OSTIAL PRO STENT POSITIONING SYSTEM

K062192 · Ostial Solutions, LLC · DQX · May 24, 2007 · Cardiovascular

Device Facts

• Record ID: K062192
• Device Name: OSTIAL PRO STENT POSITIONING SYSTEM
• Applicant: Ostial Solutions, LLC
• Product Code: DQX · Cardiovascular
• Decision Date: May 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Ostial Pro Stent Positioning System is intended for use in aorta-ostial procedures to introduce and position catheters, stents and other interventional devices within the coronary and peripheral vasculature. In addition, the Ostial Pro Stent Positioning System is intended to facilitate the alignment of interventional devices and function as an alignment tool.

Device Story

Disposable guidewire system; used by interventional cardiologists and radiologists during aorta-ostial procedures. Functions as alignment tool to facilitate precise stent implantation in coronary and renal vasculature. Compatible with 6, 7, and 8 French catheters. Provides mechanical guidance and positioning for interventional devices; assists clinicians in achieving accurate stent placement at ostial lesions. Benefits patient by improving procedural precision and reducing potential for malpositioning during stenting.

Clinical Evidence

No clinical data. Safety and efficacy supported by design verification testing, biocompatibility testing, and preclinical animal testing.

Technological Characteristics

Medical grade, disposable guidewire system. Compatible with 6, 7, and 8 French catheters. Sterile, single-use device.

Indications for Use

Indicated for patients undergoing aorta-ostial procedures requiring stent or interventional device placement within coronary and peripheral vasculature.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Cordis® Corporation, ATW™ Marker Wire Steerable Guidewire (K994358)
• Lake Region Manufacturing, Inc., Coronary, Peripheral and Renal Steerable Hydrophilic Guidewire (K042338)
• EV3® Inc., Nitrex® Guidewire (K031864)
• BioSphere Medical, Inc., Sequitor Steerable Guidewire (K061171)

Submission Summary (Full Text)

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## 510(k) SUMMARY

#### 510(k) Notification K062192

## GENERAL INFORMATION

#### Applicant:

Ostial Solutions, LLC 1111 Short Road Kalamazoo, MI 49008 Phone: [phone] FAX: [phone]

#### Contact Person:

Michael J. Billig Regulatory Consultant Experien Group, LLC 155 Moffett Park Dr., Suite A-210 Sunnyvale, CA 94089 Phone: [phone] FAX: [phone] Email: [e-mail]

#### Date of Submission:

July 28, 2006

#### DEVICE INFORMATION

#### Classification:

Class II - Standards

## Trade Name:

Ostial Pro Stent Positioning System

#### Common/Classification Name/Product Code:

Product Code: DQX Device Classification: Catheter Guidewire Regulation Number: 870.1330

## PREDICATE DEVICES

- Cordis® Corporation, ATW™ Marker Wire Steerable Guidewire, K994358 .
- Lake Region Manufacturing, Inc., Coronary, Peripheral and Renal Steerable . Hydrophilic Guidewire, K042338
- EV3® Inc., Nitrex® Guidewire, K031864 .
- BioSphere Medical, Inc., Sequitor" Steerable Guidewire, K061171 .

MAY 2 4 2007

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## INTENDED USE

The Ostial Pro Stent Positioning System is intended for use in aorta-ostial procedures to introduce and position catheters, stents and other interventional devices within the coronary and peripheral vasculature. In addition, the Ostial Pro Stent Positioning System is intended to facilitate the alignment of interventional devices and function as an alignment tool.

## PRODUCT DESCRIPTION

The Ostial Pro Stent Positioning System is a medical grade, disposable guidewire system. The Ostial Pro Stent Positioning System will be used by interventional cardiologists and interventional radiologists to ensure precise stent implantation in aorta-ostial procedures. The product will be used in coronary and renal stenting procedures. The product is provided sterile and intended for single use.

This finished product will be compatible with 6, 7 and 8 French catheters.

## SUBSTANTIAL EQUIVALENCE

The indications for use for the predicate devices are substantially equivalent to the proposed indications for the Ostial Pro Stent Positioning System. The technological characteristics for the Ostial Pro Stent Positioning System are also substantially equivalent to the predicate devices. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the Ostial Pro Stent Positioning System is substantially equivalent to the predicate devices.

#### TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

The safety of the Ostial Pro Stent Positioning System was evaluated through design verification testing, biocompatibility testing and preclinical animal testing. The collective results have demonstrated that the Ostial Pro Stent Positioning System is safe and is substantially equivalent to the respective predicate devices with regard to safety and efficacy. Any differences in technological characteristics between the Ostial Pro Stent Positioning System and the predicate devices do not raise any new issues of safety or efficacy.

#### SUMMARY

The Ostial Pro Stent Positioning System is substantially equivalent to the predicate devices.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 4 2007

Ostial Solutions, LLC c/o Mr. Michael J Billig Regulatory Consultant 1111 Short Road Kalamazoo, MI 49008

K062192 Re:

> Ostial Pro Stent Positioning System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: II (two) Product Code: DQX Dated: May 14, 2007 Received: May 15, 2007

Dear Mr. Billig:

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. Michael J Billig

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]. 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 Manufacturers, International 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 vours.

R. Valmus

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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# OSTIAL SOLUTIONS, LLC 1111 SHORT ROAD KALAMAZOO, MI 49008

## INDICATIONS FOR USE

510(k) Number (if known): K062192

Device Name: Ostial Pro Stent Positioning System

Indications for Use:

The Ostial Pro Stent Positioning System is intended for use in aorta-ostial procedures to introduce and position stents and other interventional devices within the coronary and peripheral vasculature. In addition, the Ostial Pro Stent Positioning System is intended to facilitate the alignment of interventional devices and function as an alignment tool.

Prescription Use V (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)

uma R. Vaches

(Division Sign-Off) (Division of Cardiovascular Devices

510(k) Number K062192