STIFFER COAXIAL MICRO-INTRODUCER KIT

K071574 · Enpath Medical, Inc. · DYB · Jul 5, 2007 · Cardiovascular

Device Facts

• Record ID: K071574
• Device Name: STIFFER COAXIAL MICRO-INTRODUCER KIT
• Applicant: Enpath Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jul 5, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Stiffer Coaxial Micro-Introducer Kit is indicated for use to introduce up a 0.038 inch guide wire or catheter into the vascular systems following a small 21 gauge needle stick.

Device Story

Kit includes 21 gauge aspiration/injection needle, 0.018 inch guidewire, and coaxial micro-introducer set (dilator and sheath). Modified version incorporates stainless steel stiffening hypotube within dilator to increase rigidity. Used by clinicians for vascular access; facilitates introduction of larger guide wires or catheters following initial small-gauge needle puncture. Device provides mechanical pathway for vascular intervention; benefits patient by enabling access with minimal trauma.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including functional and dimensional verification, and biocompatibility testing.

Technological Characteristics

Components: 21G needle, 0.018" guidewire, dilator, sheath (4F, 5F). Material: Stainless steel stiffening hypotube added to dilator. Principle: Mechanical vascular access via coaxial dilation. Dimensions: Inner/outer dilator dimensions unchanged from predicate. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring vascular access via a 21 gauge needle stick to introduce a guide wire or catheter up to 0.038 inches in diameter.

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. Coaxial Micro-Introducer Set (K990705)

Submission Summary (Full Text)

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JUL - 5 2007

# 510(K) Summary

510(k) Number: K071574

Date Prepared

June 7, 2007

## Submitter Information

Submitter's Name/ Address:

Enpath Medical, Inc. 2300 Berkshire 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:

Stiffer Coaxial Micro-Introducer Set Introducer, Catheter DYB Class II, 21 CFR 870.1340 Cardiovascular

## Performance Standards

No performance standards applicable tot his product have been developed under Section 514 of the Act.

### Predicate Device

Enpath Medical, Inc. Coaxial Micro-Introducer Set (K990705)

.

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#### Device Description

The Coaxial Micro-Introducer Kit contains a 21 gauge disposable aspiration and injection needle, a 0.018 inch diameter guidewire, and a coaxial micro-introducer set consisting of a dilator and sheath available in 4F, 4.5F, or 5F.

The modified device contains the same kit configuration as above except that the dilator and sheath are available in 4F or 5F. The inner dilator includes a stainless steel stiffening hypotube. The inner and outer dimensions of the dilator remain the same as the currently marketed Coaxial Micro-Introducer Kit.

#### Indications for Use

The Stiffer Coaxial Micro-Introducer Kit is indicated for use to introduce up to a 0.038 inch guide wire or catheter into the vascular systems following a small 21 gauge needle stick.

#### 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 Stiffer Coaxial 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 Stiffer Coaxial Micro-Introducer Kit 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 Stiffer Coaxial Micro-Introducer Kit to be substantially equivalent to the currently marketed Enpath Medical Inc.'s Coaxial Micro-Introducer Kit based on a comparison of the indications for use and the technological characteristics of the kit components. The testing performed confirms that the Stiffer Coaxial Micro-Introducer Kit will perform as intended.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 5 2007

Enpath Medical, Inc. c/o Ms. Patrice Stromberg Principal Regulatory Affairs Specialist 2300 Berkshire Lane North Minneapolis, MN 55441

Re: K071574

Stiffer Coaxial Micro-Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer Catheter Regulatory Class: II (two) Product Code: DYB Dated: June 7, 2007 Received: June 8, 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.

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Page 2 - Ms. Patrice Stromberg

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 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 marketed 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 Office 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 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,

M. S. Hillehem

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):_____________________________________________________________________________________________________________________________________________________

Device Name: Stiffer Coaxial Micro-Introducer Kit

Indications for Use:

+0 The Stiffer Coaxial Micro-Introducer Kit is indicated for use to introduce up a 0.038 inch guide wire or catheter into the vascular systems following a small 21 gauge needle stick.

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)

.g. Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

**510(k) Number:** K071574