CorPath GRX System

K173806 · Corindus, Inc. · DXX · Mar 1, 2018 · Cardiovascular

Device Facts

• Record ID: K173806
• Device Name: CorPath GRX System
• Applicant: Corindus, Inc.
• Product Code: DXX · Cardiovascular
• Decision Date: Mar 1, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1290
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.

Device Story

CorPath GRX System enables remote robotic-assisted percutaneous coronary intervention (PCI). Physician operates from a remote console, away from radiation source, using joysticks and touchscreen to control a bedside robotic drive. System accepts commercially available guidewires, rapid exchange balloon/stent catheters, and guide catheters loaded into a single-use cassette. Robotic drive advances, retracts, and rotates these devices under fluoroscopic guidance. Includes 'Rotate on Retract' feature for automated guidewire redirection. System consists of a bedside unit (robotic arm/drive) and a remote workspace (console/monitors). Benefits include reduced radiation exposure for the physician and precise, computer-controlled device manipulation.

Clinical Evidence

Bench testing only. No clinical data presented. Performance, functional, and software verification/validation testing were conducted to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

System comprises a bedside unit (extended reach arm, robotic drive, single-use cassette) and a remote workspace (control console, monitors). Connectivity via communication cable. Operates via computer-controlled robotic manipulation of interventional devices. Software includes automated movement functionality.

Indications for Use

Indicated for patients undergoing percutaneous coronary intervention (PCI) procedures requiring remote delivery and manipulation of guidewires, rapid exchange balloon/stent catheters, and guide catheters.

Regulatory Classification

Identification

A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.

Predicate Devices

• CorPath GRX System (K160121)

Submission Summary (Full Text)

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March 1, 2018

Corindus, Inc. Robert Lavado Manager, Regulatory Affairs 309 Waverley Oaks Road Waltham, Massachusetts 02452

Re: K173806

Trade/Device Name: CorPath GRX System Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II Product Code: DXX Dated: December 13, 2017 Received: December 15, 2017

Dear Robert Lavado:

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K173806

Device Name CorPath GRX System

Indications for Use (Describe)

The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K173806

## 6.0 510(K) SUMMARY

| Submitter's Name and<br>Address: | Corindus, Inc.<br>309 Waverley Oaks Road<br>Suite 105<br>Waltham, MA 02452 |
|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>Registration Number: | 3007822508 |
| Date of Summary: | February 28, 2018 |
| Contact Person:<br>Telephone Number:<br>Fax Number: | Robert Lavado, Manager, Regulatory Affairs<br>[phone] x211<br>[phone] |
| Name of the Device: | CorPath GRX System |
| Common Name: | CorPath GRX System |
| Regulatory Status and<br>Regulation Number: | Class II<br>21 CFR 870.1290 |
| Classification Name: | System, Catheter Control, Steerable |
| Device Classification: | Product Code:<br>DXX: Steerable Catheter Control System. |
| Indications for Use: | The CorPath GRX System is intended for use in the<br>remote delivery and manipulation of guidewires and rapid<br>exchange balloon/stent catheters, and remote<br>manipulation of guide catheters during percutaneous<br>coronary intervention (PCI) procedures. |
| Identification of the<br>Legally Marketed<br>Device (Predicate<br>Device): | CorPath GRX System<br>Device Class: II<br>Product Code: DXX<br>Regulation Number: 21 CFR 870.1290<br>510(k) Number: K160121 |
| Device Description: | The CorPath GRX System is intended to allow physicians<br>to deliver and manipulate commercially available<br>guidewires, rapid exchange balloon/stent catheters and<br>guide catheters during percutaneous coronary intervention |

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procedures. During the use of the CorPath GRX System, the physician maneuvers the devices using intuitive controls under independent angiographic fluoroscopy visual quidance using computer controlled movements while in a seated position away from the radiation source.

The CorPath GRX System is composed of the following two functional sub-units:

- 1. Bedside Unit Which consists of the Extended Reach Arm, Robotic Drive and Single-use Cassette
- 2. Remote Workspace Which consists of the Control Console, angiographic monitor(s), hemodynamic monitors, X-ray foot pedal, and optional Interventional Cockpit.

Commercially available guidewires, rapid exchange balloon/stent catheters, and guide catheters are loaded into the Single-use Cassette. By using the joysticks or the Control Console touch screen, the physician can control the Robotic Drive to advance, retract, and rotate the guidewire, advance and retract the rapid exchange catheter, and advance, retract, and rotate the guide catheter. The Robotic Drive and Control Console communicate via a single communication cable.

In addition, the CorPath GRX System Software contains a functionality for an automated movement of the guidewire, known as "Rotate on Retract." This feature, when enabled by the physician will rotate the quidewire a set amount upon retraction of the quidewire joystick to facilitate redirection of the guidewire which it is being directed to the lesion location.

Substantial The product subject of this premarket notification is Equivalence: substantially equivalent in design and functionality to the CorPath GRX System (K160121, cleared October 27, 2016).

> The proposed CorPath GRX System and the predicate CorPath GRX System have the same technological characteristics. There have been no changes to the CorPath GRX System with respect to hardware design, materials, packaging, sterilization, or indication.

Verification/validation testing of the CorPath GRX System has been conducted to demonstrate the modified CorPath GRX Systems is substantially equivalent to the predicate device. Tests conducted were identified on the basis of risk analysis activities performed to evaluate the impact of the modification on the device/components.

Specifically, the following non-clinical laboratory tests were performed to determine substantial equivalence:

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- Performance Testing .
- . Functional Testing
- Software Verification and Validation testing ●

All testing has demonstrated that the device is substantially equivalent to the predicate device.

| Safety and | The determination of substantial equivalence for this |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance: | device was based on a detailed device description and<br>non-clinical laboratory testing. The testing demonstrated<br>that the device is safe for its intended use and can be<br>considered substantially equivalent to the predicate<br>device. |

- Based on the bench testing conducted, it is concluded that Conclusion: the CorPath GRX System is substantially equivalent to the predicate CorPath GRX System (K160121, cleared October 27, 2016).