CorPath 200 System

K150892 · Corindus, Inc. · DXX · Oct 2, 2015 · Cardiovascular

Device Facts

• Record ID: K150892
• Device Name: CorPath 200 System
• Applicant: Corindus, Inc.
• Product Code: DXX · Cardiovascular
• Decision Date: Oct 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1290
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CorPath 200 System is intended for use in the remote delivery and manipulation of coronary guidewires and rapid exchange balloon/stent catheters during percutaneous coronary interventional (PCI) procedures.

Device Story

CorPath 200 System enables remote robotic-assisted PCI. System comprises bedside unit (articulated arm, robotic drive, single-use cassette) and remote workspace (interventional cockpit with console and monitors). Physician loads guidewires/catheters into cassette; uses joysticks/touchscreen at remote console to command robotic drive via communication cable. Robotic drive advances, retracts, or rotates guidewires and catheters. System allows physician to operate from seated position away from radiation source, reducing operator exposure. Software monitors communication between console and drive, alerting physician to errors. Clinical benefits include high procedural success rates and reduced radiation exposure for operators.

Clinical Evidence

PRECISE study (prospective, single-arm, multi-center, n=164) showed 97.6% clinical procedural success, 98.8% technical success, and 97.6% MACE-free rate. Radial access study (n=30) showed 100% clinical success, 0% MACE, 0% radial artery occlusion, and 3.3% radial artery spasm. Results demonstrate safety and performance comparable to manual PCI.

Technological Characteristics

System consists of bedside unit (articulated arm, robotic drive, single-use cassette) and remote workspace (cockpit, console, monitors). Energy source: electrical. Connectivity: wired communication cable between console and robotic drive. Software: monitors communication integrity. Sterilization: single-use cassette components.

Indications for Use

Indicated for patients undergoing percutaneous coronary intervention (PCI) procedures requiring delivery and manipulation of coronary guidewires and rapid exchange balloon/stent catheters.

Regulatory Classification

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.

Predicate Devices

• Corindus CorPath 200 System (K120834)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

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

October 2, 2015

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

Re: K150892

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: August 30, 2015 Received: September 2, 2015

Dear Mona Advani:

We have reviewed vour 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

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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 devicerelated 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.

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours.

M.A. Hillebrand

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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# Section 1.0 Indication for Use Statement

# Indications for Use

510(k) Number (if known): K150892

Device Name: CorPath® 200 System

Indications for Use:

The CorPath 200 System is intended for use in the remote delivery and manipulation of coronary guidewires and rapid exchange balloon/stent catheters during percutaneous coronary interventional (PCI) procedures.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# Section 2.0 510(k) Summary

# 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.<br>309 Waverly Oaks Rd.<br>Suite 105<br>Waltham, MA 02452<br>(P): [phone]<br>(C): [phone]<br>(F): [phone] |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mona Advani<br>Regulatory Affairs Consulting Agent for Corindus, Inc.<br>CardioMed Device Consultants, LLC<br>5523 Research Park Drive, Suite 205<br>Baltimore, MD 21228<br>Email: [e-mail]<br>(P): [phone]<br>(F): [phone] |
| Date Prepared: | September 29, 2015 |
| 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) |

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#### Device Description

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

#### Indication for Use

The CorPath 200 System is intended for use in the remote delivery and manipulation of coronary guidewires and rapid exchange balloon/stent catheters during percutaneous coronary intervention (PCI) procedures.

### Technological Characteristics

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 Console, as well as angiographic monitor(s). Commercially available guidewires and balloon/stent 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 balloon/stent 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.

### Performance Data

Non-clinical testing of the CorPath 200 System Device consisted of performance testing, biocompatibility, sterilization, packaging, and product shelf life testing. These tests demonstrated that the technological characteristics such as product performance, design and intended use are substantially equivalent to the currently marketed predicate device. In vitro bench testing conducted on the system is summarized in the table below:

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| Test Description |
|------------------------------------------------------------|
| PCI Device Advancement Force Test |
| PCI Device Advancement Force at High Speed Test |
| PCI Device Velocity Test |
| PCI Device Continuous Move Positional Accuracy Test |
| PCI Device Placement Accuracy Test |
| PCI Device Discrete Movement Positional Accuracy Test |
| PCI Device Torque Test |
| PCI Device Rotational Velocity Test |
| PCI Device Wear Test |
| Particulate Analysis Test |
| PCI Device Dimensional and Functional Performance<br>Tests |

GLP animal studies were conducted to support the safety and performance of the device prior to the pivotal clinical study. This study was conducted in compliance with Good Laboratory Practice (GLP) regulations (21 CFR Part 58).

# Clinical Data

The CorPath 200 System was previously evaluated 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.

In addition, a clinical study evaluating the safety and performance of the CorPath 200 System via the radial access approach was conducted in 30 patients. Of the 30 treated patients, there were no reported radial artery occlusions (RAO) and only one reported radial artery spasm (RAS) (3.3%), which occurred before engaging the CorPath System. The incidence of RAS/RAO is similar to published results for manual access procedures. No patients experienced in-hospital MACE events or adverse events related to the CorPath System. CorPath-assisted Catheterization was attempted for 36 lesions. Three (3) lesions required conversion to manual, with only one being due to device (cassette component) malfunction. Of the 36 lesions treated with the CorPath System, there was a 100% clinical success rate. Treatment outcomes were favorable and the overall safety of the alternative access approach was established in this study.

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| Clinical Study Outcome | Results |
|-------------------------|---------------|
| MACE | 0% (0/30) |
| Clinical Success | 100% (36/36) |
| Technical Success | 91.7% (33/36) |
| Radial Artery Spasm | 3.3% (1/30) |
| Radial Artery Occlusion | 0% (0/30) |
| Serious Adverse Events | 3.3% (1/30) |

# Conclusion

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