The LassoStar™ Circular Mapping Catheter is indicated for multiple electrophysiological recording and stimulation of the atrial region of the heart. The catheter is designed to obtain electrograms in the heart.

Device Description

The Biosense Webster LassoStar™ Circular Mapping Catheter is a multi-electrode circular diagnostic catheter designed to facilitate electrophysiological mapping of the atria of the heart (recording and stimulation). The catheter's distal end is a circular spine with ten ring electrodes located circularly that are used for stimulation and recording within the atria. The loop is available in multiple diameters (15 mm, 20 mm and 25 mm) to achieve optimal contact in variably sized pulmonary veins. The device is provided sterile (EtO) and intended for single use.

AI/ML Overview

This document is a 510(k) summary for the LassoStar™ Circular Mapping Catheter. It outlines the device's indications for use, technological characteristics, and performance data used to establish substantial equivalence to a predicate device. This is primarily a regulatory submission, not a detailed clinical study report on device performance based on specific acceptance criteria for diagnostic output.

Based on the provided text, there is no information present regarding specific acceptance criteria for diagnostic performance outcomes (e.g., sensitivity, specificity, accuracy) or a study proving the device meets such criteria in terms of diagnostic effectiveness.

The "Performance Data" section describes bench and animal testing related to the device's physical and functional integrity, not its diagnostic performance in identifying cardiac electrograms with a certain level of accuracy compared to a ground truth.

Here's a breakdown of why the requested information cannot be fully provided from this document:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: No specific performance acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity) are mentioned. The document states "similar pre-determined acceptance criteria as the predicate device" were used for bench and animal testing, which refers to physical and functional aspects like buckle force, tensile strength, impedance, etc.
- Reported Device Performance: The document generally states that "The results of the testing demonstrate the device in scope of this Premarket notification meet the product requirements." No specific quantitative performance metrics related to diagnostic accuracy are provided.
Sample size used for the test set and the data provenance:
- No information about a "test set" for diagnostic performance is provided. The tests mentioned are for physical and functional characteristics (e.g., "Buckle force", "Tensile strength").
- There is a "GLP animal study" mentioned, but its sample size for evaluating "mapping capabilities" is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as there is no mention of a diagnostic performance test set requiring expert ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
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 applicable. This device is an electrophysiological catheter, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the physical/functional tests, the "ground truth" would be engineering specifications and standards. For the animal study evaluating mapping capabilities, the "ground truth" would likely be the direct physiological recordings from the animal model, though this is not explicitly detailed.
The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or diagnostic image analysis.
How the ground truth for the training set was established:
- Not applicable.

Summary of available information related to performance:

The document focuses on establishing substantial equivalence to an existing predicate device (Lasso™ Deflectable Circular Mapping Catheter K002333) based on similar technology, intended use, and method of operation. The performance data presented relates to the safety and functional efficacy of the device's physical attributes, demonstrating that the design modifications (smaller outer diameter, different shaft material, no deflection) do not compromise safety or the ability to perform its intended function of "electrophysiological recording and stimulation of the atrial region of the heart" and "obtain electrograms."

Specific tests performed:

Visual Inspections
Electrical
EEPROM Burn checks
Buckle force
Insertion
Torque
Tensile strength
Impedance and resistance
Visualization
Packaging Sterile Barrier Gross Leak
Transportation
Biocompatibility
Sterilization
Simulated Use
A GLP animal study to evaluate mapping capabilities (details not provided beyond its purpose).

Summary

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June 30, 2020

Biosense Webster, Inc. Michelle Wheeler Senior Specialist, Regulatory Affairs 33 Technology Drive Irvine, California 92618

Re: K193632

Trade/Device Name: LassoStar Circular Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: May 19, 2020 Received: May 21, 2020

Dear Michelle Wheeler:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193632

Device Name LassoStar™ Circular Mapping Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92

Date Summary Prepared	23 December 2019
Applicant	Biosense Webster, Inc.33 Technology DriveIrvine, CA 92618Establishment Registration Number: 9044811
Official Correspondent	Michelle WheelerSenior Regulatory Affairs SpecialistTelephone: (949) 923-4793Fax: (949) 450- 6886
Trade Name	LassoStar™ Circular Mapping Catheter
Common Name	Electrophysiology Catheter
Classification Name	Electrode Recording Catheter or Electrode Recording Probe
Device Classification	Class II, 21 CFR 870.1220Product Code: DRF
Model Numbers	D-1390-01-S, D-1390-02-S, D-1390-03-S
Predicate device	Lasso™ Deflectable Circular Mapping Catheter (K002333)

Substantially Equivalent

The Biosense Webster Inc. LassoStar™ Catheter is substantially equivalent to the Biosense Webster LASSO™ Deflectable Circular Mapping Catheter [510(k) K002333 cleared August 31, 2000].

Description of the Device Subject to Premarket Notification

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Image /page/4/Picture/0 description: The image shows the logo for Biosense Webster, a company that is part of the Johnson & Johnson family of companies. The logo consists of a stylized heart shape on the left, followed by the company name in a sans-serif font. Below the company name, in smaller font, is the text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".

Indications for Use

The LassoStar™ Circular Mapping Catheter is indicated for multiple electrode electrophysiological recording and stimulation of the atrial region of the heart. The catheter is designed to obtain electrograms in the atrial region of the heart.

Technological Characteristics

The LassoStar™ Circular Mapping Catheter uses similar technology, intended use and method of operation as the predicate device. The proposed device includes the same number of electrodes, loop diameters, distal end shape and spine cover material as the predicate device. The main differences of the proposed device are the outer diameter size, shaft material and method of tip deflection mechanism. Table 2-1 provides a direct comparison of the Technological features of the proposed and predicate device.

	Proposed Device(LASSOSTAR)	Predicate Device(Lasso, K002333)
Subject Area
Product Code	DRF	DRF
Indications for Use	The Biosense WebsterLASSOSTAR™ CircularMapping Catheter is indicatedfor multiple electrodeelectrophysiological recordingand stimulation of the atrialregion of the heart. The catheteris designed to obtainelectrograms in the atrial regionof the heart	The catheter is indicated formultiple electrodeelectrophysiological mappingof cardiac structures, i.e.recording or stimulation only.The Lasso Catheter isdesigned to obtainelectrograms in the atrialregion of the heart.
Outer Diameter	3 French	7 French
Usable catheter Length	$193 cm \pm 3.0cm$	$115 cm \pm 5.0cm$
Number of Electrodes	10	10 or 20
Distal End Shape	Circular loop	Circular loop
Loop Diameter	3 sizes:15mm20mm25mm	6 sizes:12mm 25mm15mm 30mm20mm 35mm
Spine Cover Material	Pellethane	Pellethane
Shaft Material	Stainless Steel	Pebax
Method of TipDeflection	No deflection	deflection

	Table 2-1: Characteristic Comparison
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Image /page/5/Picture/0 description: The image shows the logo for Biosense Webster, a part of the Johnson & Johnson family of companies. The logo features a stylized graphic to the left of the company name. The text "Biosense Webster" is displayed prominently, with the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" appearing in smaller font beneath it.

Performance Data

The LassoStar™ catheter underwent bench and animal testing using similar pre-determined acceptance criteria as the predicate device. Testing was completed to support the proposed modifications. The GLP animal study evaluated various sizes of deflectable sheaths to determine mapping capabilities of the proposed device with no deflection. The decreased outer diameter and change in shaft material were analyzed using functional and biocompatibility testing. The results of the testing demonstrate the device in scope of this Premarket notification meet the product requirements. The following tests were performed in support of the substantial equivalence determination:

Visual Inspections ●
Electrical ●
EEPROM Burn checks
Buckle force ●
Insertion ●
Torque
Tensile strength
Impedance and resistance
Visualization
Packaging Sterile Barrier Gross Leak ●
Transportation
Biocompatibility
Sterilization ●
Simulated Use .

Basis for Determination of Substantial Equivalence

The LassoStar™ Circular Mapping Catheter is substantially equivalent to the currently cleared predicate device. The performance data supports the safety and effectiveness of the proposed device and demonstrates the device should perform as intended in the specified use conditions.

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).