LassoStar Circular Mapping Catheter

K193632 · Biosense Webster, Inc. · DRF · Jun 30, 2020 · Cardiovascular

Device Facts

• Record ID: K193632
• Device Name: LassoStar Circular Mapping Catheter
• Applicant: Biosense Webster, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Jun 30, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

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 Story

LassoStar™ is a multi-electrode circular diagnostic catheter for atrial electrophysiological mapping. Input: cardiac electrical signals captured via ten ring electrodes on a distal circular spine. Operation: catheter inserted into the heart to obtain electrograms; used for recording and stimulation. Output: electrogram signals transmitted to external recording/stimulation equipment. Used in clinical electrophysiology settings by physicians. Device features a 3 French outer diameter and stainless steel shaft; no tip deflection mechanism. Benefits: facilitates mapping of atrial regions to support diagnosis and treatment planning. Healthcare providers use the recorded electrograms to identify cardiac electrical activity and guide clinical decision-making during electrophysiology procedures.

Clinical Evidence

No human clinical data. Evidence consists of bench testing and a GLP animal study. Bench testing included visual inspection, electrical/impedance/resistance testing, EEPROM burn checks, buckle force, insertion, torque, tensile strength, visualization, packaging integrity, and sterilization validation. Animal study evaluated mapping capabilities using deflectable sheaths with the non-deflectable catheter. Results confirmed the device meets pre-determined acceptance criteria and functional requirements.

Technological Characteristics

Multi-electrode circular diagnostic catheter; 10 ring electrodes; 15mm, 20mm, 25mm loop diameters. Materials: Pellethane spine cover, stainless steel shaft. 3 French outer diameter. Non-deflectable. Sterile (EtO). Connectivity: wired interface to external electrophysiology recording/stimulation systems.

Indications for Use

Indicated for multiple electrode electrophysiological recording and stimulation of the atrial region of the heart in patients requiring cardiac electrogram acquisition.

Regulatory Classification

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.

Predicate Devices

• Lasso™ Deflectable Circular Mapping Catheter (K002333)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/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 element to the left of the text "Biosense Webster." Below the company name, in smaller font, is the text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES."

# 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.<br>33 Technology Drive<br>Irvine, CA 92618<br>Establishment Registration Number: 9044811 |
| Official Correspondent | Michelle Wheeler<br>Senior Regulatory Affairs Specialist<br>Telephone: [phone]<br>Fax: [phone] |
| 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 870.1220<br>Product 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

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.

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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<br>(LASSOSTAR) | Predicate Device<br>(Lasso, K002333) |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Area | | |
| Product Code | DRF | DRF |
| Indications for Use | The Biosense Webster<br>LASSOSTAR™ Circular<br>Mapping Catheter is indicated<br>for multiple electrode<br>electrophysiological recording<br>and stimulation of the atrial<br>region of the heart. The catheter<br>is designed to obtain<br>electrograms in the atrial region<br>of the heart | The catheter is indicated for<br>multiple electrode<br>electrophysiological mapping<br>of cardiac structures, i.e.<br>recording or stimulation only.<br>The Lasso Catheter is<br>designed to obtain<br>electrograms in the atrial<br>region 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:<br>15mm<br>20mm<br>25mm | 6 sizes:<br>12mm 25mm<br>15mm 30mm<br>20mm 35mm |
| Spine Cover Material | Pellethane | Pellethane |
| Shaft Material | Stainless Steel | Pebax |
| Method of Tip<br>Deflection | 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.