IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER); IVS INTRUDUCER SET, MODEL 1001

K020879 · Integrated Vascular Systems, Inc. · FZP · Sep 25, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020879
• Device Name: IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER); IVS INTRUDUCER SET, MODEL 1001
• Applicant: Integrated Vascular Systems, Inc.
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Sep 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IVS Clip Closure System is intended for use to approximate vascular tissue for achieving hemostatic closure of puncture sites to aid healing in minimally invasive procedures under direct or endoscopic visualization.

Device Story

IVS Clip Closure System consists of extravascular nitinol clip mounted on 6 French Introducer Sheath; includes manual clip applier. Device used during minimally invasive procedures to approximate vascular tissue and achieve hemostatic closure of puncture sites. Operated by physician under direct or endoscopic visualization. Clip is released into vascular tissue to provide immediate mechanical extravascular closure. Benefits include aided healing of puncture sites. Device is manually operated; no software or automated processing involved.

Clinical Evidence

Bench testing, in vitro, in vivo, and human model systems testing performed. All components contacting fluid path or tissue are biocompatible per ISO 10993. Results demonstrate safety and effectiveness for intended use.

Technological Characteristics

Nitinol implantable clip; 6 French Introducer Sheath; manual clip applier. Biocompatibility per ISO 10993. Mechanical operation.

Indications for Use

Indicated for patients undergoing minimally invasive procedures requiring hemostatic closure of vascular puncture sites.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Angiolink EVS™ Vascular Closure System

Submission Summary (Full Text)

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

K020879 page 1/2

Integrated Vascular Systems, Inc.

# SEP 2 5 2002

### 510(k) Summary

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: | July 2, 2002 | |
| Device name: | IVS Clip Closure System | |
| Common name: | Clip, clip applier, catheter introducer | |
| Classification names: | Regulation # and<br>Product Code | Classification Name |
| | 21 C.F.R. § 878.4300<br>FZP | Implantable clip |
| | 21 C.F.R. § 870.1340<br>DYB | Catheter introducer |
| Predicate devices: | The IVS Clip Closure System is substantially equivalent to<br>the Angiolink EVS™ Vascular Closure System. | |
| Device description: | The IVS Clip Closure System consists of an extravascular<br>implantable nitinol clip mounted on an Introducer Sheath.<br>A clip applier acts to release the clip into vascular tissue<br>where it closes vascular puncture wounds. | |
| Indication for Use: | The IVS Clip Closure System is intended for use to<br>approximate vascular tissue for achieving hemostatic<br>closure of puncture sites to aid healing in minimally<br>invasive procedures under direct or endoscopic<br>visualization. | |
| Technological<br>characteristics: | The subject and predicate devices have the same intended<br>use and principles of operation. Both systems stabilize the<br>site, guide and center on the wound and deliver a clip/staple<br>to the wound site for tissue approximation and immediate<br>mechanical extravascular closure. The IVS systems uses a<br>nitinol clip; the EVS system uses a titanium staple. The clip<br>applier and stapler are both manually operated although the<br>mechanisms are different. Performance testing of the IVS<br>system demonstrates that there are no new issues of safety<br>or effectiveness associated with this difference.<br><br>The IVS implantable clip is mounted on an Introducer<br>Sheath. The sheath is a standard 6 French sheath and<br>performance testing demonstrates that there are no new<br>issues of safety or effectiveness associated with the presence<br>of the clip/clip carrier assembly on the catheter introducer. | |
| Testing: | The IVS Clip Closure System has been tested in vitro, in<br>vivo and in human model systems. Test results show that<br>the device is safe and effective for the intended use. All<br>components which contact the fluid path or tissue are<br>biocompatible in accordance with ISO Standard 10993. | |

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

KOZO879 page 2/2

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

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with a design that suggests flowing hair or fabric.

MAR 1 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Susan Turner, Ph.D. Director, Regulatory Affairs & Quality Assurance Integrated Vascular Systems, Inc. 743 North Pastoria Avenue Sunnyvale, California 94085

Re: K020879

Trade/Device Name: IVS Clip Closure System, Model 1002 and IVS Introducer Set Regulation Number: 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: July 2, 2002 Received: July 2, 2002

Dear Dr. Turner:

This letter corrects our substantially equivalent letter of September 25, 2002 regarding the IVS Clip Closure System, which failed to include the IVS Introducer Set.

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 (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 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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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

#### Page 2 - Susan Turner, Ph.D.

This letter will allow you to continue 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 and additionally Part 809.10 for in vitro diagnostic devices), 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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Muriam C. Provost

to Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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

K 020879 Response to FDA request for additional information July 2, 2002

#### Indications For Use Statement Revised July 2, 2002

K020879 510(k) Number (if known)

The IVS Clip Closure System. Device Name

Indications For Use The IVS Clip Closure System is intended for use to approximate vascular tissue for achieving hemostatic closure of puncture sites to aid healing in minimally invasive procedures under direct or endoscopic visualization.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-The-Counter Use Prescription Use (Per 21 CFR § 801.109) (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number _

CONFIDENTIAL Information of Integrated Vascular Systems, Inc.

3