STARCLOSE INTRODUCER SET MODEL- 1002

K060902 · Abbott Vascular, Inc. · DYB · Jul 7, 2006 · Cardiovascular

Device Facts

• Record ID: K060902
• Device Name: STARCLOSE INTRODUCER SET MODEL- 1002
• Applicant: Abbott Vascular, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jul 7, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The StarClose™ Introducer Set is intended for use in procedures requiring percutaneous introduction of intravascular devices.

Device Story

The StarClose™ Introducer Set is a procedural kit used to gain percutaneous access to blood vessels for diagnostic and interventional procedures. The set consists of a 6F introducer, a dilator, and a "J"-tip guidewire. It is utilized by clinicians in a clinical setting to facilitate the insertion of intravascular devices. The device functions as a mechanical access tool; it does not involve electronic processing, software, or automated decision-making. By providing a stable entry point into the vasculature, it enables the physician to perform necessary diagnostic or therapeutic interventions, thereby supporting patient care during vascular procedures.

Clinical Evidence

bench testing only

Technological Characteristics

The device is a mechanical introducer set consisting of a 6F introducer, dilator, and "J"-tip guidewire. It is a non-powered, manual instrument used for vascular access. No software, electronics, or specific material standards are detailed in the provided documentation.

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

• StarClose™ Introducer Set (K030723)

Submission Summary (Full Text)

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Abbott Vascular StarClose Introducer Set

K060902

## APPENDIX A: 510(k) SUMMARY

| Sponsor/Submitter: | Abbott Laboratories<br>Abbott Vascular Inc.<br>400 Saginaw Drive<br>Redwood City, CA 94063 | JUL - 7 2006 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Daun Putnam<br>Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] | |
| Date of Submission: | March 31, 2006 | |
| Device Trade Name: | StarClose™ Introducer Set | |
| Device Common Name: | Introducer Set | |
| Device Classification: | Class II | |
| Regulation Number: | 21 CFR 870.1340 | |
| Classification Name: | Catheter Introducer | |
| Product Code: | DYB | |
| Predicate Device: | StarClose™ Introducer Set (K030723) | |
| Intended Use: | The StarClose™ Introducer Set is intended for use in<br>procedures requiring percutaneous introduction of<br>intravascular devices. | |
| Device Description: | The StarClose™ Introducer Set consists of a 6F Introducer,<br>a Dilator and a "J"-tip guidewire and is for use in gaining<br>access to blood vessels for diagnostic and interventional<br>procedures. | |
| Summary of Substantial<br>Equivalence: | The StarClose™ Introducer Set is substantially equivalent<br>to the predicate device. Substantial equivalence was<br>confirmed through non-clinical testing. | |

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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol of three stylized human profiles. The profiles are stacked on top of each other, representing the department's focus on health and human well-being. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 2006

Abbott Vascular, Inc. c/o Mr. Daun Putnam Coordinator, Regulatory Affairs 400 Saginaw Drive Redwood City, CA 94063

Re: K060902

Trade Name: StarClose™ Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II (two) Product Code: DYB Dated: June 8, 2006 Received: June 9, 2006

Dear Mr. Putnam:

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.

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Page 2 – Mr. Daun Putnam

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Drinas intatutes and regulations administered by other Federal agencies. You must or any I vith 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 CFN 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. product radiation contact provises (site of the station your device as described in your Section 510(k) This letter will and in your finding of substantial equivalence of your device to a legally premarket notification on "carsification 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 If you active 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 other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Meffey Map

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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## APPENDIX B: INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K 060902

Device Name:

StarClose™ Introducer Set

Indications for Use: The StarClose™ Introducer Set is intended for use in procedures requiring percutaneous introduction of intravascular devices.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use______________ OR (Per 21 CFR 801.109)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mefferson
Division of Nuclear Devices

(Divis. of Cardio:ascular Devices)
Division of

510(k) Number K060902