(78 days)
Not Found
No
The summary describes a robotized image-guided device that performs calculations based on surgical planning and patient registration for guidance. There is no mention of AI, ML, or related concepts like training data, test data, or specific algorithms typically associated with AI/ML in the provided text. The focus is on accurate positioning and guidance based on pre-operative planning and intra-operative registration.
No.
The device is described as an image-guided robot arm that assists surgeons by providing spatial positioning and orientation of instrument holders or tool guides, rather than directly treating a condition or disease.
No
The device is described as an image-guided robotic system intended for spatial positioning and orientation of surgical instruments during spine surgeries. Its purpose is to assist surgeons by providing "guidance" and "accurate and reproducible guidance" for instrument placement, not to diagnose conditions.
No
The device description explicitly states it is composed of two stands (robot and camera) with a robot arm, optical navigation system, and touchscreens, indicating significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Intended Use: The intended use of this device is for the spatial positioning and orientation of instrument holders or tool guides during spine surgeries. It's a surgical guidance system.
- Device Description: The device is a robotized image-guided system that assists surgeons in physically guiding instruments during surgery. It's a surgical tool, not a diagnostic test performed on a specimen.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is entirely focused on guiding surgical instruments based on imaging data and patient anatomy.
Therefore, this device falls under the category of a surgical guidance system or robotic surgical assistant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard surgical instruments during spine surgeries.
Guidance is based on an intraoperative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is intended for the placement of pedicle screws in vertebrae with a posterior approach in the thoracolumbar region.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The ROSA One device is a robotized image-guided device that assists the surgeon during spine surgeries. It provides quidance of any surgical instruments compatible with the diameter of the adaptors supplied by Medtech. It allows the user to plan the position of instruments or implants on medical images and provides stable, accurate and reproducible guidance in accordance with the planning.
The device is composed of two stands positioned around the operating table:
- a robot stand with a compact robot arm and a touchscreen.
- a camera stand with an optical navigation system and a touchscreen.
Different types of instruments may be attached to the robot arm and changed according to the intended surgical procedure.
The touchscreen ensures the communication between the device and its user by indicating the actions to be performed with respect to the procedure.
Adequate guidance of instruments is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D intra-operative CT exam
Anatomical Site
Spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Neurosurgeon
Orthopaedic Surgeon
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)
System applicative accuracy In vitro testing: Performance bench Testing in compliance with internal Medtech/Zimmer Biomet robotics procedures. Robot arm positioning accuracy
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a recognizable symbol of the agency's role in regulating and overseeing food and drug products in the United States.
October 29, 2019
Medtech S.a. % Serge Tabet Ouality and Regulatory Affairs Manager Medtech S.a ZAC Eureka - 900 Rue du Mas de Verchant Montpellier, 34000 Fr
Re: K192173
Trade/Device Name: ROSA ONE Spine application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: August 7, 2019 Received: August 12, 2019
Dear Serge Tabet:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For, Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192173
Device Name ROSA ONE Spine application
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard surgical instruments during spine surgeries.
Guidance is based on an intraoperative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is intended for the placement of pedicle screws in vertebrae with a posterior approach in the thoracolumbar region.
| 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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Image /page/3/Picture/1 description: The image shows the logo for Medtech, a company that specializes in innovative surgical technology. The logo is in blue and features the company name in a modern, sans-serif font. Below the company name is the tagline "Innovative Surgical Technology" in a smaller font. The logo is simple and clean, and it conveys a sense of innovation and expertise.
510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part క్తి807.92.
l SUBMITTER
Medtech S.A ZAC Eurêka 900 rue du Mas de Verchant 34000 Montpellier, France Tel +33 (0)4 67 10 77 40 Fax +33 (0)4 67 59 74 18
Contact Person :
Serge Tabet Quality & Regulatory Affairs Manager-Zimmer Biomet Robotics serge.tabet@zimmerbiomet.com Dated prepared: August 7, 2019
DEVICE ll
| Name of Device: | ROSA ONE Spine application |
|---|---|
| Common Name: | Computer-assisted surgical device |
| Classification Name: | Stereotaxic Instrument (21CFR 882.4560) |
| Classification Panel: | Orthopaedic |
| Regulatory Class: | |
| Product Code: | OLO (Spine) |
PREDICATE DEVICES ���
ROSA ONE Spine application, manufactured by Medtech S.A., K182848, cleared in March 22, 2019
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Image /page/4/Picture/1 description: The image shows the logo for Medtech. The logo is blue and consists of the word "medtech" in a sans-serif font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller, sans-serif font. The logo is simple and modern.
DEVICE DESCRIPTION IV
The subject ROSA ONE Spine application is identical to the most recent clearance (K182848) with the exception of an additional calibration step (software) and stand-alone arrays (instrumentation).
The ROSA One device is a robotized image-guided device that assists the surgeon during spine surgeries.
It provides quidance of any surgical instruments compatible with the diameter of the adaptors supplied by Medtech. It allows the user to plan the position of instruments or implants on medical images and provides stable, accurate and reproducible guidance in accordance with the planning.
The device is composed of two stands positioned around the operating table:
- a robot stand with a compact robot arm and a touchscreen .
- a camera stand with an optical navigation system and a touchscreen .
Different types of instruments may be attached to the robot arm and changed according to the intended surgical procedure.
The touchscreen ensures the communication between the device and its user by indicating the actions to be performed with respect to the procedure.
Adequate guidance of instruments is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
V INDICATIONS FOR USE
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard surgical instruments during spine surgeries.
Guidance is based on an intraoperative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is intended for the placement of pedicle screws in vertebrae with a posterior approach in the thoracolumbar region.
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Image /page/5/Picture/1 description: The image contains the logo for Medtech. The logo is blue and consists of the word "medtech" in a stylized font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font. The logo is simple and modern.
VI COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Device | ROSA ONE Spine application
(v.3.1.0.4)
(K182848) | ROSA ONE Spine application
(v.3.1.2.0)
(submission subject) | Comparison Analysis |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| 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
surgeons to guide standard
surgical
instruments during spine surgeries.
Guidance is based on an intraoperative plan
developed with three dimensional imaging
software provided that the required fiducial
markers and rigid patient anatomy can be
identified on 3D CT scans. The device is
intended for the placement of pedicle screws
in vertebrae with a posterior approach in the
thoracolumbar region. | The device is intended for the spatial positioning
and orientation of instrument holders or tool
guides to be used by surgeons to guide standard
surgical instruments during spine surgeries.
Guidance is based on an intraoperative plan
developed with three dimensional imaging
software provided that the required fiducial
markers and rigid patient anatomy can be
identified on 3D CT scans. The device is
intended for the placement of pedicle screws in
vertebrae with a posterior approach in the
thoracolumbar region. | Identical |
| Where used | Operating room | Operating room | Identical |
| User | Neurosurgeon
Orthopaedic Surgeon | Neurosurgeon
Orthopaedic Surgeon | Identical |
| Anatomical site | Spine | Spine | Identical |
| Principle of operation | ● Intraoperative images
● Patient registration
● Surgical planning
● Guidance of instruments
● Real-time tracking of navigated
instruments | ● Intraoperative images
● Patient registration
● Surgical planning
● Guidance of instruments
● Real-time tracking of navigated instruments | Identical |
| Device | ROSA ONE Spine application
(v.3.1.0.4)
(K182848) | ROSA ONE Spine application
(v.3.1.2.0)
(submission subject) | Comparison Analysis |
| Preoperative images & surgical planning | | | |
| Images type | 3D intra-operative CT exam | 3D intra-operative CT exam | Identical |
| DICOM compliance | Yes | Yes | Identical |
| Merge images (multimodality
image fusion capability) | Yes | Yes | Identical |
| Integrated planning software | ROSANNA SPINE
(Medtech) | ROSANNA SPINE
(Medtech) | Identical |
| Trajectory planning
parameters | Entry point, target point, length of the instrument, diameter, name, color | Entry point, target point, length of the instrument, diameter, name, color | Identical |
| Save/load planning | Yes | Yes | Identical |
| Patient Registration | | | |
| Localization means | Robot arm absolute encoders
- optical system (infrared camera) | Robot arm absolute encoders
- optical system (infrared camera) | 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 |
| Patient registration methods | 3D registration with X-Ray pattern
containing radio-opaque markers | 3D registration with X-Ray pattern
containing radio-opaque markers | Identical |
| Laser class for optical
registration | Class 2 laser
Wavelength - 635 nm, Maximum output - 1
mW (complies with 21 CFR 1040.10) | Class 2 laser
Wavelength - 635 nm, Maximum output - 1
mW (complies with 21 CFR 1040.10) | Identical |
| Cooperative movement | Yes | Yes | Identical |
| Accuracy verification on
anatomical landmarks | Yes | Yes | Identical |
| Instruments guidance | | | |
| Image-guided | Yes | Yes | Identical |
| Real time display of the
instrument position | Yes | Yes | Identical |
| Device | ROSA ONE Spine application
(v.3.1.0.4)
(K182848) | ROSA ONE Spine application
(v.3.1.2.0)
(submission subject) | Comparison Analysis |
| 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 |
| Instrument fixation | Instruments are mounted onto robot arm's
flange | Instruments are mounted onto robot arm's
flange | Identical |
| Instruments | Instrument holder, cannula, adaptors,
navigated instruments | Instrument holder, cannula, adaptors, navigated
instruments | Identical |
| Instrument calibration method | Factory calibration | Factory calibration | Identical |
| Navigated handle calibration
method | Calibration during manufacturing
Verification during surgical workflow
(Ratcheting Handle - replaced component) | Calibration/verification during surgical workflow
(Universal Navigated System, Zimmer Biomet
Spine, Inc.) | Substantially equivalent
Addition of the calibration step
during the surgical workflow |
| Associated equipment | 3D imaging system
• Retro-reflective sterile spheres
• Implants and instrumentation | 3D imaging system
• Retro-reflective sterile spheres
• Implants and instrumentation | Identical |
| Patient immobilization | No - A reference is fixed in the patient's iliac
crest through percutaneous pin or onto
the patient's spinous process through
spinous clamp for tracking system. | No - A reference is fixed in the patient's iliac
crest through percutaneous pin or onto the
patient's spinous process through spinous
clamp for tracking system. | Identical |
| Device mobility | Yes - Mobile stands with wheels; Robot
stand immobilized with stabilization
feet and camera stand immobilized
with wheels brakes | Yes - Mobile stands with wheels; Robot stand
immobilized with stabilization feet and
camera stand immobilized with wheels
brakes | Identical |
| Vigilance system | Yes - foot pedal | Yes - foot pedal | Identical |
| Sterility | Non-sterile and sterile instruments
Disposable sterile drapes for the robot arm
and touch screen | Non-sterile and sterile instruments
Disposable sterile drapes for the robot arm and
touch screen | Identical |
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Image /page/6/Picture/1 description: The image shows the Medtech logo. The logo is in blue and consists of the word "medtech" in a sans-serif font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller, sans-serif font. The logo is simple and modern, and it is likely used to represent a medical technology company.
7
Image /page/7/Picture/1 description: The image shows the logo for Medtech, a company that specializes in innovative surgical technology. The logo is in blue and features the company name in a bold, sans-serif font. Below the company name is the tagline "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller, lighter font. The logo is simple and modern, and it conveys a sense of innovation and expertise.
8
Image /page/8/Picture/1 description: The image shows the logo for Medtech. The logo is in blue and consists of the word "medtech" in a sans-serif font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller, sans-serif font. The logo is simple and modern, and the use of blue gives it a professional and trustworthy feel.
VII PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the ROSA ONE Spine application has been conducted in accordance with FDA Guidance Document: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." The evaluation reveals that biocompatibility requirements are met by the ROSA ONE device.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on ROSA ONE Spine application. The device complies with recognized electrical safety standards: IEC 60601-1 standard for electrical safety and IEC 60601-1-2 standard for electromagnetic compatibility. The EMC testing was performed according to the FDA EMC guidance document "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices" issued in July 11, 2016.
Software Verification and Validation Testing
Software tests were conducted to satisfy the requirements of the FDA Guidance 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 results
- · Integration test results
- · Overall software test report
- Verification test reports
- · Overall software verification report
Code inspections and software tests at the unit and integration levels were performed according to the Software Test Plan. Verification tests were performed for each software requirement according to the Software Verification Plan.
Conformity of software with the user needs and intended use of the device were performed through the "Validation" phase of the ROSA ONE Spine application.
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Image /page/9/Picture/1 description: The image shows the Medtech logo. The logo is in blue and consists of the word "medtech" in a sans-serif font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font. The logo is simple and modern, and it is likely used to represent a medical technology company.
Cleaning- and Sterilization Validation
MEDTECH has performed an automated cleaning validation according to FDA Guidance Document Reprocessing of Reusable Medical Devices: Information for Manufacturers and AAMI TIR 30 Technical report. Additionally, the sterilization validation was performed according to ISO 17665-1, ISO 17664 and AAMI TIR 12 Technical report using two cycles.
Animal studies
Data from animal studies were not required to support the safety and effectiveness of ROSA ONE Spine application.
Clinical Studies
Clinical data were not required to support the safety and effectiveness of ROSA ONE Spine application. All validation was performed based on non-clinical performance tests.
VIII SUMMARY OF NON CLINICAL PERFORMANCE TESTING
| Test | Test Method Summary | Results |
|---|---|---|
| System applicative accuracy | ||
| In vitro testing | Performance bench Testing in | |
| compliance with internal | ||
| Medtech/Zimmer Biomet | ||
| robotics procedures | Testing on the subject device was | |
| performed and demonstrated to be | ||
| substantially equivalent to the predicate | ||
| device: | ||
| Robot arm positioning accuracy |