ROSA ONE Spine application

K192173 · Medtech S.A · OLO · Oct 29, 2019 · Neurology

Device Facts

• Record ID: K192173
• Device Name: ROSA ONE Spine application
• Applicant: Medtech S.A
• Product Code: OLO · Neurology
• Decision Date: Oct 29, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended 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.

Device Story

Robotized image-guided system; assists surgeons during spine surgeries. Inputs: 3D CT scans; intraoperative patient registration data. Operation: surgeon plans instrument/implant positions on 3D images; robot arm provides stable, accurate, reproducible guidance for surgical instruments. Components: robot stand with arm and touchscreen; camera stand with optical navigation system and touchscreen. Used in OR by neurosurgeons/orthopedic surgeons. Output: physical guidance of surgical instruments via robot-mounted tool guides. Benefits: improved accuracy and reproducibility of pedicle screw placement. Subject device adds a calibration step during the surgical workflow and utilizes stand-alone arrays.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including system applicative accuracy (robot arm positioning accuracy <0.75 mm RMS; device applicative accuracy <2mm), electrical safety/EMC, biocompatibility, and software verification/validation.

Technological Characteristics

Computer-controlled electromechanical arm; optical navigation system (infrared camera); Class 2 laser (635 nm, 1 mW). Connectivity: DICOM compliant. Software: major level of concern. Sterilization: moist heat (ISO 17665-1). Materials: non-sterile and sterile instruments; disposable sterile drapes.

Indications for Use

Indicated for surgeons performing spine surgeries, specifically the placement of pedicle screws in vertebrae via a posterior approach in the thoracolumbar region.

Regulatory Classification

Identification

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

Predicate Devices

• ROSA ONE Spine application (K182848)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg height="16" width="16"> <path d="M2 2h12v12H2V2zm1-1h14v14H1V1z" fill="black"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg height="16" width="16"> <path d="M2 2h12v12H2V2zm1-1h14v14H1V1z" fill="white"></path> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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 [phone] Fax [phone]

### Contact Person :

Serge Tabet Quality & Regulatory Affairs Manager-Zimmer Biomet Robotics [e-mail] 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<br>(v.3.1.0.4)<br>(K182848) | ROSA ONE Spine application<br>(v.3.1.2.0)<br>(submission subject) | Comparison Analysis |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| General device description | Computer controlled electromechanical arm<br>providing guidance of neurosurgical<br>instruments | Computer controlled electromechanical arm<br>providing guidance of neurosurgical instruments | Identical |
| Indications for use | The device is<br>intended for the spatial<br>positioning and orientation of instrument<br>holders or tool guides to be used by<br>surgeons to guide standard<br>surgical<br>instruments during spine surgeries.<br>Guidance is based on an intraoperative plan<br>developed with three dimensional imaging<br>software provided that the required fiducial<br>markers and rigid patient anatomy can be<br>identified on 3D CT scans. The device is<br>intended for the placement of pedicle screws<br>in vertebrae with a posterior approach in the<br>thoracolumbar region. | The device is intended for the spatial positioning<br>and orientation of instrument holders or tool<br>guides to be used by surgeons to guide standard<br>surgical instruments during spine surgeries.<br>Guidance is based on an intraoperative plan<br>developed with three dimensional imaging<br>software provided that the required fiducial<br>markers and rigid patient anatomy can be<br>identified on 3D CT scans. The device is<br>intended for the placement of pedicle screws in<br>vertebrae with a posterior approach in the<br>thoracolumbar region. | Identical |
| Where used | Operating room | Operating room | Identical |
| User | Neurosurgeon<br>Orthopaedic Surgeon | Neurosurgeon<br>Orthopaedic Surgeon | Identical |
| Anatomical site | Spine | Spine | Identical |
| Principle of operation | ● Intraoperative images<br>● Patient registration<br>● Surgical planning<br>● Guidance of instruments<br>● Real-time tracking of navigated<br>instruments | ● Intraoperative images<br>● Patient registration<br>● Surgical planning<br>● Guidance of instruments<br>● Real-time tracking of navigated instruments | Identical |
| Device | ROSA ONE Spine application<br>(v.3.1.0.4)<br>(K182848) | ROSA ONE Spine application<br>(v.3.1.2.0)<br>(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<br>image fusion capability) | Yes | Yes | Identical |
| Integrated planning software | ROSANNA SPINE<br>(Medtech) | ROSANNA SPINE<br>(Medtech) | Identical |
| Trajectory planning<br>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<br>+ optical system (infrared camera) | Robot arm absolute encoders<br>+ optical system (infrared camera) | Identical |
| Controller | Axis controller for each joint<br>Kinematic transformation between the<br>Cartesian space and joint space<br>Supervisor module | Axis controller for each joint<br>Kinematic transformation between the<br>Cartesian space and joint space<br>Supervisor module | Identical |
| Patient registration methods | 3D registration with X-Ray pattern<br>containing radio-opaque markers | 3D registration with X-Ray pattern<br>containing radio-opaque markers | Identical |
| Laser class for optical<br>registration | Class 2 laser<br>Wavelength - 635 nm, Maximum output - 1<br>mW (complies with 21 CFR 1040.10) | Class 2 laser<br>Wavelength - 635 nm, Maximum output - 1<br>mW (complies with 21 CFR 1040.10) | Identical |
| Cooperative movement | Yes | Yes | Identical |
| Accuracy verification on<br>anatomical landmarks | Yes | Yes | Identical |
| Instruments guidance | | | |
| Image-guided | Yes | Yes | Identical |
| Real time display of the<br>instrument position | Yes | Yes | Identical |
| Device | ROSA ONE Spine application<br>(v.3.1.0.4)<br>(K182848) | ROSA ONE Spine application<br>(v.3.1.2.0)<br>(submission subject) | Comparison Analysis |
| Provide guidance for surgical<br>instruments | Yes | Yes | Identical |
| Instrument guide position<br>adjustment | Automatic (robotized) | Automatic (robotized) | Identical |
| Surgeon carries out final<br>gesture through the<br>instrument guide with<br>traditional surgical<br>instrument | Yes - through the instrument guide | Yes - through the instrument guide | Identical |
| Instrument fixation | Instruments are mounted onto robot arm's<br>flange | Instruments are mounted onto robot arm's<br>flange | Identical |
| Instruments | Instrument holder, cannula, adaptors,<br>navigated instruments | Instrument holder, cannula, adaptors, navigated<br>instruments | Identical |
| Instrument calibration method | Factory calibration | Factory calibration | Identical |
| Navigated handle calibration<br>method | Calibration during manufacturing<br>Verification during surgical workflow<br>(Ratcheting Handle - replaced component) | Calibration/verification during surgical workflow<br>(Universal Navigated System, Zimmer Biomet<br>Spine, Inc.) | Substantially equivalent<br>Addition of the calibration step<br>during the surgical workflow |
| Associated equipment | 3D imaging system<br>• Retro-reflective sterile spheres<br>• Implants and instrumentation | 3D imaging system<br>• Retro-reflective sterile spheres<br>• Implants and instrumentation | Identical |
| Patient immobilization | No - A reference is fixed in the patient's iliac<br>crest through percutaneous pin or onto<br>the patient's spinous process through<br>spinous clamp for tracking system. | No - A reference is fixed in the patient's iliac<br>crest through percutaneous pin or onto the<br>patient's spinous process through spinous<br>clamp for tracking system. | Identical |
| Device mobility | Yes - Mobile stands with wheels; Robot<br>stand immobilized with stabilization<br>feet and camera stand immobilized<br>with wheels brakes | Yes - Mobile stands with wheels; Robot stand<br>immobilized with stabilization feet and<br>camera stand immobilized with wheels<br>brakes | Identical |
| Vigilance system | Yes - foot pedal | Yes - foot pedal | Identical |
| Sterility | Non-sterile and sterile instruments<br>Disposable sterile drapes for the robot arm<br>and touch screen | Non-sterile and sterile instruments<br>Disposable sterile drapes for the robot arm and<br>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.

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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.

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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<br>In vitro testing | Performance bench Testing in<br>compliance with internal<br>Medtech/Zimmer Biomet<br>robotics procedures | Testing on the subject device was<br>performed and demonstrated to be<br>substantially equivalent to the predicate<br>device:<br>Robot arm positioning accuracy <0.75 mm RMS Device applicative accuracy <2mm |
| Electrical safety and<br>electromagnetic compatibility<br>(EMC) | Testing in compliance with the<br>IEC 60601-1:2005/A1:2012 and<br>IEC 60601-1-2:2014 | Evaluation and testing were performed on<br>the subject device and demonstrated to be<br>substantially equivalent to the predicate<br>device. |
| Biocompatibility testing | Testing in compliance with FDA<br>Guidance "Use of International<br>Standard ISO10993, Biological<br>evaluation of medical Devices<br>Part 1". | The following non clinical tests were<br>performed on the predicate device:<br>Cytotoxicity, Sensitization, Irritation and<br>Acute systemic toxicity<br><br>The subject devices were evaluated<br>against the predicate testing and<br>determined to be substantially equivalent. |
| Software Verification and<br>Validation Testing | Software verification testing in<br>compliance with FDA guidance<br>"General Principles of Software<br>Validation" and IEC 62304: 2006 | Evaluation and testing were performed on<br>the subject device and demonstrated<br>substantially equivalent performance to<br>identified predicate device |
| Cleaning- and Sterilization<br>Validation | Testing in compliance with FDA<br>Guidance "Reprocessing<br>Medical Devices in Health Care<br>Settings: Validation Methods<br>and Labeling" and the following<br>standards:<br>ISO 17665-1<br>Sterilization of health care<br>products -Moist heat - Part 1: | Evaluation was performed of the subject<br>device and demonstrated to be<br>substantially equivalent to the identified<br>predicate devices. |

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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 the<br>Development, Validation and<br>Routine Control of a Sterilization<br>Process for Medical Devices and<br>ISO 17664 Sterilization of<br>medical devices --Information to<br>be provided by the manufacturer<br>for the processing of re-<br>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.