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 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 controls the movement and maneuvering of the 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:

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, retract, and rotate the guide catheter. The Robotic Drive and Control Console communicate via a single communication cable.

In addition, the CorPath GRX Software contains the following functionality for automated movements (also referred to as the technIQ automated movements), of the interventional devices:

. Rotate on Retract - When selected, rotates the guidewire a set amount upon retraction of the quidewire joystick to facilitate redirection of the quidewire while it is being navigated to the target location (previously cleared under CorPath GRX System, K173806).
Wiggle - When selected, this movement enables a small clockwise and counterclockwise rotation of the guidewire while advancing to assist in navigation.
. Spin - When selected, this movement will enable a large clockwise and counterclockwise rotation of the quidewire while advancing to assist in lesion crossing.
. Constant Speed - When selected, the guidewire or device joysticks will advance and retract at a constant speed of either 2mm/second or 5mm/second depending on the speed selected by the operator.
. Dotter - When selected, this movement will enable a linear back and forth motion of the device when advancing to assist in lesion crossing and delivery of therapy.

AI/ML Overview

This document describes a 510(k) premarket notification for the CorPath GRX System, a robotic system for percutaneous coronary and vascular procedures. The submission focuses on software changes introducing four additional automated features (spin, wiggle, dotter, and constant speed) to the already cleared CorPath GRX System.

Here's an analysis based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, it states that "All testing has demonstrated that the device is substantially equivalent to the predicate device." The acceptance criterion is, therefore, demonstrating substantial equivalence to the predicate device (CorPath GRX System, K173806, and K173288).

Acceptance Criteria	Reported Device Performance
Device functions as intended with new automated features (Spin, Wiggle, Dotter, Constant Speed).	"All testing has demonstrated that the device is substantially equivalent to the predicate device." "The technIQ automated moves for the CorPath GRX System do not change the safety profile of the device as there is no change to delivery forces and the operator maintains complete control of all movements of the devices."
No change in safety profile due to new automated features.	"The technIQ automated moves for the CorPath GRX System do not change the safety profile of the device as there is no change to delivery forces and the operator maintains complete control of all movements of the devices."
Continued compliance with relevant regulations and performance standards.	Demonstrated through various non-clinical tests (Functional Testing, Simulated Use Testing, Particulate Testing, Software Verification and Validation testing, Cybersecurity Penetration Testing).

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

The document mentions "Simulated Use Testing" and states that "Clinical data from the post-market PRECISION GRX Study was used to help demonstrate substantial equivalence." However, it does not specify the sample size for either the simulated use testing or the PRECISION GRX Study, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective) for the clinical data.

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

This information is not provided in the document. The study appears to be focused on technical verification and validation, and a comparison against a predicate, rather than an expert-adjudicated performance study where "ground truth" would typically be established by multiple experts.

4. Adjudication method for the test set

This information is not provided in the document. Given the nature of the testing described (functional, simulated use, software verification), a formal adjudication method by multiple experts is unlikely to have been used in the same way it would be for a diagnostic AI study.

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

There is no indication that an MRMC comparative effectiveness study was done. The device is a "Steerable Catheter Control System," not an AI diagnostic tool, so the concept of "human readers improving with AI assistance" does not directly apply in the context of this submission. The "technIQ automated movements" are intended to assist the physician in manipulating devices, but the document does not include a comparative study of physician performance with vs. without these specific automated features.

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

The device is a robotic system designed to be operated by a physician ("human-in-the-loop"). The "automated movements" are features within this system, not a standalone AI algorithm. Therefore, a standalone (algorithm only) performance study as typically understood for AI diagnostic devices was not done and would not be relevant for this type of device. The verification and validation testing would have involved the system with its automated features, likely within simulated use or benchtop environments.

7. The type of ground truth used

For the non-clinical laboratory tests (Functional, Simulated Use, Particulate, Software V&V, Cybersecurity), the "ground truth" would be established by engineering specifications, design requirements, and established testing protocols. For the "Clinical data from the post-market PRECISION GRX Study," the document does not specify the type of ground truth, but for a robotic intervention system, it would typically relate to procedural success, safety outcomes, and possibly ergonomic benefits, rather than a diagnostic "ground truth" like pathology.

8. The sample size for the training set

This information is not applicable/provided. The submission concerns software updates to a robotic control system with "automated movements," which are likely rule-based or control algorithms, rather than a machine learning model that requires a distinct "training set." Therefore, no training set size is mentioned.

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

This information is not applicable/provided for the same reasons as #8. If the automated movements involve control algorithms rather than learned AI models, the "ground truth" for their development would be based on engineering principles, clinical requirements for device manipulation, and pre-defined operational parameters, not a labeled dataset.

Summary

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December 11, 2020

Corindus, Inc. Dana Hartlein Regulatory Affairs Specialist 309 Waverley Oaks Road, Suite 105 Waltham, Massachusetts 02452

Re: K202275

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: August 7, 2020 Received: August 11, 2020

Dear Dana Hartlein:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure

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Indications for Use

510(k) Number (if known) K202275

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:	August 7, 2020
Contact Person:	Dana Hartlein, Regulatory Affairs Specialist
Telephone Number:	W: (508) 653-3335 x215
Fax Number:	(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: K173806 (Primary Predicate)K173288 (Reference Predicate)
Device Description:	The CorPath GRX System is intended to allow physiciansto deliver and manipulate commercially available

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quidewires, rapid exchange catheters and quide catheters during percutaneous coronary and vascular procedures. During the use of the CorPath GRX System, the physician controls the movement and maneuvering of the 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:

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.

In addition, the CorPath GRX Software contains the following functionality for automated movements (also referred to as the technIQ™ automated movements), of the interventional devices:

. Rotate on Retract - When selected, rotates the guidewire a set amount upon retraction of the quidewire joystick to facilitate redirection of the quidewire while it is being navigated to the target location (previously cleared under CorPath GRX System, K173806).
Wiggle - When selected, this movement enables a small clockwise and counterclockwise rotation of the guidewire while advancing to assist in navigation.
. Spin - When selected, this movement will enable a large clockwise and counterclockwise rotation of the quidewire while advancing to assist in lesion crossing.
. Constant Speed - When selected, the guidewire or device joysticks will advance and retract at a constant speed of either 2mm/second or 5mm/second depending on the speed selected by the operator.

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. Dotter - When selected, this movement will enable a linear back and forth motion of the device when advancing to assist in lesion crossing and delivery of therapy.
The product subject of this premarket notification is substantially equivalent in design and functionality to the CorPath GRX System (K173806, Primary Predicate cleared March 1, 2018; and K173288, Reference Predicate cleared February 15, 2018).

The proposed CorPath GRX System and the predicate CorPath GRX System have the same technological characteristics. The modified CorPath GRX System consists of software changes to include 4 additional automated features; spin, wiggle, dotter, and constant speed. There have been no additional changes to the modified CorPath GRX System with respect to 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:

Functional Testing ●
. Simulated Use Testing
. Particulate Testing
Software Verification and Validation testing
. Cybersecurity Penetration Testing

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

Clinical data from the post-market PRECISION GRX Study was used to help demonstrate substantial equivalence.

The technIQ automated moves for the CorPath GRX System do not change the safety profile of the device as there is no change to delivery forces and the operator maintains complete control of all movements of the devices.

Substantial

Equivalence:

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Safety andPerformance:	The determination of substantial equivalence for thisdevice was based on a detailed device description, non-clinical performance testing, and supplemental clinicaldata. The performance testing and clinical datademonstrate the device is considered substantiallyequivalent to the predicate device.
Conclusion:	Based on the bench testing conducted, it is concluded thatthe CorPath GRX System is substantially equivalent to thePrimary Predicate CorPath GRX System (K173806) andthe CorPath GRX System Reference Predicate(K173288).

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).