The CS REFSTAR Catheter is indicated for electrophysiological mapping of cardiac structures ie, recording and stimulation, including the Coronary Sinus. In addition the CS REFSTAR Catheters are used with compatible CARTO EP Navigation Systems to provide catheter tip location information.

Device Description

The Biosense Webster CS REFSTAR Catheter has been designed to be used with the CARTO 3 EP Navigation System (a magnetic field location technology) to facilitate electrophysiological mapping of the heart. The CS REFSTAR Catheters have a high-torque 7 Fr shaft with a deflectable tip section containing an array of ten platinum/iridium electrodes that can be used for stimulation and recording of cardiac electrical signals. In addition, there is a single eleventh electrode located on the shaft. This Porterfield type electrode is designed to be positioned in the Vena Cava during use where it will perform as a reference unipolar electrode. The catheter has a location sensor embedded in the tip section that transmits location information to the CARTO 3 EP Navigation System. The shaft has a working length of 115 cm. The CS REFSTAR Catheter tip deflection is controlled by a proximal hand piece that features a thumb operated sliding piston and is offered in two curve types. D and F. The plane of the curved tip can be rotated during use. The CS REFSTAR Catheter interfaces with standard recording equipment and the CARTO 3 EP Navigation System via interface cables with the appropriate connectors.

AI/ML Overview

The provided document is a 510(k) summary for the Biosense Webster CS REFSTAR Catheter. It describes the device, its indications for use, and concludes its substantial equivalence to predicate devices based on various testing. However, it does not contain the detailed information needed to fill out all the requested categories in your prompt. Specifically, there is no mention of acceptance criteria, a study that proves the device meets specific acceptance criteria, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document focuses on "extensive bench (mechanical, electrical and simulated use) testing" and "animal testing" to demonstrate safety and function, but it does not quantify performance against specific, pre-defined acceptance criteria with numerical results that would typically be found in a detailed performance study report.

Therefore, I can only fill in the parts of your request that are directly available in the provided text.

Here's the information extracted from the provided document, with notes where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in document	"The catheter passed all testing in accordance with appropriate test criteria and standards."
Not specified in document	"Animal testing... demonstrated that the catheter was safe for use in the coronary sinus and that it is capable of functioning within the CARTO 3 EP Navigation System."

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not specified. The document mentions "extensive bench (mechanical, electrical and simulated use) testing" and "animal testing" but does not provide specific sample quantities for these tests.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). Animal testing is mentioned, implying controlled experimental conditions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Number of Experts: Not applicable/Not specified. The testing described (bench and animal) would typically involve engineering and veterinary expertise, but not "expert ground truth" for diagnostic accuracy in the way it's usually defined for AI/imaging studies.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/Not specified. This is typically relevant for studies involving human interpretation or grading, which is not described here.

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

MRMC Study: No. The document describes a medical device (catheter), not an AI algorithm for diagnostic interpretation that would involve human readers.

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

Standalone Performance: Not applicable. The device is a physical catheter, not an algorithm.

7. The type of ground truth used

Type of Ground Truth: For the "bench testing," the "ground truth" would be established engineering standards, design specifications, and physical measurements. For the "animal testing," the "ground truth" for safety and function would be physiological responses observed during the animal study and potentially post-mortem analysis.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable/Not specified. This is a medical device, not a machine learning model, so there is no "training set" in the conventional sense.

9. How the Ground Truth for the Training Set was Established

How Ground Truth for Training Tt was Established: Not applicable. As above, there is no "training set." The device's design and manufacturing are based on established engineering principles, material science, and regulatory standards.

Summary

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APR 2 3 2008

న. 510(K) SUMMARY

Applicant: Biosense Webster, Inc. 3333 Diamond Canyon Rd. Diamond Bar, CA 91765 USA Phone: 800-729-7272 Fax: 909-839-8804 Date: February 13, 2008 Contact Person: Balaka Das Specialist, Regulatory Affairs Proprietary Device Name: CS REFSTAR Catheter Common Device Name: Electrophysiology Mapping Catheter Classification Name: Electrode Recording Catheter (per 21 CFR 870.1220, Product Code DRF) Predicate Device: 1. NAVISTAR diagnostic catheter (K954390) 2. WEBSTER fixed curve catheter D-1086-566 (K841802) Biosense Webster, Inc. Manufacturing Facilities: 15715 Arrow Highway Irwindale, CA 91706 USA

5.1 Substantially Equivalent To:

The Biosense Webster CS REFSTAR is substantially equivalent to the Biosense Webster NAVISTAR diagnostic catheter (K954390) and the WEBSTER fixed curve catheter D-1086-566 (K841802).

Biosense Webster, Inc.

CONFIDENTIAL

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5.2 Description of the Device Subject to Premarket Notification:

The CS REFSTAR Catheters have a high-torque 7 Fr shaft with a deflectable tip section containing an array of ten platinum/iridium electrodes that can be used for stimulation and recording of cardiac electrical signals. In addition, there is a single eleventh electrode located on the shaft. This Porterfield type electrode is designed to be positioned in the Vena Cava during use where it will perform as a reference unipolar electrode. The catheter has a location sensor embedded in the tip section that transmits location information to the CARTO 3 EP Navigation System. The shaft has a working length of 115 cm.

The CS REFSTAR Catheter tip deflection is controlled by a proximal hand piece that features a thumb operated sliding piston and is offered in two curve types. D and F. The plane of the curved tip can be rotated during use.

The CS REFSTAR Catheter interfaces with standard recording equipment and the CARTO 3 EP Navigation System via interface cables with the appropriate connectors.

Indications for Use: ર્સ્ડ

The CS REFSTAR Catheter is indicated for electrophysiological mapping of cardiac structures ie., recording and stimulation, including the Coronary Sinus. In addition the CS REFSTAR Catheters are used with compatible CARTO EP Navigation Systems to provide catheter tip location information.

5.4 Performance Data:

The CS REFSTAR Catheter underwent extensive bench (mechanical, electrical and simulated use) testing. The catheter passed all testing in accordance with appropriate test criteria and standards. The catheter was also subjected to animal testing which demonstrated that the catheter was safe for use in the coronary sinus and that it is capable of functioning within the CARTO 3 EP Navigation System.

ર્સ્ડ Overall Performance Conclusions:

Based on the results of risk analysis, bench, and studies performed it is concluded that the CS REFSTAR described in this submission is as safe and effective as the predicate devices for its indicated use.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (USA). The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. (USA)" arranged around the perimeter. In the center of the seal is a stylized emblem that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 2008

Biosense Webster c/o Ms. Balaka Das Regulatory Affairs Specialist 3333 Diamond Canyon Rd. Diamond Bar, CA 91765

Re: K080425

Trade/Device Name: CS RefStar Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II (two) Product Code: DRF Dated: February 13, 2008 Received: February 15, 2008

Dear Ms. Das:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Ms. Balaka Das

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

B. Zimmerman Jr.

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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4. INDICATIONS FOR USE STATEMENT

510(k) No (if known): ________________________________________________________________________________________________________________________________________________________

Device Name: CS REFSTAR Catheter

Indications for Use:

Prescription Use ﮯ۔ (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)

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B. Blimmerman
islor Sign-Off

island Slan-Offi vision of Cardlovascular Devices

Regulation Number and Section

§ 870.1220 Electrode recording catheter or electrode recording probe.

(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).