(30 days)
No
The summary describes a robotic system for remote manipulation of catheters and guidewires during procedures, controlled by a physician using joysticks and a touchscreen. There is no mention of AI or ML in the device description, intended use, or performance studies. The control is explicitly described as physician-driven.
No.
The device is described as a system for remote delivery and manipulation of guidewires and catheters during medical procedures, not as a device that provides therapeutic treatment itself. It's a tool to assist physicians during therapeutic procedures.
No
The device is described as assisting in the remote delivery and manipulation of catheters and guidewires during interventional procedures, not for diagnostic purposes.
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). The performance studies also include hardware-specific testing like "Performance Testing Extended Reach Arm" and "IEC 60601-1 Safety Testing".
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 catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures." This describes a system used in vivo (within the living body) for surgical or interventional procedures.
- Device Description: The description details a robotic system used to control instruments inside a patient's body during procedures, allowing the physician to be seated away from the radiation source. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The CorPath GRX System does not perform any such analysis of biological specimens.
Therefore, the CorPath GRX System is an in vivo medical device used for interventional procedures, not an IVD.
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 catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures.
Product codes
DXX
Device Description
The CorPath GRX System is intended to allow physicians to deliver and manipulate commercially available guidewires, rapid exchange catheters and guide catheters during percutaneous coronary and vascular procedures. During the use of the CorPath GRX System, the physician maneuvers interventional 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 catheters, and guide catheters are loaded into the Singleuse 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, retrace, and rotate the guide catheter. The Robotic Drive and Control Console communicate via a single communication cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
angiographic fluoroscopy
Anatomical Site
coronary and vascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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 devices. 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 Extended Reach Arm ●
- IEC 60601-1 Safety Testing .
All testing has demonstrated that the device is substantially equivalent to the predicate devices.
The determination of substantial equivalence for this device was based on a detailed device description and non-clinical laboratory testing. The testing demonstrated that the device can be considered substantially equivalent to the predicate devices.
Based on the bench testing conducted, it is concluded that the CorPath GRX System is substantially equivalent to the predicate device, the CorPath GRX System (K173288, cleared February 15, 2018).
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
March 29, 2018
Corindus, Inc. Robert Lavado Manager, Regulatory Affairs 309 Waverley Oaks Road Waltham, Massachusetts 02452
Re: K180517
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: February 26, 2018 Received: February 27, 2018
Dear Robert Lavado:
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 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
1
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 mediation-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,
Nicole G. Ibrahim -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) K180517
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 catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: | March 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 catheters, and remote manipulation of guide
catheters during percutaneous coronary and vascular
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:
K173288 |
| Device Description: | The CorPath GRX System is intended to allow physicians
to deliver and manipulate commercially available
guidewires, rapid exchange catheters and guide catheters |
4
during percutaneous coronary and vascular procedures. During the use of the CorPath GRX System, the physician maneuvers interventional 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 catheters, and guide catheters are loaded into the Singleuse 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, retrace, and rotate the guide catheter. The Robotic Drive and Control Console communicate via a single communication cable.
Substantial The product subject of this premarket notification is substantially equivalent in design and functionality to the Equivalence: CorPath GRX System (K173288, cleared February 15, 2018).
The modified CorPath GRX System and the predicate CorPath GRX System have the same technological characteristics and functionality. The changes are limited to a new bedrail connection design for the Extended Reach Arm component. There have been no changes to the modified CorPath GRX System with respect to packaging, sterilization, or method of action.
Verification/validation testing of the CorPath GRX System has been conducted to demonstrate the modified CorPath GRX Systems is substantially equivalent to the predicate devices. 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 Extended Reach Arm ●
- IEC 60601-1 Safety Testing .
All testing has demonstrated that the device is
5
substantially equivalent to the predicate devices.
- 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 can be considered substantially equivalent to the predicate devices.
- Conclusion: Based on the bench testing conducted, it is concluded that the CorPath GRX System is substantially equivalent to the predicate device, the CorPath GRX System (K173288, cleared February 15, 2018).