ULTRAFLEX EV HEMOSTASIS INTRODUCER

K012922 · St Jude Medical · DYB · Sep 25, 2001 · Cardiovascular

Device Facts

• Record ID: K012922
• Device Name: ULTRAFLEX EV HEMOSTASIS INTRODUCER
• Applicant: St Jude Medical
• Product Code: DYB · Cardiovascular
• Decision Date: Sep 25, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Ultraflex™ EV Hemostasis Introducer is designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing blood loss is essential.

Device Story

The Ultraflex™ EV Hemostasis Introducer is a vascular access device consisting of a sheath, hub, hemostasis valve, sideport for a 3-way stopcock, and a dilator. It is designed to facilitate the introduction of various catheters (angiographic, closed end, balloon) and electrodes into the vascular system while providing temporary closure of the access site to minimize blood loss. The device is provided sterile and is intended for single-use only. It is used in a clinical setting by healthcare professionals to manage vascular access sites during catheterization procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological characteristics.

Technological Characteristics

The device consists of a sheath, hub, hemostasis valve, sideport, and dilator. It is a mechanical vascular access device. Sterilization is performed via standard methods. No software or electronic components are present.

Indications for Use

Indicated for the introduction of angiographic, closed end, and balloon catheters, and electrodes into a vessel in patients requiring vascular access where minimizing blood loss is essential.

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

• Ultaflex™ Hemostasis Introducer (K012922)

Submission Summary (Full Text)

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B.

012922

## SEP 2 5 2001

## 510(k) Summary (As required by 21 CFR 807.92)

#### A. Submitter Information

| Submitter's Name: | St. Jude Medical, Daig Division |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 14901 DeVeau Place<br>Minnetonka, Minnesota 55345-2126 U.S.A. |
| Telephone Number: | 952-933-4465 |
| Contact Person: | Kirk Honour |
| Date Submission Prepared: | August 24, 2001 |
| Device Information | |
| Common or Usual Name: | Ultraflex™ EV Hemostasis Introducer |
| Classification Name: | Catheter Introducer |
| Predicate Device: | Ultaflex™ Hemostasis Introducer<br>St. Jude Medical, Daig Division |
| Device Description: | The Ultraflex™ EV (9-12F) Hemostasis Introducers are<br>introducers designed to provide easy access to the<br>vascular system while providing convenient temporary<br>closure of a standard indwelling introducer access site.<br>The introducers include a sheath, hub, hemostasis valve,<br>sideport for 3-way stopcock, and dilator. The<br>introducers are provided sterile, and are intended for<br>single-use only. |
| Intended Use: | The Ultraflex™ EV Hemostasis Introducers are designed<br>for the introduction of angiographic catheters, closed end<br>catheters, balloon catheters and electrodes into a vessel<br>where minimizing blood loss is essential. |

#### C. Comparison of Required Technological Characteristics

All technological characteristics of the Ultraflex™ EV Hemostasis Introducers are substantially equivalent to the predicate device including product design, sterilization, and labeling.

D. Support of the Substantial Equivalence

St. Jude Medical, Daig Division considers the Ultraflex™ EV Hemostasis Introducers to be substantially equivalent to the predicate device, Ultraflex™ Hemostasis Introducers.

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Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 2 5 2001

Mr. Kirk Honour Regulatory Affairs St. Jude Medical Daig Division 14901 Deveau Place Minnetonka, MN 55345

Re: K012922

> Trade Name: Ultraflex™ EV Hemostasis Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer. Regulatory Class: II Product Code: DYB Dated: August 31, 2001 Received: August 31, 2001

### Dear Mr. Honour:

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

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Page 2 - Mr. Kirk Honour

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Ultraflex™ EV Hemostasis Introducer Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Ultraflex™ EV Hemostasis Introducer is designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing blood loss is essential.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices

| 510(k) Number | 12012922 |
|---------------|----------|
|---------------|----------|

| Prescription Use<br>(Per 21 CFR 801.109) | <div>✓</div> | OR | Over-The-Counter Use |
|------------------------------------------|--------------|----|----------------------|
|------------------------------------------|--------------|----|----------------------|

(Optional Format 1-2-96)