VIAPEEL PEELABLE INTRODUCER

K072248 · Enpath Medical, Inc. · DYB · Nov 9, 2007 · Cardiovascular

Device Facts

• Record ID: K072248
• Device Name: VIAPEEL PEELABLE INTRODUCER
• Applicant: Enpath Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Nov 9, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The ViaPeel™ Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Device Story

ViaPeel Peelable Introducer facilitates percutaneous venous access for pacing leads or catheters. Device consists of sheath and dilator available in 3.5F to 7F sizes and 5cm or 10cm lengths. Key modification from predicate is annular snap-fit locking mechanism between sheath and dilator, replacing rotating collar. Clinician inserts device into venous system; dilator locks into hub via snap fit to secure assembly. Device is peelable for removal after lead/catheter placement. Used in clinical settings by physicians. Benefits include secure dilator-to-sheath connection and simplified handling during lead/catheter insertion.

Clinical Evidence

No clinical evaluations of this product have been performed. Substantial equivalence is supported by bench testing, including functional and dimensional verification, and biocompatibility testing.

Technological Characteristics

Peelable introducer sheath and dilator system. Sizes: 3.5F-7F (micro) and 7F (macro). Lengths: 5cm or 10cm. Locking mechanism: Annular snap fit. Materials: Biocompatible materials. Color-coded sheath handles for size identification. Non-powered, manual device.

Indications for Use

Indicated for percutaneous insertion of pacing leads or catheters into the venous system.

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

• Enpath Medical, Inc. ViaSeal Valved Peelable Introducer (K063182)

Submission Summary (Full Text)

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# 510(K) Summary

#### 510(k) Number: K072248

NOV 0 9 2007

### Date Prepared

October 11, 2007

## Submitter Information

| Submitter's Name/<br>Address: | Enpath Medical<br>2300 Berkshire Lane N<br>Minneapolis, MN 55441 |
|-------------------------------|------------------------------------------------------------------|
|-------------------------------|------------------------------------------------------------------|

dical, Inc. shire Lane North Minneapolis, MN 55441

Establishment Registration: 2183787

Contact Person:

Patrice Stromberg Principal Regulatory Affairs Specialist [phone] phone [phone] fax [e-mail]

# Device Information

Trade Name: Classification Name: Product Code: Regulation: Panel:

ViaPeel™ Peelable Introducer Introducer, Catheter DYB Class II, 21 CFR 870.1340 Cardiovascular

# Performance Standards

No performance standards applicable to this product have been developed under Section 514 of the Act.

#### Predicate Device

Enpath Medical, Inc. ViaSeal Valved Peelable Introducer (K063182)

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# Device Description

The ViaPeel Peelable Introducer will be available in 3.5F through 7F (micro), and 7F (macro) in lengths of 5cm or 10cm. The sheath handles are color coded for identification of French size. The locking configuration has been modified on the sheath and dilator to an annular snap fit. The dilator will lock into the hub without the use of a rotating collar allowing the user to lock and secure the dilator to the sheath.

# Indications for Use

The ViaPeel™ Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

### Summary of Non-Clinical Testing

Performance Testing: 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 and dimensional testing of the ViaPeel Peelable Introducer and other testing as applicable to the 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.

Biocompatibility Testing: The material in the components used to create the ViaPeel Peelable Introducer has been demonstrated to be biocompatible through biocompatibility testing.

#### Summary of Clinical Testing

No clinical evaluations of this product have been performed.

#### Statement of Equivalence

Through the data and information presented, Enpath Medical, Inc. considers the ViaPeel Peelable Introducer to be substantially equivalent to the cleared Enpath Medical ViaSeal Valved Peelable Introducers based on a comparison of the indications for use and the technological characteristics. The testing performed confirms that the ViaPeel Peelable Introducer will perform as intended.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure, composed of three curved lines that resemble feathers or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 9 2007

Enpath Medical, Inc. c/o Ms. Patrice Stromberg, RAC 2300 Berkshire Lane North Minneapolis, MN 55441

Re: K072248

Trade/Device Name: ViaPeel™ Peelable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: October 11, 2007 Received: October 12, 2007

Dear Ms. Stromberg:

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 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

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Page 2 - Ms. Patrice Stromberg

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 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

P. luchner

A 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

510(k) Number (if known): K072248

Device Name: ViaPeel™ Peelable Introducer

Indications for Use:

The ViaPeel™ Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Prescription Use _ X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Holmes

(Division Sich-Off) Division o Cardiovascular Devices

510(k) Number_x b72248