The CorPath GRX 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 coronary guidewires, rapid exchange balloon/stent catheters, and guide catheters during percutaneous coronary intervention (PCI) procedures. During the use of the CorPath GRX System, the physician maneuvers interventional devices using intuitive controls under independent angiographic fluoroscopy visual guidance 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:

Bedside Unit: Which consists of the Articulated Arm, Robotic Drive and Single-use Cassette, and the
Remote Workspace: Which consists of the Interventional Cockpit (radiation shielded) which houses the Control Console, angiographic monitor(s), hemodynamic monitors and X-ray foot pedal.

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 screens the physician can control the Robotic Drive to advance, retract, and rotate the guide wire, advance and retract the balloon/stent catheter, and advance, retract and rotate the guide catheter. The Robotic Drive and Control Console communicate via a single communication cable.

AI/ML Overview

The provided document describes the CorPath GRX System, a robotic system for remote delivery and manipulation of guidewires, balloon/stent catheters, and guide catheters during percutaneous coronary intervention (PCI) procedures. The document confirms substantial equivalence to a predicate device, the CorPath 200 System.

Here's an analysis of the acceptance criteria and study information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria in a table format with corresponding reported device performance values. Instead, it describes various tests performed to demonstrate safety and effectiveness for substantial equivalence. The focus is on functionality and performance matching the predicate device.

Acceptance Criteria Category (Inferred)	Reported Device Performance (Summary)
Functional Equivalence	Device design and operational principles are substantially equivalent to the predicate CorPath 200 System.
- Manipulation of Guidewires	Allows linear and rotational movement, similar to predicate.
- Manipulation of Rapid Exchange Balloon/Stent Catheters	Allows linear movement, similar to predicate.
- Manipulation of Guide Catheters	New capability for linear and rotational movement, which the predicate did not have for guide catheters. This is a key difference but still deemed substantially equivalent based on testing.
Material Biocompatibility	Single-use cassette materials tested and deemed biocompatible.
Software Functionality	Software verification and validation testing performed.
Electromagnetic Compatibility (EMC)	EMC testing performed.
Particulate Release	Guide Catheter Particulate Analysis performed.
Simulated Procedure Performance	Simulated procedure testing performed.
In-Vivo Performance (Safety)	Successful PCI (balloon angioplasty and stent deployment) in porcine study using CorPath GRX, comparable to manual control group.

2. Sample size used for the test set and the data provenance

Bench Testing: The document lists several bench tests (Performance, Functional, Guide Catheter Particulate Analysis, Simulated Procedure Testing, Biocompatibility, Software V&V, EMC).
- Sample Size: Not specified. Standard testing typically uses a statistically appropriate number of units or iterations per test, but the exact numbers are not provided.
- Data Provenance: Not specified, but generally, bench tests are conducted in a controlled laboratory environment by the manufacturer.
Pre-Clinical Study (In-vivo):
- Sample Size: Eight (8) pigs underwent PCI using the CorPath GRX System, and four (4) pigs served as a control group for manual treatment.
- Data Provenance: This was an animal study (porcine), conducted specifically for this device (prospective). Country of origin is not specified but is typically within the country of the manufacturer or a designated contract research organization.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Bench Testing: Not applicable in the sense of expert consensus for ground truth. Tests are against defined specifications or engineering standards.
Pre-Clinical Study (In-vivo): The document implies that the study involved performing PCI and comparing outcomes, likely assessed by veterinary or interventional cardiology experts. However, the number of experts used to establish "ground truth" (e.g., successful PCI, absence of adverse events) and their specific qualifications are not explicitly stated in this document. It implies standard veterinary/clinical assessment.

4. Adjudication method for the test set

Bench Testing: Adjudication methods are not specified. Typically, these tests are objective, with pass/fail criteria.
Pre-Clinical Study (In-vivo): Adjudication method for the animal study outcomes (successful PCI, comparison to control) is not specified.

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, an MRMC comparative effectiveness study was not done. The CorPath GRX System is a robotic surgical assistance system, not an AI-assisted diagnostic imaging device that would typically involve human readers interpreting images. The study involved device performance during PCI procedures, not diagnostic accuracy improvement for human readers.

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

Not applicable in the typical sense of AI standalone performance. The CorPath GRX System is explicitly described as a "robot-assisted" system where the physician *maneuvers interventional devices using intuitive controls... using computer controlled movements." It's a human-in-the-loop system by design; it doesn't operate independently as a standalone algorithm without a physician. The pre-clinical study compared robotic-assisted PCI (human + robot) vs. manual PCI (human only).

7. The type of ground truth used

Bench Testing: Ground truth is established by engineering specifications, functional requirements, and recognized standards for biocompatibility, software validation, and electromagnetic compatibility.
Pre-Clinical Study (In-vivo): The ground truth for the animal study would be based on clinical outcomes observed during and after the PCI procedures in the pigs (e.g., successful guidewire advancement, balloon inflation, stent deployment, patency of the vessel, lack of complications upon necropsy/follow-up). This is outcomes data combined with direct observation and assessment by veterinary/medical professionals.

8. The sample size for the training set

Not applicable / Not specified. The CorPath GRX System is a robotic control system for medical devices, not a machine learning or AI system that requires a "training set" in the conventional sense of data-driven model training. Its functionality is based on electromechanical design and control algorithms, not learning from large datasets.

9. How the ground truth for the training set was established

Not applicable. As the device does not employ a machine learning model requiring a training set, the concept of establishing ground truth for a training set is not pertinent to this submission.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 27, 2016

Corindus, Inc. % Mona Advani Senior Consultant Cardiomed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, Maryland 21228

Re: K160121

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: October 21, 2016 Received: October 24, 2016

Dear Mona Advani:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Brian D. Pullin -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) K160121

Device Name CorPath GRX System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) SUMMARY

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 807.92 (c).

1. SUBMITTER/510(K) HOLDER

Company Name and Address:	Corindus Inc.309 Waverley Oaks RoadSuite 105Waltham, MA 02452
Company Contact:	Robert LavadoEmail:Rob.lavado@corindus.comPhone: (508) 635-3335 x 211Fax: (508) 653-3355

Establishment Registration Number: 3007822508

Contact Person:	Mona Advani
Email:	madvani@cardiomedllc.com
Phone:	(650) 575-5819
Fax:	(617) 663-6052

October 21, 2016 Date Prepared:

2. DEVICE NAME

Proprietary Name:	CorPath GRX
Common/Usual Name:	CorPath GRX System
Product Code:	DXX (Steerable catheter control system)
Classification Name:	Steerable Catheter Control System

3. PREDICATE DEVICE

CorPath 200 System manufactured by Corindus, Inc., K120834 and K150892. .

4. DEVICE DESCRIPTION

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

5. INDICATION FOR USE

The CorPath GRX 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.

6. TECHNOLOGICAL CHARACTERISTICS

The CorPath GRX System is intended to allow physicians to deliver and manipulate commercially available coronary guidewires, balloon/stent catheters, and guide catheters during percutaneous coronary intervention (PCI) procedures. During the use of the CorPath GRX System, the physician maneuvers interventional devices using intuitive controls under independent angiographic fluoroscopy.

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

1. Bedside Unit: Which consists of the Articulated Arm, Robotic Drive and Single-use Cassette, and the
1. Remote Workspace: Which consists of the Interventional Cockpit (radiation shielded) which houses the Control Console, angiographic monitor(s), hemodynamic monitors and X-ray foot pedal.

7. Substantial Equivalence

The product subject of this premarket notification is substantially equivalent in design and functionality to the CorPath 200 System (K120834, K150892).

The table below compares the technical characteristics of the CorPath GRX System to the predicate CorPath 200 System.

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Characteristics	CorPath GRX System(Subject Device, previously describedas the CorPath 300 System)	CorPath 200 SystemK150892 and K120834(Predicate Device)
Manufacturer	Corindus, Inc.	Corindus, Inc.
Indication for use	The CorPath GRX System is intendedfor use in the remote delivery andmanipulation of coronary guidewiresand rapid exchange balloon/stentcatheters, and remote manipulation ofguide catheters during percutaneouscoronary intervention (PCI) procedures.	The CorPath 200 System isintended for use in the remotedelivery and manipulation ofcoronary guidewires and rapidexchange balloon/stent cathetersduring percutaneous coronaryintervention (PCI) procedures.
Intended use	Percutaneous coronary intervention(PCI) procedures	Percutaneous coronary intervention(PCI) procedures
Device Design	The CorPath GRX System is composedof:Control ConsoleRemote WorkspaceArticulated ArmRobotic DriveCassette (single-use)	The CorPath 200 System iscomposed of:Control ConsoleRemote WorkspaceArticulated ArmRobotic DriveCassette (single-use)
Operational principles	The physician, seated at the RemoteWorkspace manipulates coronaryguidewires, balloon/stent catheters andguide catheters using joysticks or touch-screen controls on the Control Console	The physician, seated at theRemote Workspace, manipulatescoronary guidewires and/orballoon/stent catheters usingjoysticks or touch-screen controlson the Control Console.
Visualization duringProcedure	Fluoroscopy	Fluoroscopy
Compatible withCommercially availablePCI Devices	Yes, compatible with commerciallyavailable:Guide cathetersGuidewiresRapid Exchange balloon/stentcatheters	Yes, compatible with commerciallyavailable:GuidewiresRapid Exchange balloon/stentcatheters
Linear movement of PCIdevices	Yes, allows for linear movement of:GuidewiresRapid exchange balloon/stentcathetersGuide Catheters	Yes, allows for linear movementof:GuidewiresRapid Exchange balloon/stentcatheters
Rotational movement ofPCI devices	Yes, allows for rotational movement of:GuidewiresGuide Catheters	Yes, allows for rotationalmovement of:Guidewires
Materials (single-useCassette)	The single-use sterile Cassette isassembled from a variety of customplastic parts and machined stainlesssteel components, as well as off-the-shelf miniature magnets, roller bearingsand springs.	The single-use sterile Cassette isassembled from a variety of customplastic parts and machined stainlesssteel components, as well as off-the-shelf miniature magnets, rollerbearings and springs.

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Bench Testing

Bench testing and in-vivo animal studies were performed to determine substantial equivalence. Specifically, the following bench tests were performed.

Performance testing of the CorPath GRX System .
Functional testing of the CorPath GRX System .
Guide Catheter Particulate Analysis
Simulated Procedure Testing ●
Biocompatibility Testing of the Single-Use Cassette ●
Software verification and validation testing ●
EMC Testing of the CorPath GRX System

Pre-Clinical Study

To further verify the safety of the CorPath GRX System, an in-vivo porcine study was conducted. Eight (8) pigs underwent PCI (balloon angioplasty and stent deployment) of the mid left anterior descending artery (LAD) performed using the CorPath GRX System and the results were compared to a four (4) pig control group which was treated manually.

8. Conclusion

Based on the testing conducted, it is concluded that the CorPath GRX System is substantially equivalent to the predicate CorPath 200 system (K150892 cleared October 2, 2015 and K120834 cleared July 19, 2012).

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).