MODIFICATION TO IVS INTRODUCER SET, MODEL 1003

K031583 · Integrated Vascular Systems, Inc. · DYB · Jun 16, 2003 · Cardiovascular

Device Facts

• Record ID: K031583
• Device Name: MODIFICATION TO IVS INTRODUCER SET, MODEL 1003
• Applicant: Integrated Vascular Systems, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jun 16, 2003
• Decision: SESE
• Submission Type: Special
• 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 1003-7, facilitates percutaneous access for intravascular devices; consists of 7 French introducer sheath, dilator, and optional 0.38" 'J' tip guidewire. Used in clinical settings by healthcare professionals to provide vascular access. Device functions as mechanical conduit for subsequent interventional tools. Benefits include simplified, standardized percutaneous entry for intravascular procedures.

Clinical Evidence

In vitro and clinical model system testing performed. No clinical human trial data provided.

Technological Characteristics

7 French introducer sheath, dilator, and 0.38" 'J' tip guidewire. Mechanical device; no energy source or software. Materials and design identical to predicate Model 1003-6.

Indications for Use

Indicated for patients undergoing procedures requiring percutaneous introduction of intravascular devices.

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 1003-6 (K030723)

Submission Summary (Full Text)

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K631583

## JUN 1 6 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]<br>Fax: [phone] | |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Date prepared: | May 20, 2003 | |
| Device name: | IVS Introducer Set, Model 1003-7 | |
| Common name: | Catheter introducer, vessel dilator for percutaneous catheterization,<br>catheter guide wire | |
| Classification names: | Regulation # and Product 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 1003-6, K030723 | |
| Device description: | The IVS Introducer Set consists of a 7 French Introducer Sheath and a<br>Dilator with or without 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 1003-7 Introducer Set has the same technologic<br>characteristics as the Model 1003-6 (K030723) device. | |
| Testing: | The IVS Introducer Set is tested <i>in vitro</i> and in clinical model systems.<br>The modifications to the device do not affect the safety or effectiveness<br>of the device for the intended use. | |

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

JUN 1 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Integrated Vascular System, Inc. Susan Turner, Ph.D. Director, Regulatory Affairs and Quality Assurance 743 North Pastoria Avenue Sunnyvale, CA 94085

Re: K031583

> Trade/Device Name: IVS Introducer Set, Model 1003-7 Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer. Regulatory Class: Class II Product Code: DYB Dated: May 20, 2003 Received: May 21, 2003

Dear Ms. 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, 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

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Page 2 - Susan Turner, Ph.D.

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,

M

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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## Indications For Use Statement

1031583 510(k) Number (if known)

IVS Introducer Set, Model 1003-7J and Model 1003-7 Device Name

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) | |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| | |
| | (Division Sign-Off) |
| | Division of Cardiovascular Devices |
| 510(k) Number | L031583 |
| Prescription Use<br>(Per 21 CFR § 801.109) | <div style="display:inline-block; width:30px;"></div> OR <div style="display:inline-block; width:30px;"></div> Over-The-Counter Use |