FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM

K120738 · Ostial Corporation · LIT · Mar 29, 2012 · Cardiovascular

Device Facts

• Record ID: K120738
• Device Name: FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM
• Applicant: Ostial Corporation
• Product Code: LIT · Cardiovascular
• Decision Date: Mar 29, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Flash PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This catheter is not intended for use in coronary arteries.

Device Story

Flash PTA Balloon Dilatation Catheter; 0.014" guidewire-compatible, rapid exchange (RX) angioplasty catheter. Features dual balloon design: compliant proximal anchoring balloon for precise positioning at aorto-ostial anatomies and prevention of distal migration; semi-compliant high-pressure distal balloon for luminal dilatation. Used by physicians in clinical settings for peripheral vascular procedures. Operator positions catheter via guidewire; inflates anchoring balloon to stabilize; inflates dilatation balloon to treat stenosis. Benefits include improved procedural precision and stability at difficult ostial locations.

Clinical Evidence

Bench testing only. Testing included balloon crossing profile, shaft diameter, rated burst pressure/volume, compliance, inflation/deflation time, fatigue, bond/tip pull strength, torque, flexibility, kink resistance, simulated use, and radiopacity. Results demonstrate device meets all predetermined design verification acceptance criteria.

Technological Characteristics

0.014" guidewire-compatible, rapid exchange (RX) catheter. Dual balloon system: compliant anchoring balloon and semi-compliant high-pressure dilatation balloon. Compatible with 6 French guide catheters. Length: 135cm. Balloon diameters: 4.0-6.0mm; lengths: 14-19mm. Radiopaque markers included.

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty in peripheral vasculature at aorto-ostial locations, including iliac, renal, and carotid arteries. Not for use in coronary arteries.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Flash PTA Balloon Dilatation Catheter (K102482)

Submission Summary (Full Text)

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K120738 page 1 of 2

MAR 2 9 2012

# 510(k) SUMMARY

# A. Submitter Information

- Submitter's Name: Address:
SECTION 5:

Telephone: Fax: Email: Contact Person: Date of Preparation:

#### B. Subject Device

Trade Name: Common/Usual Name: Classification Name: Product Code:

Ostial Corporation 510 Clyde Avenue Mountain View. CA 94043 650-903-9100 650-903-9119 [e-mail] Kaitlin von Hoffmann March 9, 2012

Flash PTA Balloon Dilatation Catheter Balloon Catheter Catheters, Angioplasty, Peripheral, Transluminal LIT per 21 C.F.R. 870.1250

# C. Device Description:

The Flash PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This catheter is not intended for use in coronary arteries. The Flash PTA Balloon Dilatation Catheter is a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The device uses a dual balloon design featuring a compliant anchoring balloon, which enables the operator to precisely position the catheter at aorto-ostial anatomies and prevent distal migration of the balloon during angioplasty. The second semi-compliant high pressure balloon allows for luminal dilatation.

### D. Intended Use:

The Flash PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This catheter is not intended for use in coronary arteries.

# E. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use:

The Flash PTA Balloon Dilatation Catheter that is the subject of this 510(k) is an extension of a product line of the same name, which was cleared via 510(k) #K102482 on February 25, 2011. Minor design and process changes to decrease the crossing profile of the device have been implemented. This submission includes devices with balloon diameters ranging from 4.0 to 6.0mm and balloon lengths of 14 to 19mm. The new sizes are 135cm in length and compatible with 6 French guide catheters.

# F. Performance Data:

Bench testing performed on the Flash PTA device included the following:

- Balloon crossing profile .
- . Catheter shaft diameter
- . Angioplasty balloon rated burst pressure and maximum burst pressure
- . Anchoring balloon rated burst volume
- . Balloon compliance and diameter
- . Balloon inflation and deflation time
- . Angioplasty balloon fatigue

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K120738 page 2 of 2

Ostial Corporation 510(k) Notification: Flash PTA Balloon Dilatation Catheter

- Anchoring balloon fatigue .
- . Catheter bond and tip pull strength
- Catheter torque strength, flexibility and kink .
- . Simulated use
- . Radiopacity

All test results demonstrate that the materials, manufacturing process, and design of the Flash PTA Balloon Dilatation Catheter meet the established specifications necessary for consistent performance according to its intended use.

#### G. Conclusions:

The Flash PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This catheter is not intended for use in coronary arteries. The purpose of this 510(k) is to request clearance for an extension of the Flash PTA Balloon Dilatation Catheter product line, which was initially cleared via 510(k) #K102482 on February 25, 2011. All test results demonstrate that the Flash PTA Balloon Dilatation Catheter meets all predetermined design verification acceptance criteria.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAR 2 9 2012

Ostial Corporation c/o Ms. Kaitlin von Hoffman 510 Clyde Ave. Mountain View, CA 94043

Re: K120738

Trade/Device Name: Flash PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: LIT, DQY Dated: March 9, 2012 Received: March 12, 2012

Dear Ms. Von Hoffmann:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2 - Ms. Kaitlin von Hoffmann

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M. G. Allehen

Ja 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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K120738 page 1 of 1

#### INDICATIONS FOR USE STATEMENT SECTION 4:

510(k) Number:

Device Name:

K120738

Flash PTA Balloon Dilatation Catheter

Indication For Use:

The Flash PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This catheter is not intended for use in coronary arteries.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

CM of Hillehem

Division Sign-C (Division of Cardiovascular Devices

201388 510(k) Number