(78 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 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.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| System Applicative Accuracy (In vitro testing) | Robot arm positioning accuracy < 0.75 mm RMS; Device applicative accuracy < 2mm |
| Electrical Safety | Complies with IEC 60601-1:2005/A1:2012 |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2:2014 & FDA EMC guidance document |
| Biocompatibility | Biocompatibility requirements met (evaluated against ISO 10993-1) |
| Software Verification and Validation | Satisfies FDA Guidance and IEC 62304 Standard for "major" level of concern software |
| Cleaning and Sterilization Validation | Complies with FDA Guidance "Reprocessing Medical Devices..." and standards ISO 17665-1, ISO 17664, AAMI TIR 12 |
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes non-clinical performance tests. Therefore, there isn't a "test set" in the traditional sense involving patient or human subject data.
- System Applicative Accuracy: Performance bench testing was conducted in compliance with internal Medtech/Zimmer Biomet robotics procedures. The specific sample size (e.g., number of tests, repetitions) is not detailed.
- Electrical Safety & EMC: Testing was conducted on the device. Specific sample size (e.g., number of units tested) is not detailed.
- Biocompatibility: Tests were performed on the predicate device. The subject device was then evaluated against these predicate test results. No specific sample size for the predicate testing is provided within this document.
- Software Verification and Validation: Software tests were conducted. The specific number of test cases or test runs is not detailed.
- Cleaning and Sterilization Validation: Validation was performed using two cycles.
Data Provenance: The tests are described as non-clinical and conducted by Medtech/Zimmer Biomet, implying internal lab testing. No country of origin for test data or retrospective/prospective status is relevant in this non-clinical context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the studies are entirely non-clinical performance tests measuring device specifications against engineering and regulatory standards, not against "ground truth" established by clinical experts.
4. Adjudication Method for the Test Set
This is not applicable as there is no human-in-the-loop assessment or expert review for establishing ground truth in these non-clinical performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission 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."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device itself is a robotized image-guided surgical device that assists the surgeon. While its performance (e.g., accuracy) is measured independently in non-clinical settings ("robot arm positioning accuracy," "device applicative accuracy"), these are measures of its mechanical and computational precision, not of a standalone diagnostic algorithm's performance. Therefore, a standalone "algorithm only without human-in-the-loop performance" study in the typical AI/diagnostic sense was not performed because it's an assistive surgical device, not a diagnostic algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to established engineering specifications and compliance with recognized standards.
- System Applicative Accuracy: Ground truth is defined by the target accuracy specifications (e.g., < 0.75 mm RMS for robot arm positioning, < 2mm for device applicative accuracy).
- Electrical Safety & EMC: Ground truth is compliance with international standards (IEC 60601-1, IEC 60601-1-2) and FDA guidance.
- Biocompatibility: Ground truth is compliance with ISO 10993-1.
- Software Verification and Validation: Ground truth is compliance with FDA Guidance for software and IEC 62304 standard.
- Cleaning and Sterilization Validation: Ground truth is compliance with FDA Guidance and standards ISO 17665-1, ISO 17664, and AAMI TIR 12.
8. The Sample Size for the Training Set
This information is not applicable. The ROSA ONE Spine application is a robotized surgical assistance device, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its "intelligence" comes from programmed algorithms and controls, validated through engineering means, not trained on large datasets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as above. The device doesn't use a "training set."
{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) |
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
"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}------------------------------------------------
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
{4}------------------------------------------------
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.
{5}------------------------------------------------
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 armproviding guidance of neurosurgicalinstruments | Computer controlled electromechanical armproviding guidance of neurosurgical instruments | Identical |
| Indications for use | The device isintended for the spatialpositioning and orientation of instrumentholders or tool guides to be used bysurgeons to guide standardsurgicalinstruments 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 pedicle screwsin vertebrae with a posterior approach in thethoracolumbar region. | The device is intended for the spatial positioningand orientation of instrument holders or toolguides to be used by surgeons to guide standardsurgical instruments 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 pedicle screws invertebrae with a posterior approach in thethoracolumbar region. | Identical |
| 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 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 (multimodalityimage fusion capability) | Yes | Yes | Identical |
| Integrated planning software | ROSANNA SPINE(Medtech) | ROSANNA SPINE(Medtech) | Identical |
| Trajectory planningparameters | 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 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 |
| Real time display of theinstrument 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 surgicalinstruments | Yes | Yes | Identical |
| Instrument guide positionadjustment | Automatic (robotized) | Automatic (robotized) | Identical |
| Surgeon carries out finalgesture through theinstrument guide withtraditional surgicalinstrument | 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, navigatedinstruments | Identical |
| Instrument calibration method | Factory calibration | Factory calibration | Identical |
| Navigated handle calibrationmethod | Calibration during manufacturingVerification during surgical workflow(Ratcheting Handle - replaced component) | Calibration/verification during surgical workflow(Universal Navigated System, Zimmer BiometSpine, Inc.) | Substantially equivalentAddition of the calibration stepduring 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 iliaccrest through percutaneous pin or ontothe patient's spinous process throughspinous clamp for tracking system. | No - A reference is fixed in the patient's iliaccrest through percutaneous pin or onto thepatient's spinous process through spinousclamp for tracking system. | Identical |
| Device mobility | Yes - Mobile stands with wheels; Robotstand immobilized with stabilizationfeet and camera stand immobilizedwith wheels brakes | Yes - Mobile stands with wheels; Robot standimmobilized with stabilization feet andcamera stand immobilized with wheelsbrakes | 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 arm andtouch screen | Identical |
{6}------------------------------------------------
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.
{9}------------------------------------------------
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 accuracyIn vitro testing | Performance bench Testing incompliance with internalMedtech/Zimmer Biometrobotics 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 to besubstantially equivalent to the predicatedevice. |
| Biocompatibility testing | Testing in compliance with FDAGuidance "Use of InternationalStandard ISO10993, 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. |
| 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: | Evaluation was performed of the subjectdevice and demonstrated to besubstantially equivalent to the identifiedpredicate devices. |
{10}------------------------------------------------
Image /page/10/Picture/1 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. The logo is simple and modern, and it conveys a sense of innovation and technology.
| Requirements for theDevelopment, Validation andRoutine Control of a SterilizationProcess for Medical Devices andISO 17664 Sterilization ofmedical devices --Information tobe provided by the manufacturerfor the processing of re-sterilizable medical devices | ||
|---|---|---|
| Animal studies | Not applicable | Not applicable |
| Clinical Studies | Not applicable | Not applicable |
IX CONCLUSIONS
ROSA ONE Spine application (v.3.1.2.0) is substantially equivalent in design and intended use to the predicate device – ROSA ONE Spine application (v.3.1.0.4) (K182848).
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 (v.3.1.2.0) 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).