The Flash-C PTCA 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-C PTCA 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 semi-compliant higherpressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Flash-C PTCA Balloon Dilatation Catheter" and does not contain information about a study proving the device meets acceptance criteria.

The document details the device's intended use, its substantial equivalence to predicate devices, and the performance data refers to a list of in-vitro bench testing and biocompatibility testing. These tests are used to confirm the performance characteristics as compared to the predicate device and meet established specifications, rather than proving achievement of specific clinical acceptance criteria in a study.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted from the provided text, as this type of clinical study was not described.

Here's a breakdown of what can be extracted or inferred based on the context of a 510(k) submission for this type of device:

1. Table of acceptance criteria and the reported device performance:

The document broadly states: "All test results demonstrate that the device materials, the manufacturing process, and the design for the Flash-C PTCA Balloon Dilatation Catheter met the established specifications necessary for consistent performance according to its intended use." And "The Flash-C PTCA Balloon Dilatation Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, test protocols, and/or customer inputs."

However, specific quantitative acceptance criteria and their corresponding reported device performance values are NOT provided in the text. The document only lists the types of tests performed.

Acceptance Criterion (Test Type)	Reported Device Performance
Biocompatibility Testing:	"Non-toxic and non-sensitizing to biological tissues consistent with its intended use." (Specific quantitative results not provided)
ISO MEM Elution Assay	Met established specifications
ASTM Hemolysis Assay	Met established specifications
Complement Activation C3a and SC5b-9 Assay	Met established specifications
Thromboresistance Evaluation	Met established specifications
Materials Mediated Rabbit Pyrogen	Met established specifications
ISO Guinea Pig Maximization Sensitization	Met established specifications
ISO Acute Systemic Injection Test	Met established specifications
ISO Intracutaneous Reactivity Test	Met established specifications
Pyrogen (LAL) Chromogenic	Met established specifications
In-vitro Performance Bench Testing:	"Confirmed the performance characteristics as compared to the predicate device." (Specific quantitative results not provided)
Balloon Crossing Profile	Met established specifications
Catheter Shaft Diameter	Met established specifications
Catheter Working Length	Met established specifications
Catheter Inner Diameter	Met established specifications
Angioplasty Balloon Rated Burst Pressure	Met established specifications
Anchoring Balloon Burst Volume	Met established specifications
Angioplasty Balloon Compliance	Met established specifications
Balloon Inflation Time	Met established specifications
Balloon Deflation Time	Met established specifications
Angioplasty Balloon Rated Burst Pressure (in Stent)	Met established specifications
Anchoring Balloon Burst Volume (in Stent)	Met established specifications
Angioplasty Balloon Fatigue	Met established specifications
Anchoring Balloon Fatigue	Met established specifications
Catheter Bond Strength	Met established specifications
Catheter Tip Pull Strength	Met established specifications
Catheter Torque Strength	Met established specifications
Simulated Use	Met established specifications
Flexibility and Kink Resistance	Met established specifications
Radiopacity	Met established specifications
Angioplasty Balloon Fatigue (in Stent)	Met established specifications
Anchoring Balloon Fatigue (in Stent)	Met established specifications

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for any of the in-vitro or biocompatibility tests.
Data Provenance: Not specified. These are laboratory bench tests and in-vitro biocompatibility tests, not clinical data from patients.

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

This information is not applicable as the "test set" described consists of in-vitro and biocompatibility testing, not human-read clinical data requiring expert ground truth establishment.

4. Adjudication method for the test set:

Not applicable for the described in-vitro and biocompatibility testing.

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 MRMC study was done. This device is a PTCA Balloon Dilatation Catheter (a physical medical device, not an AI or imaging diagnostic tool). The provided text does not mention any AI component or human reader interpretation studies.

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

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

7. The type of ground truth used:

Not applicable in the sense of expert consensus, pathology, or outcomes data for clinical performance. The 'ground truth' for the in-vitro and biocompatibility tests would be the established engineering specifications and biological safety standards, respectively.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable.

Summary

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Ostial Corporation 5 10(k) Notification: Flash-C PTCA Balloon Dilatation Catheter

OCT 1 1

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

A. Submitter Information
Submitter's Name: Address:

Telephone: Fax: Contact Person:

Date of Preparation:

B. Subject Device

Trade Name: Common/Usual Name: Classification Name:

Ostial Corporation 510 Clyde Avenue Mountain View, CA 94043 650-903-9100 x 232 650-903-0119 Kaitlin von Hoffmann Clinical and Regulatory Associate July 20, 2012

Flash-C PTCA Balloon Dilatation Catheter Balloon Catheter Catheters, Transluminal Coronary Angioplasty, Percutaneous (21 CFR 870.5100, Product Code LOX)

K122178 Pa

C. Predicate Device Name(s)

Primary Predicate: Trade Name(s):

Classification Name:

Secondary Predicate:

Classification Name:

Maverick XL Monorail PTCA Dilatation Catheter, P860019/S183 Catheters, Transluminal Coronary Angioplasty, Percutaneous (21 CFR 870.5100, Product Code LOX)

Flash-C PTCA Balloon Dilatation Catheter, K113775 Catheters, Transluminal Coronary Angioplasty, Percutaneous (21 CFR 870.5100, Product Code LOX)

D. Device Description:

Trade Name(s):

The Flash-C PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The Flash-C PTCA Balloon Dilatation Catheter is also indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature. The Flash-C PTCA 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-C PTCA 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 semi-compliant higherpressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.

E. Intended Use:

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Ostial Corporation
510(k) Notification: Flash-C PTCA Balloon Dilatation Catheter

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 six of the Flash-C PTCA Balloon Dilatation Catheter models cleared by 510(k) #K113775 on June 29, 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 subject Flash-C PTCA Balloon Dilatation Catheter is consistent with the overall intended use of the predicate devices, namely balloon dilatation of a coronary artery, bypass graft or stent.

Substantial equivalence was established between the first iteration of the Flash-C PTCA Balloon Dilatation Catheter and the primary predicate Maverick XL Monorail PTCA Balloon Dilatation Catheter via the original Traditional 510(k) for the device product line, #K111284 cleared on August 17, 2011. The expanded indications for use for the Flash-C PTCA Balloon Dilatation Catheter is identical to the Maverick XL Monorail PTCA Balloon Dilatation Catheter. The Maverick XL device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The Maverick XL balloon catheter is also indicated for the post delivery expansion of balloon expandable stents. With respect to the subject device, the Maverick catheter features equivalent indications for use, design, packaging, fundamental technology, manufacturing and sterilization.

The secondary predicate Flash-C PTCA Balloon Dilatation Catheter was cleared with an indication that is a subset of the proposed expanded indications for use are being modified to add an indication for the post delivery expansion of balloon expandable stents within the coronary vasculature. The predicate and subject Flash-C PTCA Balloon Dilatation Catheters are the same device. No design modifications or changes to packaging, manufacturing or sterilization have been made since the clearance of the predicate Flash-C device.

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-C PTCA 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
Complement Activation C3a and SC5b-9 Assay
Thromboresistance Evaluation
Materials Mediated Rabbit Pyrogen
ISO Guinea Pig Maximization Sensitization

K122178 Page 2 of 3

ISO Acute Systemic Injection Test
ISO Intracutaneous Reactivity Test
Pyrogen (LAL) Chromogenic

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Ostial Corporation 510(k) Notification: Flash-C PTCA Balloon Dilatation Catheter

The Flash-C PTCA 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
Catheter Working Length .
Catheter Inner Diameter .
Angioplasty Balloon Rated Burst Pressure .
Anchoring Balloon Burst Volume t
. 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 and Kink Resistance
Radiopacity
Angioplasty Balloon Fatigue (in Stent)
Anchoring Balloon Fatigue (in Stent)

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

H. Conclusions:

The Flash-C PTCA 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-C PTCA 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

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

OCT 1 2012

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

Re: K122178

Trade/Device Name: Flash-C PTCA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Standard Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: July 20, 2012 Received: July 23, 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.

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

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Page 2 - Ms. von Hoffman

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

Sincerely yours.

.g. billah

Bram 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 S 10(k) Notification: Flash-C PTCA Balloon Dilatation Catheter

SECTION 4.0: INDICATIONS FOR USE STATEMENT

K122178

510(k) Number:

Flash-C PTCA Balloon Dilatation Catheter

Indication For Use:

Device Name:

The Flash-C PTCA Balloon Dilatation Catheter is indicated for balloon The I last Of TOT Banconting of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The Flash-C PTCA Balloon Dilatation Catheter is also indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature.

X Prescription Use (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)

MAST

(Division Sign-Off) Division of Cardiovascular Devices

122178 510(k) Number_

Regulation Number and Section

§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.

(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.