COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM

K023937 · Cook Vascular, Inc. · DYB · May 27, 2003 · Cardiovascular

Device Facts

• Record ID: K023937
• Device Name: COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM
• Applicant: Cook Vascular, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: May 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The SERPENTA™ Coronary Sinus Introducer System is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus. SERPENTA™ Coronary Sinus Introducer System is supplied sterile and intended for one time use

Device Story

SERPENTA™ Coronary Sinus Introducer System is a percutaneous catheter introducer set; used in clinical settings by physicians. System components include PTFE introducer sheaths (7 Fr. and 10 Fr.) with varying curves; PTFE dilators; silicone peel-away introducer valves; hydrophilic-coated guide wire with torque handle; 10cc plastic syringe; stainless steel introducer needle; optional polyethylene obturator. Device facilitates access to coronary sinus for balloon catheter or lead placement. System is supplied sterile for single-use. No electronic or software components.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: PTFE (Teflon) sheaths and dilators, silicone peel-away valves, stainless steel needle, polyethylene obturator. Mechanical device; no energy source, connectivity, or software.

Indications for Use

Indicated for patients requiring introduction of balloon catheters into the coronary sinus or leads into left heart vessels via the coronary sinus.

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

• Cook Introducer (A176790)
• Attain LDS 6216 Left Heart Delivery System (K012130)
• Attain Access 6218 Left Heart Delivery System (K012083)
• SafeSheath MSP (K003731)

Submission Summary (Full Text)

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

K023937

510 (k) Premarket Notification Cook Vascular SERPENTA™ Coronary Sinus Introducer System 8 of 9

#### 510 (K) SUMMARY K.

#### Submitted By:

Thomas J. Kardos Vice President, Regulatory Affairs Cook Vascular Incorporated P.O. Box 529 Leechburg, PA 15656 Phone [phone] FAX [phone] November 14, 2002

Device: Trade Name:

Common/Usual Name:

Cook Vascular SERPENTA™ Coronary Sinus Introducer System

Percutaneous Catheter Introducer

Proposed Classification Name:

Introducer, Catheter 21 CFR Part 870.1340 (74-DYB)

### Device Description:

The Cook Vascular SERPENTA™ Coronary Sinus Introducer System consists of two Teflon (PTFE) introducer sheaths (7 Fr. and 10 Fr.) with varying shaped curves, two Teflon (PTFE) dilators (7 Fr. and 10 Fr.) two silicone Peel-Away introducer valves (D.C.# K010128), a hydrophilic coated guide wire with a torque handle, a 10cc plastic syringe and a stainless steel introducer needle. Some sets include a polyethylene obturator.

### Indications for Use:

The intended use of Cook Vascular SERPENTA™ Coronary Sinus Introducer System is for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

### Substantial Equivalence:

The device will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to devices currently marketed and distributed by Cook Vascular Incorporated. This device is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510 (k) substantial equivalency.

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

## Predicate Devices:

The Cook Vascular SERPENTA™ Coronary Sinus Introducer System is substantially equivalent to devices currently marketed as identified with respect to intended use, material composition, and method of operation.

| Predicate Device | Manufacturer | 510(k) |
|--------------------------------------------------|-------------------|----------------------------|
| Cook Introducer | Cook Incorporated | Pre-amendment<br># A176790 |
| Attain LDS 6216 Left Heart<br>Delivery System | Medtronic | DC# K012130 |
| Attain Access 6218 Left Heart<br>Delivery System | Medtronic | DC# K012083 |
| SafeSheath MSP<br>(same as SafeSheath CSG) | Thomas Medical | DC# K003731 |

{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 stylized eagle with three lines representing its body and wings. The eagle's head is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

MAY 2 7 2003

.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cook Vascular Incorporated c/o Mr. Thomas J. Kardos Vice President, Regulatory Affairs P.O. Box 529, Rt. 66 River Road Leechburg, PA 1565-0529

Re: K023937

Trade Name: SERPENTA® Coronary Sinus Introducer System Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II (two) Product Code: DYB Dated: April 25, 2003 Received: April 28, 2003

Dear Mr. Kardos:

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

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

Page 2 – Mr. Thomas J. Kardos

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,

V. OheT M

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

Enclosure

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

Page 1 of 1

# 510(k) Number (if known): K023937

Device Name: SERPENTA™ Coronary Sinus Introducer System

Indications For Use:

The SERPENTA™ Coronary Sinus Introducer System is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus. SERPENTA™ Coronary Sinus Introducer System is supplied sterile and intended for one time use

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

510(k) Number K023937

Perscription Use
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

1.3