MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)

K023447 · St Jude Medical · DYB · Oct 31, 2002 · Cardiovascular

Device Facts

• Record ID: K023447
• Device Name: MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)
• Applicant: St Jude Medical
• Product Code: DYB · Cardiovascular
• Decision Date: Oct 31, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The UltimumTM EV Hemostasis Introducers are 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 Ultimum EV Hemostasis Introducer (14F-22F) provides vascular access for catheters and electrodes while minimizing blood loss. The device consists of a sheath, hub, hemostasis valve, sideport for a 3-way stopcock, radiopaque tip marker, and dilator. It is a sterile, single-use device used by clinicians in a clinical setting. The device facilitates the insertion of diagnostic or therapeutic catheters into the vascular system. By incorporating a hemostasis valve, it reduces blood loss during the procedure, aiding the clinician in maintaining a clear access site and improving procedural efficiency.

Clinical Evidence

Bench testing only. Confirmatory testing included tensile testing, flexure testing, hemostasis seal testing, and visibility testing.

Technological Characteristics

Introducer sheath system (14F-22F) including hub, hemostasis valve, sideport, radiopaque tip marker, and dilator. Sterile, single-use. No software or electronic components.

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

• UltimumTM EV Hemostasis Introducer (K003729)

Submission Summary (Full Text)

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B.

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

#### A. Submitter Information

# OCT 31 2002

| Submitter's Name: | St. Jude Medical, Daig Division |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 14901 DeVeau Place<br>Minnetonka, Minnesota 55345-2126 U.S.A. |
| Telephone Number: | [phone] |
| Contact Person: | Glenn Jacques |
| Date Submission Prepared: | October 11, 2002 |
| Device Information | |
| Common or Usual Name: | UltimumTM EV Hemostasis Introducer |
| Classification Name: | Catheter Introducer |
| Predicate Device: | UltimumTM EV Hemostasis Introducer<br>St. Jude Medical, Daig Division |
| Device Description: | The UltimumTM EV (14F-22F) Hemostasis Introducers<br>are 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, radiopaque tip marker, and<br>dilator. The introducers are provided sterile, and are<br>intended for single-use only. |
| Intended Use: | The UltimumTM 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. |

### Comparison of Required Technological Characteristics C.

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

### Support of the Substantial Equivalence D.

St. Jude Medical, Daig Division considers the Ultimum™ EV Hemostasis Introducer, 22F, to be substantially equivalent to the predicate device, Ultimum™ EV Hemostasis Introducers which received marketing clearance January 3, 2001 (K003729) Confirmatory testing included tensile testing, flexure testing, hemostasis seal testing and visibility testing comparing competitor devices.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three figures instead of one.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

St. Jude Medical c/o Mr. Glenn Jacques Regulatory Affairs Specialist Daig Division 14901 DeVeau Place Minnetonka, MN 55345

Re: K023447

Trade Name: Ultimum™ EV Hemostasis Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: October 11, 2002 Received: October 15, 2002

Dear Mr. Jacques:

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 - Mr. Glenn Jacques

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 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 vour 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,

Dalton

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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Page

510(k) Number (if known):

KO2344

Ultimum™ EV Hemostasis Introducer Device Name:

Indications for Use:

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K023447

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)