The Gallant PTCA Dilatation Catheter is indicated for:
• Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion;
• Post-deployment stent expansion.

Device Description

The Gallant is a sterile, single-use, intravascular medical device. The Gallant is a combination of single lumen and dual lumen catheter comprising an expandable semi-compliant (SC) coronary balloon on a rapid exchange (RX) catheter.

AI/ML Overview

The provided text is a 510(k) summary for the Gallant PTCA Dilatation Catheter. It outlines the device's indications for use, its comparison to a predicate device, and the performance data used to demonstrate substantial equivalence. However, it does not contain the detailed acceptance criteria or the specific results of a study as typically required for AI/ML device evaluations.

Instead, this document describes a traditional medical device (a PTCA dilatation catheter) and the engineering and biocompatibility tests performed on it. The performance data section lists various types of tests conducted:

Bench Testing: Includes visual and handling performance, dimensional verification, crossing profile, simulated use, kissing balloon technique (KBT), balloon rated burst pressure, balloon fatigue, various balloon diameter and length measurements, non-uniformity markers positioning, catheter bond strength, tip pull test, flexibility and kink resistance, torque strength, catheter radiopacity, particulate evaluation, coating integrity, balloon rated burst pressure (in stent), balloon fatigue (in stent), catheter corrosion resistance, packaging integrity, and environmental & shipping & accelerated shelf-life.
Biocompatibility Testing: Cytotoxicity, sensitization, intracutaneous toxicity, material mediated pyrogenicity, in vitro hemolysis, SC5b-9 complement activation assay.
Chemical Characterization: Performed.
Pre-clinical Studies: A GLP Acute Performance Study of Novel Gallant PTCA Balloons in a Porcine Model.

The document states that these tests were performed "according to the requirements of Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010." It concludes that "No new safety or performance issues were raised during the testing and, therefore, the Gallant may be considered substantially equivalent to the predicate device."

Based on the provided text, I cannot complete most of the requested fields because they relate to the evaluation of AI/ML-based devices and clinical performance studies with specific statistical outcomes, which are not present in this 510(k) summary for a catheter.

Here's an attempt to answer what can be extracted or inferred, and explicitly state what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or detailed numerical performance results for the various tests. It only lists the types of tests performed. The acceptance criteria would be defined by the "Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010" and Medinol's internal specifications, but these are not enumerated in the summary. The "reported device performance" is summarized qualitatively as "No new safety or performance issues were raised during the testing."

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

Test Set Sample Size: Not specified in the document. For bench and biocompatibility tests, sample sizes would vary per test type (e.g., number of catheters, number of test articles). For the porcine model, the number of animals or procedures is not stated.
Data Provenance: The preclinical "GLP Acute Performance Study... in a Porcine Model" implies animal data. Bench testing and biocompatibility testing are laboratory-based. The country of origin for the studies is not explicitly stated, but the submitter's address is Israel.

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

Not applicable, as this is not an AI/ML device with ground truth established by human experts for image or data interpretation. The "ground truth" for the performance of a PTCA catheter would be the physical properties and functional performance against engineering standards.

4. Adjudication method for the test set

Not applicable. This concept pertains to resolving discrepancies in expert opinions for AI/ML ground truth, which is not relevant here.

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 is not an AI/ML device that assists human readers.

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

The "ground truth" for this device's performance is based on engineering specifications and biological safety standards. This includes:

Physical measurements and properties (e.g., balloon diameter, burst pressure, tensile strength).
Functional performance in simulated use models (e.g., crossing profile, kink resistance).
Biological responses (biocompatibility tests).
Acute physiological response in an animal model (porcine study).

8. The sample size for the training set

Not applicable, as this is not an AI/ML device that requires a training set.

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

Not applicable, as this is not an AI/ML device that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 25, 2018

Medinol, Ltd. % H. Semih Oktay President CardioMed Device Consultants 5523 Research Park Drive Suite 205 Baltimore, Maryland 21228

Re: K173581

Trade/Device Name: Gallant PTCA Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: November 16, 2017 Received: November 20, 2017

Dear H. Semih Oktay:

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Kenneth J. Cavanaugh -S

for

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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Indications for Use

510(k) Number (if known) K173581

Device Name Gallant PTCA Dilatation Catheter

Indications for Use (Describe)

The Gallant PTCA Dilatation Catheter is indicated for:

· Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion;

· Post-deployment stent expansion.

Type of Use (Select one or both, as applicable):

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the Medinol logo. On the left is a blue and green abstract shape. To the right of the shape is the word "Medinol" in green, with the words "Ingenuity for life" in a smaller font below it.

510(k) SUMMARY -- K173581 Medinol LTD's Gallant PTCA Catheter

Submitter'sName andAddress	Medinol Ltd.Kiryat Atidim, Building 8,Tel Aviv 6158101,Israel
Contact NameandInformation	Marina Tikhonov DemishteinVP Regulatory AffairsPhone: +972 3 7679000Fax: +972 3 648 2310marinat@medinol.com
Date Prepared	November 16 2017
ProprietaryName(s)	Gallant PTCA Dilatation Catheter
CommonName	Catheters, transluminal coronary angioplasty, percutaneous
Product Code	LOX
Classification	Class II, 21 CFR Part 870.5100
PredicateDevices	NC Gallant PTCA Dilatation Catheter (K162434)
ReferenceDevices	Trek & Mini-Trek, Abbott (K103110)
DeviceDescription	The Gallant is a sterile, single-use, intravascular medical device. TheGallant is a combination of single lumen and dual lumen cathetercomprising an expandable semi-compliant (SC) coronary balloon ona rapid exchange (RX) catheter.
Intended Useof Device	The Gallant PTCA Dilatation Catheter is intended for the dilatationof stenosis in coronary arteries or bypass grafts.
Indications forUse	The Gallant PTCA Dilatation Catheter is indicated for:• Balloon dilatation of the stenotic portion of a coronary artery orbypass graft stenosis for the purpose of improving myocardialperfusion;• Post-deployment stent expansion.
Comparison ofTechnologicalCharacteristics	The Gallant PTCA Dilatation Catheter incorporates substantiallyequivalent device design, fundamental technology, manufacturingprocesses, sterilization and intended use as those featured in thepredicate device: NC Gallant PTCA Dilatation Catheter (K162434).Minor differences identified between the Gallant and it's predicatedevice were evaluated in the frame of performance testing asdescribed below.

Medinol	Kiryat Atidim, Building 8, POB 58165 Tel Aviv 6158101, Israel	Main: +972-3-767-9000Fax: +972-3-648-2310
Ltd.	Beck Tech Building, 8 Hartom St., POB 45026 Jerusalem 9777508, Israel	Main: +972-2-541-7777Fax: +972-2-541-7764

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Image /page/4/Picture/0 description: The image shows the logo for Medinol. The logo consists of a blue and green abstract shape on the left, resembling a heart or a Mobius strip. To the right of the shape is the word "Medinol" in green, with the tagline "Ingenuity for life" in a smaller font below it, also in green.

PerformanceData	The Gallant PTCA Dilatation Catheter was subjected to testingaccording to the requirements of Guidance for Industry and FDA Staff– Class II Special Controls for Certain Percutaneous TransluminalCoronary Angioplasty (PTCA) Catheters, September 8, 2010.Bench testing, pre-clinical studies, biocompatibility testing andchemical characterization testing were performed to support adetermination of substantial equivalence. The results of these testsprovide reasonable assurance that the proposed device has beendesigned and tested to assure conformance to the requirements for itsintended use. No new safety or performance issues were raised duringthe testing and, therefore, the Gallant may be considered substantiallyequivalent to the predicate device.
	The following biocompatibility tests were completed on the GallantPTCA Dilatation Catheter:
	Cytotoxicity	Sensitization
	Intracutaneous Toxicity	Material Mediated Pyrogenicity
	In Vitro Hemolysis	SC5b-9 Complement Activation
		Assay
	Chemical Characterization
	The following in-vitro performance tests were completed on theGallant PTCA Catheter:
	Visual and HandlingPerformance	Dimensional Verification
	Crossing Profile	Simulated Use
	Kissing Balloon Technique(KBT)	Balloon Rated Burst Pressure
	Balloon Fatigue (Repeat BalloonInflations)	Balloon Diameter vs. BalloonPressure (Compliance), BalloonDiameter at NIP, BalloonDiameter at RBP, BalloonWorking Length, Balloon Non-uniformity Markers Positioning,
	Catheter Bond Strength	Tip Pull Test
	Flexibility and Kink Resistance	Torque Strength
	Catheter Radiopacity	Particulate Evaluation
	Coating Integrity	Balloon Rated Burst Pressure (inStent)
	Balloon Fatigue (Repeat BalloonInflations; in Stent)	Catheter corrosion resistance
	Packaging Integrity	Environmental & Shipping &Accelerated Shelf-Life

MedinolLtd.	Kiryat Atidim, Building 8, POB 58165 Tel Aviv 6158101, IsraelBeck Tech Building, 8 Hartom St., POB 45026 Jerusalem 9777508, Israel	Main: +972-3-767-9000Fax: +972-3-648-2310Main: +972-2-541-7777Fax: +972-2-541-7764
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Image /page/5/Picture/0 description: The image shows the logo for Medinol. The logo features a stylized heart shape in blue and green on the left. To the right of the heart is the company name "Medinol" in green, with the tagline "Ingenuity for life" in a smaller green font below it.

	The following in-vitro performance tests were completed on theGallant PTCA Catheter:
	GLP Acute Performance Study of Novel Gallant PTCA Balloons in aPorcine Model
Conclusion	Based on the indications for use, technological characteristics, safetyand performance testing, the Gallant PTCA Dilatation Catheter hasbeen shown to be appropriate for its intended use and is considered tobe substantially equivalent to the predicate device.

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.