ENPATH SAFETY INTRODUCER

K041708 · Enpath Medical Incorporated · DYB · Nov 30, 2004 · Cardiovascular

Device Facts

• Record ID: K041708
• Device Name: ENPATH SAFETY INTRODUCER
• Applicant: Enpath Medical Incorporated
• Product Code: DYB · Cardiovascular
• Decision Date: Nov 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Enpath Safety Introducer is intended to minimize needle stick injuries when used to introduce catheters, pacemaker leads and similar devices into the venous system

Device Story

Enpath Safety Introducer is a single-use, sterile catheter introducer designed to reduce needle stick injuries during venous access. Device combines features of a peelable sheath and micro-introducer; utilizes Seldinger technique. Features a spring-loaded safety shield that covers the needle bevel upon removal of the needle subassembly from the sheath. Operated by clinicians in clinical settings. After vessel access, needle is undocked; removal of the introducer sheath passively activates and locks the safety shield over the needle tip. Protects healthcare workers and patients from accidental needle sticks. Sizes range from 3.5 FR to 7 FR; includes 21-gauge needle.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing verified the effectiveness of the safety shield mechanism and adherence to design specifications. Risk analysis was conducted per ISO 14971:2000 standards.

Technological Characteristics

Sheath: PTFE with bismuth trioxide radiopacifier; polypropylene handles. Dilator: HDPE with HDPE hub. Luer/Front hub: Polycarbonate. Needle/Spring: Stainless steel. Swivel luer cap/needle cover: Polypropylene. Assembly: UV-cured adhesive; silicone lubricant coating. Sizes: 3.5 FR to 7 FR; 21-gauge needle. Sterilization: EtO. Connectivity: None.

Indications for Use

Indicated for use in patients requiring venous access for the introduction of catheters, pacemaker leads, or similar devices. Intended for use by healthcare professionals.

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

• TFX Medical Safety Needle with Introducer (K000665)

Submission Summary (Full Text)

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NOV 3 0 2004

#### IV. 510(k) Summary

### Submitter

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

Date Prepared

June 18, 2004

### Trade Name

Enpath Safety Introducer

## Common Name

Catheter Introducer

## Predicate Device

TFX Medical Safety Needle with Introducer, K000665

#### Device Description

The Enpath Safety Introducer is designed to minimize needle stick injuries when used to introduce catheters, pacemaker leads and similar devices into the venous system. Sheath needles consisting of a peelable sheath over a needle, or peelable micro-introducers using the Seldinger Technique, are common methods for placing such devices. This Safety Introducer device combines various attributes of both the needle and the micro-introducer with the inclusion of a safety feature. The Safety Introducer allows for a one-step process of accessing the body. The Safety Introducer includes a safety shield which is spring-loaded in position during the ready-to-use state. After gaining vessel access, the needle subassembly is undocked from the introducer sheath and removed, leaving the sheath in the vessel for Removing the introducer sheath during standard practice passively catheter placement. advances (activates) the safety shield that locks in place. The safety shield covers the sharp of the needle bevel to protect patients and healthcare workers from accidental needle sticks.

The sheath body is constructed of PTFE and is filled with bismuth trioxide as a radiopacifier. The sheath handles, made of polypropylene resin, are overmolded onto the PTFE sheath tubing. The dilator is made of HDPE (high density polyethylene) and has a hub made of HDPE resin overmolded onto the dilator shaft. The front bub and the luer components are both molded of Polycarbonate resin. The needle and spring are stainless steel. The swivel luer cap and needle cover are both made of Polypropylene. UV cured adhesive is used during the assembly to hold the needle to the luer. The final assembly is coated with silicone lubricant from the tip of the needle to the handles of the sheath to reduce insertion force.

Sizes of the assembly range from 3.5 FR to 7FR. The needle is 21gauge for all French sizes, and the materials and construction are the same for all French sizes. The Safety Introducer will be packaged and EtO sterilized for one time use in a Tyvek pouch. The packaging configuration may include sterile kit containing a stainless steel guidewire or a bulk, nonsterile configuration.

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## Intended Use

The Enpath Safety Introducer is intended to minimize needle stick injuries when used to introduce catheters, pacemaker leads and similar devices into the venous system

## Technological Characteristics

The device is technologically equivalent to other safety needle and introducer products.

## Summary of Studies

A Risk Analysis for the Safety Introducer was performed per Enpath Medical, Inc internal procedure, WI42020, Hazard Analysis, FMEA and Risk Analysis. This document is modeled closely after European Standard ISO 14971: 2000 Medical Devices - Application of Management to Medical Devices

The performance testing for this device included testing to verify that the device safety function performed effectively. Additional testing verified that the device performed per specification requirements.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 0 2004

Ms. Karyl D. Haskell Quality Assurance and Regulatory Affairs Manager Enpath Medical Incorporated -- Delivery Systems Division 15301 Highway 55 West Minneapolis, MN 55477

Re: K041708 Enpath Safety Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: 74 DYB Dated: October 20, 2004 Received: October 21, 2004

Dear Ms. Haskell:

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 I ou may a 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. Karyl D. Haskell

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/dsma/dsmamain.html

Sincerely yours,

puma D. lochner

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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#### V. Indications for Use

# Indications for Use

510(k) Number (if known):___Not Assigned Ko41708

Device Name: Enpath Safety Introducer

Indications For Use: The Enpath Safety Introducer is intended to minimize needle stick injuries when used to introduce catheters, pacemaker leads and similar devices into the venous system

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)

Duna R. La hner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number Ko4) Jo 8