoid any mechanical movement. | - Required (MAYFIELD /DORO head holder is recommended).- The Moving Detector, which includes Tag S, Tag Support Arm, and IR Module, can detect the movement of a patient.- The IR Module fixed in the trolley- Tag S, Tag Support Arm are secured on the head holder. | Different Detect patient movement without fixed secured |
| Patient immobilization | Yes - The device is attached to the head holder or the frame via an adaptor. | - Required (MAYFIELD /DORO head holder is recommended).- The Moving Detector, which includes Tag S, Tag Support Arm, and IR Module, can detect the movement of a patient.- The IR Module fixed in the Trolley | Different Detect patient movement without fixed secured |
Sec 8-3 (Rev. 2025/5/23)
Brain Navi NaoTrac S
K242575
Page 3 of 7
Page 8
| Device | ROSA ONE® Brain Application v 3.1 (Predicate Device: K182417) | Stereotaxic Guiding Surgical Devices, NaoTrac S (Subject device) | Comparison Analysis |
|---|---|---|---|
| Patient Registration methods | - Fiducial makers (skin or bone)- Optical registration device- Stereotactic frame (fiducials mounted on the frame)- Surface Matching (Optical registration device) | - Surface Matching (Optical registration device) | Different in registration algorithm |
| Fiducial markers registration with pointer probe | Yes | No | Different in registration algorithm |
| Surface matching registration with optical distance sensor | Yes | Yes | Similar method, but with different registration procedures |
| Laser class for optical registration | Class 2 laser Wavelength – 658 nm, Maximum output – 1mW (complies with 21 CFR 1040.10) | Blue LED light, Wavelength 465nm | Different in optical source |
| Cooperative movement | Yes | Yes | Identical |
| Accuracy verification on anatomical landmarks | Yes | Yes | Identical |
| Guidance of instruments | |||
| Instrument fixation | Instruments are mounted onto robotic arm's flange | Instruments are mounted onto Insulator | Different mounted part but still on robotic arm's flange |
| Instrument Calibration Method | Factory calibration | Factory calibration | Identical |
| Instruments | Instrument holder, endoscope holder and adaptors, optical sensor | Instrument Holder S, Instrument Adaptor, Catheter Adaptor, SEEG Adaptor, Reference Stylus | Different, but not affect safety and effectiveness |
| Image-guided | Yes | Yes | Identical |
| Real time display of the instrument position | Yes | Yes | Identical |
| Provide guidance for surgical instruments | Yes | Yes | Identical |
| Instrument guide position adjustment | Automatic (robotized) | Automatic (robotized) | Identical |
| Surgeon carries out final gesture through the instrument guide with traditional surgical instrument | Yes—through the instrument guide | Yes—through the instrument guide | Identical |
| Associated equipment | - Pointer probe- Standard tool holder | - Instrument Holder S Set■ Instrument Holder S | Different, but not affect |
Sec 8-4 (Rev. 2025/5/23)
Brain Navi NaoTrac S
K242575
Page 4 of 7
Page 9
| Device | ROSA ONE® Brain Application v 3.1 (Predicate Device: K182417) | Stereotaxic Guiding Surgical Devices, NaoTrac S (Subject device) | Comparison Analysis |
|---|---|---|---|
| - Endoscope holder- Microdrive holder- Optical sensor- Fiducial markers- Head holder- Leksell frame registration plates- CRW Frame | ■ Thumb Screw of Instrument Holder■ Set Screw of Instrument Holder■ Instrument Adaptor■ Catheter Adaptor■ SEEG Adaptor■ Pin Screw of Instrument Adaptor- Reference Stylus- Moving Detector■ Tag S■ Tag Support Arm■ IR module*- Foot Controller- USB Mouse- Surgical Equipment Drape■ Display Screen Drape■ Robotic Arm Drape■ Tape- Instrument Registration Platform Cover(PET) | safety and effectiveness. *Since the IR Module is fixed on the Trolley, only Tag S and Tag Support Arm need to be packaged. | |
| Specifications | |||
| Energy Source | - 220-240 Vac, 50/60Hz, 4 A (for Europe)- 115 Vac, 50/60Hz, 6 A (for USA/Canada)- 100 Vac, 50/60Hz, 8 A (for Japan) | - 100-120 Vac, 50/60Hz, 6A- 220-240 Vac, 50/60Hz, 3A | Different, but not affect safety and effectiveness |
| Operation environmental conditions | - Temperature range of + 10°C to + 35°C- Humidity range of 8% to 93% (without condensation)- Atmospheric pressure range of 800 hPa to 1060 hPa | - Ambient temperature range of + 10°C to + 40°C- Relative humidity range of 30% to 85%- Atmospheric pressure range of 800 hPa to 1013 hPa | Different, but not affect safety and effectiveness |
| Transport and storage environmental conditions | - Temperature range of -5°C to + 50°C- Humidity range of 8% to 93% (without condensation)- Atmospheric pressure range of 800 hPa to 1060 hPa | - Ambient temperature range of 0°C to + 60°C;- Relative humidity range of 30% to 85%, including condensation; | Different, but not affect safety and effectiveness |
| Device dimensions | - 121 cm (L) x 65 cm (W) x 102 cm (H)- 121 cm (L) x 65 cm (W) x 150 cm (H) (Include robotic arm) | - 112 cm (L) x 65 cm (W) x 110 cm (H)- 112 cm (L) x 65 cm (W) x 215 cm (H) (Include robotic arm) | Different, but not affect safety and effectiveness |
| Main Components | Robotic Stand:- 6-axis robotic arm- The touchscreen for operating the device- The immobilization system- The vigilance device- The computer and software | Trolley:- 6 axis robotic arm- Computer and software- Display Screen- Face Camera- Moving Detector- Instrument Registration Platform- Foot Pedal- Jack system | Different, but not affect safety and effectiveness |
Sec 8-5 (Rev. 2025/5/23)
Brain Navi NaoTrac S
K242575
Page 5 of 7
Page 10
| Device | ROSA ONE® Brain Application v 3.1 (Predicate Device: K182417) | Stereotaxic Guiding Surgical Devices, NaoTrac S (Subject device) | Comparison Analysis |
|---|---|---|---|
| - Endoscope holder- Microdrive holder- Optical sensor- Fiducial markers- Head holder- Leksell frame registration plates- CRW Frame | ■ Thumb Screw of Instrument Holder■ Set Screw of Instrument Holder■ Instrument Adaptor■ Catheter Adaptor■ SEEG Adaptor■ Pin Screw of Instrument Adaptor- Reference Stylus- Moving Detector■ Tag S■ Tag Support Arm■ IR module*- Foot Controller- USB Mouse- Surgical Equipment Drape■ Display Screen Drape■ Robotic Arm Drape■ Tape- Instrument Registration Platform Cover(PET) | safety and effectiveness. *Since the IR Module is fixed on the Trolley, only Tag S and Tag Support Arm need to be packaged. | |
| Specifications | |||
| Energy Source | - 220-240 Vac, 50/60Hz, 4 A (for Europe)- 115 Vac, 50/60Hz, 6 A (for USA/Canada)- 100 Vac, 50/60Hz, 8 A (for Japan) | - 100-120 Vac, 50/60Hz, 6A- 220-240 Vac, 50/60Hz, 3A | Different, but not affect safety and effectiveness |
| Operation environmental conditions | - Temperature range of + 10°C to + 35°C- Humidity range of 8% to 93% (without condensation)- Atmospheric pressure range of 800 hPa to 1060 hPa | - Ambient temperature range of + 10°C to + 40°C- Relative humidity range of 30% to 85%- Atmospheric pressure range of 800 hPa to 1013 hPa | Different, but not affect safety and effectiveness |
| Transport and storage environmental conditions | - Temperature range of -5°C to + 50°C- Humidity range of 8% to 93% (without condensation)- Atmospheric pressure range of 800 hPa to 1060 hPa | - Ambient temperature range of 0°C to + 60°C;- Relative humidity range of 30% to 85%, including condensation; | Different, but not affect safety and effectiveness |
| Device dimensions | - 121 cm (L) x 65 cm (W) x 102 cm (H)- 121 cm (L) x 65 cm (W) x 150 cm (H) (Include robotic arm) | - 112 cm (L) x 65 cm (W) x 110 cm (H)- 112 cm (L) x 65 cm (W) x 215 cm (H) (Include robotic arm) | Different, but not affect safety and effectiveness |
| Main Components | Robotic Stand:- 6-axis robotic arm- The touchscreen for operating the device- The immobilization system- The vigilance device- The computer and software | Trolley:- 6 axis robotic arm- Computer and software- Display Screen- Face Camera- Moving Detector- Instrument Registration Platform- Foot Pedal- Jack system | Different, but not affect safety and effectiveness |
| Robotized arm | - Degree of freedom:6 rotating joints; absolute encoders- Payload:3.7kg- Reach range:920 mm- Pose repeatability: ±0.03 mm | - Degree of freedom:6 rotating joints; absolute encoders- Payload:5.0kg- Reach range:850 mm- Pose repeatability: ±0.1 mm | Different, but not affect safety and effectiveness |
| Device mobility | Yes - Mobile stand with wheels, immobilized with 4 stabilization feet | Yes - Mobile stand with wheels, immobilized with 4 stabilization feet (Jack System) | Identical |
| Sterility | Non-sterile and sterile instruments Disposable sterile drapes for the robotic arm and touch screen | Non-sterile and sterile instruments Disposable sterile drapes for the robotic arm and touch screen | Identical |
| Vigilance system | Yes -foot pedal | Yes -Foot Controller | Identical |
| Software | - ROSANNA v3.1.0- The software provides three major functionalities: Planning, Navigation and Surgery. | - NaoTrac S Software ver.1.1.0- Our software provides three major functionalities: Planning, Navigation and Surgery. | Different, but not affect safety and effectiveness |
| Device performance: application accuracy | - < 2 mm (Euclidean distance) | - < 2 mm (Euclidean distance) | Identical |
| Device performance: Angular error | - < 2 degrees | - < 2 degrees | Identical |
Sec 8-6 (Rev. 2025/5/23)
Brain Navi NaoTrac S
K242575
Page 6 of 7
Page 11
8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:
Accuracy Testing
The accuracy tests include systematic accuracy, tested according to internally defined methods. This test comprises two assessments: position accuracy and angular accuracy.
Overall Accuracy Performance Validation
| Positional Error (mm) | Trajectory Angle Error (degrees) | |||||
|---|---|---|---|---|---|---|
| Mean | Standard Deviation | 99% Confidence Interval | Mean | Standard Deviation | 99% Confidence Interval | |
| NaoTrac S | 1.13 | 0.38 | 1.31 | 0.64 | 0.37 | 0.82 |
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the NaoTrac S. The system complies with the IEC 60601-1 and ANSI AAMI ES 60601-1 standards for safety and the IEC 60601-1-2 for EMC.
Software Verification and Validation
Software tests were conducted to satisfy the requirements of the FDA guidance document for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 Standard (Medical Device Software - Life Cycle Process). The software was considered as a "major" level of concern since a failure of the software could result in serious injury or death to the patient.
Software verification activities were performed during the "Design, coding & testing" and "Verification" phases of software lifecycle. Outputs generated during these phases include:
- Code guidelines
- Unit test reports
- Integration test reports
- System test reports
- Verification test reports
Cleaning and Sterilization Validation for Re-use Accessories
Brain Navi Biotechnology Co., Ltd. conducted a cleaning validation in compliance with the FDA Guidance Document on "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,'", AAMI TIR30, and AAM TIR12 Technical Report. Furthermore, the sterilization validation was executed per ISO 17665-1, ISO 17664, ISO 11737-1, ISO 11737-2, and AAMI TIR12 Technical Report using two cycles.
Sterilization Validation for Single-use Accessories
The sterilization validation of the single-use accessories was conducted in compliance with ISO 11137-1. Moreover, the shelf-life and packaging testing of the accessories was carried out in compliance with the following standards: ASTM F1980 and ISO 11607-1.
9. Discussion of Clinical Tests Performed:
Clinical data were not required to support the safety and effectiveness of NaoTrac S. All validation was performed based on non-clinical performance tests.
10. Conclusions:
Results of performance evaluation of Stereotaxic Guiding Surgical Devices, NaoTrac S demonstrate that the device is substantial equivalence to the predicate device, ROSA ONE Brain Application.
Sec 8-7 (Rev. 2025/5/23)
Brain Navi NaoTrac S
K242575
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§ 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).