Who is the manufacturer of Sinobot X1?

Sinovation (Beijing) Medical Technology Co., Ltd. filed the 510(k) submission for Sinobot X1 (K220072).

What is the FDA product code for Sinobot X1?

HAW. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Sinobot X1?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Sinobot X1?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Sinobot X1

Q: What are the predicate devices for Sinobot X1?

ROSA ONE Brain application (K200511).

K220072 · Sinovation (Beijing) Medical Technology Co., Ltd. · HAW · Jun 18, 2023 · Neurology

Device Facts

Record ID	K220072
Device Name	Sinobot X1
Applicant	Sinovation (Beijing) Medical Technology Co., Ltd.
Product Code	HAW · Neurology
Decision Date	Jun 18, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2

Intended Use

The Sinobot X1 is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained 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 neurosurgery may be appropriate.

Device Story

Computer-aided, robotized image-guided surgical system for neurosurgery. Inputs: 3D MRI/CT images for pre-operative planning; 3D optical scanner (projector/camera) for patient facial surface registration. Operation: Surgeon performs pre-operative planning on medical images; system provides robotic guidance for instrument holders. Output: Stable, precise, reproducible positioning of surgical instruments (biopsy needle, stimulation/recording electrodes). Used in neurosurgical operating rooms by neurosurgeons. Benefits: Enhanced precision and reproducibility in stereotactic neurosurgical procedures.

Clinical Evidence

Bench testing only. Performance validation included positional accuracy (mean 0.613 mm) and angular accuracy (mean 0.439 degrees). Biocompatibility (ISO 10993), electrical safety (IEC 60601-1), EMD (IEC 60601-1-2), usability (IEC 62366-1), software V&V (IEC 62304), laser safety (IEC 60825-1), sterilization (SAL 10^-6), shelf life (10 years), and transportation (ASTM D4169) testing were successfully completed.

Technological Characteristics

Robotic stand with compact arm and touch screen. 3D optical scanner (projector/visible light camera). Class 2 laser (655nm, 560μW). Connectivity: DICOM compliant. Power: AC. Sterilization: Disposable sterile drapes for robotic arm/screen. Standards: IEC 60601 series, ISO 10993, IEC 62304, IEC 60825-1, ASTM D4169.

Indications for Use

Indicated for neurosurgical procedures requiring stereotactic guidance, including biopsy, stimulation, or recording electrode placement, performed by trained neurosurgeons.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

ROSA ONE Brain application (K200511)

Related Devices

K214065 — ROSA ONE Brain application · Medtech S.A.S · May 4, 2022
K182417 — ROSA ONE Brain Application · Medtech S.A · Feb 7, 2019
K120812 — RENAISSANCE · Mazor Robotics , Ltd. · Jul 12, 2012
K180206 — neuromate Gen III · Renishaw Mayfield Sarl · Apr 24, 2018
K242351 — Zeta Cranial Navigation System (ZNS131-US) · Zeta Surgical, Inc. · Oct 4, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ June 18, 2023 Image /page/0/Picture/1 description: The image shows 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. Sinovation (Beijing) Medical Technology Co., Ltd % Giselle Zhang Regulatory Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746 Re: K220072 Trade/Device Name: Sinobot X1 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: May 15, 2023 Received: May 18, 2023 Dear Giselle Zhang: 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 {1}------------------------------------------------ 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Digitally signed Adam D . by Adam D. Pierce -5 Pierce -S Date: 2023.06.18 10:18:57 -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) K220072 Device Name Sinobot X1 #### Indications for Use (Describe) The Sinobot X1 is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained 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 neurosurgery may be appropriate. Type of Use (Select one or both, as applicable) | <div> <table border="0" style="border-collapse: collapse;"><tbody><tr><td style="border: 1px solid #000000; padding: 2px;"><div> X Prescription Use (Part 21 CFR 801 Subpart D) </div></td></tr></tbody></table> </div> | <div> X Prescription Use (Part 21 CFR 801 Subpart D) </div> | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | <div> X Prescription Use (Part 21 CFR 801 Subpart D) </div> | | | <div> <table border="0" style="border-collapse: collapse;"><tbody><tr><td style="border: 1px solid #000000; padding: 2px;"><div> Over-The-Counter Use (21 CFR 801 Subpart C) </div></td></tr></tbody></table> </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | #### 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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 5. 510(k) Summary The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary: ## 5.1 Submitter Information | Company: | Sinovation (Beijing) Medical Technology Co. Ltd Rm 401, Bld 12-1, No.26 Yongwang West Road, Z- park Daxing, Beijing, Beijing 102600 P.R.China Telephone: Fax: N/A | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Manman Xu RA Specialist xumanman@sinovationmed.com Giselle Zhang Regulatory Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746 USA Telephone: (512) 327-9997 Fax: (512)327-9998 LST.AUS.ProjectManagement@ul.com | | Date Summary Prepared: | June 18, 2023 | | 5.2 Name of the Device | | | Trade/Device Name: | Sinobot X1 | | Common Name: | Stereotaxic Instrument | | Classification Name: | Neurology | | Review Panel: | Neurology (NE) | | Regulation: | 882.4560 | | Class: | Class II | | Product Code: | HAW | ## 5.3 Equivalence Claimed to Predicate Device The Sinovation is equivalent to the ROSA ONE Brain application (K200511), manufactured by Medtech S.A. ## 5.4 Indications for Use Statement The Sinobot X1 is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained neurosurgeons to guide standard neurosurgical instruments {4}------------------------------------------------ (biopsy needle, stimulation or recording electrode). The device is indicated for any neurosurgical procedure in which the use of stereotactic neurosurgery may be appropriate. ## 5.5 Device Description The Sinobot X1 device is a computer-aided, robotized image-guided interactive surgical system. The system integrates medical image processing technology with robotic surgery technology to assist the surgeon during brain surgeries. The system allows the surgeon to utilize the spatial positioning technology to pre-plan the instruments on medical images and provide stable, precise and reproducible guidance in accordance with the planning. The device consists of a robotic stand with a compact robotic arm and a touch screen. The robotic arm can attach to different types of instruments and be changed based on the intended surgical procedures. For different surgical procedures a biopsy needle, stimulation or recording electrode could be attached to the device. The 3D Optical scanner is an optical device combined by a projector and a visible light camera. Which provide a high-resolution point cloud scanning of patients' facial skin surface in order to perform patient registration. ### 5.6 Substantial Equivalence Discussion The following table compares the Sinovation to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device. | Attribute | Sinovation Sinobot X1 | ROSA ONE 3.1.3.2 Brain Application (K200511) | Comparison | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Manufacturer | Sinovation (Beijing) Medical Technology Co., Ltd | Medtech S.A | N/A | | Product Code | HAW | HAW | Same | | Regulation Number | 882.4560 | 882.4560 | Same | | Indications for Use | The Sinobot X1 is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or | The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, recording electrode). The device is | Same | {5}------------------------------------------------ | | device is indicated for any neurosurgical procedure in which the use of stereotactic neurosurgery may be appropriate. | indicated for any neurosurgical procedure in which the use of stereotactic neurosurgery may be appropriate. | | |---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Pre-Operative Planning Intra-Operative Registration Intra-Operative Guidance | Pre & intraoperative images Surgical planning Patient Registration Guidance of instruments | Same | | Mechanism of Action | | | Only the description is different. | | Where Used | Neurosurgical operating room | Neurosurgical operating room | Same | | User | Neurosurgeon | Neurosurgeon | Same | | Anatomical Site | Head | Head | Same | | Images Type | 3D MRI / CT | 3D MRI / CT | Same | | DICOM Compliance | Yes | Yes | Same | | Integrated Planning Software | Stereotactic Planning System Software | ROSANNA BRAIN (Medtech) | Different All software functions and features are similar. | | Trajectory Planning Parameters | Parameters for planning trajectories: entry point, target point, length of the instrument, diameter, name | Parameters for planning trajectories: entry point, target point, length of the instrument, diameter, name, security radius (10mm by default), security aperture (10° by default) | Different | | Trajectory Definition (Endoscopy Module) | No endoscopic 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) | Different The subject device does not contain endoscopic module, the difference of the two devices will not raise concerns related to the safety and effectiveness. | | Save/Load Planning | Yes | Yes | Same | | Patient Registration Methods | Fiducial markers (bone) Optical registration device | Fiducial markers (skin, bone) Optical registration device | Same | {6}------------------------------------------------ | | | Stereotactic frame (fiducials mounted on the frame) | | |---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Fiducial Markers Registration with Pointer Probe | Yes | Yes | Same | | Surface Matching Registration with Optical Distance Sensor | Yes | Yes | Same | | | | | Different | | Laser Class for Optical Registration | Class 2 laser Wavelength - 655nm Maximum Output – 560μW (complies with 21 CFR 1040.10) | Class 2 laser Wavelength - 658 nm Maximum output – 1 mW (complies with 21 CFR 1040.10) | Even though the specifications are different, the subject device passed the standards requirements and is safe to use, hence the difference will not raise concerns in safety and effectiveness. | | Image-Guided | Yes | Yes | Same | | Real Time Display of the Instrument Position | Yes | Yes | Same | | Provide Guidance for Surgical Instruments | Yes | Yes | Same | | Instrument Guide Position Adjustment | Automatic (robotized) | Automatic (robotized) | Same | | Instrument Fixation | Instruments are mounted on robotic arm | Instruments are mounted on robotic arm | Same | | | | | Different | | Instruments | Instrument holder, holder and adaptors, optical sensor | Instrument endoscope holder and adaptors, optical sensor | The instruments of both devices are the same except the endoscopic module, which the subject device does not have. The difference will not affect the use of the device and will not affect | {7}------------------------------------------------ | | | | and raise new risks related to safety and effectiveness of the device. | |-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | device. | | Instrument Calibration Method | Factory calibration | Factory calibration | Same | | Associated Equipment | Navigation Probe (Pointer Probe) Standard Tool Holder (Guider) Microdrive Holder Optical Sensor (Optical Distance Sensor and Optical 3D scanner) Fiducial markers Head holder Frame Registration Plates Frame Adapter Head Holder Adapter | Navigation probe Standard tool holder Endoscope holder Microdrive holder Optical sensor Fiducial markers Head holder Leksell frame registration plates CRW Frame Head Holder Adapter | Different Both the subject device and predicate device shares similar components or associated equipment, only the predicate device contains the endoscopic module, and the difference will not affect the use of the device and will not affect and raise new risks related to safety and effectiveness of the device. | | Patient Immobilization | Yes - The device is attached to the head holder or the frame via an adaptor | Yes - The device is attached to the head holder or the frame via an adaptor | Same | | Device Mobility | Yes - Mobile stands with wheels; Robotic stand immobilized with stabilization feet | Yes - Mobile stands with wheels; Robotic stand immobilized with stabilization feet | Same | | Vigilance System | Yes - foot pedal | Yes - foot pedal | Same | | Sterile | 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 | Same | | Single-Use | No | No | Same | | Ac Powered | Yes | Yes | Same | | Electrical Safety Testing | IEC 60601 Series of Standards | IEC 60601 Series of Standards | Same | {8}------------------------------------------------ ## 5.7 Non-Clinical Performance Data To demonstrate safety and effectiveness of Sinovation and to show substantial equivalence to the predicate device, Sinovation completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The Sinovation passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device: - Risk Assessment of the Biocompatibility per ISO 10993-1 Requirements Met ● - Cytotoxicity testing per ISO 10993-5 Passed ● - Sensitization testing per ISO 10993-10 Passed ● - Electrical safety testing per IEC 60601-1 Passed ● - Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 Passed ● - Usability per IEC 60601-1-6 Demonstrates the usability was considered during design ● - Usability per IEC 62366-1 Demonstrates the usability was considered during design ● - Software verification and validation per IEC 62304/FDA Guidance results ● /conclusion - Safety of Laser Products per IEC 60825-1 Passed ● - Sterilization validation - demonstrates SAL of 10-6 - Shelf Life Testing Supports shelf life of 10 years ● - Transportation Testing per ASTM D4169 Demonstrates package integrity maintained ● Sinovation also conducted the accuracy tests and the data as reported in Table 5.2 below: | Device Performance | Mean | Standard deviation | Confidence interval at 99% confidence level | |---------------------------|-------|-----------------------|------------------------------------------------| | Positional accuracy [mm] | 0.613 | 0.197 | 1.205 | | Angular accuracy [degree] | 0.439 | 0.241 | 1.163 | #### Table 5.2 Accuracy Testing Results ### 5.8 Statement of Substantial Equivalence The Sinobot X1 has the same intended use as the predicate device, and the same or similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Performance testing has demonstrated the Sinobot X1 is as safe and effective as the predicate device. Therefore, the Sinobot X1 is substantially equivalent to the predicate device.