ENPATH DEFLECTABLE CATHETER

K043489 · Enpath Medical Incorporated · DQY · May 19, 2005 · Cardiovascular

Device Facts

• Record ID: K043489
• Device Name: ENPATH DEFLECTABLE CATHETER
• Applicant: Enpath Medical Incorporated
• Product Code: DQY · Cardiovascular
• Decision Date: May 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Enpath Deflectable Catheter is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.

Device Story

Enpath Deflectable Catheter is a guide catheter/delivery sheath designed to facilitate interventional device placement in peripheral and coronary vasculature. Device features a deflectable distal tip controlled by a handle mechanism, allowing variable curve shapes to navigate tortuous anatomy or occlusions. Handle includes a luer fitting or hemostasis valve and allows locking the tip curve at desired positions. Used by clinicians in interventional procedures to gain access to difficult-to-reach locations. Benefits include improved access for pulmonary vein ablation, transseptal access, and renal/carotid stenting. Device is provided sterile for single use.

Clinical Evidence

Bench testing only. Performance testing verified device specifications, including functional testing of articulation, deflection radius, deflection force, hemostasis valve performance, and deflection cycle testing, consistent with FDA guidance for intravascular catheters.

Technological Characteristics

Catheter shaft: Pebax, PTFE-lined, Barium Sulfate radiopacifier. Hub: Nylon 12 (10% glass filled) with silicone rubber hemostasis valve. Handle: Machined ABS. Dilator: MDPE/HDPE blend with silicone lubricant. Sizes: 7 FR to 14 FR. Sterilization: EtO. Single-use. Mechanical deflection mechanism.

Indications for Use

Indicated for facilitating placement of interventional devices into peripheral and coronary systems, including access for 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

• Medtronic Model 10600 Deflectable Catheter System (K013517)

Submission Summary (Full Text)

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# K643489

#### 510(k) Summary IV.

MAY 1 9 2005

#### Submitter

Enpath Medical Incorporated 15301 Highway 55 West Minneapolis, MN 55447 Main: 763-15301 Fax: [phone] email: www.enpathmed.com

#### Date Prepared

December 12, 2004

### Trade Name

Enpath Deflectable Catheter

#### Submission Correspondent

Karyl Haskell Regulatory Affairs Manager

#### Submission Correspondent Telephone, Fax, and Email

Office: [phone] FAX: [phone] email: khaskell(@enpathmed.com

#### Common Name

Catheter Introducer

#### Intended Use

The Enpath Deflectable Catheter is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.

#### Predicate Device

· Medtronic, Inc: Medtronic Model 10600 Deflectable Catheter System 510(k) K013517

#### Device Description

The Enpath Deflectable Catheter 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. The product specifications, drawings and photographs are located in Appendix E of this submission.

The Enpath Deflectable Catheter 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

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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 Deflectable Catheter, with its deflection capability, enables access to these areas. Primary applications for product focus on access for Pulmonary Vein Ablation, Transseptal access, Renal Stenting, and Carotid Stenting.

The deflectable catheter shaft is constructed of Pebax, lined with PTFE and filled with Barium Sulfate as a radiopacifier. The catheter hub is overmolded Nylon 12 (10% glass filled). The catheter hub houses a hemostasis valve which is molded silicone rubber.

The deflectable catheter handle is made of machined ABS, and is cyanoacrylate bonded onto the deflectable shaft. The handle configuration may vary based on specific user requirements. The handle modifications will not effect the functionality or safety of the device. For example, the shape of the handle, method of deflection (i.e. slide, rotate etc) may change, but the curve of the deflection and the shaft of the device will remain the same. Any handle changes will be validated and appropriately tested to ensure safety and effectiveness.

The dilator tube is made of MDPE (high density/low density polyethylene blend) and has a hub made of HDPE resin overmolded onto the dilator tube. The dilator assembly is coated with silicone lubricant to reduce insertion force through the sheath hemostasis valve.

The deflectable tip sheath size range is from 7 FR (ID) to 14 FR. The materials and construction are the same for all French sizes.

The Deflectable Tip Sheath will be packaged and EtO sterilized for single use in a Tyvek pouch. The sterile kit packaging configuration will include the deflectable catheter and the dilator. The product may be provided as a bulk non-sterile device to OEM customers for further processing and packaging.

## Technological Characteristics / substantially equivalent devices

The Enpath Deflectable Catheter is technologically equivalent to the predicate device:

| Enpath Deflectable<br>Catheter | Predicate Device | Predicate Device<br>Manufacturer | 510(k) |
|-------------------------------------------------------------------|---------------------------------------------------------|-------------------------------------------|---------|
| Deflectable Catheter | Medtronic Model<br>10600 Deflectable<br>Catheter System | Medtronic, Inc<br>Minneapolis MN<br>55432 | K013517 |
| Deflectable Catheter<br>Dilator<br>Adjustable<br>Hemostasis Valve | Medtronic Model<br>10600 Catheter<br>System | Medtronic, Inc<br>Minneapolis MN<br>55432 | K013517 |

In addition, the sterilization process and biocompatibility of the Enpath Deflectable Catheter are substantially equivalent to the above documented predicate device, the Medtronic Model 10600 510(k) K013517

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## 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, hemostasis of the valve portion, deflection cycle testing and testing consistent with the requirements in FDA 'Guidance on premarket notification [510(k)] submission for shortterm and long-term intravascular catheters (3/19/1995)' as applicable to this device. Test results verify that the device performs per specification requirements.

# Statement of Substantial Equivalence

Through the data and information presented, Enpath concludes that the Enpath Deflectable Catheter is substantially equivalent to the predicate device:

> Medtronic Model 10600 Deflectable Catheter System 510(k) K013517

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Image /page/3/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Enpath Medical Incorporated c/o Ms. Karyl Haskell Regulatory Affairs Manager Enpath Medical Incorporated 15301 Highway 55 West Minneapolis, MN 55447

MAY 1 9 2005

Re: K043489

Trade/Device Name: Enpath Deflectable Catheter Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 15, 2005 Received: April 18, 2005

Dear Ms. Haskell:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have love ready our occared the device is substantially equivalent (for the indications for referenced in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass sumed in also enoted as ) the Medical Device Amendments, or to devices that prior to may 26, 1970, and cordance with the provisions of the Federal Food, Drug, and Cosmetic liate ooch recidentive approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general thereofe, maniel me de rios, backed sequirements for annual registration, listing of devices, good controll provisions or a 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 if your device to such additional controls. Existing major regulations affecting your device can be finay of subject to sam adaments, 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 r least be advised that I DX is issualite t your device complies with other requirements of the Act or that F 271 has mude a determilations administered by other Federal agencies. You must comply with ally i cocrar statutes and regardants abut not limited to: registration and listing (21 CFR Part 807); an the Act 3 requirements) increasing practice requirements as set forth in the quality

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Page 2 – Ms. Karyl Haskell

systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation in systems (QS) regalation (21-531-542 of the Act); 21 CFR 1000-1050. control provisions (Sections 551-942 of the Fee), 21 US is described in your Section 510(k) I his letter will anow you to begin marketing your antial equivalence of your device to a legally premarket notification. The FDA miding of sucstantal equice 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 specific advice for your at [phone]. Also, please note the regulation entitled, contact the Office of Compliance at (210) 21 0 120. Press. 12.97. You may obtain other
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obta "Misoranding by relefected to premail.or institution in Division of Small
general information on your responsibilities under the Act from the 1900 for general information on your responsionner Assistance at its toll-free number [phone] or Manufacturers, International Consumer Prosition Prospectivindustry/support/index.html.

Sincerely yours,

Blzommerna for
Brad 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 V.

# Indications for Use

510(k) Number (if known):__Not Assigned

K043489

Device Name: Enpath Deflectable Catheter

Indications For Use: The Enpath Deflectable Catheter is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

.

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blmrmema

Sign-C lloyascular Devices 04.241