FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM

K122379 · Ostial Corporation · LIT · Sep 5, 2012 · Cardiovascular

Device Facts

• Record ID: K122379
• Device Name: FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM
• Applicant: Ostial Corporation
• Product Code: LIT · Cardiovascular
• Decision Date: Sep 5, 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 Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.

Device Story

Flash PTA Balloon Dilatation Catheter is a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter; features dual balloon design for proximal anchoring to prevent distal migration during angioplasty; distal semi-compliant higher-pressure balloon performs luminal dilatation of de novo lesions and post-deployment stent expansion. Used in clinical settings by physicians for peripheral vascular interventions. Device provides mechanical dilatation; output is physical expansion of stenotic lesions or stents. Benefits include improved vessel patency and stent apposition.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via in-vitro testing: balloon crossing profile, shaft diameter, rated burst pressure, fatigue testing (in stent), inflation/deflation times, bond/tip/torque strength, and flexibility/kink resistance. Biocompatibility confirmed per ISO-10993 (MEM elution, hemolysis, pyrogenicity, sensitization, thromboresistance).

Technological Characteristics

0.014" guidewire-compatible, rapid exchange (RX) catheter; dual balloon design (anchoring and dilatation); semi-compliant distal balloon. Materials evaluated per ISO-10993. Dimensions: 4.0-7.0mm balloon diameters, 14-19mm lengths, 135cm working length. Compatible with 6F or 7F guide catheters. Mechanical sensing/actuation via hydraulic inflation.

Indications for Use

Indicated for patients requiring Percutaneous Transluminal Angioplasty in peripheral vasculature at aorto-ostial locations (iliac, renal, carotid arteries) or post-dilatation of balloon-expandable stents.

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 (K121175)
• Flash PTA Balloon Dilatation Catheter (K120738)

Submission Summary (Full Text)

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#### 510(k) SUMMARY

# A. Submitter Information

SECTION 5:

Submitter's Name: Address:

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 August 3, 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 designed for the dilation of stenotic ostial lesions in the peripheral vasculature. The Flash PTA Balloon Dilatation Catheter is a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The Flash PTA Balloon Dilatation Catheter uses a dual balloon design, which prevents distal migration of the balloon during angioplasty. The distal semi-compliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.

#### D. Intended Use:

The Flash PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.

# 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) #K121175 on June 29, 2012. This submission includes devices with balloon diameters ranging from 4.0 to 7.0mm and balloon lengths of 14 and 19mm. The new sizes feature a working catheter length of 135cm, and are compatible with either 6 or 7 French guide catheters. With the exception of the 7mm model, all of these models have previously been cleared by the FDA for a subset of the proposed indication via 510(k) #K120738 on March 29, 2012.

#### F. Performance Data:

Biocompatibility testing has previously been completed on the Flash PTA Balloon Dilatation Catheter. Requirements for biological evaluation of the proposed device were based on the Blue Book Memorandum issued on May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices, Part 1:Evaluation and Testing." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissues consistent with its intended use. The following biocompatibility tests were completed:

.

- ISO MEM Elution Assay .
- ASTM Hemolysis Assay .
- Materials Mediated Rabbit Pyrogen ●
- ISO Guinea Pig Maximization Sensitization

5 2012

SEP

08/03/12

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510(k) Notification: Flash PTA Balloon Dilatation Catheter

- Complement Activation C3a and SC5b-9 Assay t
- . Thromboresistance Evaluation
- Pyrogen (LAL) Chromogenic .
- . ISO Acute Systemic Injection Test
- . ISO Intracutaneous Reactivity Test

The Flash PTA Balloon Dilatation Catheter was evaluated using the following in-vitro performance bench testing to confirm the performance characteristics as compared to the predicate device:

- Balloon Crossing Profile .
- . Catheter Shaft Diameter
- . Angioplasty Balloon Rated Burst Pressure
- Anchoring Balloon Burst Volume .
- Angioplasty Balloon Compliance .
- . Balloon Inflation Time
- . Balloon Deflation Time
- Angioplasty Balloon Rated Burst Pressure (in . Stent)
- · Anchoring Balloon Fatigue (in Stent)
- Anchoring Balloon Burst Volume (in Stent)
- Angioplasty Balloon Fatigue .
- Anchoring Balloon Fatigue ◆
- Catheter Bond Strength
- . Catheter Tip Pull Strength
- . Catheter Torque Strength
- . Simulated Use
- . Flexibility and Kink Resistance
- Radiopacity ●
- Angioplasty Balloon Fatigue (in Stent)

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

#### G. Conclusions:

The Flash PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.

The purpose of this 510(k) is to request clearance for an extension of the Flash PTA Balloon Dilatation Catheter product line cleared via 510(k) #K121175 on June 29, 2012. The Fiash PTA Balloon Dilatation Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, test protocols, and/or customer inputs.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

SEP 5 2012

Ostial Corporation c/o Kaitlin von Hoffmann 510 Clyde Avenue Mountain View, CA 94043

Re: K122379

Trade/Device Name: Flash PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870:1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DOY Dated: August 03, 2012 Received: August 06, 2012

### Dear Ms. 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 iddictions for use stated in the enclosure) to legally marketed predicate devices marketed in intestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmants, 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, lists 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 devine can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, TDA may publish further announcements concerning your device in the Federal Reguster.

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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 (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.

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/CDRH/CDRHOffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Guig Hillen

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

#### INDICATIONS FOR USE STATEMENT SECTION 4:

510(k) Number:

# K122379

Device Name:

Flash PTA Balloon Dilatation Catheter

Indication for Use:

The Flash PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.

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)

R. Hilleben

Division Sign-Off (Division Sign-Oil)
Division of Cardiovascular Devices

510(k) Number K122379