K Number

Device Name

NC Gallant PTCA Catheter

Manufacturer

MEDINOL LTD.

Date Cleared

2017-01-19

(141 days)

Product Code

LOX

Regulation Number

870.5100

Intended Use

The NC Gallant PTCA 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 NC Gallant is a sterile, single-use, intravascular medical device. The NC Gallant is a double lumen catheter comprising an expandable non-compliant (NC) coronary balloon on a rapid exchange (RX) catheter.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K110134, K121667

Reference Devices

K110134,K121667

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical medical device (a balloon catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on bench testing and biocompatibility, typical for a physical device, not on algorithmic performance metrics.

Therapeutic

Yes

The device is indicated for "Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion," which is a direct treatment of a medical condition.

Diagnostic

Explanation: The device is a PTCA (Percutaneous Transluminal Coronary Angioplasty) Catheter used for therapeutic purposes (balloon dilatation, stent expansion) and not for identifying or characterizing a disease or condition.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical, intravascular catheter with a balloon, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
Device Description and Intended Use: The NC Gallant PTCA Catheter is a device used inside the body (in vivo) to physically dilate a coronary artery or bypass graft. It's a mechanical device used for a therapeutic procedure, not for analyzing biological samples.

The information provided clearly describes a device used for a surgical/interventional procedure, not for laboratory testing of specimens.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The NC Gallant PTCA 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.

Product codes

LOX

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary artery or bypass graft

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The NC Gallant PTCA Catheter was subjected to testing 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.

Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, the NC Gallant may be considered substantially equivalent to the predicate devices.

The following in-vitro performance tests were completed on the NC Gallant PTCA Catheter:
Visual and Handling Performance
Dimensional Verification
Crossing Profile
Simulated Use
Kissing Balloon Technique (KBT)
Balloon Rated Burst Pressure
Balloon Fatigue (Repeat Balloon Inflations)
Balloon Diameter vs. Balloon Pressure (Compliance), Balloon Diameter at NIP, Balloon Diameter at RBP, Markers Positioning, Balloon Working Length
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 (Repeat Balloon Inflations; in Stent)
Catheter corrosion resistance
Packaging Integrity
Environmental & Shipping & Accelerated Shelf-Life

The following in-vitro performance tests were completed on the Gallant PTCA Catheter:
GLP Acute Performance Study of Novel NC PTCA Balloons in Porcine Model

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

NC Trek, Abbott (K110134), NC Quantum, Boston Scientific (K121667)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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

January 19, 2017

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

Re: K162434

Trade/Device Name: NC Gallant PTCA Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: December 12, 2016 Received: December 20, 2016

Dear 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 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,

Fernando Aguel-S
Fernando Aguel

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K162434

Device Name NC Gallant PTCA Catheter

Indications for Use (Describe)

The NC Gallant PTCA 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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	Medinol LTD's NC Gallant PTCA Catheter
Submitter's
Name and
Address	Medinol Ltd.
Kiryat Atidim, Building 8,
Tel Aviv 6158101,
Israel
Contact Name
and
Information	Michal Hershkovitz
VP Clinical and Regulatory Affairs
Phone: +972 3 7679000/ext.
Fax: +972 3 648 2310
michalh@medinol.com
Date Prepared	August 18 2016
Proprietary
Name(s)	NC Gallant PTCA Catheter
Common
Name	Catheters, transluminal coronary angioplasty, percutaneous
Product Code	LOX
Classification	Class II, 21 CFR Part 870.5100
Predicate
Devices	NC Trek, Abbott (K110134)
NC Quantum, Boston Scientific (K121667)
Device
Description	The NC Gallant is a sterile, single-use, intravascular medical device.
The NC Gallant is a double lumen catheter comprising an expandable
non-compliant (NC) coronary balloon on a rapid exchange (RX)
catheter.
Intended Use
of Device	The NC Gallant PTCA Catheter is indicated for the dilatation of
stenosis in coronary arteries or bypass grafts.
Indications for
Use	The NC Gallant PTCA 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.
Comparison of
Technological
Characteristics	The NC Gallant PTCA Catheter incorporates substantially equivalent
device design, fundamental technology, manufacturing processes,
sterilization and intended use as those featured in the Boston Scientific
predicate devices: NC Quantum, Boston Scientific (K121667) and NC
Trek, Abbott (K110134)
Performance
Data	The NC Gallant PTCA Catheter was subjected to testing 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.

Bench testing and biocompatibility testing were performed to support a
determination of substantial equivalence. The results of these tests
provide reasonable assurance that the proposed device has been
designed and tested to assure conformance to the requirements for its
intended use. No new safety or performance issues were raised during
the testing and, therefore, the NC Gallant may be considered
substantially equivalent to the predicate devices. |

Image /page/4/Picture/0 description: The image shows the Medinol logo. The logo consists of a blue and green abstract shape on the left, and the word "Medinol" in green on the right. Below "Medinol" is the phrase "Ingenuity for life" in a smaller font, also in green. The logo is clean and modern, with a focus on the company name and tagline.

Gallant PTCA Catheter:
Cytotoxicity	Sensitization
Intracutaneous Toxicity	Material Mediated Pyrogenicity
In Vitro Hemolysis	Partial Thromboplastin Time
In Vivo Thromboresistance	Bacterial Reverse Mutation
Mouse Lymphoma Assay	Mouse Peripheral Blood
	Micronucleus Study
C3a Complement Activation
Assay	SC5b-9 Complement Activation
Assay
The following in-vitro performance tests were completed on the
NC Gallant PTCA Catheter:
Visual and Handling Performance	Dimensional Verification
Crossing Profile	Simulated Use
Kissing Balloon Technique (KBT)	Balloon Rated Burst Pressure
Balloon Fatigue (Repeat Balloon
Inflations)	Balloon Diameter vs. Balloon
Pressure (Compliance), Balloon
Diameter at NIP, Balloon
Diameter at RBP, Markers
Positioning, Balloon Working
Length
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 (Repeat Balloon
Inflations; in Stent)	Catheter corrosion resistance
Packaging Integrity	Environmental & Shipping &
Accelerated Shelf-Life
The following in-vitro performance tests were completed on the
Gallant PTCA Catheter:
GLP Acute Performance Study of Novel NC PTCA Balloons in
Porcine Model

Based on the indications for use, technological characteristics, safety Conclusion and performance testing, the NC Gallant PTCA Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the predicate device.