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 Description

The proposed Flash PTA Balloon Dilatation Catheter is designed for dilation of aorto-ostial lesions of peripheral vessels in the arterial system. The Flash PTA Balloon Dilatation Catheter is a .014" guidewirecompatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The Flash PTA Balloon Dilatation Catheter uses a dual balloon design that features a compliant anchoring balloon that 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the Flash PTA Balloon Dilatation Catheter, structured according to your request:

Acceptance Criteria and Study for Flash PTA Balloon Dilatation Catheter

The provided document describes the Flash PTA Balloon Dilatation Catheter, a device for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature. The information details the device's characteristics, intended use, and performance data used to establish substantial equivalence to a predicate device (Sterling PTA Balloon Dilation Catheter).

However, it's crucial to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone clinical trial with pre-defined acceptance criteria for a novel device. Therefore, some of the requested information, particularly regarding specific performance metrics with numerical acceptance criteria and a detailed clinical study with human readers, is not explicitly present in this type of submission.

The "acceptance criteria" discussed in the document refer to the successful completion of various biocompatibility tests and in-vitro bench tests to ensure the materials and design meet established specifications and perform comparably to the predicate device. The conclusion states: "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." This implies that the device successfully passed these tests, but specific numerical thresholds are not provided in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, specific numerical acceptance criteria for performance metrics (e.g., target accuracy, sensitivity, specificity) for a diagnostic or AI-driven device are not applicable here. Instead, the document lists various tests that were successfully completed. The "reported device performance" is essentially that the device passed these tests and was found to be "substantially equivalent" to the predicate.

Category	Acceptance Criteria (Implied by successful completion)	Reported Device Performance
Biocompatibility	Materials are non-toxic and non-sensitizing per ISO-10993 standards and specific assays (MEM Elution, Hemolysis, Complement Activation, Thromboresistance, Pyrogen, Sensitization, Systemic Injection, Intracutaneous Reactivity, LAL Chromogenic).	All specified biocompatibility tests were completed and results show materials are non-toxic and non-sensitizing, consistent with intended use.
In-vitro Bench Testing	Device characteristics (e.g., Crossing Profile, Shaft Diameter, Burst Pressure, Compliance, Inflation/Deflation Time, Fatigue, Bond Strength, Tip Pull, Torque, Flexibility/Kink, Radiopacity) meet established specifications and compare favorably to predicate.	All specified in-vitro performance bench tests confirmed performance characteristics as compared to the predicate device.
In-vivo Testing	Device performs as intended in a simulated angioplasty procedure, with no adverse downstream or cognitive effects post-procedure.	In-vivo testing in a swine model demonstrated successful simulated angioplasty and no adverse effects during observation.

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

Test Set Sample Size:
- In-vitro Bench Testing: Not specified for each individual test. The document states "The proposed Flash PTA Balloon Dilatation Catheter was evaluated using the following in-vitro performance bench testing," implying multiple units were tested for each characteristic.
- In-vivo Testing: "a swine model" was used. The specific number of animals is not provided.
Data Provenance:
- Biocompatibility & In-vitro Bench Testing: Likely performed in a controlled laboratory setting (manufacturer's or contract lab). No specific country of origin is mentioned.
- In-vivo Testing: Animal model (swine). No specific country of origin is mentioned.
Retrospective or Prospective: These tests are inherently prospective as they are specifically conducted to evaluate the device.

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

This device is not an AI/diagnostic device that requires expert-established ground truth in the same way. The "ground truth" for its performance is derived from objective physical measurements, chemical analyses, and biological responses (e.g., burst pressure, material reactions, animal physiological responses).
Expert involvement would primarily be in designing and interpreting the technical and biological tests, likely by engineers, material scientists, and toxicologists, rather than clinicians establishing a diagnostic ground truth. The document does not specify the number or qualifications of these technical experts.

4. Adjudication Method for the Test Set

Not applicable in the context of this type of device and testing. Adjudication methods like 2+1 or 3+1 are typically used for clinical endpoints or diagnostic interpretations, not for bench or animal testing. The "adjudication" here would be the successful completion of the pre-defined test protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance

No. This is a balloon dilatation catheter, a physical medical device for interventional procedures, not an AI-assisted diagnostic tool. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant and were not conducted.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

As mentioned in point 3, the "ground truth" for this device's performance is based on:
- Objective Technical Measurements: Such as precise measurements of catheter shaft diameter, balloon dimensions, inflation/deflation times, pressure endurance (rated burst pressure), and material strengths (bond, tip pull, torque).
- Standardized Biological Assays: Following ISO 10993 for biocompatibility, detecting specific biological reactions (hemolysis, complement activation, pyrogenicity, sensitization).
- In-vivo Physiological Responses: Observing the physical effects and downstream/cognitive impacts in a live animal model during and after a simulated angioplasty procedure.
- The term "ground truth" as typically used for AI/diagnostic devices (e.g., pathology, clinical outcomes) doesn't directly apply here.

8. The Sample Size for the Training Set

Not applicable. This submission describes a physical medical device, not an AI or machine learning model that requires a training set. The "training" for this device involved design and engineering development, not data-driven algorithm training.

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

Not applicable. As explained above, there is no "training set" in the context of an AI/ML model for this device.

Summary

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

K102482

CONFIDENTIAL

A. Submitter Information
Submitter's Name:	Ostial Corporation
Address:	510 Clyde AvenueMountain View, CA 94043
Telephone:	650-903-9100
Fax:	650-903-9119
Contact Person:	Eric AnkerudExecutive Vice President Clinical, Regulatory, Quality
Date of Preparation:	August 25, 2010
B. Subject Device
Trade Name:	Flash PTA Balloon Dilatation Catheter
Common/Usual Name:	Balloon Catheter

Classification Name:

Catheter, Angioplasty, Peripheral, Transluminal (21 CFR 870.1250, Product Code LIT)

C. Predicate Device Name(s)

Trade Name(s): Classification Name:

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

D. Device Description:

E. Intended Use:

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

The proposed Flash PTA Balloon Dilatation Catheter and the predicate Sterling PTA Balloon Dilation Catheter have the same intended use. Both are indicated for treatment of obstructive lesions by high pressure dilation in the arterial system. The indication statement for the Flash PTA Balloon Dilatation Catheter is a subset of the broader indication statement of the Sterling PTA Balloon Dilation Catheter.

The proposed Flash PTA Balloon Dilatation Catheter and the Sterling PTA Balloon Dilation Catheter contain an inflatable semi-compliant balloon for dilation of obstructive lesions. The proposed Flash PTA Balloon Dilatation Catheter includes a second compliant balloon for locating and anchoring the device at ostial vessel locations.

The usable length of the proposed Flash PTA Balloon Dilatation Catheter is 135 cm which is the same usable length as the predicate Sterling Balloon Dilation Catheter. Both the proposed and predicate devices are offered in 5mm and 6mm balloon diameter sizes and approximately 20mm balloon lengths.

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

G. Performance Data:

Biocompatibility testing on the proposed Flash PTA Balloon Dilatation Catheter has been completed. 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
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 proposed 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 �
Balloon Rated Burst Pressure (Angioplasty) .
Balloon Burst Volume (Anchoring) .
. Angioplasty Balloon Compliance
. Balloon Inflation Time
Balloon Deflation Time .
Angioplasty Balloon Fatigue .
Anchoring Balloon Fatigue .
Catheter Bond Strength .
Catheter Tip Pull Strength .
. Catheter Torque Strength
Simulated Use/Flexibility/Kink .
Radiopacity .

In-vivo testing was completed using a swine model. A simulated angioplasty procedure was performed on test and control comparator groups. Post procedure animals were survived and observed for a predetermined period to assess for downstream and cognitive effects.

All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized 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 device and does not raise any new safety or effectiveness questions.

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

FEB 2 5 2511

Ostial Corporation c/o Mr. Mark Smutka Clinical, Regulatory, and Quality Consultant 510 Clyde Avenue Mountain View, CA 94043

Re: K102482

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: February 15, 2011 Received: February 16, 2011

Dear Mr. Smutka:

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 idence) on 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 Amendmonts, 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 lightlity 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.

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Page 2 - Mr. Mark Smutka

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

Sincerely yours,

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:

K102482.

Device Name:

Indication For Use:

Flash PTA Balloon Dilatation Catheter

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)

Division Sign-Off

Division of Cardiovascular Devices
510(k) Number K102482

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).