(164 days)
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 ROSA One device is a robotized image-guided device that assists the surgeon during spine surgeries.
It provides quidance of surgical instruments compatible with the diameter of the adaptors supplied by Medtech. It allows the user to plan the position of instruments or screws 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 end of 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.
The provided text describes the ROSA ONE Spine application, a robotized image-guided device intended to assist surgeons during spine surgeries. The information focuses on its substantial equivalence to a predicate device (ROSA SPINE, K151511) and the non-clinical performance data supporting this claim.
Here's an analysis of the acceptance criteria and study proving device performance, based only on the information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied/Directly Stated) | Reported Device Performance |
|---|---|---|
| System Applicative Accuracy (In vitro) | Robot arm positioning accuracy < 0.75 mm RMS; Device applicative accuracy < 2mm | Robot arm positioning accuracy < 0.75 mm RMS; Device applicative accuracy < 2mm |
| Electrical Safety & EMC | Compliance with IEC 60601-1 and IEC 60601-1-2 standards | Complies with IEC 60601-1:2005/A1:2012 and IEC 60601-1-2:2014 |
| Biocompatibility Testing | Compliance with FDA Guidance ISO 10993-1 | Evaluation reveals biocompatibility requirements are met (predicate device testing used: Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity) |
| Software Verification & Validation | Compliance with FDA Guidance for Software in Medical Devices and IEC 62304 standard (Major level of concern) | Software tests conducted, verification activities performed, and conformity with user needs/intended use through Validation phase. Substantially equivalent performance to predicate. |
| Cleaning & Sterilization Validation | Compliance with FDA Guidance and relevant ISO/AAMI standards | Automated cleaning validation performed; Sterilization validation performed according to ISO 17665-1, ISO 17664, ANSI/AAMI ST79, and AAMI TIR 12. Substantially equivalent to predicate. |
| In vitro studies | Validation of extension of indication to thoracic spine | Evaluation and tests performed demonstrated validation of the extension of the indication for use to thoracic spine (on phantom and cadaver). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for any of the non-clinical tests (e.g., how many robots/devices were tested for accuracy, how many phantom/cadaver units for in vitro studies).
The data provenance is stated as non-clinical performance tests.
- Country of Origin: Not explicitly stated for testing, but Medtech S.A. is located in Montpellier, France.
- Retrospective or Prospective: Not specified, but given these are performance tests (not clinical trials), they are inherently experiments designed to prospectively test specific parameters.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The tests described are primarily engineering and laboratory-based (e.g., accuracy measurements, electrical safety, software validation, cleaning/sterilization validation), which don't typically involve human expert ground truth in the same way clinical image interpretation studies do. The in vitro studies on phantom and cadaver are described, but the method of establishing "ground truth" for the thoracic spine extension is not detailed beyond "evaluation and tests were performed."
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods are typically relevant for clinical studies involving human interpretation or outcome assessment, not for the technical performance tests described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "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." Therefore, there is no information on how human readers might improve with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is described as "a robotized image-guided device that assists the surgeon." While it has software and automated functions, its purpose is to guide human surgeons. The listed performance tests are for the device system (robot arm accuracy, electrical safety, software function), not a standalone diagnostic algorithm. The "Device applicative accuracy" test likely reflects the system's ability to guide to a target, which is a form of standalone performance for a guidance system. However, it's not an "algorithm-only" performance in the sense of an AI model making a diagnosis without human input.
7. The Type of Ground Truth Used
For the technical performance tests:
- System Applicative Accuracy: The ground truth is likely defined by the physical target points and the robot's measured position relative to those points, verified by precise measurement tools.
- Electrical Safety & EMC / Biocompatibility / Cleaning & Sterilization Validation: Ground truth is compliance with specified regulatory standards and test methods.
- Software Verification & Validation: Ground truth is compliance with software requirements and design specifications.
- In vitro studies (phantom/cadaver): The ground truth for validating the thoracic spine extension is not explicitly detailed but would likely involve comparison against pre-defined planned trajectories or anatomical landmarks in the phantom/cadaver, measured by a precision tracking system. It is not "expert consensus, pathology, or outcomes data" in the clinical sense.
8. The Sample Size for the Training Set
This information is not provided. The document focuses on performance testing for regulatory clearance, not the development or training of an AI model. While the device is "robotized" and "image-guided," the document does not elaborate on machine learning model training. The software verification mentions "Code inspections and software tests at the unit, integration and system levels" which relates to traditional software engineering, not necessarily machine learning training.
9. How the Ground Truth for the Training Set Was Established
Since the document does not provide information about a "training set" for a machine learning model, the method for establishing its ground truth is not applicable/not provided.
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Medtech S.A. Serge Tabet RA Manager ZAC Eureka - 900 Rue du Mas de Verchant Montpellier, 34000 FR
Re: K182848
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: February 15, 2019 Received: February 21, 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 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
March 22, 2019
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jesse Muir -S
For: Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182848
Device Name ROSA One Spine application
Indications for Use (Describe)
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)
2 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/0 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 it conveys a sense of innovation and technology.
K182848
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: October 8, 2018
ll DEVICE
| 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: | II |
| Product Code: | OLO (Spine) |
PREDICATE DEVICES ���
ROSA SPINE, manufactured by Medtech S.A., K151511, cleared in January 4, 2016
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Image /page/4/Picture/0 description: The image shows the logo for Medtech. The logo is in 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.
DEVICE DESCRIPTION IV
The ROSA One device is a robotized image-guided device that assists the surgeon during spine surgeries.
It provides quidance of surgical instruments compatible with the diameter of the adaptors supplied by Medtech. It allows the user to plan the position of instruments or screws 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 end of 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/0 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 font. The logo is simple and modern.
VI COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Device | ROSA SPINE(K151511) | ROSA ONE 3.1Spine application(submission subject) | Comparison Analysis |
|---|---|---|---|
| Device description and indications for use | |||
| General device description | Computer controlled electromechanical armproviding guidance of neurosurgicalinstruments | Computer controlled electromechanical armproviding guidance of neurosurgicalinstruments | Identical |
| Indications for use | The device is intended for the spatialpositioning and orientation of instrumentholders or tool guides to be used bysurgeons to guide standard neurosurgicalinstruments during spine surgery.Guidance is based on an intra-operativeplan developed with three dimensionalimaging software provided that the requiredfiducial markers and rigid patient anatomycan be identified on 3D CT scans. Thedevice is indicated for the placement ofpedicle screws in lumbar vertebrae with aposterior approach. | The device is intended for the spatialpositioning and orientation of instrumentholders or tool guides to be used bysurgeons to guide standard surgicalinstruments during spine surgeries.Guidance is based on an intraoperative plandeveloped with three dimensional imagingsoftware provided that the required fiducialmarkers and rigid patient anatomy can beidentified on 3D CT scans. The device isintended for the placement of pediclescrews in vertebrae with a posteriorapproach in the thoracolumbar region. | Identical, the only addition is theexpansion of the SpineApplication to thethoracolumbar spine |
| Where used | Operating room | Operating room | Identical |
| User | NeurosurgeonOrthopaedic Surgeon | NeurosurgeonOrthopaedic Surgeon | Identical |
| Anatomical site | Spine | Spine | Identical |
| Principle of operation | Intraoperative images•Patient registration•Surgical planning•Guidance of instruments•Real-time tracking of navigatedinstruments | Intraoperative images•Patient registration•Surgical planning•Guidance of instruments•Real-time tracking of navigatedinstruments | Identical |
| Preoperative images & surgical planning | |||
| Device | ROSA SPINE(K151511) | ROSA ONE 3.1Spine application(submission subject) | Comparison Analysis |
| Images type | 3D intra-operative CT exam | 3D intra-operative CT exam | Identical |
| DICOM compliance | Yes | Yes | Identical |
| Merge images (multimodalityimage fusion capability) | Yes | Yes | Identical |
| Integrated planning software | ROSANNA SPINE(Medtech) | ROSANNA SPINE(Medtech) | Identical |
| Trajectory planningparameters | Entry point, target point, length of theinstrument, diameter | Entry point, target point, length of theinstrument, diameter, name, color | Identical, with addition of name andcolor |
| 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 jointKinematic transformation between theCartesian space and joint spaceSupervisor module | Axis controller for each jointKinematic transformation between theCartesian space and joint spaceSupervisor module | Identical |
| Patient registration methods | 3D registration with X-Ray patterncontaining radio-opaque markers | 3D registration with X-Ray patterncontaining radio-opaque markers | Identical |
| Laser class for opticalregistration | Class 2 laserWavelength – 635 nm, Maximum output – 1mW (complies with 21 CFR 1040.10) | Class 2 laserWavelength – 635 nm, Maximum output – 1mW (complies with 21 CFR 1040.10) | Identical |
| Cooperative movement | Yes | Yes | Identical |
| Accuracy verification onanatomical landmarks | Yes | Yes | Identical |
| Instruments guidance | |||
| Image-guided | Yes | Yes | Identical |
| Device | ROSA SPINE(K151511) | ROSA ONE 3.1Spine application(submission subject) | Comparison Analysis |
| Real time display of theinstrument position | Yes | Yes | Identical |
| Provide guidance for surgicalinstruments | Yes | Yes | Identical |
| Instrument guide positionadjustment | Automatic (robotized) | Automatic (robotized) | Identical |
| Surgeon carries out finalgesture through theinstrument guide withtraditional surgical instrument | Yes - through the instrument guide | Yes - through the instrument guide | Identical |
| Instrument fixation | Instruments are mounted onto robot arm'sflange | Instruments are mounted onto robot arm'sflange | Identical |
| Instruments | Instrument holder, cannula, adaptors,navigated instruments | Instrument holder, cannula, adaptors,navigated instruments | Identical |
| Instrument calibration method | Factory calibration | Factory calibration | Identical |
| 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 iliaccrest for tracking system. | No - A reference is fixed in the patient's iliaccrest through percutaneous pin or ontothe patient's spinous process throughspinous clamp for tracking system. | Identical with the addition of theSpinous Clamp with PatientReference for the use duringthoracolumbarspineinterventions |
| Device mobility | Yes - Mobile stands with wheels; Robotstand immobilized with stabilizationfeet and camera stand immobilizedwith wheels brakes | Yes - Mobile stands with wheels; Robotstand immobilized with stabilizationfeet and camera stand immobilizedwith wheels brakes | Identical |
| Vigilance system | Yes - foot pedal | Yes - foot pedal | Identical |
| Sterility | Non-sterile and sterile instrumentsDisposable sterile drapes for the robot armand touch screen | Non-sterile and sterile instrumentsDisposable sterile drapes for the robot armand touch screen | Identical |
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Image /page/6/Picture/0 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 font. The logo is simple and modern.
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Image /page/7/Picture/0 description: The image shows the logo for Medtech, a company that specializes in innovative surgical technology. The logo is composed of the word "medtech" in a bold, sans-serif font, with the "h" stylized to resemble a surgical instrument. Below the company name is the tagline "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller, lighter font. The logo is clean and modern, and the use of the surgical instrument in the "h" gives it a unique and memorable look.
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Image /page/8/Picture/0 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 technology.
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 walkthroughs
- · Unit test reports
- · Integration test reports
- · System test reports
- · Overall software test report
- Verification test reports
- · Overall software verification report
Code inspections and software tests at the unit, integration and system levels were performed according to the Software Test Plan. Verification tests were performed for each software requirement according to the Software Verification Plan.
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Image /page/9/Picture/0 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 font. The logo is simple and modern, and it conveys a sense of innovation and expertise.
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 .
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, ANSI/AAMI ST79, and AAMI TIR 12 Technical report using two cycles.
In vitro studies
Tests on phantom and cadaver were performed to extend the indication for use to the thoracic spine.
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.
| Test | Test Method Summary | Results |
|---|---|---|
| System applicative accuracyIn vitro testing | Performance bench Testing in compliance with internal BiometMedtech/Zimmerrobotics procedures | Testing on the subject device wasperformed and demonstrated to besubstantially equivalent to the predicatedevice:Robot arm positioning accuracy $<$ 0.75 mm RMS Device applicative accuracy $<$ 2mm |
| Electrical safety andelectromagnetic compatibility(EMC) | Testing in compliance with theIEC 60601-1:2005/A1:2012 andIEC 60601-1-2:2014 | Evaluation and testing were performed onthe subject device and demonstrated tobe substantially equivalent to thepredicate device. |
| Biocompatibility testing | Testing in compliance with FDAGuidance "Use of InternationalStandard IS10993, Biologicalevaluation of medical DevicesPart 1". | The following non clinical tests wereperformed on the predicate device:Cytotoxicity, Sensitization, Irritation andAcute systemic toxicityThe subject devices were evaluatedagainst the predicate testing anddetermined to be substantially equivalent. |
VIII SUMMARY OF NON CLINICAL PERFORMANCE TESTING
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Image /page/10/Picture/0 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 font. The logo is simple and modern, and it conveys a sense of innovation and expertise.
| Software Verification andValidation Testing | Software verification testing incompliance with FDA guidance"General Principles of SoftwareValidation" and IEC 62304:2006 | Evaluation and testing were performed onthe subject device and demonstratedsubstantially equivalent performance toidentified predicate device |
|---|---|---|
| Cleaning and SterilizationValidation | Testing in compliance with FDAGuidance "ReprocessingMedical Devices in Health CareSettings: Validation Methodsand Labeling" and the followingstandards:ISO 17665-1Sterilization of health careproducts -Moist heat - Part 1:Requirements forthe Development, Validationand Routine Control of aSterilization Process for MedicalDevices and ISO 17664-Sterilization of medical devices --Information to be provided bythe manufacturer for theprocessing of re-sterilizablemedical devices | Evaluation was performed of the subjectdevice and demonstrated to besubstantially equivalent to the identifiedpredicate devices. |
| In vitro studies | Testing in compliance withinternalMedtech/ZimmerBiomet robotics procedures | The evaluation and tests were performedon the subject device and demonstratedthe validation of the extension of theindication for use to thoracic spine. |
| Animal studies | Not applicable | Not applicable |
| Clinical Studies | Not applicable | Not applicable |
CONCLUSIONS IX
ROSA ONE Spine application is substantially equivalent in design and intended use to the predicate device – ROSA SPINE (K151511).
Any differences between the subject and predicate devices have no significant influence on safety or effectiveness as established through performance testing. Therefore, ROSA ONE Spine application raises no new issues of safety or effectiveness when compared to the predicate device.
§ 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).