The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures.

Device Description

The CorPath GRX System is intended to allow physicians to deliver and manipulate commercially available guidewires, rapid exchange catheters and guide catheters during percutaneous coronary and vascular procedures. During the use of the CorPath GRX System, the physician maneuvers interventional 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
1. 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 catheters, and guide catheters are loaded into the Singleuse 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, retrace, and rotate the guide catheter. The Robotic Drive and Control Console communicate via a single communication cable.

AI/ML Overview

The provided text is a 510(k) summary for the CorPath GRX System, which is a steerable catheter control system used for remote delivery and manipulation of guidewires, rapid exchange catheters, and guide catheters during percutaneous coronary and vascular procedures.

This document describes a submission for a modificiation (K180517) to an already cleared device, the CorPath GRX System (K173288). The modification is specifically "limited to a new bedrail connection design for the Extended Reach Arm component."

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (What was measured)	Reported Device Performance (Result)
Demonstration of substantial equivalence to predicate device (K173288) after modification (new bedrail connection for Extended Reach Arm component).	"All testing has demonstrated that the device is substantially equivalent to the predicate devices." (Page 5) "The testing demonstrated that the device can be considered substantially equivalent to the predicate devices." (Page 5) "Based on the bench testing conducted, it is concluded that the CorPath GRX System is substantially equivalent to the predicate device, the CorPath GRX System (K173288, cleared February 15, 2018)." (Page 5)
Performance Testing of Extended Reach Arm (specifically related to the new bedrail connection design).	"Performance Testing Extended Reach Arm" was conducted, and the results contributed to the overall finding of substantial equivalence. The document doesn't provide specific quantitative metrics, but states the testing was successful. (Page 5)
Compliance with IEC 60601-1 Safety Testing.	"IEC 60601-1 Safety Testing" was conducted, and the results contributed to the overall finding of substantial equivalence. The document doesn't provide specific quantitative metrics, but states the testing was successful. (Page 5)

2. Sample Size Used for the Test Set and the Data Provenance:

The document describes non-clinical laboratory tests rather than studies involving human subjects or real-world patient data. Therefore, the concepts of "sample size for the test set" and "data provenance (e.g., country of origin of the data, retrospective or prospective)" as typically applied to clinical or AI performance studies are not directly applicable here. The testing was performed on the device itself and its components.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This information is not applicable. The study involved engineering and safety testing of a medical device, not a diagnostic or prediction task that would require expert-established ground truth on a test set.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This was a 510(k) submission for a robotic catheter control system, not an AI-assisted diagnostic or interpretation device that would involve human readers or MRMC studies. The device itself performs actions (delivery and manipulation of catheters) under human control.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device is inherently a "human-in-the-loop" system, as physicians maneuver interventional devices using controls. The testing described focuses on the device's mechanical, electrical, and safety performance following a modification, not on an "algorithm only" performance.

7. The Type of Ground Truth Used:

The "ground truth" for this type of submission is the functional and safety standards (e.g., IEC 60601-1) and the performance characteristics of the predicate device. The testing's purpose was to demonstrate that the modified device's performance meets these established benchmarks and remains substantially equivalent to the original cleared device despite the design change.

8. The Sample Size for the Training Set:

This information is not applicable. This is not an AI/machine learning device that involves a training set. The "training" for such a device would be its design, engineering, and manufacturing processes, culminating in verification and validation testing.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reason as point 8.

Summary

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March 29, 2018

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

Re: K180517

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: February 26, 2018 Received: February 27, 2018

Dear Robert Lavado:

We have reviewed vour 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

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manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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,

Nicole G. Ibrahim -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) K180517

Device Name CorPath GRX System

Indications for Use (Describe)

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)

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510(K) SUMMARY

Submitter's Name andAddress:	Corindus, Inc.309 Waverley Oaks RoadSuite 105Waltham, MA 02452
EstablishmentRegistration Number:	3007822508
Date of Summary:	March 28, 2018
Contact Person:Telephone Number:Fax Number:	Robert Lavado, Manager, Regulatory Affairs(508) 653-3335 x211(508) 653-3355
Name of the Device:	CorPath GRX System
Common Name:	CorPath GRX System
Regulatory Status andRegulation Number:	Class II21 CFR 870.1290
Classification Name:	System, Catheter Control, Steerable
Device Classification:	Product Code:DXX: Steerable Catheter Control System.
Indications for Use:	The CorPath GRX System is intended for use in theremote delivery and manipulation of guidewires and rapidexchange catheters, and remote manipulation of guidecatheters during percutaneous coronary and vascularprocedures.
Identification of theLegally MarketedDevice (PredicateDevice):	CorPath GRX SystemDevice Class:IIProduct Code:DXXRegulation Number: 21 CFR 870.1290510(k) Number:K173288
Device Description:	The CorPath GRX System is intended to allow physiciansto deliver and manipulate commercially availableguidewires, rapid exchange catheters and guide catheters

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during percutaneous coronary and vascular procedures. During the use of the CorPath GRX System, the physician maneuvers interventional 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
1. Remote Workspace Which consists of the Control Console, angiographic monitor(s), hemodynamic monitors, X-ray foot pedal, and optional Interventional Cockpit.

Substantial The product subject of this premarket notification is substantially equivalent in design and functionality to the Equivalence: CorPath GRX System (K173288, cleared February 15, 2018).

The modified CorPath GRX System and the predicate CorPath GRX System have the same technological characteristics and functionality. The changes are limited to a new bedrail connection design for the Extended Reach Arm component. There have been no changes to the modified CorPath GRX System with respect to packaging, sterilization, or method of action.

Verification/validation testing of the CorPath GRX System has been conducted to demonstrate the modified CorPath GRX Systems is substantially equivalent to the predicate devices. 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:

Performance Testing Extended Reach Arm ●
IEC 60601-1 Safety Testing .

All testing has demonstrated that the device is

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substantially equivalent to the predicate devices.

The determination of substantial equivalence for this Performance: device was based on a detailed device description and non-clinical laboratory testing. The testing demonstrated that the device can be considered substantially equivalent to the predicate devices.
Conclusion: Based on the bench testing conducted, it is concluded that the CorPath GRX System is substantially equivalent to the predicate device, the CorPath GRX System (K173288, cleared February 15, 2018).

Regulation Number and Section

§ 870.1290 Steerable catheter control system.

(a)
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.(b)
Classification. Class II (performance standards).