IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677

K051125 · Abbott Laboratories · FZP · Jun 8, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051125
• Device Name: IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677
• Applicant: Abbott Laboratories
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Jun 8, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The StarClose™ Vascular Closure System is intended for use 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

StarClose Vascular Closure System delivers nitinol clip to vascular puncture sites; achieves hemostasis by approximating vascular tissue. Used in minimally invasive procedures; operated by clinicians under direct or endoscopic visualization. Device facilitates healing of puncture sites post-procedure.

Clinical Evidence

Bench testing only.

Technological Characteristics

Device utilizes a nitinol clip for vascular closure. Mechanical delivery system. Class II device.

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

• StarClose™ Vascular Closure System (K020879)

Submission Summary (Full Text)

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051125

JUN 8 - 2005

Abbott Vascular Devices IVS Clip Closure System

## APPENDIX A. 510(k) SUMMARY

| Sponsor/Submitter: | Abbott Laboratories (Perclose, Inc.)<br>Abbott Vascular Devices<br>400 Saginaw Drive<br>Redwood City, CA 94063 |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kim Smith-Servance<br>Regulatory Affairs Manager<br>Phone:[phone]<br>Fax:[phone] |
| Date of Submission: | May 2, 2005 |
| Device Trade Name: | StarClose™ Vascular Closure System |
| Device Common Name: | Vascular Closure System |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 878.4300<br>21 CFR 870.1340 |
| Classification Name: | General and Plastic Surgery Devices |
| Product Code: | FZP<br>DYB |
| Predicate Device: | StarClose™ Vascular Closure System (K020879) |
| Intended Use: | The StarClose™ Vascular Closure System is intended for use for use to<br>approximate vascular tissue for achieving hemostatic closure of puncture<br>sites to aid healing in minimally invasive procedures under direct or<br>endoscopic visualization |
| Device Description: | The StarClose™ Vascular Closure System is designed to deliver a<br>nitinol clip to close vascular puncture sites to achieve hemostasis. |
| Summary of Substantial<br>Equivalence: | The StarClose™ Vascular Closure System is substantially<br>equivalent to the predicate device. Substantial equivalence was<br>confirmed through non-clinical testing. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with outstretched wings.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 8 - 2005

Ms. Kim Smith-Servance Manager, Regulatory Affairs Abbott Laboratories (Perclose, Inc.) Abbott Vascular Devices 400 Saginaw Drive Redwood City, California 94063

Re: K051125

K031123
Trade/Device Name: StarClose™ Vascular Closure System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: May 2, 2005 Received: May 10, 2005

Dear Ms. Smith-Servance:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained is substantially equivalent (for the indications felerenced above and nave decembed the acted predicate devices marketed in interstate for use stated in the encrosule) to regally manated provide in the Medical Device Ameralments, or to commerce prior to May 28, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have been recultion in acceracy of of a premarket approval application (PMA). and Cosment Act (Act) that do not require approval of the general controls provisions of the Act. The You may, merelore, market the device, bacycer to the Beller of annual registration, listing of general Controls of the Hereness of the Hereas some in the manage inst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is Classified (SCC above) into existins major regulations affecting your device in the subject to successful in a FDA it may be subject to such additional concelsi - marting 21, Parts 800 to 898. In addition, FDA can be lound in the Code of Feceral rogerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dr is ibsumes or wor device complies with other requirements of the Act that IDA has made a decorminations administered by other Federal agencies. You must of ally rederal statutes and regulations and including, but not limited to: registration and listing (21 comply with an the Act 3 requirements, moreans, and manufacturing practice requirements as set CFK Fatt 807), adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.

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### Page 2 – Ms. Kim Smith-Servance

This letter will allow you to begin marketing your device as described in your Section 510(k)
The success of the supply of any for heat the suice to a legal This letter will allow you to begin marketing your averale of your device of your device to a legally
premarket notification. The FDA finding of substantial end the permits premarket notification. "The FDA Intuing of bassantas - p
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
rs in the results of the most 10 15 - Alge - also - places note the requira If you desire specific advice for your device of our on the regulation entitled.
contact the Office of Compliance at [phone] . Also, please note the regulation contact the Office of Colliptialicc at (24) 210 - 1 (21CFR Patt 807.97). You may obtain
"Misbranding by reference to premarket notification the Division of Small "Misbranding by reference to premarket nonlineation" (1) 32 oct from the Division of Small
other general information on your responsibilities under (1800 number (800) 638-204 other general information on your responsionner Assistance at its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-firences Manufacturers, International and Colisuner Assistance as tos over in and and and and and and and a

Sincerely yours,

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Kosi12S

Abbott Vascular Devices IVS Clip Closure System Special 510(k): Device Modification CONFIDENTIAL

# APPENDIX B. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K

Device Name:

StarClose™ Vascular Closure System

Indications For Use:

The StarCloseTM Vascular Closure System is intended for use for use to The StarCloseIM Vascular Closure of actrieving hemostatic closure of puncture sites to
approximate vascular tissue for accidents and ander direct or endoscopic approximate vascular tissue for acineving nomestate became of endoscopic visualization.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ivision Sie - Off) Fivision of General, Restorative Nourological Devices

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