The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording and stimulation only. The LASSO 2515 Variable Circular Mapping catheter is designed to obtain electrograms in the atrial regions of the heart.

Device Description

The LASSO 2515 Variable mapping catheter when used in conjunction with electrophysiological pacing and recording equipment is designed to acquire, analyze and display electrical activity in the human heart. In particular the device is targeted for use in the atrial chambers of the heart and is particularly well-suited for placement in or near the pulmonary veins in the left atrium. The catheter transmits electrical pulses from the pacing equipment and intracardiac electrical signals to the recording equipment for display as electrograms (ECG traces). Trained physicians interpret the electrograms in diagnosing cardiac arrhythmias.

The Variable LASSO™ 2515 electrophysiologic mapping catheter now incorporates a tip with a variable radius mechanism that allows selection of radii in a range from 15-25 mm. The LASSO predicate device cleared in K002333 is marketed with fixed radii of 10, 15, 20 and 25 mm. The subject device will allow the user to select a continuum of radii from 10- 25 mm. To facilitate user selection of this range of radii, design changes were required in the handle of the catheter. The Variable Lasso handle mechanism now has two independently operating deflecting mechanisms that control tip deflection and circular spine expansion and contraction. Tip deflection is controlled with a thumbknob attached to the distal end of a piston mechanism enclosed in the handle barrel. The spine contraction and expansion mechanism is also controlled by the movement of a puller wire attached to a cam assembly mechanism in the catheter handle that when rotated either contracts or expands the distal loop in a diameter range from 15 to 25 mm.

AI/ML Overview

The provided 510(k) summary for the LASSO™ 2515 Variable Circular Mapping Catheter describes the device's design, intended use, and comparison to a predicate device, but it does not contain details of a clinical study or specific acceptance criteria with quantifiable performance metrics.

The document states:

"Various non - clinical bench tests were conducted to verify conformance of Variable Lasso catheter to design and performance specifications. Mechanical, dimensional, and reliability tests were performed and all requirements were met prior to submission of the 510k. No new questions of safety and effectiveness were raised as a result of these tests."

This indicates that the device's acceptance was based on bench testing ensuring it met design and performance specifications, likely related to its mechanical function, dimensions, and reliability. The 510(k) pathway for this device relies on substantial equivalence to a predicate, not on new clinical efficacy studies establishing performance against specific acceptance criteria in patient populations.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as a formal clinical study with such elements was not conducted or reported in this summary.

Here's a breakdown of what can be inferred or directly stated, and what is missing:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in quantitative terms within this document. The general criteria appear to be "conformance... to design and performance specifications" and "all requirements were met." These requirements would likely relate to mechanical properties (e.g., deflection range, circular spine expansion/contraction, durability).
- Reported Device Performance: The document states that "all requirements were met" for mechanical, dimensional, and reliability tests. No specific performance values (e.g., precision of radius selection, force required for deflection, number of cycles tested for durability) are provided.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable as no human-subject clinical test set is described. Bench tests would have involved a sample size of catheters, but this detail is not provided.
- Data Provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as no human-subject clinical test set is described where expert ground truth would be established. For bench testing, "ground truth" would be engineering specifications and measurements.
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 is a medical device for mapping cardiac electrical activity, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable; this is a physical medical device, not an algorithm. Bench testing assesses the device's physical performance, which is "standalone" in that it's testing the device itself, but it's not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the bench tests, the "ground truth" would have been the engineering design specifications and objective physical measurements (e.g., measuring the exact radius achieved, forces, deflections) using standard metrology and testing equipment.
The sample size for the training set
- Not applicable. This device does not use an AI/ML algorithm that requires a "training set."
How the ground truth for the training set was established
- Not applicable.

In summary, the 510(k) relies on bench testing and a comparison to a predicate device for substantial equivalence, rather than a clinical study with specific performance acceptance criteria for patient outcomes or diagnostic accuracy. The "acceptance criteria" were implied to be the successful meeting of the device's design and performance specifications during in-house mechanical, dimensional, and reliability testing.

Summary

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K031161

Image /page/0/Picture/1 description: The image shows the logo for Biosense Webster, a Johnson & Johnson company. The logo consists of a stylized graphic to the left of the company name. The graphic is an abstract design that resembles a heart or a stylized letter. The text "Biosense Webster" is written in a bold, sans-serif font, with the words stacked on top of each other. Below the company name, in a smaller font, is the text "a Johnson & Johnson company."

JUL 2 2 2003

510(k) Summary for the LASSO™ 2515 Variable Circular Mapping
	Catheter
510(k) Notification submitted by:	Biosense Webster, Inc.3333 Diamond Canyon Rd.Diamond Bar, CA 91765USAPhone: +1-800-729-9010Fax: +1-909-839-8804
Contact person:	William WelchRegulatory Affairs Project Manager
Proprietary device name:	LASSO 2515 Mapping Catheter
Classification name:	Electrode Recording Catheter(per 21 CFR 870.1220)
Common device name:	Deflectable Electrophysiologic MappingCatheter
Predicate device:	LASSO Deflectable Circular Mapping Catheter510(k) No. K002333
Manufacturer:	Biosense Webster Inc.3333 Diamond Canyon RoadDiamond Bar, CA 91765

Overview

Design

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required in the handle of the catheter. The Variable Lasso handle mechanism now has two independently operating deflecting mechanisms that control tip deflection and circular spine expansion and contraction. Tip deflection is controlled with a thumbknob attached to the distal end of a piston mechanism enclosed in the handle barrel. The spine contraction and expansion mechanism is also controlled by the movement of a puller wire attached to a cam assembly mechanism in the catheter handle that when rotated either contracts or expands the distal loop in a diameter range from 15 to 25 mm.

Testing

Various non - clinical bench tests were conducted to verify conformance of Variable Lasso catheter to design and performance specifications. Mechanical, dimensional, and reliability tests were performed and all requirements were met prior to submission of the 510k. No new questions of safety and effectiveness were raised as a result of these tests.

Biocompatibility and sterilization validation testing were not repeated since patient contact materials identical to the predicate device are used and since the described design changes do not affect the ability to sterilize the product.

Indications and Contraindications for Use

The intended use of this device is identical to the predicate Lasso device, namely:

Contraindications - No new contraindications have been introduced as a result of implementing the design changes necessary to operate a Variable Lasso catheter.

Packaging and Shelf Life

The catheter is packaged in a thermoformed tray and sealed in a nylon/Tyvek breather pouch. The pouch is placed in a preprinted unit box, labeled, and with other units, is placed in an outer shipping box prior to sterilization. Testing has been conducted to establish the expiration date of the product which is printed on the pouch and unit box labels as a "Use By" date.

Risks

An additional risk to patient safety involves failure of the handle rotation mechanism and associated components which may require the catheter to be replaced with another catheter. This is a standard practice for any catheter when one or more performance features of the catheter are compromised and thus this is not viewed as a new risk but

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Image /page/2/Picture/1 description: The image shows the logo for Biosense Webster, a Johnson & Johnson company. The logo consists of a stylized heart shape on the left, followed by the company name "Biosense Webster" in a bold, sans-serif font. Below the company name, the text "a Johnson & Johnson company" is written in a smaller, cursive font. The logo is black and white.

instead an additional cause for the risk. All risks have been mitigated by appropriate means.

Summary of Substantial Equivalence

The design differences between the Variable Lasso 2515 and Lasso predicate device do not raise new questions of safety and effectiveness. The devices use the same fundamental technology, energy source, patient contact materials, and have the same the intended use as the predicate device. Finally, verification testing has raised no new questions of safety or effectiveness.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 2 2003

Biosense Webster, Inc. c/o Mr. William Welch Regulatory Affairs Project Manager 3333 Diamond Canyon Road Diamond Bar, CA 92128

Re: K031161

Trade Name: Lasso 2515 Variable Circular Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II (two) Product Code: DRF Dated: July 17, 2003 Received: July 18, 2003

Dear Mr. Welch:

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 such 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

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Page 2 – Mr. William Welch

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Kortu

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 Statement

K031161

510(k) No:

Device Name: Variable LASSO™ 2515 Circular Mapping Catheter

Indications For Use:

Prescription Use Only

Ve Vettl

on Sian-Off Division of Cardiova 510(k) Numbe

Biosense Webster CONFIDENTIAL April 10, 2003

000023

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).