IVS INTRODUCER SET, MODEL 1003

K030723 · Integrated Vascular Systems, Inc. · DYB · Apr 3, 2003 · Cardiovascular

Device Facts

• Record ID: K030723
• Device Name: IVS INTRODUCER SET, MODEL 1003
• Applicant: Integrated Vascular Systems, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Apr 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The IVS Introducer Set is indicated for use in procedures requiring percutaneous introduction of intravascular devices.

Device Story

IVS Introducer Set, Model 1003, comprises 6 French introducer sheath, dilator, and 0.38" (0.97mm) 'J' tip guidewire. Used by clinicians in clinical settings for percutaneous access to vasculature. Facilitates introduction of intravascular devices. Mechanical device; no electronic or software components.

Clinical Evidence

Bench testing and clinical model system testing performed. Results indicate modifications do not affect safety or effectiveness.

Technological Characteristics

6 French introducer sheath, dilator, and 0.38" 'J' tip guidewire. Mechanical device. No software, electronics, or energy source.

Indications for Use

Indicated for patients requiring percutaneous introduction of intravascular devices during clinical procedures.

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

• IVS Introducer Set, Model 1001 (K020789, K021004, K964814)

Submission Summary (Full Text)

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

APR - 3 2003

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 C. F.R. § 807.92.

| Submitted by: | Susan Turner, Ph.D.<br>Director, Regulatory Affairs & Quality Assurance<br>Integrated Vascular Systems, Inc.<br>743 N. Pastoria Ave.<br>Sunnyvale, CA 94085<br>Telephone: [phone] | |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| | Fax: [phone] | |
| Date prepared: | March 5, 2003 | |
| Device name: | IVS Introducer Set, Model 1003 | |
| Common name: | Catheter introducer, vessel dilator for percutaneous catheterization,<br>catheter guide wire | |
| Classification names: | Regulation # and Product<br>Code | Classification Name |
| | 21 C.F.R. § 870.1340<br>DYB | Catheter introducer |
| | 21 C.F.R. § 870.1310<br>DYB | Vessel dilator for percutaneous<br>catheterization |
| | 21 C.F.R. § 870.1330<br>DYB | Catheter guide wire |
| Predicate devices: | IVS Introducer Set, Model 1001, K020789, K021004, K964814 | |
| Device description: | The IVS Introducer Set consists of a 6 French Introducer Sheath, a<br>Dilator and a 0.38" (0.97mm) 'J' tip Guidewire | |
| Indication for Use: | The IVS Introducer Set is indicated for use in procedures requiring<br>percutaneous introduction of intravascular devices. | |
| Technological characteristics: | The Model 1003 Introducer Set has the same technologic characteristics<br>as the Model 1001 (K020879) device. | |
| Testing: | The IVS Introducer Set has been tested in vitro and in clinical model<br>systems. Test results show that the modifications to the device do not<br>affect the safety or effectiveness of the device for the intended use. | |

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design of the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 3 2003

Integrated Vascular Systems, Inc. c/o Susan Turner, Ph.D. 743 N. Pastoria Avenue Sunnyvale, CA 94085

Re: K030723

> IVS Introducer Set, Model 1003 Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: March 6, 2003 Received: March 7, 2003

Dear Dr. Turner:

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. Iisting 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.

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

Page 2 - Susan Turner, Ph.D.

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), 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,

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

Enclosure

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

Integrated Vascular Systems, Inc. Special 510(k) IVS Introducer Set, Model 1003

## Indications For Use Statement

510(k) Number (if known)

K030723

Device Name

IVS Introducer Set, Model 1003

Indications For Use The IVS Introducer Set is indicated for use in procedures requiring percutaneous introduction of intravascular devices.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X
(Per 21 CFR § 801.109)
OR
Over-The-Counter Use ***_***