(76 days)
Not Found
No
The description focuses on robotic control and automated movements based on physician input, not on learning or adaptive algorithms. The "Rotate on Retract" feature is a pre-programmed automation, not AI/ML.
No
The device is described as a system for remote delivery and manipulation of guidewires and catheters during PCI procedures, helping physicians perform the procedure but not directly providing a therapeutic effect itself.
No
The device is described as a system for remote delivery and manipulation of catheters and guidewires during PCI procedures, allowing physicians to perform interventions, not diagnose conditions.
No
The device description explicitly details hardware components like the Bedside Unit (Extended Reach Arm, Robotic Drive, Single-use Cassette) and the Remote Workspace (Control Console, monitors, foot pedal). While software is mentioned as a component and has specific functionalities, the system is clearly a combination of hardware and software.
Based on the provided information, the CorPath GRX System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the system 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 system used during a medical procedure on a patient, not for testing samples outside the body.
- Device Description: The description details a robotic system that interacts with medical devices (guidewires, catheters) and is used by a physician during a procedure. It involves physical manipulation of instruments within the patient's body.
- Lack of IVD Characteristics: There is no mention of the system being used to test biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such testing. IVD devices are designed to diagnose diseases or conditions based on in vitro examination of specimens.
Therefore, the CorPath GRX System is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CorPath GRX System 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 guidewires, rapid exchange balloon/stent catheters and guide catheters during percutaneous coronary intervention procedures. During the use of the CorPath GRX System, the physician maneuvers the 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:
-
- Bedside Unit Which consists of the Extended Reach Arm, Robotic Drive and Single-use Cassette
-
- 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 balloon/stent catheters, and guide catheters are loaded into the Single-use 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, retract, and rotate the guide catheter. The Robotic Drive and Control Console communicate via a single communication cable.
In addition, the CorPath GRX System Software contains a functionality for an automated movement of the guidewire, known as "Rotate on Retract." This feature, when enabled by the physician will rotate the quidewire a set amount upon retraction of the quidewire joystick to facilitate redirection of the guidewire which it is being directed to the lesion location.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
angiographic fluoroscopy
Anatomical Site
coronary
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification/validation testing of the CorPath GRX System has been conducted to demonstrate the modified CorPath GRX Systems is substantially equivalent to the predicate device. 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.
- . Functional Testing
- Software Verification and Validation testing l
All testing has demonstrated that the device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 1, 2018
Corindus, Inc. Robert Lavado Manager, Regulatory Affairs 309 Waverley Oaks Road Waltham, Massachusetts 02452
Re: K173806
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: December 13, 2017 Received: December 15, 2017
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. 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); 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.
1
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.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
2
Indications for Use
510(k) Number (if known) K173806
Device Name CorPath GRX System
Indications for Use (Describe)
The CorPath GRX System 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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6.0 510(K) SUMMARY
| Submitter's Name and
Address: | Corindus, Inc.
309 Waverley Oaks Road
Suite 105
Waltham, MA 02452 |
|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration Number: | 3007822508 |
| Date of Summary: | February 28, 2018 |
| Contact Person:
Telephone Number:
Fax Number: | Robert Lavado, Manager, Regulatory Affairs
(508) 653-3335 x211
(508) 653-3355 |
| Name of the Device: | CorPath GRX System |
| Common Name: | CorPath GRX System |
| Regulatory Status and
Regulation Number: | Class II
21 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 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. |
| Identification of the
Legally Marketed
Device (Predicate
Device): | CorPath GRX System
Device Class: II
Product Code: DXX
Regulation Number: 21 CFR 870.1290
510(k) Number: K160121 |
| Device Description: | The CorPath GRX System is intended to allow physicians
to deliver and manipulate commercially available
guidewires, rapid exchange balloon/stent catheters and
guide catheters during percutaneous coronary intervention |
4
procedures. During the use of the CorPath GRX System, the physician maneuvers the 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:
-
- Bedside Unit Which consists of the Extended Reach Arm, Robotic Drive and Single-use Cassette
-
- 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 balloon/stent catheters, and guide catheters are loaded into the Single-use 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, retract, and rotate the guide catheter. The Robotic Drive and Control Console communicate via a single communication cable.
In addition, the CorPath GRX System Software contains a functionality for an automated movement of the guidewire, known as "Rotate on Retract." This feature, when enabled by the physician will rotate the quidewire a set amount upon retraction of the quidewire joystick to facilitate redirection of the guidewire which it is being directed to the lesion location.
Substantial The product subject of this premarket notification is Equivalence: substantially equivalent in design and functionality to the CorPath GRX System (K160121, cleared October 27, 2016).
The proposed CorPath GRX System and the predicate CorPath GRX System have the same technological characteristics. There have been no changes to the CorPath GRX System with respect to hardware design, materials, packaging, sterilization, or indication.
Verification/validation testing of the CorPath GRX System has been conducted to demonstrate the modified CorPath GRX Systems is substantially equivalent to the predicate device. 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:
5
- Performance Testing .
- . Functional Testing
- Software Verification and Validation testing ●
All testing has demonstrated that the device is substantially equivalent to the predicate device.
| Safety and | The determination of substantial equivalence for this |
|---|---|
| Performance: | device was based on a detailed device description and |
| non-clinical laboratory testing. The testing demonstrated | |
| that the device is safe for its intended use and can be | |
| considered substantially equivalent to the predicate | |
| device. |
- Based on the bench testing conducted, it is concluded that Conclusion: the CorPath GRX System is substantially equivalent to the predicate CorPath GRX System (K160121, cleared October 27, 2016).