(122 days)
No
The description focuses on computer-controlled robotic manipulation based on direct physician input via joysticks and a touchscreen. There is no mention of automated decision-making, pattern recognition, or learning from data, which are characteristic of AI/ML. The software's role is described as monitoring communication, not performing complex analysis or prediction.
No.
Explanation: The device is a robotic system that assists physicians in delivering and manipulating medical instruments during PCI procedures, rather than directly treating a condition itself. It is an interventional guidance system, not a therapeutic device.
No
The device is intended for the remote delivery and manipulation of guidewires and catheters during therapeutic percutaneous coronary intervention (PCI) procedures, not for diagnostic purposes.
No
The device description clearly outlines hardware components like the Bedside Unit (Articulated Arm, Robotic Drive, Cassette) and the Remote Workspace (Interventional Cockpit, Control Console), in addition to software.
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 is for the remote delivery and manipulation of coronary guidewires and balloon/stent catheters during percutaneous coronary intervention (PCI) procedures. This is a procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a system used to physically manipulate instruments within the patient's coronary vasculature. It involves a Bedside Unit and a Remote Workspace for controlling the movement of guidewires and catheters.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The CorPath 200 System does not perform any such analysis of biological samples.
- Input Imaging Modality: Angiography is an imaging technique used to visualize blood vessels in vivo, not a method for analyzing biological samples.
- Anatomical Site: The coronary vasculature is an anatomical location within the body, not a type of biological sample.
In summary, the CorPath 200 System is a medical device used for performing a surgical procedure (PCI) on a patient, not for conducting diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The CorPath 200 System is intended for use in the remote delivery and manipulation of coronary guidewires and balloon/stent catheters during percutaneous coronary intervention (PCI) procedures.
Product codes
DXX
Device Description
The CorPath 200 System is intended for use by physicians in the delivery and manipulation of coronary guidewires and balloon/stent catheters during percutaneous coronary intervention ("PCI") procedures. The CorPath 200 System allows the physician to deliver and manipulate guidewires and balloon/stent catheters through the coronary 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 balloon/stent 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 balloon/stent 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
Fluoroscopy
Anatomical Site
coronary vasculature / heart vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians / clinical sites
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)
Non-clinical testing of the CorPath 200 System Device consisted of performance testing, biocompatibility, sterilization, packaging, and product shelf life testing. These tests demonstrated that the technological characteristics such as product performance, design and intended use are substantially equivalent to the currently marketed predicate device.
Biocompatibility testing conducted on the system is summarized in the table below:
- Cytotoxicity
- Sensitization (Guinea Pig Maximization)
- Intracutaneous Reactivity (Irritation)
- Systemic / Acute Toxicity
- Hemocompatibility (Hemolysis - direct contact method)
- Hemolysis - Partial Thromboplastin Time (PTT)
- Hemolysis-Platelet & Leukocyte (P&L)
- Material-Mediated Pyrogenicity
In vitro bench testing conducted on the system is summarized in the table below:
- PCI Device Advancement Force Test
- PCI Device Advancement Force at High Speed Test
- PCI Device Velocity Test
- PCI Device Continuous Move Positional Accuracy Test
- PCI Device Placement Accuracy Test
- PCI Device Discrete Movement Positional Accuracy Test
- PCI Device Torque Test
- PCI Device Rotational Velocity Test
- PCI Device Wear Test
- Particulate Analysis Test
- PCI Device Dimensional and Functional Performance Tests
Additionally, GLP animal studies were conducted to support the safety and performance of the device prior to the pivotal clinical study. The purpose of the GLP Studies was to evaluate the performance of the CorPath 200 System for Delivery and Deployment of Standard PTCA Devices in a porcine model acutely and at 30 days. The study was titled "Robotically-Assisted PCI: Evaluation of CorPath 200 System for Delivery and Deployment of Standard PTCA Devices in Acute and 30-day Chronic Swine" to support the design and development of the CorPath 200 System. This study was conducted in compliance with Good Laboratory Practice (GLP) regulations (21 CFR Part 58).
The CorPath 200 System was evaluated 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 PC1 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%. Although there were some limitations with the collection of operator radiation exposure data, the PRECISE trial results show a reduction in radiation exposure to the primary operator.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Clinical procedural success: 97.6%
- Post-procedure stenosis of less than 30%: 100%
- Absence of Major Adverse Cardiac Events (MACE): 97.6%
- Overall device technical success rate: 98.8%
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
K12-0834
P 1 of 5
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. 11 Erie Drive JUL 1 9 2012 Natick, MA 01760, USA Michail M. Pankratov, MD, PhD Vice President, Clinical and Regulatory Affairs Email: Michail.Pankratov(@Corindus.com Telephone: (508) 653-3335 x 206 Fax: (508) 589-4050 Cell: (617) 480-4543 Contact Person: Mona Advani Regulatory Affairs Consulting Agent for Corindus, Inc. CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 360
Baltimore, MD 21228 Email: madvani@cardiomedIlc.com (b): (650) 575-5819 (F): (617) 663-6052
Date Prepared: March 16, 2012
Device_Information:
Corindus CorPath® 200 System Trade Name: Common Name: CorPath System Product Code: DXX (Steerable catheter control system) Regulation Number: 21 CFR 870.1290 (Steerable catheter control system)
Predicate Device(s):
- Niobe® MNS w/Navigant ™ Navigation Workstation (K060967) l.
-
- Sensei® Robotic Catheter System (K091808)
1
K12 08 sf
P. 2 of 5
| Device Name | CorPath 200 System | Sensei Robotic Catheter System | Niobe MNS w/Navigant Navigation Workstation (NWS05) |
|---|---|---|---|
| Comparison Criteria | |||
| Manufacturer | Corindus, Inc. | Hansen Medical, Inc. | Stereotaxis, Inc. |
| 510(k) Number | TBD | K091808 | K060967 |
| Product Code | DXX | DXX | NDQ |
| Regulation Number | 21 CFR 870.1290 | 21 CFR 870.1290 | 21 CFR 870.1290 |
| Device Class | II | II | II |
| Intended Use | Remote delivery and manipulation of coronary guidewires and balloon/stent catheters. | Remote manipulation and positioning of robotically steerable catheters. | Remote navigation of magnetically-adapted coronary guidewires and catheters. |
| Indications for Use | Percutaneous Coronary Intervention (PCI) | Cardiac Mapping | Navigation through coronary vasculature |
| Cardiac Mapping | |||
| Device Design | The CorPath 200 System is composed of: a Remote Workspace with an operator interface and a Bedside Unit with a robotic drive. | The Sensei Robotic Catheter System is composed of a Remote Workstation with an operator interface, a robotic arm and a control catheter. | The Stereotaxis Niobe MNS with Navigant System is composed of a Remote Workstation with an operator interface and a magnetic navigation system. |
| Operational Principles | The physician, seated at the Remote Workspace, manipulates coronary guidewires and/or balloon/stent catheters using joysticks or touch-screen controls on the Control Console. | The physician, seated at the Remote Workstation, manipulates catheters using joysticks or track ball controls. | The physician, seated at the Remote Workstation, manipulates magnetic coronary devices through use of joysticks and/or touch screen technology. |
| Device Name | CorPath 200 System | Sensei Robotic Catheter System | Niobe MNS w/Navigant Navigation Workstation (NWS05) |
| Comparison Criteria | |||
| Use of Fluoroscopy | Yes | Yes | Yes |
Summary of Comparison of the CorPath 200 System to Predicate Devices
8
.
2
Device Description
The CorPath 200 System is intended for use by physicians in the delivery and manipulation of coronary guidewires and balloon/stent catheters during percutaneous coronary intervention ("PCI") procedures. The CorPath 200 System allows the physician to deliver and manipulate guidewires and balloon/stent catheters through the coronary vasculature under angiography-assisted visual guidance using computer controlled movements while in a seated position and away from the radiation source.
Indication for Use
The CorPath 200 System is intended for use in the remote delivery and manipulation of coronary guidewires and balloon/stent catheters during percutaneous coronary intervention (PCI) 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 balloon/stent 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 balloon/stent 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.
A comparison of the device design shows that there is substantial equivalence between the CorPath 200 System and the predicate devices. All products are designed for the remote navigation of devices through the heart vasculature. All robotic systems are composed of a bedside unit and a remote workstation. In all robotic system the navigation of devices is accomplished by use of joysticks or track balls and touch-screen controls by the physician seated in a remote seated positioned.
The CorPath 200 System uses an electromechanical interface to manipulate commercially available PCI devices. In contrast, in the case of the Niobe MNS system, navigation is achieved through the use of magnetic fields. Also in contrast to the CorPath 200 System, in the case of the Sensei Robotic system, navigation is achieved through the use of a mechanical interface.
Performance Data
3
Non-clinical testing of the CorPath 200 System Device consisted of performance testing, biocompatibility, sterilization, packaging, and product shelf life testing. These tests demonstrated that the technological characteristics such as product performance, design and intended use are substantially equivalent to the currently marketed predicate device.
Biocompatibility testing conducted on the system is summarized in the table below:
| Test Description |
|---|
| Cytotoxicity |
| Sensitization (Guinea Pig Maximization) |
| Intracutaneous Reactivity (Irritation) |
| Systemic / Acute Toxicity |
| Hemocompatibility (Hemolysis - direct contact method) |
| Hemolysis - Partial Thromboplastin Time (PTT) |
| Hemolysis-Platelet & Leukocyte (P&L) |
| Material-Mediated Pyrogenicity |
In vitro bench testing conducted on the system is summarized in the table below:
| Test Description |
|---|
| PCI Device Advancement Force Test |
| PCI Device Advancement Force at High Speed Test |
| PCI Device Velocity Test |
| PCI Device Continuous Move Positional Accuracy Test |
| PCI Device Placement Accuracy Test |
| PCI Device Discrete Movement Positional Accuracy Test |
| PCI Device Torque Test |
| PCI Device Rotational Velocity Test |
| PCI Device Wear Test |
| Particulate Analysis Test |
| PCI Device Dimensional and Functional Performance Tests |
Additionally, GLP animal studies were conducted to support the safety and performance of the device prior to the pivotal clinical study. The purpose of the GLP Studies was to evaluate the performance of the CorPath 200 System for Delivery and Deployment of Standard PTCA Devices in a porcine model acutely and at 30 days. The study was titled "Robotically-Assisted PCI: Evaluation of CorPath 200 System for
4
Delivery and Deployment of Standard PTCA Devices in Acute and 30-day Chronic Swine" to support the design and development of the CorPath 200 System. This study was conducted in compliance with Good Laboratory Practice (GLP) regulations (21 CFR Part 58).
Clinical Data
The CorPath 200 System was evaluated 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 PC1 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%. Although there were some limitations with the collection of operator radiation exposure data, the PRECISE trial results show a reduction in radiation exposure to the primary operator.
Conclusion
Based on similar intended use, technological characteristics, and performance characteristics, the CorPath 200 System is substantially equivalent to the predicate devices.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 19 2012
Corindus, Inc. c/o Mona Advani Regulatory Affairs Consulting Agent CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 360 Baltimore, MD 21228
Re: K120834
Trade/Device Name: Corindus CorPath® 200 System Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable catheter control system Regulatory Class: Class II Product Code: DXX Dated: May 25, 2012 Received: May 29, 2012
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 for are case of to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner to may 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 r ou may, mereleve, issues of the Act include requirements for annual registration, listing of general controls provision 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.
6
Page 2 - Ms. Mona Advani
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 device-related adverse events) (21 CFR 803); good 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): ________________
Device Name: CorPath® 200 System
Indications for Use:
The CorPath 200 System is intended for use in the remote delivery and manipulation of coronary guidewires and balloon/stent catheters during percutaneous coronary intervention (PCI) procedures.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K120834 |
|---|---|
| --------------- | --------- |