CorPath GRX System

K160121 · Corindus, Inc. · DXX · Oct 27, 2016 · Cardiovascular

Device Facts

• Record ID: K160121
• Device Name: CorPath GRX System
• Applicant: Corindus, Inc.
• Product Code: DXX · Cardiovascular
• Decision Date: Oct 27, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1290
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Robotic system for remote PCI; enables physician to manipulate guidewires, balloon/stent catheters, and guide catheters from a shielded cockpit. System consists of a bedside unit (articulated arm, robotic drive, single-use cassette) and a remote workspace (control console, monitors, foot pedal). Physician uses joysticks and touchscreens to control robotic drive; system provides linear and rotational movement of interventional devices. Operates under independent angiographic fluoroscopy. Used in cath labs; allows physician to remain seated away from radiation source, reducing occupational radiation exposure. Output is physical movement of catheters/wires; assists in precise device placement during coronary interventions.

Clinical Evidence

Bench testing included performance, functional, guide catheter particulate analysis, simulated procedure testing, biocompatibility, software V&V, and EMC testing. Pre-clinical in-vivo porcine study conducted with 8 pigs treated via CorPath GRX and 4 pigs treated manually (control) for PCI (balloon angioplasty and stent deployment) in the mid-LAD artery to verify safety.

Technological Characteristics

System comprises a bedside unit (articulated arm, robotic drive, single-use cassette) and a remote workspace (control console, monitors). Cassette materials include custom plastic parts, machined stainless steel, miniature magnets, roller bearings, and springs. Connectivity via communication cable between robotic drive and control console. Operates under fluoroscopic guidance.

Indications for Use

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

• CorPath 200 System (K120834)
• CorPath 200 System (K150892)

Submission Summary (Full Text)

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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 [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,

# 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)

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.

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.<br>309 Waverley Oaks Road<br>Suite 105<br>Waltham, MA 02452 |
|---------------------------|------------------------------------------------------------------------------------------------------|
| Company Contact: | Robert Lavado<br>Email:[e-mail]<br>Phone: [phone] x 211<br>Fax: [phone] |

# Establishment Registration Number: 3007822508

| Contact Person: | Mona Advani |
|-----------------|--------------------------|
| Email: | [e-mail] |
| Phone: | [phone] |
| Fax: | [phone] |

- 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

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

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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
- 2. 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.

# 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<br>(Subject Device, previously described<br>as the CorPath 300 System) | CorPath 200 System<br>K150892 and K120834<br>(Predicate Device) |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Corindus, Inc. | Corindus, Inc. |
| Indication for use | The CorPath GRX System is intended<br>for use in the remote delivery and<br>manipulation of coronary guidewires<br>and rapid exchange balloon/stent<br>catheters, and remote manipulation of<br>guide catheters during percutaneous<br>coronary intervention (PCI) procedures. | The CorPath 200 System is<br>intended for use in the remote<br>delivery and manipulation of<br>coronary guidewires and rapid<br>exchange balloon/stent catheters<br>during percutaneous coronary<br>intervention (PCI) procedures. |
| Intended use | Percutaneous coronary intervention<br>(PCI) procedures | Percutaneous coronary intervention<br>(PCI) procedures |
| Device Design | The CorPath GRX System is composed<br>of:<br>Control Console<br>Remote Workspace<br>Articulated Arm<br>Robotic Drive<br>Cassette (single-use) | The CorPath 200 System is<br>composed of:<br>Control Console<br>Remote Workspace<br>Articulated Arm<br>Robotic Drive<br>Cassette (single-use) |
| Operational principles | The physician, seated at the Remote<br>Workspace manipulates coronary<br>guidewires, balloon/stent catheters and<br>guide catheters using joysticks or touch-<br>screen controls on the Control Console | The physician, seated at the<br>Remote Workspace, manipulates<br>coronary guidewires and/or<br>balloon/stent catheters using<br>joysticks or touch-screen controls<br>on the Control Console. |
| Visualization during<br>Procedure | Fluoroscopy | Fluoroscopy |
| Compatible with<br>Commercially available<br>PCI Devices | Yes, compatible with commercially<br>available:<br>Guide cathetersGuidewiresRapid Exchange balloon/stent<br>catheters | Yes, compatible with commercially<br>available:<br>GuidewiresRapid Exchange balloon/stent<br>catheters |
| Linear movement of PCI<br>devices | Yes, allows for linear movement of:<br>GuidewiresRapid exchange balloon/stent<br>cathetersGuide Catheters | Yes, allows for linear movement<br>of:<br>GuidewiresRapid Exchange balloon/stent<br>catheters |
| Rotational movement of<br>PCI devices | Yes, allows for rotational movement of:<br>GuidewiresGuide Catheters | Yes, allows for rotational<br>movement of:<br>Guidewires |
| Materials (single-use<br>Cassette) | The single-use sterile Cassette is<br>assembled from a variety of custom<br>plastic parts and machined stainless<br>steel components, as well as off-the-<br>shelf miniature magnets, roller bearings<br>and springs. | The single-use sterile Cassette is<br>assembled from a variety of custom<br>plastic parts and machined stainless<br>steel components, as well as off-<br>the-shelf miniature magnets, roller<br>bearings 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).