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 Coronary Sinus Deflectable Mapping Catheters (D-1263-01-S & D-1263-02-S) 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, 2-5-2 mm or 2-8-2 mm electrode spacing, have uni-directional deflection with an MZ curve, and are 115 cm long. The catheters include a handle with a thumb knob, which allows deflection of the distal end of the catheter. The handle also has a 10-pin connector for interfacing to a recording system though a standard catheter cable. The braided, bendable/conformable shaft allows torque and contact force to be transmitted from the handle to the distal end. The distal tip is unbraided and soft. These two predicate models are identical except that the electrode spacing is 2-5-2 mm for D-1263-01-S and 2-8-2 mm for D-1263-02-S.

The Webster CS Catheters with EZ Steer Technology (D-1263-04-S & D-1263-05-S) 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 bi-directional deflection and are 115 cm long. These catheters include a braided bi-directional deflectable tip section. The braided bidirectional tip provides the user with two 180° opposed single plane curves. Currently, the available curves for the Webster CS Catheters with EZ Steer Technology include FJ (D-1263-04-S) and DF (D-1263-05-S). These catheters include a handle with a Rocker Lever, which is used to deflect the tip. The hightorque 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 Technology (D-1263-06-S & D-1263-07-S) 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 bi-directional deflection and are 115 cm long. These catheters include a braided bi-directional deflectable tip section. The braided bidirectional tip provides the user with two 180° opposed single plane curves. Currently, the available curves for the modified Webster CS Catheters include FJ (D-1263-06-S) and DF (D-1263-07-S). 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 catheters 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Biosense Webster Coronary Sinus Deflectable Mapping Catheters:

Acceptance Criteria and Device Performance:

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed performance metrics from a clinical study. Instead, it relies on demonstrating substantial equivalence to a previously cleared predicate device (K050877).

The "Summary of Testing" section states: "The Webster CS Catheters have been subjected to performance testing to validate the integrity of the catheters and the performance of the catheters with the ancillary equipment." However, it does not provide the results of this testing in a quantifiable manner or against pre-defined acceptance criteria related to accuracy, sensitivity, specificity, or other performance characteristics typically measured in a clinical study for AI/diagnostic devices.

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the provided document as it does not contain this specific information.

Missing Information/Not Applicable Based on Provided Text:

The following information cannot be extracted from the provided 510(k) summary because it primarily focuses on substantial equivalence for a medical device (catheter), not on the performance of a diagnostic AI algorithm. Many of the questions are more relevant to AI/ML device submissions.

Sample sized used for the test set and the data provenance: Not described in the document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not described in the document.
Adjudication method for the test set: Not described in the document.
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: Not described in the document. This is not an AI device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not described in the document. This is not an AI device.
The type of ground truth used: Not explicitly described in the context of a clinical study or diagnostic performance. The ground truth for this type of device would typically be observed physiological responses during electrophysiological procedures rather than a diagnostic label.
The sample size for the training set: Not applicable as this is not an AI/ML device, and no training set is mentioned.
How the ground truth for the training set was established: Not applicable as this is not an AI/ML device.

Key Takeaway from the Document:

The 510(k) submission for the Biosense Webster Coronary Sinus Catheters (new models and models with EZ Steer and Auto ID) demonstrates their safety and effectiveness by asserting substantial equivalence to an existing, legally marketed predicate device (K050877). The document indicates "performance testing" was conducted to validate integrity and performance with ancillary equipment, but the details, specific criteria, and results of these tests are not included for public review in this summary. The FDA's clearance (K090898) confirms their agreement on substantial equivalence based on the submitted data.

Summary

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Ko90898

SEP 04 2009

510(K) SUMMARY

Applicant:

Biosense Webster, Inc. 3333 Diamond Canyon Rd. Diamond Bar, CA 91765, USA Phone: 800-839-8599 Fax: 909-839-8804

Date:

September 2, 2009

Contact Person:

Natalie Bennington, Regulatory Affairs Manager

Proprietary Device Name / Manufacturing Part Number:

· Coronary Sinus Deflectable Mapping Catheters (D-1263-01-S & D-1263-02-S)
· Webster CS Catheter with EZ Steer Technology (D-1263-04-S & D-1263-05-S)
· Webster CS Catheter with EZ Steer Technology and Auto ID (D-1263-06-S & D-1263-07-S)

Common Device Name:

Electrophysiology Mapping Catheter

Classification Name:

Electrode Recording Catheter (per 21 CFR 870.1220, Product code DRF)

Predicate Device:

Biosense Webster Coronary Sinus Deflectable Mapping Catheters (D-1263-01-S & D-1263-02-S), originally cleared via 510(k) K050877 on June 24, 2005.

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Manufacturing Facilities:

· Biosense Webster, Inc. Circuito Interior Norte #1820 Parque Industrial Salvacar Juarez, Chihuahua Mexico, Mexico 32599

. Biosense Webster, Inc. 15715 Arrow Highway Irwindale, CA 91706

Device Description

The Webster Coronary Sinus Catheter (D-1263-01-S & D-1263-02-S)

· D-1221-21-S
· D-1221-26-S
. D-1221-25-S

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

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catheters include a braided bi-directional deflectable tip section. The braided bidirectional tip provides the user with two 180° opposed single plane curves. Currently, the available curves for the Webster CS Catheters with EZ Steer Technology include FJ (D-1263-04-S) and DF (D-1263-05-S). These catheters include a handle with a Rocker Lever, which is used to deflect the tip. The hightorque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. The following cables are used to provide a means for interface of the catheters with the appropriate equipment:

· D-1221-21-S
· D-1221-25-S
. D-1221-26-S

The Webster Coronary Sinus Catheter with EZ Steer Technology (D-1263-06-S & D-1263-07-S)

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

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.

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Summary of Testing

ﺎ

The Webster CS Catheters have been subjected to performance testing to validate the integrity of the catheters and the performance of the catheters with the ancillary equipment.

Substantial Equivalence

The Webster CS Catheters (D-1263-01-S, D-1263-02-S, D-1263-04-S, D-1263-05-S, D-1263-06-S & D-1263-07-S) are substantially equivalent to the Biosense Webster Coronary Sinus Deflectable Mapping Catheters (D-1263-01 & D-1263-02), originally cleared via 510(k) K050877 on June 24, 2005.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

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

SEP 0 4 2009

Biosense Webster. Inc. c/o Ms. Natalie Bennington Manager, Regulatory Affairs 3333 Diamond Canyon Road Diamond Bar, CA 91765

Re: K090898

Trade/Device Name:

. Webster CS Catheter (D-1263-01-S and D-1263-02-S);
Webster CS Catheter with EZ Steer Technology (D-1263-04-S and D-1263-05-S); and
Webster CS Catheter with EZ Steer Technology and Auto ID (D-1263-06-S and D-1263-07-S).

Regulatory Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II (Two) Product Code: DRF Dated: July 28, 2009 Received: August 5, 2009

Dear Ms. Bennington:

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.

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Page 2 - Ms. Natalie Bennington

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 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/CDRHQffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,
W.M.J.

or 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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INDICATIONS FOR USE

510(k) No (if known): K090898

Device Name:

· Webster CS Catheter D-1263-01-S D-1263-02-S
· Webster CS Catheter with EZ Steer Technology D-1263-04-S D-1263-05-S
· Webster CS Catheter with EZ Steer Technology and Auto ID D-1263-06-S D-1263-07-S

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)


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(Division Sign-Off)
Division of Cardiovascular Devices

F510(k) Number

Page 1 of 1

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).