(122 days)
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.
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 intervention 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.
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 provided text describes a 510(k) premarket notification for the CorPath GRX System, a steerable catheter control system used in percutaneous coronary and vascular procedures. The submission states that the device is substantially equivalent to previously cleared predicate devices (CorPath 200 System and an earlier CorPath GRX System).
However, the document does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:
- A table of acceptance criteria with reported device performance.
- Sample sizes for test sets, data provenance, specific ground truth methods, or expert qualifications for performance evaluation.
- Details on MRMC studies or standalone algorithm performance.
- Information regarding training set size or how ground truth was established for training.
The document primarily focuses on demonstrating substantial equivalence through non-clinical laboratory testing (Device Compatibility Testing and Simulated Use Testing) and referencing prior clinical evaluations of predicate devices for safety. It does not provide performance metrics or studies of the current device against specific acceptance criteria.
Therefore, I can only extract limited information based on what is available in the text:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a specific table of acceptance criteria or quantitative performance metrics for the CorPath GRX System itself. It asserts that "All testing has demonstrated that the device is substantially equivalent to the predicate devices." and "The testing demonstrated that the device is safe for its intended use and can be considered substantially equivalent to the predicate devices."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample size used for the "non-clinical laboratory tests" (Device Compatibility Testing and Simulated Use Testing) for the CorPath GRX System. It also does not mention data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. The non-clinical testing described does not involve expert-established ground truth in the context of diagnostic or interpretive performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The non-clinical testing described does not involve an adjudication method among experts for establishing ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study is mentioned for the CorPath GRX System itself. This device is a steerable catheter control system, not an AI diagnostic tool, so such a study would not be directly relevant in the context of human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The CorPath GRX System is a robotic control system for medical procedures, inherently designed for human-in-the-loop operation, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical laboratory tests (Device Compatibility Testing and Simulated Use Testing) conducted for the CorPath GRX System, the "ground truth" would be the engineering specifications, functional requirements, and expected performance under simulated conditions. This is not comparable to clinical ground truth types like pathology or expert consensus.
The document mentions a "clinical evaluation of the predicate device (reference K152999) demonstrates that the device is safe for use in a clinical setting." However, it does not detail the specific ground truth used in that predicate device's clinical evaluation.
8. The sample size for the training set:
Not applicable. As a robotic control system, the CorPath GRX System does not describe a "training set" in the context of machine learning or AI models. Its development would involve engineering design, calibration, and verification/validation testing.
9. How the ground truth for the training set was established:
Not applicable, for the same reasons as #8.
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Image /page/0/Picture/0 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
February 15, 2018
Corindus, Inc. Robert Lavado Manager, Regulatory Affairs 309 Waverley Oaks Road Waltham, Massachusetts 02452
Re: K173288
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: January 12, 2018 Received: January 16, 2018
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. Iisting 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.
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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
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Indications for Use
510(k) Number (if known)
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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6.0 510(K) SUMMARY
| Submitter's Name andAddress: | Corindus, Inc.309 Waverley Oaks RoadSuite 105Waltham, MA 02452 |
|---|---|
| EstablishmentRegistration Number: | 3007822508 |
| Date of Summary: | February 15, 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 andRegulation Number: | Class II21 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 theremote delivery and manipulation of guidewires and rapidexchange catheters, and remote manipulation of guidecatheters during percutaneous coronary and vascularprocedures. |
| Identification of theLegally MarketedDevice (PredicateDevice): | Primary Predicate:CorPath 200 SystemDevice Class: IIProduct Code: DXXRegulation Number: 21 CFR 870.1290510(k) number: K152999Reference Predicate:CorPath GRX System |
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| 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 catheters and guide catheters during percutaneous coronary and vascular intervention 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. |
|---|---|
| --------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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 Substantial substantially equivalent in design and functionality to the Equivalence: CorPath GRX System (K160121, cleared October 27, 2016); and the CorPath 200 System (K152999, cleared March 18, 2016).
The modified CorPath GRX System and the predicate CorPath GRX System have the same technological characteristics. There have been no changes to the modified CorPath GRX System with respect to design, materials, packaging, sterilization, or method of action.
The CorPath GRX System uses the same method of action for driving guidewires and catheters as the predicate CorPath 200 System. The predicate CorPath 200 System was evaluated in a clinical setting and found to be safe for use in the periphery (reference K152999).
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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:
- Device Compatibility Testing
- Simulated Use Testing
All testing has demonstrated that the device is
substantially equivalent to the predicate devices.
| Safety and 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 is safe for its intended use and can be considered substantially equivalent to the predicate devices. Previously conducted clinical evaluation of the predicate device (reference K152999) demonstrates that the device is safe for use in a clinical setting. |
|---|---|
| Conclusion: | Based on the bench testing conducted, it is concluded that the CorPath GRX System is substantially equivalent to the predicate devices: the CorPath 200 System (K152999, cleared March 18, 2016) and the CorPath GRX System (K160121, cleared October 27, 2016). |
§ 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).