CorPath GRX System
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 |
Indications for 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)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
{2}------------------------------------------------
## 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)
## 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 PRAStaff@fda.hhs.gov
"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}------------------------------------------------
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>(508) 653-3335 x211<br>(508) 653-3355 |
| 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 |
{4}------------------------------------------------
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:
{5}------------------------------------------------
- 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).
