APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582

K051096 · St. Jude Medical, Daig Division, Inc. · DYB · May 17, 2005 · Cardiovascular

Device Facts

• Record ID: K051096
• Device Name: APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582
• Applicant: St. Jude Medical, Daig Division, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: May 17, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Apeel CS Plus Catheter Delivery System is intended to provide vascular access including the coronary sinus and serve as a conduit for the delivery and support of other devices where minimizing blood loss is essential.

Device Story

Apeel CS Plus Catheter Delivery System provides vascular access, specifically for the coronary sinus; serves as a conduit for delivering and supporting other medical devices. System components include a peelable introducer sheath, dilator, cannulator, detachable hemostasis valve with side port and 3-way stopcock, guidewire, syringe, needle, and valve bypass tools. Used in clinical settings by physicians to facilitate device placement while minimizing blood loss. Sterile, single-use device.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Percutaneous catheter introducer system. Components: peelable introducer sheath, dilator, cannulator, hemostasis valve, stopcock, guidewire, syringe, needle. Sterile, single-use. Class II device (21 CFR 870.1340).

Indications for Use

Indicated for patients requiring vascular access, including the coronary sinus, for the delivery and support of other medical devices while minimizing blood loss.

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

• Apeel CS Catheter Delivery System

Reference Devices

• Spyglass Angiographic Catheter

Submission Summary (Full Text)

{0}------------------------------------------------

K051096

______________________________________________________________________________________________________________________________________________________________________________

## MAY 1 7 2005

Special 510(k): Device Modification

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

#### A. Submitter Information

| Submitter's Name: | St. Jude Medical |
|---------------------------|---------------------------------------------------------------|
| Address: | 14901 DeVeau Place<br>Minnetonka, Minnesota 55345-2126 U.S.A. |
| Telephone Number: | [phone] |
| Contact Person: | Mike Burnside |
| Date Submission Prepared: | 28-April-2005 |

#### B. Device Information

| Trade Name: | Apeel™ CS Plus Catheter Delivery System |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Percutaneous Catheter Introducer |
| Classification Name: | Percutaneous Catheter Introducer<br>(per 21 CFR Part 870.1340) |
| Device Classification: | Class II (per 21 CFR Part 870.1340)<br>Panel - Cardiovascular |
| Predicate Device:<br>Reference Device: | Apeel CS Catheter Delivery System<br>Spyglass Angiographic Catheter |
| Device Description: | The Apeel™ CS Plus Catheter Delivery System<br>includes a Peelable Introducer Sheath, Dilator,<br>Cannulator, Detachable Hemostasis Valve with Side<br>Port with 3-way Stopcock, Guidewire, Syringe,<br>Needle, and 2 Valve Bypass Tools. The introducer<br>kits are provided sterile, and are intended for single-<br>use only. |
| Intended Use: | The Apeel CS Plus Catheter Delivery System is<br>intended to provide vascular access including the<br>coronary sinus and serve as a conduit for the<br>delivery and support of other devices where<br>minimizing blood loss is essential. |

{1}------------------------------------------------

#### C. Comparison of Required Technological Characteristics

All technological characteristics of the Apeel™ CS Plus Catheter Delivery System are substantially equivalent to the predicate and referenced devices including product design, packaging, sterilization, and labeling.

#### D. Support of the Substantial Equivalence

St. Jude Medical considers the Apeel CS Plus Catheter Delivery System to be substantially equivalent to the predicate and referenced devices.

{2}------------------------------------------------

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" around the perimeter. Inside the circle is a stylized eagle emblem, with three curved lines representing the eagle's body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 7 2005

Mr. Mike Burnside Senior Regulatory Affairs Specialist St. Jude Medical 14900 Minnetonka Ind. Rd. Minnetonka, MN 55345

K051096 Re:

Trade/Device Name: Apeel™ CS Plus Catheter Delivery System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: II Product Code: DYB Dated: April 28, 2005 Received: April 29, 2005

Dear Mr. Burnside:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave reach 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

{3}------------------------------------------------

Page 2 -- Mr. Mike Burnside

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. product railation only to begin marketing your device as described in your Section 510(k) rms retet 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,

Blymmerman for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): _Ko51694

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Apeel CS Plus Catherer Delivery System is intended to provide vascular
System in the same and serve as a conduit for the delivery an The Apeel CS Plus Catheter Denvery system is mondus as promotive for the delivery and
access including the coronary sinis wiring hood loss is essential. access including the coronaly since and ber. C of the best is essential.
support of other devices where minimizing blood loss is essential.

Prescription Use (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
) OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blummenstiel

Division Sign-Off) Division of Cardiovascular Devices 510(k) Number

l of ... Page