APEEL CS CATHETER DELIVERY SYSTEM

K031906 · St Jude Medical · DYB · Jul 18, 2003 · Cardiovascular

Device Facts

• Record ID: K031906
• Device Name: APEEL CS CATHETER DELIVERY SYSTEM
• Applicant: St Jude Medical
• Product Code: DYB · Cardiovascular
• Decision Date: Jul 18, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Apeel CS 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 Catheter Delivery System provides vascular access, specifically for coronary sinus procedures. System components include peelable introducer sheath, dilator, cannulator, detachable hemostasis valve with side port, guidewire, syringe, and needle. Device functions as conduit for delivery and support of other medical devices; hemostasis valve minimizes blood loss during procedure. Used in clinical settings by physicians; provided sterile for single-use only.

Clinical Evidence

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

Technological Characteristics

System includes peelable introducer sheath, dilator, cannulator, detachable hemostasis valve with side port, guidewire, syringe, and needle. Sterile, single-use device. Mechanical percutaneous catheter introducer. No electronic or software components.

Indications for Use

Indicated for patients requiring vascular access, including the coronary sinus, for the delivery and support of other 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

• Seal-Away CS Introducer Kit
• Seal-Away Hemostasis Adapter
• Alliance Catheter Delivery System

Submission Summary (Full Text)

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A.

B.

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

| Submitter Information | JUL 1 8 2003 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | Mike Burnside |
| Date Submission Prepared: | 19-June-2003 |
| Device Information | |
| Trade Name: | ApeelTM CS Catheter Delivery System |
| Common or Usual Name: | Percutaneous Catheter Introducer |
| Classification Name: | Percutaneous Catheter Introducer (per 21 CFR Part<br>870.1340) |
| Device Classification: | Class II (per 21 CFR Part 870.1340)<br>Panel - Cardiovascular |
| Predicate Devices: | Seal-Away CS Introducer Kit,<br>Seal-Away Hemostasis Adapter, and<br>Alliance Catheter Delivery System<br>St. Jude Medical, Daig Division |
| Device Description: | The Apeel™ CS Catheter Delivery System includes a<br>Peelable Introducer Sheath, Dilator, Cannulator,<br>Detachable Hemostasis Valve with Side Port,<br>Guidewire, Syringe and Needle. The introducer kits are<br>provided sterile, and are intended for single-use only. |
| Intended Use: | The Apeel CS Catheter Delivery System is intended<br>to provide vascular access including the coronary<br>sinus and serve as a conduit for the delivery and<br>support of other devices where minimizing blood<br>loss is essential. |

## C. Comparison of Required Technological Characteristics

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

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## D. Support of the Substantial Equivalence

St. Jude Medical, Daig Division considers the Apeel CS Catheter Delivery System to be substantially equivalent to the predicate devices.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's emblem, which features a stylized caduceus-like symbol with three wavy lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem within the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2003

St. Jude Medical c/o Mike Burnside 14901 Deveau Place Minnetonka, MN 553452

Re: K031906

> Apeel CS Catheter Delivery System Regulation Number: 870.1340 Regulation Name: Percutaneous Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: June 19, 2003 Received: June 20, 2003

Dear Mr. Burnside:

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

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## Page 2 - Mike Burnside

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]. 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) you may obtain. 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,

A. Oerle Tu

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

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Page _________________________________________________________________________________________________________________________________________________________________________ of

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Apeel™ CS Catheter Delivery System_ Device Name:

Indications for Use:

The Apeel CS 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) |
|------------------------------------|
| Division of Cardiovascular Devices |

| 510(k) Number | K031906 |
|---------------|---------|
|---------------|---------|

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
|------------------------------------------|----|--------------------------------------------------|
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