LASSO® 2515 NAV eco Variable Catheter: The LASSO® 2515 NAV eco Variable Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart. The LASSO® 2515 NAV eco Variable Catheter provides location information when used with compatible CARTO® 3 EP Navigation Systems. (This catheter is not compatible with CARTO® 3 EP Navigation Systems prior to Version 2.3.)

LASSO® NAV eco Catheter: The LASSO® NAV eco Catheter is indicated for multiple electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart. The LASSO® NAV eco Catheter provides location information when used with compatible CARTO® 3.EP Navigation Systems. (This catheter is not compatible with CARTO® 3 EP Navigation Systems prior to Version 2.3.)

Device Description

The LASSO 2515 NAV eco Variable Catheter and the LASSO NAV eco Catheter have been designed to facilitate electrophysiological mapping of the atria of the heart with the CARTO 3 EP Navigation System and a reference device. Both catheters are deployed in the right or left atrium through an 8F guiding sheath. Both deflectable catheters consists of a circular spine on the distal tip, with platinum/iridium electrodes that can be used for stimulation and recording. The purpose of this Premarket Notification is to modify the catheter connector, so that the Printed Circuit Board (PCB) can be removed from the single-use only catheter and placed in a reusable interface cable as part of the CARTO 3 EP Navigation System.

The LASSO 2515 NAV eco Variable Catheter features a Nitinol loop design that allows the expansion and contraction of the loop to custom-fit veins with different sizes, ranging from 25mm to 15mm diameter (± 15%).

The LASSO NAV eco Catheter is a fixed catheter with three fixed catheter sizes, namely 15, 20, and 25 mm loop sizes to accommodate different vein sizes. Each loop size will be available with either 10 or 20 electrodes.

The proposed catheters will continue to interface with standard recording equipment via interface cables and appropriate connectors.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain specific quantitative acceptance criteria or detailed reported device performance metrics in a tabular format as would typically be seen for a new device submission with novel claims. Instead, it focuses on demonstrating substantial equivalence to predicate devices through general safety and effectiveness.

The closest we can get to "acceptance criteria" based on this document is the overarching goal of showing the new devices are "safe and effective for anatomic mapping of the heart" and establish "equivalence... to their respective predicate devices." The performance data section broadly states:

Acceptance Criterion (Implied)	Reported Device Performance
Safety	Passed all intended criteria in accordance with appropriate standards.
Effectiveness	Passed all intended criteria in accordance with appropriate standards.
Equivalence to Predicate	Established through nonclinical studies.

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

The text states that the devices underwent "Bench and Animal Testing."

Test Set Sample Size: Not explicitly stated. The document refers to "Bench and Animal Testing" generally, without providing sample sizes for either.
Data Provenance: Not explicitly stated. The document does not specify the country of origin for the "Bench and Animal Testing," nor does it classify them as retrospective or prospective. Animal testing is inherently prospective experimentation.

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

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

Adjudication Method: Not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. The document describes "Bench and Animal Testing" to establish safety, effectiveness, and equivalence to predicate devices. There is no mention of human readers, comparative effectiveness with or without AI assistance, or effect size.

6. If a Standalone (Algorithm Only) Performance Study Was Done

Standalone Performance Study: Not applicable. This device is an electrophysiological mapping catheter, not an AI algorithm. Its performance is intrinsically tied to its physical interaction with the heart and its interface with the CARTO 3 EP Navigation System. The "performance data" refers to the device's physical and functional characteristics, not an isolated algorithm.

7. The Type of Ground Truth Used

Based on "Bench and Animal Testing," the ground truth would likely be established through:

Bench Testing: Engineering specifications, material properties, electrical measurements, mechanical stress tests, and functional tests against predefined criteria.
Animal Testing: Physiological measurements (e.g., electrogram recording comparisons, navigation accuracy verification within the animal heart), histological analysis (if relevant for tissue interaction), and direct observation of device performance and integrity within a living biological system.

The document does not detail specific "ground truth" methodologies beyond these general categories.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is a hardware medical device (catheter) with an updated connector design, not an AI system that requires a training set.

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

Ground Truth for Training Set Establishment: Not applicable, as detailed above.

Summary

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DEC - 5 2011

18. 510(K) SUMMARY

. .

Applicant:	Biosense Webster, Inc.3333 Diamond Canyon RoadDiamond Bar, CA 91765Phone: 800-729-9010 x8534Fax: 909-839-8804
Contact Person:	John JimenezSenior Specialist, Regulatory Affairs
Date:	October 31, 2011
Trade or Proprietary Name:	LASSO® 2515 NAV eco Variable CatheterLASSO® NAV eco Catheter
Common or UsualName of Device:	Electrophysiological Mapping Catheter
Classification Name:	Electrode Recording Catheter(21 CFR 870.1220, Product Code DRF)
Predicate Devices:	LASSO® 2515 NAV Variable Catheter510(k): K081258LASSO® NAV Catheter510(k): K093376
Manufacturer:	Biosense Webster, Inc.3333 Diamond Canyon RoadDiamond Bar, CA 91765
Manufacturing Sites:	Biosense Webster, Inc.15715 Arrow HighwayIrwindale, CA 91706Biosense Webster, Inc.Cordis de MexicoCircuito Interior Norte #1820Parque Industrial Salvarcar 32599Juarez, Chihuahua, Mexico

CONFIDENTIAL

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18.1 Substantially Equivalent To

The Biosense Webster LASSO®2515 NAV eco Variable Catheter is substantially equivalent to the Biosense Webster LASSO®2515 NAV Variable Catheter [510(k) K081258, cleared January 6, 2009] and the Biosense Webster LASSO® NAV Catheter (510(k) K093376. cleared June 18, 2010).

18.2 Description of the Device Subject to Premarket Notification

The proposed catheters will continue to interface with standard recording equipment via interface cables and appropriate connectors.

18.3 Indications for Use

LASSO® 2515 NAV eco Variable Catheter

The LASSO® 2515 NAV eco Variable Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart. .

The LASSO® 2515 NAV eco Variable Catheter provides location information when used with compatible CARTO® 3 EP Navigation Systems. (This catheter is not compatible with CARTO® 3 EP Navigation Systems prior to Version 2.3.)

LASSO® NAV eco Catheter

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The LASSO® NAV eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart.

The LASSO® NAV eco Catheter provides location information when used with compatible CARTO® 3 EP Navigation Systems. (This catheter is not compatible with CARTO® 3 EP Navigation Systems prior to Version 2.3.)

18.4 Performance Data

The LASSO 2515 NAV eco Variable Catheter and the LASSO NAV eco Catheter underwent Bench and Animal Testing. Both catheters passed all intended criteria in accordance with appropriate standards and test criteria.

18.5 Overall Performance Conclusions

The nonclinical studies demonstrate that the LASSO 2515 NAV eco Variable Catheter and the LASSO NAV eco Catheter are safe and effective for anatomic mapping of the heart and establish equivalence of the LASSO 2515 NAV eco Variable Catheter and the LASSO NAV eco Catheter to their respective predicate devices, the LASSO 2515 NAV Variable Catheter and the LASSO NAV Catheter.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

DEC - 5 2011

Biosense Webster, Inc. c/o Mr. John Jimenez Senior Specialist, Regulatory Affairs 3333 Diamond Canyon Road Diamond Bar, CA 91765

Re: K113213

Trade/Device Name: LASSO® 2515 V eco Variable Catheter and LASSO® NAV Catheter Regulatory Number: 21 CFR 870.1220 Regulation Name: Catheter, Electrode Recording Regulatory Class: II (two) Product Code: 74 DRF Dated: October 31, 2011 Received: November 1, 2011

Dear Mr. Jimenez:

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 - Mr. John Jimenez

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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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7. INDICATIONS FOR USE STATEMENT

510(k) No (if known):

Device Name: LASSO® 2515 NAV eco Variable Catheter and LASSO®NAV eco Catheter

Indication for Use:

LASSO® 2515 NAV eco Variable Catheter

LASSO® NAV eco Catheter

The LASSO® NAV eco Catheter is indicated for multiple electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart.

The LASSO® NAV eco Catheter provides location information when used with compatible CARTO® 3.EP Navigation Systems. (This catheter is not compatible with CARTO® 3 EP Navigation Systems prior to Version 2.3.)

AND/OR

Prescription Use V (Part 21 CFR 801 Subpart D)

Over-The-Counter (21 CFR 801 Subpart C)

Use

(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

510(k) Number_ KIB213

Division of Cardiovascular Devices

(Division Sign-Off)

Biosense Webster, Inc.

CONFIDENTIAL

Page 24 of 165

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).