The CorPath 200 System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventional (PVI) procedures.

Device Description

The CorPath 200 System is intended for use by physicians in the delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventional (PVI) procedures. The CorPath 200 System allows the physician to deliver and manipulate guidewires and catheters through the vasculature under angiography-assisted visual guidance using computer controlled movements while in a seated position and away from the radiation source.

The CorPath 200 System is composed of two functional sub-units; the Bedside Unit and the Remote Workspace. The Bedside Unit consists of the Articulated Arm, the Robotic Drive and the single-use Cassette. The Remote Workspace consists of the Interventional Cockpit (radiation shield) which houses the Control Console, as well as angiographic monitor(s). Commercially available guidewires and rapid exchange catheters are loaded into the single-use Cassette. By using the joysticks or touch screen of the Control Console, the physician can send commands to the Robotic Drive via a communication cable that advances, retracts or rotates the guidewire, and/or advances or retracts the catheters. The CorPath 200 System's software continuously monitors the communication between the Control Console and the Robotic Drive and alerts the physician if any communication error occurs.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study data for the CorPath 200 System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of pre-defined thresholds that the device needed to meet. Instead, it presents the reported performance directly from two clinical studies. However, based on the studies' objectives and reported outcomes, we can infer the implicit "acceptance criteria" related to safety and effectiveness.

Implicit Acceptance Criteria (Inferred from Study Objectives)	Reported Device Performance (PRECISE Study - PCI)	Reported Device Performance (RAPID Study - PVI)
Effectiveness:
Successful clinical procedural outcome (general)	97.6% clinical procedural success	100% (29/29) clinical procedural success
Successful device technical operation	98.8% overall device technical success	100% (20/20) Device Technical Success (cannulation of target vessel)
Achievement of treatment goal (e.g., residual stenosis)	100% subjects achieved post-procedure stenosis of <30% (Core Lab evaluated)	100% (<50% residual stenosis in treated lesions)
No unplanned switch to manual procedure	Not explicitly stated, but implied by high success rates.	100% (no unplanned switch to manual procedure)
Safety:
Absence of Major Adverse Cardiac Events (MACE)	97.6% absence of MACE	Not applicable for RAPID study (PVI)
Absence of device-related Serious Adverse Events (SAEs)	Not explicitly quantified, but implied by overall safety profile.	100% (No subjects had a device-related SAE during the procedure)
Absence of device malfunctions	Not explicitly quantified, but implied by overall success.	0% (0/20) device malfunctions
Absence of angiographic complications	Not explicitly quantified, but implied by overall success.	0% (0/29) angiographic complications

2. Sample Sizes Used for the Test Set and Data Provenance

PRECISE Clinical Study (PCI):
- Sample Size: 164 subjects.
- Data Provenance: Prospective, multi-center, non-randomized study. The document does not explicitly state the country of origin, but "nine (9) clinical sites" typically implies a domestic (US) study for FDA submissions unless otherwise specified.
RAPID Study (PVI):
- Sample Size: 20 Rutherford Class 2 to 5 subjects (with 29 treated lesions).
- Data Provenance: Prospective, non-randomized feasibility evaluation. The document does not explicitly state the country of origin.

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

PRECISE Clinical Study (PCI):
- Specifics of ground truth experts are not explicitly detailed. However, it mentions "post-procedure stenosis of less than 30% (as evaluated by a Core Laboratory)." A Core Laboratory implies a specialized facility with imaging experts (e.g., interventional cardiologists, radiologists) responsible for standardized, blinded evaluation of angiographic images. The number and specific qualifications (years of experience) are not provided.
RAPID Study (PVI):
- Specifics of ground truth experts are not explicitly detailed. Angiographic assessments (e.g., <50% residual stenosis) would typically be made by the interventional cardiologists or radiologists involved in the study, likely with independent verification, but this is not explicitly stated.

4. Adjudication Method for the Test Set

PRECISE Clinical Study (PCI):
- The document refers to a "Core Laboratory" for stenosis evaluation. Core laboratories typically employ adjudicated methods to ensure consistency and minimize bias, often involving multiple readers and consensus, but the specific adjudication method (e.g., 2+1, 3+1) is not explicitly mentioned.
RAPID Study (PVI):
- The document does not describe the adjudication method for the performance metrics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improving with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study, as typically understood for AI-assisted diagnostic devices, was explicitly described. The provided studies (PRECISE and RAPID) evaluated the robotic system's performance during the procedure, not as an AI diagnostic tool assisting human readers in interpreting medical images.
The PRECISE trial did demonstrate "a reduction of radiation exposure to the primary operator," which is a beneficial effect related to using the robotic system, allowing the operator to be further from the radiation source. This is a safety benefit for the human operator, not an improvement in diagnostic accuracy or speed for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done because the CorPath 200 System is a robotic-assisted catheter control system designed for human-controlled manipulation during procedures, not a diagnostic AI algorithm. Its function is to execute the physician's commands remotely, not to provide independent analysis or decisions. The performance metrics reflect the combined performance of the system and the physician using it.

7. The Type of Ground Truth Used

PRECISE Clinical Study (PCI):
- Expert Consensus/Clinical Outcomes: This includes evaluation by a "Core Laboratory" for angiographic stenosis, and clinical endpoints like Major Adverse Cardiac Events (MACE) and overall procedural success. MACE is an important clinical outcome.
RAPID Study (PVI):
- Clinical Outcomes/Procedural Success: This includes successful cannulation, <50% residual stenosis, absence of device-related SAEs, and absence of angiographic complications, all as determined by clinical assessment during and after the procedure.

8. The Sample Size for the Training Set

Not Applicable / Not Provided. The CorPath 200 System, as described, is a robotic control system for physical manipulation of medical devices, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its "software continuously monitors the communication," but this refers to operational control, not a learning algorithm that processes data to improve its diagnostic or predictive capability. Therefore, there is no mention of a "training set" for the device's core functionality.

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

Not Applicable / Not Provided. As there is no described training set for an AI algorithm, the method for establishing its ground truth is not relevant to this device's description.

Summary

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

March 18, 2016

Corindus, Inc. % Ms. Mona Advani Senior Consultant CardioMed Device Consultants 5523 Research Park Drive, Suite 205 Baltimore, MD 21228

Re: K152999

Trade/Device Name: CorPath 200 System Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II Product Code: DXX Dated: February 19, 2016 Received: February 22, 2016

Dear Ms. 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,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K152999

Device Name CorPath 200 System

Indications for Use (Describe)

The CorPath 200 System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventional (PVI) procedures.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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).

Applicant:	Corindus, Inc.309 Waverly Oaks Rd., Suite 105Waltham, MA 02452(P): (508) 653-3335(F): (617) 500-0978
Contact Person:	Mona AdvaniRegulatory Affairs Consulting Agent for Corindus, IncCardioMed Device Consultants, LLC5523 Research Park Drive, Suite 205Baltimore, MD 21228Email: madvani@cardiomedllc.com(P): (650) 575-5819(F): (617) 663-6052
Date Prepared:	March 16, 2016
Device Information:
Trade Name:	Corindus CorPath® 200 System
Common Name:	CorPath System
Product Code:	DXX (Steerable catheter control system)
Regulation Number:	21 CFR 870.1290 (Steerable catheter control system)
Predicate Device(s):	Corindus CorPath 200 System (K120834. K150892)

Magellan Robotic System (K111004, K141614)

Device Description

Indication for Use

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The CorPath 200 System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventional (PVI) procedures.

Technological Characteristics

Performance Data

The CorPath 200 System for PVI is identical in design to the predicate CorPath 200 System for PCI and thus no new performance testing was conducted. Non-clinical testing of the predicate CorPath 200 System leveraged previously conducted bench and animal performance testing. biocompatibility, sterilization, packaging, and product shelf life testing from the predicate device, and is applicable to the CorPath 200 System for PVI. These tests demonstrated that the technological characteristics such as product performance, design and intended use are substantially equivalent to the currently marketed predicate devices.

Clinical Data

The CorPath 200 System was previously evaluated for PCI in the PRECISE Clinical Study. The PRECISE Clinical Study was a prospective, single-arm, multi-center, nonrandomized study of the CorPath 200 System. The objective of the study was to evaluate the safety and effectiveness of the clinical and technical performance of the CorPath 200 System in the delivery and manipulation of coronary guidewires and stent/balloon devices for use in PCI procedures. One hundred and sixty-four (164) subjects were enrolled and evaluated in the PRECISE Clinical Study at nine (9) clinical sites. The overall rate of clinical procedural success was 97.6%. One hundred percent of subjects achieved post-procedure stenosis of less than 30% (as evaluated by a Core Laboratory) and 97.6% of subjects had an absence of Major Adverse Cardiac Events (MACE). The overall device technical success rate was 98.8%. The PRECISE Trial demonstrated a reduction of radiation exposure to the primary operator.

The Robotic-Assisted Peripheral Intervention for peripheral arterial Disease (RAPID) Study was also conducted, which was a prospective non-randomized feasibility evaluation of the CorPath 200 System for use in the remote delivery and manipulation of guidewires and rapid exchange catheters during peripheral interventions. Subjects eligible to participate in the study had symptomatic

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disease with either presence of critical limb ischemia, or lifestyle-limiting claudication requiring percutaneous transluminal angioplasty (PTA). This study enrolled 20 Rutherford Class 2 to 5 subjects. There were 29 treated lesions all of which were successfully treated with the CorPath System by either balloon angioplasty (19/29; 65.5%) or balloon angioplasty with provisional stenting (10/29; 34.5%). The primary endpoints of device success (cannulation of the target vessel) and safety (absence of SAEs during the procedure) were achieved in all cases. In addition, clinical procedural success (<50% residual stenosis in all CorPath 200 System treated lesions at the completion of the interventional procedure without an unplanned switch to the manual procedure in the absence of device-related SAEs) was achieved in all subjects. A summary of the study results is presented in the table below.

Clinical Study Outcome	Result	Observations
Device Technical SuccessPer Subject	100% (20/20)	All target vessels successfully cannulated with the CorPath System.
Subjects Absent Device –related SAEs during theProcedure	100% (20/20)	No subjects had a device-related SAE during the procedure.
Clinical ProceduralSuccess	100% (29/29)	Less than 50% residual stenosis in all CorPath 200 System treated lesions at the completion of the interventional procedure without an unplanned switch to the manual procedure in the absence of device-related SAEs
Device malfunctions	0% (0/20)	No device malfunctions occurred.
Angiographiccomplications	0% (0/29)	No angiographic complications occurred in any of the treated lesions.
Clinical events	3/20 (15%)	Puncture site hematoma in three subjects.

Conclusion

Based on similar intended use, technological characteristics, and performance characteristics, the CorPath 200 System is substantially equivalent to the predicate devices.

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).