(157 days)
No
The description focuses on computer-controlled robotic movements based on physician input via joysticks or touch screen, and basic software monitoring for communication errors. There is no mention of AI/ML terms, image processing for automated decision-making, or data training/testing.
No.
The device is intended for the remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventional (PVI) procedures, which are interventional procedures, not therapeutic ones.
No
The CorPath 200 System is a robotic system used to remotely manipulate guidewires and catheters during interventional vascular procedures. Its purpose is to assist in the delivery and manipulation of tools for treatment, not to diagnose conditions.
No
The device description clearly outlines multiple hardware components including a Bedside Unit (Articulated Arm, Robotic Drive, single-use Cassette) and a Remote Workspace (Interventional Cockpit, Control Console). While software is mentioned as part of the system, it is integral to the function of these physical components, making it a hardware-software system, not a software-only device.
Based on the provided information, the CorPath 200 System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventional (PVI) procedures." This describes a device used within the body for a medical procedure, not a device used to examine specimens outside the body.
- Device Description: The description details a system with a Bedside Unit and a Remote Workspace, designed to assist physicians in manipulating instruments during procedures. This aligns with an interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
Therefore, the CorPath 200 System is a medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The CorPath 200 System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventional (PVI) procedures.
Product codes
DXX
Device Description
The CorPath 200 System is intended for use by physicians in the delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventional (PVI) procedures. The CorPath 200 System allows the physician to deliver and manipulate guidewires and catheters through the vasculature under angiography-assisted visual guidance using computer controlled movements while in a seated position and away from the radiation source.
The CorPath 200 System is composed of two functional sub-units; the Bedside Unit and the Remote Workspace. The Bedside Unit consists of the Articulated Arm, the Robotic Drive and the single-use Cassette. The Remote Workspace consists of the Interventional Cockpit (radiation shield) which houses the Control Console, as well as angiographic monitor(s). Commercially available guidewires and rapid exchange catheters are loaded into the single-use Cassette. By using the joysticks or touch screen of the Control Console, the physician can send commands to the Robotic Drive via a communication cable that advances, retracts or rotates the guidewire, and/or advances or retracts the catheters. The CorPath 200 System's software continuously monitors the communication between the Control Console and the Robotic Drive and alerts the physician if any communication error occurs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
angiography-assisted visual guidance
Anatomical Site
vascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians / 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
The CorPath 200 System for PVI is identical in design to the predicate CorPath 200 System for PCI and thus no new performance testing was conducted. Non-clinical testing of the predicate CorPath 200 System leveraged previously conducted bench and animal performance testing. biocompatibility, sterilization, packaging, and product shelf life testing from the predicate device, and is applicable to the CorPath 200 System for PVI. These tests demonstrated that the technological characteristics such as product performance, design and intended use are substantially equivalent to the currently marketed predicate devices.
The CorPath 200 System was previously evaluated for PCI in the PRECISE Clinical Study. The PRECISE Clinical Study was a prospective, single-arm, multi-center, nonrandomized study of the CorPath 200 System. The objective of the study was to evaluate the safety and effectiveness of the clinical and technical performance of the CorPath 200 System in the delivery and manipulation of coronary guidewires and stent/balloon devices for use in PCI procedures. One hundred and sixty-four (164) subjects were enrolled and evaluated in the PRECISE Clinical Study at nine (9) clinical sites. The overall rate of clinical procedural success was 97.6%. One hundred percent of subjects achieved post-procedure stenosis of less than 30% (as evaluated by a Core Laboratory) and 97.6% of subjects had an absence of Major Adverse Cardiac Events (MACE). The overall device technical success rate was 98.8%. The PRECISE Trial demonstrated a reduction of radiation exposure to the primary operator.
The Robotic-Assisted Peripheral Intervention for peripheral arterial Disease (RAPID) Study was also conducted, which was a prospective non-randomized feasibility evaluation of the CorPath 200 System for use in the remote delivery and manipulation of guidewires and rapid exchange catheters during peripheral interventions. Subjects eligible to participate in the study had symptomatic disease with either presence of critical limb ischemia, or lifestyle-limiting claudication requiring percutaneous transluminal angioplasty (PTA). This study enrolled 20 Rutherford Class 2 to 5 subjects. There were 29 treated lesions all of which were successfully treated with the CorPath System by either balloon angioplasty (19/29; 65.5%) or balloon angioplasty with provisional stenting (10/29; 34.5%). The primary endpoints of device success (cannulation of the target vessel) and safety (absence of SAEs during the procedure) were achieved in all cases. In addition, clinical procedural success (
§ 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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2016
Corindus, Inc. % Ms. Mona Advani Senior Consultant CardioMed Device Consultants 5523 Research Park Drive, Suite 205 Baltimore, MD 21228
Re: K152999
Trade/Device Name: CorPath 200 System Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II Product Code: DXX Dated: February 19, 2016 Received: February 22, 2016
Dear Ms. 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,
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152999
Device Name CorPath 200 System
Indications for Use (Describe)
The CorPath 200 System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventional (PVI) 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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4
510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 807.92(c).
| Applicant: | Corindus, Inc.
309 Waverly Oaks Rd., Suite 105
Waltham, MA 02452
(P): (508) 653-3335
(F): (617) 500-0978 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mona Advani
Regulatory Affairs Consulting Agent for Corindus, Inc
CardioMed Device Consultants, LLC
5523 Research Park Drive, Suite 205
Baltimore, MD 21228
Email: madvani@cardiomedllc.com
(P): (650) 575-5819
(F): (617) 663-6052 |
| Date Prepared: | March 16, 2016 |
| Device Information: | |
| Trade Name: | Corindus CorPath® 200 System |
| Common Name: | CorPath System |
| Product Code: | DXX (Steerable catheter control system) |
| Regulation Number: | 21 CFR 870.1290 (Steerable catheter control system) |
| Predicate Device(s): | Corindus CorPath 200 System (K120834. K150892) |
Magellan Robotic System (K111004, K141614)
Device Description
The CorPath 200 System is intended for use by physicians in the delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventional (PVI) procedures. The CorPath 200 System allows the physician to deliver and manipulate guidewires and catheters through the vasculature under angiography-assisted visual guidance using computer controlled movements while in a seated position and away from the radiation source.
Indication for Use
5
The CorPath 200 System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventional (PVI) procedures.
Technological Characteristics
The CorPath 200 System is composed of two functional sub-units; the Bedside Unit and the Remote Workspace. The Bedside Unit consists of the Articulated Arm, the Robotic Drive and the single-use Cassette. The Remote Workspace consists of the Interventional Cockpit (radiation shield) which houses the Control Console, as well as angiographic monitor(s). Commercially available guidewires and rapid exchange catheters are loaded into the single-use Cassette. By using the joysticks or touch screen of the Control Console, the physician can send commands to the Robotic Drive via a communication cable that advances, retracts or rotates the guidewire, and/or advances or retracts the catheters. The CorPath 200 System's software continuously monitors the communication between the Control Console and the Robotic Drive and alerts the physician if any communication error occurs.
Performance Data
The CorPath 200 System for PVI is identical in design to the predicate CorPath 200 System for PCI and thus no new performance testing was conducted. Non-clinical testing of the predicate CorPath 200 System leveraged previously conducted bench and animal performance testing. biocompatibility, sterilization, packaging, and product shelf life testing from the predicate device, and is applicable to the CorPath 200 System for PVI. These tests demonstrated that the technological characteristics such as product performance, design and intended use are substantially equivalent to the currently marketed predicate devices.
Clinical Data
The CorPath 200 System was previously evaluated for PCI in the PRECISE Clinical Study. The PRECISE Clinical Study was a prospective, single-arm, multi-center, nonrandomized study of the CorPath 200 System. The objective of the study was to evaluate the safety and effectiveness of the clinical and technical performance of the CorPath 200 System in the delivery and manipulation of coronary guidewires and stent/balloon devices for use in PCI procedures. One hundred and sixty-four (164) subjects were enrolled and evaluated in the PRECISE Clinical Study at nine (9) clinical sites. The overall rate of clinical procedural success was 97.6%. One hundred percent of subjects achieved post-procedure stenosis of less than 30% (as evaluated by a Core Laboratory) and 97.6% of subjects had an absence of Major Adverse Cardiac Events (MACE). The overall device technical success rate was 98.8%. The PRECISE Trial demonstrated a reduction of radiation exposure to the primary operator.
The Robotic-Assisted Peripheral Intervention for peripheral arterial Disease (RAPID) Study was also conducted, which was a prospective non-randomized feasibility evaluation of the CorPath 200 System for use in the remote delivery and manipulation of guidewires and rapid exchange catheters during peripheral interventions. Subjects eligible to participate in the study had symptomatic
6
disease with either presence of critical limb ischemia, or lifestyle-limiting claudication requiring percutaneous transluminal angioplasty (PTA). This study enrolled 20 Rutherford Class 2 to 5 subjects. There were 29 treated lesions all of which were successfully treated with the CorPath System by either balloon angioplasty (19/29; 65.5%) or balloon angioplasty with provisional stenting (10/29; 34.5%). The primary endpoints of device success (cannulation of the target vessel) and safety (absence of SAEs during the procedure) were achieved in all cases. In addition, clinical procedural success (