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.

Device Description

The Flash-C PTCA 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 medical device, the Flash-C PTCA Balloon Dilatation Catheter, and its performance evaluation for a 510(k) submission. However, it does not include information about AI/ML device performance, acceptance criteria, or a study comparing its performance against predefined criteria using metrics like accuracy, sensitivity, or specificity. The document focuses on regulatory approval based on substantial equivalence to existing devices and standard medical device performance testing, such as biocompatibility and bench testing.

Therefore, many of the requested sections about AI/ML performance, sample sizes for test/training sets, expert adjudication, or MRMC studies cannot be answered from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

The document lists various performance bench tests and in-vivo testing, but it does not explicitly state acceptance criteria (e.g., "Balloon Burst Pressure must be > X psi"). It only states that the device "meet the established specifications necessary for consistent performance" and "meets all predetermined design verification and validation acceptance criteria." Without the specific criteria, a comparative table cannot be created.

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

Test Set Sample Size:
- In-vitro Bench Testing: Not specified. Standard tests would involve multiple units, but the exact number isn't mentioned.
- In-vivo Testing: "A swine model" was used. The number of animals in the test and control groups is not specified.
Data Provenance: Not specified, but a swine model implies animal testing, likely in a controlled laboratory environment. The location of the testing is not mentioned.
Retrospective/Prospective: The in-vivo study would be prospective in nature, as it involved performing a procedure and observing animals post-procedure.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable and not provided. The ground truth for the device's performance is established through direct physical/biological measurements and observations in the bench and in-vivo tests, not by expert interpretation as would be the case for an AI/ML diagnostic device.

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

This is not applicable and not provided, as the tests performed are not based on subjective interpretation requiring adjudication.

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:

Not applicable. This device is a physical medical device (catheter), not an AI/ML-driven diagnostic tool that assists human readers.

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.

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

For Biocompatibility: Laboratory test results based on established ISO and ASTM standards (e.g., MEM Elution Assay results, Hemolysis Assay results).
For In-vitro Bench Testing: Direct physical measurements against established engineering specifications (e.g., precise measurements of balloon crossing profile, rated burst pressure tests until failure).
For In-vivo Testing: Physiological and clinical observations in the swine model post-procedure (e.g., assessment for downstream and cognitive effects).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

Not applicable, as there is no training set.

Summary

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SECTION 5: 510(k) SUMMARY

A. Submitter Information
Submitter's Name: Address:

Telephone: Fax: Email: 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 650-903-9119 kvonhoffmann(@ostialcorp.com Kaitlin von Hoffmann December 19, 2011

Flash-C PTCA Balloon Dilatation Catheter PTCA Catheter Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX per 21 C.F.R. 870.5100

Product Code:

C. Device Description:

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 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:

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.

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

The Flash-C PTCA 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) #K 11284 on August 19, 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:

Biocompatibility testing was completed and submitted as part of the Flash PTA 510(k) #K102482. The Flash-C PTCA Balloon Dilatation Catheter (#K111284) is identical in design, materials, and manufacturing to the Ostial Corporation's Flash PTA Balloon Dilatation Catheter, cleared by the FDA in 510(k) #K102482 on February 25, 2011. Since no changes have been

JUN 2 9 2012

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

K113775
p. 20fa

implemented which would affect the biocompatibility of the device, these results are applicable to the subject device.

Requirements for biological evaluation of the device were based on 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 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	• Materials Mediated Pyrogen
• ASTM Hemolysis Assay	• ISO Guinea Pig Maximization
• Complement Activation C3a and SC5b-9Assay	Sensitization
• Thromboresistance Evaluation	• ISO Acute Systemic Toxicity
	• ISO Intracutaneous Reactivity

.
Pyrogen (LAL) Chromogenic

The Flash device was evaluated using the following in-vitro performance bench testing to confirm the performance characteristics:

. 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
g Catheter Torque Strength
. Simulated Use/Flexibility/Kink

In-vivo testing was completed on the previously cleared Flash device using a swine model. A simulated angioplasty procedure was performed on test and control groups (the control group used the Sterling PTA Balloon Dilatation Catheter). 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, manufacturing process, and design of the Flash-C PTCA Balloon Dilatation Catheter meet the established specifications necessary for consistent performance according to its intended use.

G. Conclusions:

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 purpose of this 510(k) is to request clearance for an extension of the Flash-C PTCA Balloon · Dilatation Catheter product line, which was initially cleared via 510(k) K111284 on August 19, 2011. All test results demonstrate that the Flash-C PTCA Balloon Dilatation Catheter meets all predetermined design verification and validation acceptance criteria.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

JUN 2 9 2012

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

Re: K113775

Trade/Device Name: Flash-C PTCA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Catheters, Transluminal Coronary Angioplasty, Percutaneous Regulatory Class: Class II Product Code: LOX Dated: June 1, 2012 Received: June 4, 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

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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Page 2 - Ms. Kaitlin von Hoffman

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 (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,

M. G. Hillen

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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Ostial Corporation

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

SECTION 4:

510(k) Number:	K113775
Device Name:	Flash-C PTCA Balloon Dilatation Catheter
Indication For Use:	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.

Prescription Use ਮ (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.A. Hillebran

(Division Sign-Off) Division of Cardiovascular Devices

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.