(524 days)
Not Found
No
The summary describes image processing and robotic guidance but does not mention AI, ML, or any related concepts like training or test sets for algorithmic performance.
Yes.
The device is intended for "spatial positioning and orientation of instrument holders or tool guides to be used by trained neurosurgeons to guide standard neurosurgical instruments" in "any neurosurgical procedure in which the use of stereotactic neurosurgery may be appropriate," indicating it directly aids in surgical treatment or therapy.
No
The device is described as an image-guided surgical system that assists neurosurgeons in spatial positioning and guidance of instruments during brain surgery, rather than providing a medical diagnosis.
No
The device description explicitly states it consists of a robotic stand with a compact robotic arm, a touch screen, and a 3D Optical scanner, which are hardware components.
Based on the provided information, the Sinobot X1 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. This includes things like blood, urine, tissue samples, etc., to provide information about a person's health status.
- The Sinobot X1 is a surgical guidance system. Its intended use is to assist neurosurgeons in the spatial positioning and orientation of instruments during surgery on the patient's brain. It does not analyze samples taken from the body.
The description clearly states its function is to guide instruments in vivo (within the living body) based on pre-operative imaging. This falls under the category of surgical or therapeutic devices, not diagnostic devices that analyze samples in vitro (outside the living body).
N/A
Intended Use / 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 recording electrode). The device is indicated for any neurosurgical procedure in which the use of stereotactic neurosurgery may be appropriate.
Product codes
HAW
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.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D MRI / CT
Anatomical Site
Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained neurosurgeons to be used in a Neurosurgical 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
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:
Table 5.2 Accuracy Testing Results:
Device Performance: Positional accuracy [mm], Mean: 0.613, Standard deviation: 0.197, Confidence interval at 99% confidence level: 1.205
Device Performance: Angular accuracy [degree], Mean: 0.439, Standard deviation: 0.241, Confidence interval at 99% confidence level: 1.163
Key Metrics
Positional accuracy: Mean 0.613 mm, Standard deviation 0.197 mm, Confidence interval at 99% confidence level 1.205 mm.
Angular accuracy: Mean 0.439 degrees, Standard deviation 0.241 degrees, Confidence interval at 99% confidence level 1.163 degrees.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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)
| X Prescription Use (Part 21 CFR 801 Subpart D) | X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.