(282 days)
Not Found
No
The description focuses on robotic control and manipulation of devices based on physician input, with no mention of AI or ML for decision-making, image analysis, or autonomous functions.
No.
The device is a robotic system that assists physicians in performing percutaneous coronary intervention (PCI) procedures by remotely manipulating guidewires and catheters. It does not directly provide therapy but rather facilitates the delivery and manipulation of therapeutic devices.
No
The device is intended for remote delivery and manipulation of interventional devices during percutaneous coronary intervention (PCI) procedures, which is a treatment, not a diagnostic, procedure.
No
The device description clearly outlines physical hardware components (Bedside Unit with Articulated Arm, Robotic Drive, Single-use Cassette, and Remote Workspace with Interventional Cockpit, Control Console, monitors, and foot pedal) that are integral to the device's function. While software is mentioned for verification and validation, the device is not solely software.
Based on the provided information, the CorPath GRX is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for 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." This describes a device used during a medical procedure on a patient, not a device used to examine specimens outside of the body to provide diagnostic information.
- Device Description: The description details a robotic system used to control instruments within a patient's coronary arteries. This is consistent with an interventional device, not an IVD.
- Input Imaging Modality: The use of "angiographic fluoroscopy" is a real-time imaging technique used during procedures, not a method for analyzing samples in a lab.
- Anatomical Site: The focus on the "coronary" arteries confirms its use within the body.
- Performance Studies: The studies described involve bench testing, in-vivo animal studies, and simulated procedures, all of which are typical for evaluating the performance and safety of interventional devices. There is no mention of studies related to diagnostic accuracy or the analysis of biological samples.
IVD devices are used to examine specimens (like blood, urine, tissue) obtained from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The CorPath GRX does not perform this function. It is an interventional device used to assist physicians in performing a medical procedure.
N/A
Intended Use / Indications 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.
Product codes
DXX
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy, angiographic fluoroscopy
Anatomical Site
coronary
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians in a clinical setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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. 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.
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
1
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,
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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.
309 Waverley Oaks Road
Suite 105
Waltham, MA 02452 |
|---------------------------|------------------------------------------------------------------------------------------------------|
| Company Contact: | Robert Lavado
Email:Rob.lavado@corindus.com
Phone: (508) 635-3335 x 211
Fax: (508) 653-3355 |
Establishment Registration Number: 3007822508
| Contact Person: | Mona Advani |
|---|---|
| Email: | madvani@cardiomedllc.com |
| Phone: | (650) 575-5819 |
| Fax: | (617) 663-6052 |
- 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
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
4
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:
-
- Bedside Unit: Which consists of the Articulated Arm, Robotic Drive and Single-use Cassette, and the
-
- 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.
5
| Characteristics | CorPath GRX System
(Subject Device, previously described
as the CorPath 300 System) | CorPath 200 System
K150892 and K120834
(Predicate Device) |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Corindus, Inc. | Corindus, Inc. |
| Indication for use | The CorPath GRX System is intended
for use in the remote delivery and
manipulation of coronary guidewires
and rapid exchange balloon/stent
catheters, and remote manipulation of
guide catheters during percutaneous
coronary intervention (PCI) procedures. | 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. |
| Intended use | Percutaneous coronary intervention
(PCI) procedures | Percutaneous coronary intervention
(PCI) procedures |
| Device Design | The CorPath GRX System is composed
of:
Control Console
Remote Workspace
Articulated Arm
Robotic Drive
Cassette (single-use) | The CorPath 200 System is
composed of:
Control Console
Remote Workspace
Articulated Arm
Robotic Drive
Cassette (single-use) |
| Operational principles | The physician, seated at the Remote
Workspace manipulates coronary
guidewires, balloon/stent catheters and
guide catheters using joysticks or touch-
screen controls on the Control Console | The physician, seated at the
Remote Workspace, manipulates
coronary guidewires and/or
balloon/stent catheters using
joysticks or touch-screen controls
on the Control Console. |
| Visualization during
Procedure | Fluoroscopy | Fluoroscopy |
| Compatible with
Commercially available
PCI Devices | Yes, compatible with commercially
available:
Guide cathetersGuidewiresRapid Exchange balloon/stent
catheters | Yes, compatible with commercially
available:
GuidewiresRapid Exchange balloon/stent
catheters |
| Linear movement of PCI
devices | Yes, allows for linear movement of:
GuidewiresRapid exchange balloon/stent
cathetersGuide Catheters | Yes, allows for linear movement
of:
GuidewiresRapid Exchange balloon/stent
catheters |
| Rotational movement of
PCI devices | Yes, allows for rotational movement of:
GuidewiresGuide Catheters | Yes, allows for rotational
movement of:
Guidewires |
| Materials (single-use
Cassette) | The single-use sterile Cassette is
assembled from a variety of custom
plastic parts and machined stainless
steel components, as well as off-the-
shelf miniature magnets, roller bearings
and springs. | The single-use sterile Cassette is
assembled from a variety of custom
plastic parts and machined stainless
steel components, as well as off-
the-shelf miniature magnets, roller
bearings and springs. |
6
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).