ENPATH MEDICAL STEERABLE SHEATH

K061119 · Enpath Medical, Inc. · DQY · May 18, 2006 · Cardiovascular

Device Facts

• Record ID: K061119
• Device Name: ENPATH MEDICAL STEERABLE SHEATH
• Applicant: Enpath Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: May 18, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Enpath Medical Steerable Sheath is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.

Device Story

The Enpath Steerable Sheath is a guide catheter/delivery sheath used by clinicians during interventional procedures to access difficult-to-reach areas of the peripheral and coronary vasculature. The device features a distal tip that deflects to create variable curve shapes, controlled by a handle mechanism that allows for locking the tip at any point along its travel. The handle includes a luer fitting or hemostasis valve. By providing adjustable curvature, the device enables access to vessels characterized by occlusion or tortuosity that standard catheters cannot reach. The clinician operates the handle to navigate the sheath to the target site, facilitating the subsequent placement of interventional devices. The device benefits patients by allowing successful completion of procedures in anatomically challenging vascular locations.

Clinical Evidence

No clinical evaluations were conducted. Evidence consists of bench testing to verify device specifications, including functional testing of articulation, deflection radius, deflection force, hemostasis of the valve, and deflection cycle testing.

Technological Characteristics

Guide catheter/delivery sheath with deflectable distal tip. Features a molded handle with integrated deflection and locking mechanism. Includes luer fitting or hemostasis valve. Biocompatible materials. Manual operation. Non-powered. Sterilized.

Indications for Use

Indicated for patients requiring interventional procedures in the peripheral and coronary systems where access is difficult due to occlusion, tortuosity, or need for specific curve angles. Applications include pulmonary vein ablation, transseptal access, renal stenting, and carotid stenting.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Enpath Medical Steerable Sheath (K043489)

Submission Summary (Full Text)

{0}------------------------------------------------

Enpath Medical, Inc. Steerable Sheath

Special 510(k) Submission Summary

Image /page/0/Picture/2 description: The image shows a sequence of alphanumeric characters, specifically "K061119". The characters are written in a bold, sans-serif font, and they appear to be handwritten or stylized. The sequence consists of a mix of uppercase letters and numbers.

# 510(k) Summary

# Submitter

Enpath Medical Inc. 15301 Highway 55 West Minneapolis, MN 55447 Main: 763-559-2613 763-559-0148 Fax: email: www.enpathmed.com

# Contact Person

James Jenkins Regulatory Associate 952-653-2412

Date Prepared

April 20, 2006

Trade Name Enpath Medical Steerable Sheath

#### Common Name

Catheter Introducer

### Classification Name

Percutaneous Catheter (21 CFR 870.1250, Product Code DQY)

MAY 18 2005

# Predicate Device

Enpath Medical Steerable Sheath; K043489.

#### Device Description

The Enpath Steerable Sheath is a guide catheter (delivery sheath) which has a distal tip that deflects to create a variable curve shape. The deflection is controlled through a handle mechanism with the ability to lock at any point along the catheter tip curve travel. The handle incorporates a luer fitting or a hemostasis valve.

{1}------------------------------------------------

Special 510(k) Submission Summary

The Enpath Steerable Sheath will be used clinically in the same way that a guide catheter or sheath is used as part of an interventional procedure, to gain access to locations that are not easily accessed with existing tools. Certain parts of the vasculature are difficult to access because of occlusion, tortuosity, or simply because standard catheters do not provide the necessary curve angle(s). The Steerable Sheath, with its deflection capability, enables access to these areas. Primary applications for the product remain focused on access for Pulmonary Vein Ablation, Transseptal access, Renal Stenting, and Carotid Stenting.

## Intended Use

The Enpath Medical Steerable Sheath is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.

### Comparison of Technological Characteristics

All technological characteristics of the Enpath Steerable Sheath are substantially equivalent to the predicate device (K043489) including biocompatibility, product design, function, packaging, sterilization and labeling. The molded handle configuration incorporates a handle material change and an integrated deflection and locking mechanism. The molded handle configuration does not alter the intended use or fundamental scientific technology of the device.

# Summary of Studies

The performance testing for this device included testing to verify that the device functions in a safe and effective manner. The performance testing included the device specifications, functional testing of the articulation, deflection radius, deflection force, hemostatsis of the valve portion, deflection cycle testing and other testing as applicable to this device. Test results verify that the device performs per specification requirements and is equivalent to the predicate device without creating additional risk to the patient or user.

No clinical evaluations for this submission have been conducted.

### Substantial Equivalence

The molded handle Steerable Sheath is as safe, as effective, and performs as well as, and is substantially equivalent to the original "cleared" machined handle Enpath Steerable Sheath, K043489. The design modification of the sheath handle assembly does not affect the indications for use nor alter the fundamental scientific technology of the device.

- 2 -

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 8 2006

Enpath Medical Inc. c/o Mr. James Jenkins Regulatory Associate 15301 Highway 55 West Minneapolis, MN 55447

Re: K061119 Enpath Medical Steerable Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter Introducer Regulatory Class: II Product Code: DQY Dated: April 20, 2006 Received: April 21, 2006

Dear Mr. Jenkins:

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.

{3}------------------------------------------------

Page 2 - Mr. James Jenkins

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised hat I Dri 3 issualite or are device complies with other requirements of the Act that IDA has made a qeterimation administered by other Federal agencies. You must of any reaclar statutes and regulations and limited to: registration and listing (21 Comply with an the Hot 3 requirements)
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality bybeline (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro herens (veting your device as described in your Section 510(k) This icher witi anow you to oegin mailing of substantial equivalence of your device to a legally premated 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 If you desire of Compliance at [phone]. 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 other general micrinational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Dring R. Lochines

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Proprietary and Confidential

Enpath Medical, Inc. Steerable Sheath Special 510(k) Submission

#### VI Indications for Use

510(k) Number (if known): Not Assigned> K66 (! 1 9

Device Name: Enpath Medical Steerable Sheath

The Enpath Medical Steerable Sheath is intended to be used to Indications for Use: facilitate the placement of interventional devices into the peripheral and coronary systems.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Vachner
(Division Sign-Off)

proveron Sign-Oir)
Division of Cardiovascular Devices

510(k) Number_K0 ( 1 | 9