CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath

K170997 · Biosense Webster, Inc. · DYB · Jul 25, 2017 · Cardiovascular

Device Facts

• Record ID: K170997
• Device Name: CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
• Applicant: Biosense Webster, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jul 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Biosense Webster CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The sheath curve can be visualized when used with compatible CARTO® 3 EP Navigation Systems.

Device Story

The CARTO VIZIGO 8.5F is a steerable, bi-directional guiding sheath used to introduce cardiovascular catheters into the heart. It features a handle with a rotating collar for bi-directional tip deflection, a hemostasis valve to prevent blood loss, and a sideport for fluid infusion or aspiration. The device includes four ring electrodes along the shaft, which allow for real-time visualization of the sheath curve when connected to a compatible CARTO 3 EP Navigation System. Used by physicians in clinical settings, the device facilitates catheter navigation to specific cardiac anatomy. The visualization capability assists the clinician in tracking the sheath's position, potentially improving procedural efficiency and catheter placement accuracy. The device also includes a radiopaque tip marker for fluoroscopic visualization.

Clinical Evidence

Bench testing and pre-clinical animal studies were conducted. Bench testing verified mechanical integrity, deflection performance, electrical resistance, leakage, and electrode functionality. Pre-clinical testing in an animal model evaluated the sheath's performance in maneuvering catheters within the right and left atria and ventricles. Study endpoints were met with no product integrity issues, no hemostatic valve leakage, no thrombus formation, and no clinically significant tissue injury.

Technological Characteristics

8.5F bi-directional guiding sheath; rotary-type deflection mechanism; four ring electrodes for electromagnetic navigation; radiopaque tip marker; hemostasis valve; sideport with three-way stopcock; available in three curve sizes (Small, Medium, Large).

Indications for Use

Indicated for introducing cardiovascular catheters into the heart, including the left side of the interatrial septum, in patients requiring cardiac catheterization procedures.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• St. Jude Agilis™ NxT Steerable Introducer (K081645)

Reference Devices

• Webster® CS Catheter with EZ Steer® Technology (K101345)

Submission Summary (Full Text)

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Public Health Service

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

July 25, 2017

Biosense Webster, Inc. John Jimenez Senior Program Lead, Regulatory Affairs 33 Technology Drive Irvine, California 92618

Re: K170997

Trade/Device Name: CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: June 9, 2017 Received: June 12, 2017

Dear John 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. 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 801); medical device reporting of medical device

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

M & Tillelrem

for 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) Number (if known) K170997

Device Name

CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath

Indications for Use (Describe)

The Biosense Webster CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is indicated for introducing various cardiovascular catheters into the heart, including the left side of the interatrial septum.

The sheath curve can be visualized when used with compatible CARTO® 3 EP Navigation Systems.

Type of Use (Select one or both, as applicable)

| <span style="font-size:12px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# 1. 510(K) SUMMARY

This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| APPLICANT | Biosense Webster, Inc. |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| | 33 Technology Drive |
| | Irvine, CA 92618 |
| OFFICIAL<br>CORRESPONDENT | John Jimenez<br>Senior Program Lead, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| DATE SUMMARY<br>PREPARED | March 31, 2017 |
| TRADE NAME | CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath |
| COMMON NAME | Guiding Sheath |
| CLASSIFICATION NAME | Catheter Introducer |
| DEVICE CLASSIFICATION | Class II, 21 CFR §870.1340<br>Product Code: DYB |
| PRODUCT CODES | D-1385-01-S, D-1385-02-S, D-1385-03-S |
| PREDICATE DEVICE | St. Jude Agilis™ NxT Steerable Introducer<br>[510(k) K081645] |
| REFERENCE DEVICE | Webster® CS Catheter with EZ Steer® Technology<br>[510(k) K101345] |

### SUBSTANTIALLY EQUIVALENT TO:

The Biosense Webster CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is substantially equivalent to the St. Jude Agilis™ NxT Steerable Introducer [510(k) K081645, cleared December 9, 2008]. Like the predicate device, the CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath features a rotary-type deflection mechanism, allowing for bi-directional deflection of the shaft. The proposed sheath also has similar Flex Shaft Curve Size offerings, the same French Size, the same patient contact materials, and the same Useable Length. The original intended use of the predicate device as a catheter delivery system remains the same in the proposed device; however, the proposed device will now have the added ability of shaft visualization when used with a compatible

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CARTO® 3 EP navigation System. This latter capability is substantially equivalent to and can be referenced in the Webster® CS Catheter with EZ Steer® Technology. The Webster® CS Catheter with EZ Steer® Technology utilizes the same visualization technology and was approved under 510(k) K101345, cleared June 22, 2010.

# DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, and fluid infusion. A handle equipped with a rotating collar to deflect the tip clockwise < 180° and counterclockwise ≤ 180°. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to allow fluoroscopic visualization. The purpose of this Premarket Notification is to create a bidirectional, flexible-tipped, guiding sheath, with visualization capabilities to facilitate catheter accessibility to various areas of interest within the heart. The new sheath will utilize an existing cable/connector to support visualization.

The CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath features a flex shaft curve design available in three curve sizes, Small, Medium, and Large curve. Each sheath with four (4) electrodes spaced along its shaft to enable shaft visualization when used with compatible CARTO® 3 EP Navigation Systems.

### INDICATIONS FOR USE:

The Biosense Webster CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The sheath curve can be visualized when used with compatible CARTO® 3 EP Navigation Systems.

# TECHNICAL CHARACTERISTICS:

The CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is a typical bi-directional guiding sheath that is unique only in the presence of four ring electrodes spaced along its shaft. Otherwise, there are no special technical aspects of the ability of this sheath to facilitate the introduction of various cardiovascular catheters into the heart.

# PERFORMANCE DATA:

The CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath underwent bench and preclinical testing under simulated clinical conditions to verify the safety and effectiveness of its features. The CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath passed all tests in accordance with appropriate test criteria and standards.

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| Summary of Bench Tests and Results | | |
|------------------------------------------------------------|-------------|--|
| Test Description | Results | |
| Usable Length | Pass | |
| Lumen Inner Diameter | Pass | |
| Distal Tip Inner Diameter | Pass | |
| Overall Length | Pass | |
| Cap to hub retention | Pass | |
| Sheath OD | Pass | |
| Sheath OD - Flex Section | Pass | |
| PU adhesion | Pass | |
| Marker Band Location1 | Pass | |
| Vent Hole Location | Pass | |
| Vent Hole Diameter | Pass | |
| Vent Hole Orientation | Pass | |
| Sheath leak | Pass | |
| Vacuum decay | Pass | |
| In-Plane Deflection | Pass | |
| Handle deflection direction | Pass | |
| Shaft torque | Pass | |
| Tip drag force | Small: Pass | |
| | Large: Pass | |
| Side load | Small: Pass | |
| | Large: Pass | |
| Pigtail to Connector2 | Pass | |
| Pigtail to Handle | Pass | |
| Hub to shaft | Pass | |
| Stopcock to handle | Pass | |
| Stopcock to tube | Pass | |
| Shaft distal segments | Pass | |
| Shaft proximal segments | Pass | |
| Hemostasis valve and sheath must not leak | Pass | |
| Valve insertion force | Pass | |
| Valve friction | Pass | |
| Curve Span | Small: Pass | |
| | Large: Pass | |
| Electrode Location | Small: Pass | |
| | Large: Pass | |
| Electrical Resistance | Small: Pass | |
| | Large: Pass | |
| Current Leakage | Small: Pass | |
| | Large: Pass | |
| Connector mating, flex fatigue, and pigtail torque testing | Pass | |
| Electrical Isolation | Small: Pass | |
| | Large: Pass | |
| External lead cable length | Pass | |
| Corrosion | Pass | |
| Continuous pouch seal | Pass | |
| Pouch particulate | Pass | |
| Label adhesion and legibility | Pass | |
| Dilator OD | Pass | |
| Dilator to cap retention force | Pass | |

Dilator to dilator hub tensile

Dilator hub has standard luer

Dilator tip ID

Dilator overall length (straightened)

Pass

Pass

Pass

Pass

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# Summary of Pre-Clinical Tests and Results

The study placed one Test or one Control sheath in the animal to aid in maneuvering of various therapeutic and diagnostic catheters for mapping of the right atrium, right ventricle, left atrium and left ventricle of the heart.

The findings met all Study Endpoints concerning safety and

performance of the CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath:

- 1) No damage or product integrity issues related to CARTO VIZIGO™ 8.5F
Bi-Directional Guiding Sheath.

- 2) No leakage through hemostatic valve.
- 3) No thrombus observed inside or at the tip of the sheath.

4) No clinically significant tissue injury related to the use of the Test article.

# BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

The CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is substantially equivalent to its currently cleared predicate based on the successful completion of nonclinical bench testing and pre-clinical studies, as well as the technological comparison exhibiting similar principles of design, operation, and indications for use.