The Webster CS Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

Device Description

The Webster CS Catheters with EZ Steer Bi-directional Technology (D-1263-04 & D-1263-05) are diagnostic, 7Fr, deflectable, mapping electrophysiology (EP) catheters with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The catheters incorporate a 2 mm tip electrode, 10 total electrodes, 2-8-2 mm electrode spacing, have bidirectional deflection and are 115 cm long. These catheters include a braided bidirectional deflectable tip section. The braided bi-directional tip provides the user with two 180° opposed single plane curves. Currently, the available curves include FJ (D-1263-04) and DF (D-1263-05). These catheters include a handle with a Rocker Lever, which is used to deflect the tip. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.

The Webster CS Catheters with EZ Steer Bi-directional Technology (D-1263-06 & D-1263-07) are diagnostic, 7Fr, deflectable, mapping electrophysiology (EP) catheters with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The catheters incorporate a 2 mm tip electrode, 10 total electrodes, 2-8-2 mm electrode spacing, have bidirectional deflection and are 115 cm long. These catheters include a braided bidirectional deflectable tip section. The braided bi-directional tip provides the user with two 180° opposed single plane curves. Currently, the available curves include FJ (D-1263-06) and DF (D-1263-07). These catheters include a handle with a Rocker Lever which is used to deflect the tip. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.

The Webster CS Catheters with EZ Steer Bi-directional Technology and Auto ID (D-1263-06 & D-1263-07) are equipped with Electronically Erasable Programable Read Only Memory (EEPROM) which is used to store unique catheter identification information. Carto EP Navigation Systems equipped with Auto ID Technology can access the stored information and automatically recognize the catheter information.

The catheters interface with Carto EP Navigation Systems via an interface cable (D-1286-16) with the appropriate connectors.

AI/ML Overview

The provided text describes a 510(k) summary for the "Webster CS Catheter with EZ Steer Technology" and "Webster CS Catheter with EZ Steer Technology and Auto ID." This is a medical device, and the information focuses on its substantial equivalence to a predicate device, its description, and its indications for use.

Crucially, the provided document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically expected for an AI/ML medical device.

Here's why and what can be extracted:

Device Type: This is a diagnostic electrophysiology mapping catheter, a hardware device. The "EZ Steer Technology" and "Auto ID" suggest mechanical and electronic features, not an AI/ML algorithm that requires performance metrics like sensitivity, specificity, or AUC against a ground truth.
Performance Data Section: The document explicitly states under "5.4 Performance Data": "The Webster CS Catheters have passed bench testing to validate the mechanical and electrical integrity of the catheters and the performance of the catheters with the ancillary equipment." This confirms the focus is on physical and electrical device function, not an AI model's diagnostic accuracy.

Therefore, many of the requested categories (sample size, data provenance, number of experts, adjudication, MRMC, standalone performance, training set details) are not applicable or not provided in this type of 510(k) summary for a non-AI/ML hardware device.

However, I can extract what is implied about "acceptance criteria" and "study" from the context of a 510(k) for such a device:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied for a Hardware Catheter)	Reported Device Performance
Mechanical Integrity: Ability to deflect, steer, and maintain structural soundness.	Passed bench testing to validate mechanical integrity.
Electrical Integrity: Proper functioning of electrodes for mapping and stimulation.	Passed bench testing to validate electrical integrity.
Performance with Ancillary Equipment: Compatibility and proper function when connected to other systems (e.g., Carto EP Navigation Systems).	Passed bench testing to validate performance with ancillary equipment.
Bi-directional Deflection: Achieve two 180° opposed single-plane curves.	Catheters provide two 180° opposed single-plane curves (FJ and DF models).
Electrode Spacing and Number: Meet specified design (2mm tip electrode, 10 total electrodes, 2-8-2mm spacing).	Catheters incorporate 2mm tip electrode, 10 total electrodes, 2-8-2mm electrode spacing.
Catheter Length: Meet specified design (115 cm).	Catheters are 115 cm long.
Auto ID Functionality (for Auto ID models): Ability to store and be recognized by Carto EP Navigation Systems.	EEPROM stores unique catheter identification; Carto EP Navigation Systems can access.

Sample size used for the test set and the data provenance: Not applicable/not provided for this type of hardware bench testing. The "test set" would be the manufactured catheters and components subjected to engineering tests. Data provenance would be internal Biosense Webster engineering labs.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical/electrical testing is established by engineering specifications and measurements, not clinical expert consensus.
Adjudication method for the test set: Not applicable. Engineering tests rely on pass/fail criteria against specifications.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable for a hardware catheter. This type of study is relevant for AI/ML diagnostic tools where human readers interpret data.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, not applicable. This device is a physical catheter, not an algorithm.
The type of ground truth used: Engineering specifications, physical measurements, electrical measurements, and functional checks against design requirements.
The sample size for the training set: Not applicable. This is not an AI/ML device that requires a "training set."
How the ground truth for the training set was established: Not applicable.

In summary, the provided document details a hardware medical device and its clearance based on substantial equivalence, relying on standard engineering bench testing to ensure mechanical and electrical integrity and performance with ancillary equipment. It is not an AI/ML device, and thus the specific questions related to AI/ML performance metrics are not addressed or relevant in this context.

Summary

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5.	510(K) SUMMARY	JUN 22 2010K101345
	Applicant:	Biosense Webster, Inc.3333 Diamond Canyon Rd.Diamond Bar, CA 91765USAPhone: 800-729-7272Fax: 909-839-8804
	Date:	May 11, 2010
	Contact Person:	Balaka DasSenior Specialist, Regulatory Affairs
	Proprietary Device Name:	Webster CS Catheter with EZ Steer TechnologyWebster CS Catheter with EZ Steer Technology andAuto ID
	Common Device Name:	Electrophysiology Mapping Catheter
	Classification Name:	Electrode Recording Catheter(per 21 CFR 870.1220, Product Code DRF)
	Predicate Device:	Webster CS Catheter with EZ Steer TechnologyWebster CS Catheter with EZ Steer Technology andAuto ID
	Manufacturing Facilities:	Biosense Webster, Inc.15715 Arrow HighwayIrwindale, CA 91706 USABiosense Webster, Inc.Circuito Interior Norte #1820Parque Industrial SalvacarJuarez, Chihuahua, Mexico, 32599

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5.1 Substantially Equivalent To:

Webster CS Catheters with EZ Steer Technology and Webster CS Catheters with EZ Steer Technology and Auto ID cleared via 510(k) K090898 cleared on September 4, 2009.

5.2 Description of the Device Subject to Premarket Notification:

The Webster Coronary Sinus Catheter with EZ Steer Bi-directional Technology (D-1263-04 & D-1263-05)

D-1221-21 .
D-1221-26 .
D-1221-25 .

The Webster Coronary Sinus Catheter with EZ Steer Bi-directional Technology and Auto ID

(D-1263-06 & D-1263-07)

Page 2 of 3

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Carto EP Navigation Systems equipped with Auto ID Technology can access the stored information and automatically recognize the catheter information.

The catheters interface with Carto EP Navigation Systems via an interface cable (D-1286-16) with the appropriate connectors.

5.3 Indications for Use:

The Webster CS Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

5.4 Performance Data:

The Webster CS Catheters have passed bench testing to validate the mechanical and electrical integrity of the catheters and the performance of the catheters with the ancillary equipment.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

JUN 2 2 2010

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

K101345 Re:

Trade/Device Name: Webster CS Catheter with EZ Steer Technology; and, Webster CS Catheter with EZ Steer Technology and Auto ID. Regulatory Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: II (two) Product Code: 74 DQO Dated: May 11 2010 Received: May 13, 2010

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 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); 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/ReportalProblem/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,

M. A. Hellekson

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): K101345

Device Name:

Webster CS Catheter with EZ Steer Technology . (D-1263-04 & D-1263-05)
Webster CS Catheter with EZ Steer Technology and Auto ID . (D-1263-06 & D-1263-07)

Indications for Use:

The Webster CS Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

Prescription Use V (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)

Page 1 of

U.f. Willelm

(Division Sign-Off) Division of Čardiovascular Devices

510(k) Number

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).