FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm

K150946 · Ostial Corporation · LIT · May 8, 2015 · Cardiovascular

Device Facts

• Record ID: K150946
• Device Name: FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm
• Applicant: Ostial Corporation
• Product Code: LIT · Cardiovascular
• Decision Date: May 8, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Flash Ostial System OTW 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

The FLASH Ostial System OTW is an over-the-wire (OTW) angioplasty balloon catheter designed for use in peripheral vasculature. It features a dual-balloon design: a compliant proximal balloon that anchors the device to prevent distal migration during angioplasty, and a semi-compliant distal balloon for dilating de novo lesions and expanding stents. The device is compatible with 0.035" guidewires and 6F guiding sheaths. It is operated by a physician in a clinical setting. By providing stable positioning at ostial locations, the device allows for precise angioplasty or stent post-dilatation, potentially improving procedural outcomes and reducing the risk of balloon slippage.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (ISO 10993-1, MEM Elution, Hemolysis, Complement Activation, Thromboresistance, Pyrogenicity, Sensitization, Acute Systemic Injection, Intracutaneous Reactivity) and performance bench testing (crossing profile, burst pressure, compliance, inflation/deflation time, fatigue, bond/pull/torque strength, simulated use, flexibility, kink resistance, and radiopacity).

Technological Characteristics

Over-the-wire (OTW) angioplasty balloon catheter; 0.035" guidewire compatible; 6F guiding sheath compatible; dual-balloon design (compliant proximal, semi-compliant distal); materials evaluated per ISO 10993-1; radiopaque marker bands; lengths 80cm or 135cm.

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 Ostial System OTW (K133861)

Submission Summary (Full Text)

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

May 8, 2015

Ostial Corporation Mr. Jake Wolenberg Ouality Assurance and Regulatory Affairs Manager 1221 Innsbruck Drive Sunnyvale, California 94089

#### Re: K150946

Trade/Device Name: Flash Ostial System OTW - 6.0mm x 12mm x 80cm, Flash Ostial System OTW - 6.0mm x 12mm x 135cm, Flash Ostial System OTW - 7.0mm x 12mm x 80cm, Flash Ostial System OTW - 7.0mm x 12mm x 135cm Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: April 7, 2015 Received: April 8, 2015

Dear Mr. Wolenberg:

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.

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

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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -S

for

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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## Indications for Use

510(k) Number (if known) K150946

Device Name FLASH Ostial System OTW

#### Indications for Use (Describe)

The FLASH Ostial System OTW 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> × Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image contains the logo for Ostial Corporation. The logo consists of a stylized, circular graphic to the left of the company name. The graphic is made up of interwoven lines in light blue and gray. The text "Ostial" is in a dark gray sans-serif font, with "corporation" in a smaller, light blue font underneath, underlined with a light blue line.

Ostial Corporation 510(k) Notification: FLASH Ostial System OTW

# 510(k) Summary FLASH Ostial System OTW - Product Line Extension

## A. Submitter Information

Submitter's Name: Address:

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

#### B. Subject Device

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

#### C. Predicate Device Name

Proprietary Name: 510(k) #'s: Common/Usual Name: Classification Name: Product Code:

Ostial Corporation 1221 Innsbruck Drive Sunnyvale, CA 94089 408-541-1006 408-541-1007 [e-mail] Jake Wolenberg April 7, 2015

FLASH Ostial System OTW Balloon Catheter Catheter, Angioplasty, Peripheral, Transluminal LIT per 21 C.F.R. 870.1250

FLASH Ostial System OTW K133861 Balloon Catheter Catheter, Angioplasty, Peripheral, Transluminal LIT per 21 C.F.R. 870.1250

#### D. Device Description:

The Flash Ostial System OTW is designed for the dilatation of stenotic ostial lesions in the peripheral vasculature. The FLASH Ostial System OTW is a 0.035" guidewire-compatible, over the wire (OTW) angioplasty balloon catheter with proximal anchoring and a working length of either 80cm or 135cm. All device sizes in the Flash Ostial System OTW product family are designed to be compatible with 6F guiding sheaths. The FLASH Ostial System OTW uses a dual balloon design that features a compliant proximal balloon, which prevents distal migration of the balloon during angioplasty. The second semi-compliant higher-pressure distal balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.

#### E. Intended Use:

The Flash Ostial System OTW 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.

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Image /page/4/Picture/1 description: The image contains the logo for "Ostial corporation". The logo consists of a stylized, geometric shape resembling a flower or star with rounded petals, rendered in light blue and gray. To the right of the geometric shape, the word "Ostial" is written in a gray, sans-serif font. Below "Ostial", the word "corporation" is written in a smaller, light blue font, underlined with a thin, light blue line.

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

The FLASH Ostial System OTW device sizes that are the subject of this Special 510(k) are a line extension of the FLASH Ostial System OTW product line, previously cleared under 510(k) # K133861. The proposed line extension device sizes and previously cleared device sizes are indicated for reference in the table below with a format of Balloon Diameter x Balloon Length x Catheter Length.

| | Table 8-1: Previously Cleared and Proposed Line Extension Device Sizes | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | | |
| Flash OTW Line Cleared | Flash OTW Line Extension | |
| The Children Children | WA CHANGE CHANGE AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND A A CHANGE AND A A CHANGE AND A A | |

| Flash OTW Line Cleared<br>Device Sizes | Flash OTW Line Extension<br>Device Sizes |
|---------------------------------------------|--------------------------------------------------------------------------------------------|
| 7.0mm x 17mm x 80cm<br>7.0mm x 17mm x 135cm | 6.0mm x 12mm x 80cm<br>6.0mm x 12mm x 135cm<br>7.0mm x 12mm x 80cm<br>7.0mm x 12mm x 135cm |

The device sizes included in the line extension all share the exact same catheter design as the currently cleared sizes of the Flash Ostial System OTW. The only differences are the diameter and length of the balloons and the marker band spacing which indicates the length of the balloons. Additionally, the Indications for Use for both versions of the device are exactly the same.

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Image /page/5/Picture/0 description: The image contains the logo for "Ostial corporation". The logo consists of a circular design on the left, resembling an interconnected chain or ring, with alternating light blue and gray segments. To the right of the circular design is the word "Ostial" in a dark gray, sans-serif font. Below "Ostial" is the word "corporation" in a light blue, sans-serif font, underlined with a light blue line.

## Ostial Corporation 510(k) Notification: FLASH Ostial System OTW

## G. Performance Data:

Biocompatibility testing has previously been completed on product equivalent to the FLASH Ostial System OTW. 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," and the current FDA recognized standard ISO 10993-1: Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process. 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
- . Complement Activation C3a and SC5b-9 Assay
- Thromboresistance Evaluation
- Materials Mediated Rabbit Pyrogen ●
- ISO Guinea Pig Maximization Sensitization
- ISO Acute Systemic Injection Test ●
- ISO Intracutaneous Reactivity Test ●
- Pyrogen (LAL) Chromogenic

The FLASH Ostial System OTW line extension device sizes or product equivalent were evaluated using the following in-vitro and performance bench testing to confirm the performance characteristics as compared to the product performance requirements:

- Balloon Crossing Profile .
- Catheter Shaft Diameter ●
- Catheter Working Length ●
- Catheter Inner Diameter ●
- Angioplasty Balloon Rated Burst Pressure
- . Proximal Balloon Burst Volume
- Angioplasty Balloon Compliance
- . Balloon Inflation Time
- Balloon Deflation Time ●
- Angioplasty Balloon Rated Burst Pressure (in 0 Stent)
- Proximal Balloon Burst Volume (in Stent) .
- Angioplasty Balloon Fatigue ●
- Proximal Balloon Fatigue ●
- Catheter Bond Strength ●
- Catheter Tip Pull Strength
- Catheter Torque Strength ●
- Simulated Use ●
- Flexibility and Kink Resistance ●
- Radiopacity
- Angioplasty Balloon Fatigue (in Stent)
- Proximal Balloon Fatigue (in Stent)

All test results demonstrate that the FLASH Ostial System OTW line extension device sizes meet the established product specifications.

#### H. Conclusions:

All test results demonstrated that the FLASH Ostial System OTW line extension device sizes meet all predetermined design verification and validation acceptance criteria necessary to verify safe and consistent performance of the devices for their Indications for Use in "Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries" and "post-dilatation of balloon expandable stents in the peripheral vasculature." As such, Ostial Corporation is requesting clearance for the FLASH Ostial System OTW line extension device sizes to the FLASH Ostial System OTW product family, which was most recently cleared via Premarket Notification 510(k) # K133861 on July 2, 2014.