The catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. In addition, the Webster Duo-Decapolar Catheter is designed to facilitate electrogram mapping in the atrial region of the heart and the coronary sinus.

Device Description

The Biosense Webster. Duo-Decapolar Catheter, manufacturing part number D-1171-35. is designed for electrophysiological mapping of cardiac structures. The catheter has a high-torque 7 Fr shaft with a tip section containing 10 pairs of platinum-iridium electrodes that can easily be seen under fluoroscopy. The 10 pairs of electrodes are arranged in two sets of five with a spacing of 60 mm between the sets. The electrode spacing within each set is 2-8-2 mm. The D-1171-35 catheter facilitates simultaneous local electrograms due to the greater number of electrodes and its deflection capabilities. All of the electrodes may be used for recording and stimulation purposes.

Tip deflection is controlled at the proximal end by a tubular hand piece in which a piston slides. The piston in the handpiece is attached to an internal puller wire which changes the radius of the curvature. When the piston is pushed forward with the thumbknob, the radius of the curvature is reduced; when the thumbknob is pulled back, the radius of the curvature is increased until the tip section straightens. 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 catheter has a bifurcated Pigtail Connector Subassembly at the proximal end of the hand piece that houses a pair of 10-pin circular connectors. This connector provides a means for the catheter to connect to an interface cable and allow interface of the catheter with standard recording equipment.

AI/ML Overview

The provided text describes a medical device, the Webster Duo-Decapolar Catheter, and its performance data in the context of a 510(k) premarket notification. However, it does not include a table of acceptance criteria or a detailed study proving the device meets those criteria, nor does it contain information about AI integration, human readers, or an MRMC study.

Here's a breakdown of the available information based on your requested categories:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in a table format. The text generally indicates that the device "passed all testing in accordance with appropriate test criteria and standards."
Reported Device Performance: The device "underwent extensive bench (mechanical, electrical and simulated use) testing." It was also "assessed to be safe and effective for use in the coronary sinus based on an animal study performed with the similarly designed Webster CS Catheter with EZ Steer Technology." Specific numerical performance metrics or detailed results are not provided.

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

Test Set (Animal Study): Not explicitly stated, but it refers to "an animal study." The provenance is also not specified (e.g., country of origin, retrospective or prospective).
Test Set (Bench Testing): Not applicable for sample size in the traditional sense, as it refers to mechanical, electrical, and simulated use testing of the device itself rather than patient data.

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

This information is not provided in the text.

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

This information is not provided in the text.

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:

An MRMC study, AI assistance, or human reader improvement data are not mentioned in the provided text. The device is an electrophysiology mapping catheter, not an AI-powered diagnostic tool.

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

This is not applicable as the device is a physical medical instrument, not an algorithm.

7. The type of ground truth used:

For the animal study, the ground truth would likely be established through direct observation and measurements during the animal procedures, with efficacy and safety assessments based on physiological responses and potentially post-mortem analysis. However, the exact methodology is not detailed.
For bench testing, the ground truth would be based on engineering specifications and established test standards for mechanical and electrical properties.

8. The sample size for the training set:

A "training set" in the context of algorithm development is not applicable to this device. The development process involved "extensive bench (mechanical, electrical and simulated use) testing" which served to refine and validate the device's design.

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

As above, a "training set" for an algorithm is not applicable. The device's design was likely validated against engineering specifications and performance expectations derived from predicate devices and clinical understanding of electrophysiology catheters.

Summary

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MAY - 2 20i1

510(K) SUMMARY 6.

Applicant:	Biosense Webster, Inc.3333 Diamond Canyon Rd.Diamond Bar, CA 91765USAPhone: 800-729-9010Fax: 909-839-8804
Date:	July 13, 2010
Contact Person:	Balaka DasSenior Specialist, Regulatory Affairs
Proprietary Device Name:	Webster Duo-Decapolar Catheter
Common Device Name:	Electrophysiology Mapping Catheter
Classification Name:	Electrode Recording Catheter(per 21 CFR 870.1220, Product Code DRF)
Predicate Device:	1. The Cordis Webster A20 DiagnosticDeflectable Tip Catheter (510(k) K953768)2. The Webster CS Catheter with EZ SteerTechnology (510(k) K090898 and K101345)
Manufacturing Facilities:	Biosense Webster, Inc.15715 Arrow HighwayIrwindale, CA 91706 USABiosense Webster, Inc.Circuito Interior Norte, #1820Parque Industrial SalvacarJuarez, Chihuahua MX 32599

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6.1 Substantially Equivalent To:

The Webster Duo-Decapolar Catheter is substantially equivalent to:

1. The Cordis Webster A20 Diagnostic Deflectable Tip Catheter D-1097-442 (510(k) K953768)
1. The Webster CS Catheter with EZ Steer Technology D-1263-04 (510(k) K090898 and K101345)

6.2 Description of the Device Subject to Premarket Notification:

6.3 Indications for Use:

The catheter is indicated for electrophysiological mapping of cardiac structures: i.e., stimulation and recording only. In addition, the Webster Duo-Decapolar Catheter is designed to facilitate electrogram mapping in the atrial region of the heart and the coronary sinus.

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6.4 Performance Data:

The design of the Webster Duo-Decapolar 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 assessed to be safe and effective for use in the coronary sinus based on an animal study performed with the similarly designed Webster CS Catheter with EZ Steer Technology.

ર્ભ.ર Overall Performance Conclusions:

Based on the results of bench, and animal and studies performed it is concluded that the Webster Duo-Decapolar Catheter, part number D-1171-35, described in this submission is as safe and effective as the predicate devices for its indicated use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with outstretched wings, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The logo is black and white.

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

Biosense Webster, Inc. c/o James Petrie Regulatory Affairs Manager 3333 Diamond Canyon Road Diamond Bar, CA 91765

MAY - 2 2011

Re: K101991

Trade/Device Name: Webster Duo-Decapolar Catheter D-1171-35 Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: April 27, 2011 Received: April 28, 2011

Dear Mr. Petrie:

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.

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

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Page 2 - Mr. James Petrie

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (feporting of medical CFR Part 807); labeling (21 CFR Parl 601); pood manufacturing practice requirements as set
device-related adverse events) (21 CFR 803); pood manufacturing practice absettonic device-related adverse events) (21 CFR 803); good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path Ag); 11 CFR 1000-1050 forth in the quality systems (QS) regulation (21-51-142 of the Act); 21 CFR 1000-1050.
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
lycm (1580) http://www.comment.com/accr.com/offices/ucm115809.htm for If you desire specific advice for your device of top november of the more of the form for the go to http://www.tda.gov/AboutfDA/CentersOffices CDHs) Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDH) assessesses notification" (2 the Center for Devices and Radiological Health 3 (2007 and the motification" (21 CFR Part
note the regulation entitled, "Misbranding by reference overs under the MDR regulati note the regulation entitled, "Misoralding by relection to promations of the MDR regulation (21 CFR Part 803), please go to

CFR Part 803), please go to http://www.ida.gov/Micaletrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the You may obtain other general information' on your l Copysioner Assistance at its toll-free number
Division of Small Manufacturers, International and Copyrigh (800) 638-2041 or (301) 796-7100 or at its Internet address

(800) 038-2041 of (301) 770 - 100 of ar in tw ressfor You/Industry/default.htm.

Sincerely yours,

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

Enclosure

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INDICATIONS FOR USE STATEMENT న్.

510(k) No (if known): K 10199/

Device Name: Webster Duo-Decapolar Catheter

Indications for Use:

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_1_

(Division Sidn-Off) ardiovascular 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).