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.

Device Description

The Flash PTA Balloon Dilatation Catheter is designed for dilation of stenotic ostial lesions in the peripheral vasculature. The Flash PTA Balloon Dilatation Catheter is a .014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring and a working length of 135cm. The Flash PTA Balloon Dilatation Catheter uses a dual balloon design that features a compliant anchoring balloon, which prevents distal migration of the balloon during angioplasty. The second semicompliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.

AI/ML Overview

This document describes the acceptance criteria and the study conducted for the Flash PTA Balloon Dilatation Catheter.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Biocompatibility	Materials used in design and manufacture are non-toxic and non-sensitizing to biological tissues, consistent with intended use, as per ISO-10993 and Blue Book Memorandum May 1, 1995.	All biocompatibility test results demonstrated that the materials in the design and manufacture are non-toxic and non-sensitizing to biological tissues consistent with its intended use.
ISO MEM Elution Assay	Met established specifications.	Results met established specifications.
ASTM Hemolysis Assay	Met established specifications.	Results met established specifications.
Complement Activation C3a and SC5b-9 Assay	Met established specifications.	Results met established specifications.
Thromboresistance Evaluation	Met established specifications.	Results met established specifications.
Materials Mediated Rabbit Pyrogen	Met established specifications.	Results met established specifications.
ISO Guinea Pig Maximization Sensitization	Met established specifications.	Results met established specifications.
ISO Acute Systemic Injection Test	Met established specifications.	Results met established specifications.
ISO Intracutaneous Reactivity Test	Met established specifications.	Results met established specifications.
Pyrogen (LAL) Chromogenic	Met established specifications.	Results met established specifications.
In-vitro Performance Bench Testing	Performance characteristics confirm equivalence to the predicate device and meet established specifications for consistent performance according to its intended use.	All test results demonstrated that the device materials, the manufacturing process, and the design met the established specifications necessary for consistent performance according to its intended use.
Balloon Crossing Profile	Met established specifications.	Results met established specifications.
Catheter Shaft Diameter	Met established specifications.	Results met established specifications.
Angioplasty Balloon Rated Burst Pressure	Met established specifications.	Results met established specifications.
Anchoring Balloon Burst Volume	Met established specifications.	Results met established specifications.
Angioplasty Balloon Compliance	Met established specifications.	Results met established specifications.
Balloon Inflation Time	Met established specifications.	Results met established specifications.
Balloon Deflation Time	Met established specifications.	Results met established specifications.
Angioplasty Balloon Rated Burst Pressure (in Stent)	Met established specifications.	Results met established specifications.
Anchoring Balloon Burst Volume (in Stent)	Met established specifications.	Results met established specifications.
Angioplasty Balloon Fatigue	Met established specifications.	Results met established specifications.
Anchoring Balloon Fatigue	Met established specifications.	Results met established specifications.
Catheter Bond Strength	Met established specifications.	Results met established specifications.
Catheter Tip Pull Strength	Met established specifications.	Results met established specifications.
Catheter Torque Strength	Met established specifications.	Results met established specifications.
Simulated Use/Flexibility/Kink	Met established specifications.	Results met established specifications.
Radiopacity	Met established specifications.	Results met established specifications.
Angioplasty Balloon Fatigue (in Stent)	Met established specifications.	Results met established specifications.
Anchoring Balloon Fatigue (in Stent)	Met established specifications.	Results met established specifications.

2. Sample Size Used for the Test Set and the Data Provenance

The provided document does not specify a separate "test set" in the context of clinical data or patient samples. The study described is a series of in-vitro performance bench tests and biocompatibility tests. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) and sample size in terms of clinical cases is not applicable here. The samples for these tests would be physical devices or materials, not patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. The "ground truth" for the in-vitro and biocompatibility tests would be established through predefined scientific and engineering specifications, and validated laboratory methodologies, rather than human expert consensus on clinical findings.

4. Adjudication Method for the Test Set

Not applicable. As described above, the acceptance criteria are based on pre-defined specifications and validated laboratory testing, not human-reviewed clinical cases that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes laboratory (in-vitro) and biocompatibility testing, not clinical studies involving human readers or patient cases.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a physical medical device (balloon catheter), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on:

Established Scientific and Engineering Specifications: For the in-vitro performance bench testing, the device's performance characteristics (e.g., burst pressure, inflation/deflation time, fatigue) must meet predetermined quantitative and qualitative standards.
Regulatory Standards and Guidelines: For biocompatibility, the ground truth is defined by compliance with international standards such as ISO-10993 and FDA guidelines (e.g., Blue Book Memorandum May 1, 1995) which specify acceptable biological responses to the device materials.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set was used.

Summary

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SECTION 5.0: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

A. Submitter Information Submitter's Name: Address:

Telephone: Fax: Contact Person:

Date of Preparation:

B. Subject Device Trade Name: Common/Usual Name: Classification Name:

C. Predicate Device Name(s)

Primary Predicate:

Trade Name(s): Classification Name:

Secondary Predicate:

Trade Name(s): Classification Name: Ostial Corporation 510 Clyde Avenue Mountain View, CA 94043 650-903-9100 x 232 650-903-9119 Kaitlin von Hoffmann Clinical and Regulatory Associate April 17, 2012

Flash PTA Balloon Dilatation Catheter Balloon Catheter Catheter, Angioplasty, Peripheral, Transluminal (21 CFR 870.1250, Product Code LIT)

Sterling PTA Balloon Dilation Catheter, K053118 Catheter, Percutaneous (21 CFR 870.1250, Product Code DQY)

Flash PTA Balloon Dilatation Catheter, K120738 Catheter, Angioplasty, Peripheral, Transluminal (21 CFR 870.1250, Product Code LIT)

D. Device Description:

E. 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.

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

The purpose of this Traditional 510(k) is to seek an expanded indication for two of the Flash PTA Balloon Dilatation Catheter models cleared by 510(k) #K120738 on April 3, 2012.

In accordance with the current thinking of the FDA as reflected by The 510k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Draft Guidance dated December 27, 2011, Ostial Corporation is claiming two predicates for the subject device. The expanded indication for the

JUN 2 9 2012

K1211 15

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510(k) Notification: Flash PTA Balloon Dilatation Catheter

subject Flash PTA Balloon Dilatation Catheter is consistent with the overall intended use of the predicate devices, namely balloon dilatation within the peripheral vasculature.

The predicate Flash PTA Balloon Dilatation Catheter was cleared with an indication that is a subset of the proposed expanded indication. The expanded indication adds that the device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature. The predicate and subject Flash PTA Balloon Dilatation Catheters are the exact same device. No design modifications or changes to packaging, manufacturing or sterilization have been made since the clearance of the predicate Flash device.

Additionally, substantial equivalence was established between the first iteration of the Flash PTA Balloon Dilatation Catheter and the primary predicate Sterling PTA Balloon Dilatation Catheter via the original Traditional 510(k) for the device product line, #K102482 dated February 25, 2011. The Sterling PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, renal and carotid arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. With respect to the subject device, the Sterling catheter features an equivalent design, packaging, fundamental technology, manufacturing and sterilization. The scope of the subject device's indication for use is narrower than that of the Sterling catheter, and both are indicated for post-dilatation of balloon expandable stents.

The subject device and predicate devices are substantially equivalent in terms of intended use, fundamental scientific technology, target population, and operating principles.

G. 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 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 .
. 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 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 Burst Volume (in Stent) �
Angioplasty Balloon Fatigue .
Anchoring Balloon Fatigue ●
Catheter Bond Strength ●
Catheter Tip Pull Strength �
Catheter Torque Strength �
Simulated Use/Flexibility/Kink .
Radiopacity .
Angioplasty Balloon Fatigue (in Stent) ●
Anchoring Balloon Fatigue (in Stent)

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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.

H. Conclusions:

The Flash 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. The Flash PTA Balloon Dilatation Catheter is substantially equivalent to the legally marketed predicate devices and does not raise any new safety or effectiveness questions.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

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

JUN 2 9 2012

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

Re: K121175

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, DQY Dated: April 17, 2012 Received: April 18, 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. However, we remind you 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

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Page 2 – Ms. Kaitlin von Hoffmann

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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

M.G. Wilhelm

Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4.0: INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name:

، _،

K121175

Flash PTA Balloon Dilatation Catheter

Indication For Use:

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)

M.R. Hilleman

(Division Sign-Off) Division of Cardiovascular Devices

11-12-11-75 510(k) Number

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).