The CorPath 200 System is intended for use in the remote delivery and manipulation of coronary guidewires and rapid exchange balloon/stent catheters during percutaneous coronary interventional (PCI) procedures.

Device Description

The CorPath 200 System is intended for use by physicians in the delivery and manipulation of coronary guidewires and rapid exchange 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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the CorPath 200 System:

1. Table of acceptance criteria and reported device performance:

The document primarily focuses on the clinical outcomes of the PRECISE Clinical Study and a subsequent study evaluating radial access. It doesn't explicitly state quantitative acceptance criteria for each- metric prior to the study. Instead, the reported results are presented as evidence of safety and effectiveness, implying that these results met internal criteria for substantial equivalence.

Metric (Implied Acceptance Criteria)	Reported Device Performance (PRECISE Study)	Reported Device Performance (Radial Access Study)
Overall Clinical Procedural Success	97.6%	100% (for 36 lesions treated with CorPath)
Post-procedure stenosis < 30%	100%	Not explicitly stated for radial access study, but "favorable treatment outcomes" implies meeting this.
Absence of Major Adverse Cardiac Events (MACE)	97.6%	0% (0/30 patients in-hospital)
Overall Device Technical Success Rate	98.8%	91.7% (33/36 lesions)
Radiation exposure to primary operator reduction	Demonstrated	Not detailed for radial access study, but assumed as a benefit of the system.
Radial Artery Occlusion (RAO)	N/A (PRECISE likely femoral access)	0% (0/30 patients)
Radial Artery Spasm (RAS)	N/A	3.3% (1/30 patients)
Serious Adverse Events	Not explicitly detailed for PRECISE, but 97.6% MACE absence is a proxy.	3.3% (1/30 patients)

Note: The document does not clearly define numerical acceptance criteria that were pre-specified for these metrics. The reported performance is the evidence evaluated for substantial equivalence.

2. Sample sizes used for the test set and data provenance:

PRECISE Clinical Study:
- Sample Size: 164 subjects
- Data Provenance: Prospective, multi-center, single-arm study. The country of origin is not explicitly stated, but clinical studies for FDA submissions are typically conducted in the US or in countries with comparable regulatory standards.
Radial Access Study:
- Sample Size: 30 patients, treating 36 lesions.
- Data Provenance: Clinical study. The country of origin is not explicitly stated. It's prospective.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

The document mentions that "post-procedure stenosis of less than 30% (as evaluated by a Core Laboratory)" was a key outcome.

Number of experts: Not specified, but "Core Laboratory" implies a group of trained professionals.
Qualifications of experts: Not specified beyond being a "Core Laboratory," which denotes a specialized group performing standardized, blinded assessments in clinical trials. They would typically involve experienced interventional cardiologists or cardiovascular imaging specialists.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

The document does not explicitly state an adjudication method for the clinical endpoints such as MACE or stenosis evaluation. The use of a "Core Laboratory" suggests standardized assessment protocols, which often include blinded, independent review, but the specific adjudication process (e.g., how disagreements were resolved) is not detailed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, the provided text does not describe a multi-reader multi-case (MRMC) comparative effectiveness study comparing AI-assisted vs. non-AI-assisted human readers. The CorPath 200 System is a robotic system that assists a single operator, not an AI for image interpretation or diagnosis that would typically be evaluated with MRMC studies. The "PRECISE Trial demonstrated a reduction of radiation exposure to the primary operator," which is a comparative benefit to traditional manual PCI, but not an MRMC study in the typical sense of evaluating diagnostic accuracy with and without AI.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The CorPath 200 System is a robotic device designed for human interaction and control (physician sends commands via joysticks/touch screen). It is not an "algorithm only" device that operates autonomously or performs diagnostic tasks. Therefore, a standalone performance evaluation in the context of an AI algorithm is not applicable or described. The performance data presented (clinical outcomes, technical success) are inherently "human-in-the-loop."

7. The type of ground truth used:

Clinical Outcomes (PRECISE Study & Radial Access Study):
- Stenosis < 30%: Evaluated by a "Core Laboratory," likely using quantitative coronary angiography (QCA) or similar imaging analysis, which serves as an established expert consensus-based ground truth.
- MACE (Major Adverse Cardiac Events): Clinical events, typically adjudicated by an independent clinical events committee based on pre-defined clinical definitions and patient outcomes data. This represents outcomes data.
- Procedural Success/Technical Success: Based on intra-procedural observations and immediate post-procedural assessments, reflecting clinical and technical outcomes.

8. The sample size for the training set:

The document describes the CorPath 200 System as a robotic device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense of data used to train a model. Therefore, a sample size for a training set is not applicable to the description of this device. The development process would involve engineering, bench testing, and optimization, not data-driven machine learning training.

9. How the ground truth for the training set was established:

As the CorPath 200 System is not an AI/machine learning algorithm requiring a "training set," this question is not applicable. The "ground truth" for its development would be engineering specifications, performance benchmarks from predicate devices, and user requirements, rather than a labeled dataset.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 2, 2015

Corindus, Inc. % Mona Advani Senior Consultant CardioMed Device Consultants 5523 Research Park Drive Suite 205 Baltimore, Maryland 21228

Re: K150892

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: August 30, 2015 Received: September 2, 2015

Dear Mona Advani:

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

{1}------------------------------------------------

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 devicerelated 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.

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.

M.A. Hillebrand

for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Section 1.0 Indication for Use Statement

Indications for Use

510(k) Number (if known): K150892

Device Name: CorPath® 200 System

Indications for Use:

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)

{3}------------------------------------------------

Section 2.0 510(k) Summary

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 105Waltham, MA 02452(P): (508) 653-3335(C): (267) 884-3727(F): (508) 232-6008
Contact Person:	Mona AdvaniRegulatory Affairs Consulting Agent for Corindus, Inc.CardioMed Device Consultants, LLC5523 Research Park Drive, Suite 205Baltimore, MD 21228Email: madvani@cardiomedllc.com(P): (650) 575-5819(F): (617) 663-6052
Date Prepared:	September 29, 2015
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)

{4}------------------------------------------------

Device Description

Indication for Use

Technological Characteristics

Performance Data

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. In vitro bench testing conducted on the system is summarized in the table below:

{5}------------------------------------------------

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 PerformanceTests

GLP animal studies were conducted to support the safety and performance of the device prior to the pivotal clinical study. This study was conducted in compliance with Good Laboratory Practice (GLP) regulations (21 CFR Part 58).

Clinical Data

The CorPath 200 System was previously 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 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.

In addition, a clinical study evaluating the safety and performance of the CorPath 200 System via the radial access approach was conducted in 30 patients. Of the 30 treated patients, there were no reported radial artery occlusions (RAO) and only one reported radial artery spasm (RAS) (3.3%), which occurred before engaging the CorPath System. The incidence of RAS/RAO is similar to published results for manual access procedures. No patients experienced in-hospital MACE events or adverse events related to the CorPath System. CorPath-assisted Catheterization was attempted for 36 lesions. Three (3) lesions required conversion to manual, with only one being due to device (cassette component) malfunction. Of the 36 lesions treated with the CorPath System, there was a 100% clinical success rate. Treatment outcomes were favorable and the overall safety of the alternative access approach was established in this study.

{6}------------------------------------------------

Clinical Study Outcome	Results
MACE	0% (0/30)
Clinical Success	100% (36/36)
Technical Success	91.7% (33/36)
Radial Artery Spasm	3.3% (1/30)
Radial Artery Occlusion	0% (0/30)
Serious Adverse Events	3.3% (1/30)

Conclusion

Based on similar intended use, technological characteristics, and performance characteristics, the CorPath 200 System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).