(69 days)
None
No
The description focuses on robotic control and manipulation of devices, with no mention of AI or ML for decision-making, image analysis, or other functions. The "computer controlled movements" refer to the robotic system's execution of physician commands.
No.
The device is described as a system for remote delivery and manipulation of guidewires and catheters during percutaneous coronary and vascular procedures, allowing a physician to control interventional devices. It is explicitly stated to allow physicians to "deliver and manipulate commercially available guidewires, rapid exchange catheters and guide catheters". This describes an assistive technology for performing a medical procedure, rather than a device that directly provides a therapeutic effect. The therapeutic effect is achieved by the underlying procedure, not by the robotic system itself.
No
The device is described as a system for remote delivery and manipulation of guidewires and catheters during percutaneous coronary and vascular procedures. Its function is to assist in interventional procedures, not to diagnose medical 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), indicating it is a hardware-based system with software control, not a software-only device.
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 during a medical procedure on a patient, not for testing samples outside the body.
- Device Description: The description details a robotic system for manipulating medical devices within a patient's body under fluoroscopic guidance. It involves physical interaction with the patient's anatomy.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The CorPath GRX System is a surgical/interventional robotic system.
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
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
Non-clinical laboratory tests were performed to determine substantial equivalence: Performance Testing Single-Use Cassette. All testing has demonstrated that the device is substantially equivalent to the predicate devices.
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).
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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.
Corindus, Inc. Robert Lavado Sr. Manager, Regulatory Affairs 309 Waverley Oaks Road, Suite 105 Waltham, Massachusetts 02452
Re: K221464
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: May 6, 2022 Received: May 19, 2022
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221464
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) | |
---|---|
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
| Submitter's Name and
Address: | Corindus, Inc.
309 Waverley Oaks Road
Suite 105
Waltham, MA 02452 |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration Number: | 3007822508 |
| Date of Summary: | July 27, 2022 |
| Contact Person:
Telephone Number:
Fax Number: | Robert Lavado, Sr. Manager, Regulatory Affairs
(978) 760-7727
(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. |
| ldentification of the
Legally Marketed
Device (Predicate
Device): | CorPath GRX System
Device Class:
Product Code:
DXX
Regulation Number: 21 CFR 870.1290
510(k) Number:
K202275 |
| 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.
The product subject of this premarket notification is substantially equivalent in design and functionality to the CorPath GRX System (K202275, cleared December 11, 2020).
The modified CorPath GRX System and the predicate CorPath GRX System have the same technological characteristics and functionality. The changes are limited to modified cassette design to allow an alternate off-theshelf hemostasis valve to be utilized with the Single-Use Cassette. 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 Single-Use Cassette .
Substantial Equivalence:
5
All testing has demonstrated that the device is substantially equivalent to the predicate devices.
- Performance: 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 and 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 (K202275, cleared December 11, 2020).