CorPath GRX System by Corindus, Inc.

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 Description

The CorPath GRX System is intended to allow physicians to deliver and manipulate commercially available guidewires, rapid exchange balloon/stent catheters and guide catheters during percutaneous coronary intervention 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
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 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.

AI/ML Overview

The medical device in question is the CorPath GRX System, a steerable catheter control system used for remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for performance in a quantitative manner. Instead, it focuses on demonstrating substantial equivalence to a predicate device (CorPath GRX System, K160121). The "acceptance criteria" are implied to be that the модифицированный CorPath GRX System maintains the same performance, safety, and functionality as its predicate.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Functional Equivalence: Device performs the same intended functions as the predicate device (remote delivery and manipulation of guidewires, rapid exchange balloon/stent catheters, and guide catheters during PCI).	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. The system allows physicians to deliver and manipulate commercially available guidewires, rapid exchange balloon/stent catheters and guide catheters using intuitive controls under independent angiographic fluoroscopy visual guidance, with computer-controlled movements while in a seated position away from the radiation source. An automated "Rotate on Retract" feature is also present.
Performance Equivalence: Device performance (e.g., precision, speed, reliability of manipulation) is comparable to the predicate device.	Performance Testing was conducted. All testing has demonstrated that the device is substantially equivalent to the predicate device. (Specific quantitative performance metrics are not provided in the summary).
Safety Equivalence: Device is as safe as the predicate device and does not introduce new or increased safety risks.	The determination of substantial equivalence for this device was based on a detailed device description and non-clinical laboratory testing. The testing demonstrated that the device is safe for its intended use and can be considered substantially equivalent to the predicate device. (Specific details of safety testing are not provided in the summary beyond general mention of non-clinical tests).
Software Equivalence: Software functions identically or acceptably different with no adverse impact.	Software Verification and Validation testing was conducted. All testing has demonstrated that the device is substantially equivalent to the predicate device.
Functional Testing Equivalence: All components and sub-units operate as intended.	Functional Testing was conducted. All testing has demonstrated that the device is substantially equivalent to the predicate device.

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

The document describes non-clinical laboratory tests (Performance Testing, Functional Testing, Software Verification and Validation testing). It does not mention a "test set" in the context of clinical data, human subjects, or images from a specific country. This is a submission for a robotic system, not an AI diagnostic algorithm. Therefore, the testing refers to bench testing and software validation.
The provenance of these non-clinical tests is internal to the manufacturer (Corindus, Inc.).

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

Not applicable. This device is a robotic system for performing PCI, not an AI diagnostic device that requires expert-established ground truth for image interpretation. The "ground truth" for this device's performance would be its ability to correctly manipulate catheters and guidewires as designed and safely.

4. Adjudication Method for the Test Set:

Not applicable, as this is a non-clinical device performance and verification study, not a study involving human interpretation of data requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document assesses the substantial equivalence of an updated robotic system to its predicate, not the impact of AI assistance on human readers for a diagnostic task.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable in the context of typical AI diagnostic algorithms. The CorPath GRX System itself is a system that operates with "human-in-the-loop" (the physician controls it). The "Rotate on Retract" feature is an automated movement (an algorithm within the system), but its standalone performance as a diagnostic tool is not relevant here. The overall system's performance is intrinsically linked to the physician's operation.

7. Type of Ground Truth Used:

The "ground truth" for this device is based on engineering specifications, functional requirements, and safety standards demonstrated through non-clinical laboratory testing. This includes verifying that the device correctly performs the mechanical movements for guidewire and catheter manipulation, and that its software functions as intended, adhering to safety protocols. It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic AI would be.

8. Sample Size for the Training Set:

Not applicable. This document describes the validation of a robotic system, not the training of an AI algorithm from a dataset of cases. The "training" of the system refers to its design, engineering, and programming according to established principles, not machine learning from a data set.

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

Not applicable. As noted above, there isn't a "training set" in the machine learning sense. The "ground truth" for the development and testing of such a system is established through a rigorous engineering design process, functional specifications, and adherence to relevant standards for medical device safety and performance.

Summary

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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 (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

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Indications for Use

510(k) Number (if known) K173806

Device Name CorPath GRX System

Indications for Use (Describe)

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 andAddress:	Corindus, Inc.309 Waverley Oaks RoadSuite 105Waltham, MA 02452
EstablishmentRegistration Number:	3007822508
Date of Summary:	February 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 balloon/stent catheters, and remotemanipulation of guide catheters during percutaneouscoronary intervention (PCI) procedures.
Identification of theLegally MarketedDevice (PredicateDevice):	CorPath GRX SystemDevice Class: IIProduct Code: DXXRegulation Number: 21 CFR 870.1290510(k) Number: K160121
Device Description:	The CorPath GRX System is intended to allow physiciansto deliver and manipulate commercially availableguidewires, rapid exchange balloon/stent catheters andguide 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
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 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 andnon-clinical laboratory testing. The testing demonstratedthat the device is safe for its intended use and can beconsidered substantially equivalent to the predicatedevice.

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).

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).