Gallant PTCA Dilatation Catheter

K173581 · Medinol, Ltd. · LOX · Jan 25, 2018 · Cardiovascular

Device Facts

• Record ID: K173581
• Device Name: Gallant PTCA Dilatation Catheter
• Applicant: Medinol, Ltd.
• Product Code: LOX · Cardiovascular
• Decision Date: Jan 25, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gallant PTCA Dilatation Catheter is intended for the dilatation of stenosis in coronary arteries or bypass grafts.

Device Story

Sterile, single-use, intravascular PTCA dilatation catheter; features semi-compliant coronary balloon on rapid exchange (RX) catheter; used by interventional cardiologists in clinical settings for percutaneous transluminal coronary angioplasty; device inserted into coronary vasculature to dilate stenotic segments or expand stents; inflation of balloon restores vessel patency and improves myocardial perfusion; benefits patient by relieving coronary obstruction.

Clinical Evidence

Bench testing only. Included biocompatibility (cytotoxicity, sensitization, intracutaneous toxicity, pyrogenicity, hemolysis, complement activation), chemical characterization, and extensive in-vitro performance testing (crossing profile, simulated use, KBT, burst pressure, fatigue, bond strength, flexibility, kink resistance, torque, radiopacity, coating integrity, corrosion, packaging/shelf-life). Also included GLP acute performance study in a porcine model.

Technological Characteristics

Single/dual lumen rapid exchange (RX) catheter with semi-compliant balloon. Materials and design equivalent to predicate. Sterilization method not specified. No software or electronic components.

Indications for Use

Indicated for balloon dilatation of stenotic coronary artery or bypass graft lesions to improve myocardial perfusion and for post-deployment stent expansion.

Regulatory Classification

Identification

Standard PTCA Catheter: 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. Cutting/scoring PTCA Catheter: 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.

Special Controls

*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.

Predicate Devices

• NC Gallant PTCA Dilatation Catheter (K162434)

Reference Devices

• Trek & Mini-Trek, Abbott (K103110)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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):

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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's<br>Name and<br>Address | Medinol Ltd.<br>Kiryat Atidim, Building 8,<br>Tel Aviv 6158101,<br>Israel |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name<br>and<br>Information | Marina Tikhonov Demishtein<br>VP Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Prepared | November 16 2017 |
| Proprietary<br>Name(s) | Gallant PTCA Dilatation Catheter |
| Common<br>Name | Catheters, transluminal coronary angioplasty, percutaneous |
| Product Code | LOX |
| Classification | Class II, 21 CFR Part 870.5100 |
| Predicate<br>Devices | NC Gallant PTCA Dilatation Catheter (K162434) |
| Reference<br>Devices | Trek & Mini-Trek, Abbott (K103110) |
| Device<br>Description | The Gallant is a sterile, single-use, intravascular medical device. The<br>Gallant is a combination of single lumen and dual lumen catheter<br>comprising an expandable semi-compliant (SC) coronary balloon on<br>a rapid exchange (RX) catheter. |
| Intended Use<br>of Device | The Gallant PTCA Dilatation Catheter is intended for the dilatation<br>of stenosis in coronary arteries or bypass grafts. |
| Indications for<br>Use | The Gallant PTCA Dilatation Catheter is indicated for:<br>• Balloon dilatation of the stenotic portion of a coronary artery or<br>bypass graft stenosis for the purpose of improving myocardial<br>perfusion;<br>• Post-deployment stent expansion. |
| Comparison of<br>Technological<br>Characteristics | The Gallant PTCA Dilatation Catheter incorporates substantially<br>equivalent device design, fundamental technology, manufacturing<br>processes, sterilization and intended use as those featured in the<br>predicate device: NC Gallant PTCA Dilatation Catheter (K162434).<br>Minor differences identified between the Gallant and it's predicate<br>device were evaluated in the frame of performance testing as<br>described below. |

| Medinol | Kiryat Atidim, Building 8, POB 58165 Tel Aviv 6158101, Israel | Main: [phone]<br>Fax: [phone] |
|---------|-----------------------------------------------------------------------|-----------------------------------------------|
| Ltd. | Beck Tech Building, 8 Hartom St., POB 45026 Jerusalem 9777508, Israel | Main: [phone]<br>Fax: [phone] |

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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.

| Performance<br>Data | The Gallant PTCA Dilatation Catheter was subjected to testing<br>according to the requirements of Guidance for Industry and FDA Staff<br>– Class II Special Controls for Certain Percutaneous Transluminal<br>Coronary Angioplasty (PTCA) Catheters, September 8, 2010.<br>Bench testing, pre-clinical studies, biocompatibility testing and<br>chemical characterization testing were performed to support a<br>determination of substantial equivalence. The results of these tests<br>provide reasonable assurance that the proposed device has been<br>designed and tested to assure conformance to the requirements for its<br>intended use. No new safety or performance issues were raised during<br>the testing and, therefore, the Gallant may be considered substantially<br>equivalent to the predicate device. | |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The following biocompatibility tests were completed on the Gallant<br>PTCA 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 the<br>Gallant PTCA Catheter: | |
| | Visual and Handling<br>Performance | Dimensional Verification |
| | Crossing Profile | Simulated Use |
| | Kissing Balloon Technique<br>(KBT) | Balloon Rated Burst Pressure |
| | Balloon Fatigue (Repeat Balloon<br>Inflations) | Balloon Diameter vs. Balloon<br>Pressure (Compliance), Balloon<br>Diameter at NIP, Balloon<br>Diameter at RBP, Balloon<br>Working Length, Balloon Non-<br>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<br>Stent) |
| | Balloon Fatigue (Repeat Balloon<br>Inflations; in Stent) | Catheter corrosion resistance |
| | Packaging Integrity | Environmental & Shipping &<br>Accelerated Shelf-Life |

| Medinol<br>Ltd. | Kiryat Atidim, Building 8, POB 58165 Tel Aviv 6158101, Israel<br>Beck Tech Building, 8 Hartom St., POB 45026 Jerusalem 9777508, Israel | Main: [phone]<br>Fax: [phone]<br>Main: [phone]<br>Fax: [phone] |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|

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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 the<br>Gallant PTCA Catheter: |
|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | GLP Acute Performance Study of Novel Gallant PTCA Balloons in a<br>Porcine Model |
| Conclusion | Based on the indications for use, technological characteristics, safety<br>and performance testing, the Gallant PTCA Dilatation Catheter has<br>been shown to be appropriate for its intended use and is considered to<br>be substantially equivalent to the predicate device. |