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 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, a medical device used for remote delivery and manipulation of guidewires and catheters during percutaneous coronary and vascular procedures. However, the document does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria for the following reasons:

This is a 510(k) for a modified device, not a new AI/algorithm driven device. The current 510(k) (K221464) describes a modification to a previously cleared device (CorPath GRX System, K202275). The modification is specifically "limited to modified cassette design to allow an alternate off-the-shelf hemostasis valve to be utilized with the Single-Use Cassette."
The testing described is for substantial equivalence of the modification. The "Verification/validation testing" mentioned focuses on demonstrating that the modified system is substantially equivalent to the predicate, specifically through "Performance Testing Single-Use Cassette." This is typical for a 510(k) update for a minor change.
There is no mention of AI, machine learning, or algorithm performance. The questions you've posed (acceptance criteria for AI, training/test sets, human readers, ground truth, etc.) are highly relevant to AI/ML medical devices where the algorithm's performance is the primary subject of evaluation. This document describes a mechanical/hardware modification, not an AI component.

Therefore, based solely on the provided text, I cannot answer the questions about acceptance criteria for an AI device or a study proving an AI device meets those criteria. The information required (e.g., performance metrics like sensitivity/specificity, sample sizes for AI validation, expert consensus for ground truth) is not present because this 510(k) is not about an AI-driven device or its performance.

Summary

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Corindus, Inc. Robert Lavado Sr. Manager, Regulatory Affairs 309 Waverley Oaks Road, Suite 105 Waltham, Massachusetts 02452

Re: K221464

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: May 6, 2022 Received: May 19, 2022

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. 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 (OS) 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 medical devices and radiation-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/cdrl-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.

for 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) K221464

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

Submitter's Name andAddress:	Corindus, Inc.309 Waverley Oaks RoadSuite 105Waltham, MA 02452
EstablishmentRegistration Number:	3007822508
Date of Summary:	July 27, 2022
Contact Person:Telephone Number:Fax Number:	Robert Lavado, Sr. Manager, Regulatory Affairs(978) 760-7727(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.
ldentification of theLegally MarketedDevice (PredicateDevice):	CorPath GRX SystemDevice Class:Product Code:DXXRegulation Number: 21 CFR 870.1290510(k) Number:K202275
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.

The product subject of this premarket notification is substantially equivalent in design and functionality to the CorPath GRX System (K202275, cleared December 11, 2020).

The modified CorPath GRX System and the predicate CorPath GRX System have the same technological characteristics and functionality. The changes are limited to modified cassette design to allow an alternate off-theshelf hemostasis valve to be utilized with the Single-Use Cassette. 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 Single-Use Cassette .
Substantial Equivalence:

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

Performance: 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 and 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 (K202275, cleared December 11, 2020).

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).