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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Flash PTA Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to a previously cleared device (K102482) and reports on bench testing for product line extensions.

The document does not contain information on acceptance criteria or a study proving the device meets those criteria in a clinical setting. The performance data section exclusively mentions "Bench testing."

Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or directly stated based on the given document:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Inferred/Generic)	Reported Device Performance
Balloon crossing profile met specifications	Bench testing performed; all test results demonstrate meeting "established specifications necessary for consistent performance."
Catheter shaft diameter met specifications	Bench testing performed; all test results demonstrate meeting "established specifications necessary for consistent performance."
Angioplasty balloon rated burst pressure and maximum burst pressure met specifications	Bench testing performed; all test results demonstrate meeting "established specifications necessary for consistent performance."
Anchoring balloon rated burst volume met specifications	Bench testing performed; all test results demonstrate meeting "established specifications necessary for consistent performance."
Balloon compliance and diameter met specifications	Bench testing performed; all test results demonstrate meeting "established specifications necessary for consistent performance."
Balloon inflation and deflation time met specifications	Bench testing performed; all test results demonstrate meeting "established specifications necessary for consistent performance."
Angioplasty balloon fatigue met specifications	Bench testing performed; all test results demonstrate meeting "established specifications necessary for consistent performance."
Anchoring balloon fatigue met specifications	Bench testing performed; all test results demonstrate meeting "established specifications necessary for consistent performance."
Catheter bond and tip pull strength met specifications	Bench testing performed; all test results demonstrate meeting "established specifications necessary for consistent performance."
Catheter torque strength, flexibility and kink met specifications	Bench testing performed; all test results demonstrate meeting "established specifications necessary for consistent performance."
Simulated use met specifications	Bench testing performed; all test results demonstrate meeting "established specifications necessary for consistent performance."
Radiopacity met specifications	Bench testing performed; all test results demonstrate meeting "established specifications necessary for consistent performance."

Explanation: The document states, "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." This indicates that for each bench test listed, there were pre-defined acceptance criteria (specifications) that the device successfully met. However, the exact numerical or qualitative specifications themselves are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample size: Not specified. The document only mentions "Bench testing performed."
Data provenance: Not specified. This was bench testing, not human or animal study data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This document describes bench testing of a physical medical device, not a diagnostic algorithm that requires expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This document describes bench testing of a physical medical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This document is for a physical balloon catheter, not an AI or diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No. This document is for a physical balloon catheter.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable. For physical device bench testing, "ground truth" refers to the established engineering specifications and physical measurements.

8. The sample size for the training set:

Not applicable. There is no mention of a training set as this is not an algorithm being developed.

9. How the ground truth for the training set was established:

Not applicable. There is no mention of a training set.

Summary

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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 kvonhoffmann@ostialcorp.com 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:

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 (800) 638-2041 or (301) 796-7100 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:

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

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).