Q50 PLUS STENT GRAFT BALLOON CATHETER

K120381 · Qxmedical, LLC · DQY · Feb 24, 2012 · Cardiovascular

Device Facts

• Record ID: K120381
• Device Name: Q50 PLUS STENT GRAFT BALLOON CATHETER
• Applicant: Qxmedical, LLC
• Product Code: DQY · Cardiovascular
• Decision Date: Feb 24, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.

Device Story

Q50 PLUS Stent Graft Balloon Catheter is a multi-lumen, single-use, sterile percutaneous catheter; features compliant polyurethane balloon (10mm-50mm diameter) on 8Fr PEBA shaft; includes platinum-iridium radiopaque marker bands for placement; proximal PEBA bifurcation manifold with female luer ports for inflation and guidewire access; PVC extension tube with stopcock for handling. Used by physicians in clinical settings to temporarily occlude large vessels or expand vascular prostheses. Device is compatible with 12Fr introducer sheaths and 0.038" guidewires. Physician advances catheter over guidewire to target site; inflates balloon via inflation lumen to achieve occlusion or expansion; deflates for removal. Benefits include controlled vessel occlusion or prosthesis expansion during endovascular procedures.

Clinical Evidence

Bench testing only. Testing included visual/dimensional inspections, vessel occlusion, balloon fatigue, kink resistance, burst/leak volume, tensile strength, torque strength, deflation time, radiopacity, corrosion resistance, shelf life, and package integrity. All tests met specifications.

Technological Characteristics

Multi-lumen catheter; 8Fr PEBA shaft; compliant polyurethane balloon (max 50mm diameter, 60cc volume); Pt-Ir radiopaque marker bands; PEBA bifurcation manifold; PVC extension tube; 1-way polycarbonate/acetal stopcock; compatible with 12Fr sheaths and 0.038" guidewires; ethylene oxide sterilization.

Indications for Use

Indicated for temporary occlusion of large vessels or expansion of vascular prostheses in patients requiring endovascular intervention.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Stent Graft Balloon Catheter (K091624)

Submission Summary (Full Text)

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.K120381

#### 5 510(k) Summary

## Date Prepared: December 30, 2011

### Submitter Information:

| Submitter's Name/Address | Contact Person |
|--------------------------|----------------------------------------|
| QXMédical, LLC | Fernando Di Caprio, |
| 1747 Summit Avenue | Chief Technical Officer |
| Saint Paul, MN 55105 | Phone: [phone] |
| | Email: [e-mail] |

#### Device Information:

| Trade Name | Q50® PLUS Stent Graft Balloon Catheter | |
|---------------------|----------------------------------------|--|
| Common Name | Catheter, Percutaneous | |
| Classification Name | Catheter, Percutaneous | |
| Product Code | DQY, MJN | |
| Regulation | Class II, 21 CFR 870.1250 | |
| Panel | Cardiovascular | |

### Performance Standards:

No performance standards applicable to this product have been developed under Section 514 of the Act.

### Predicate Device:

| Predicate Device | Manufacturer | 510(k) Status |
|------------------------------|----------------------|---------------|
| Stent Graft Balloon Catheter | Via Biomedical, Inc. | K091624 |

### Device Description:

The OXMédical Stent Graft Balloon Catheter is a multi-lumen catheter which has a compliant polyurethane balloon with a maximum diameter of 50mm at 60cc inflation volume. The device is constructed with an 8Fr diameter blended PEBA shaft and is available in two usable lengths, 65 cm and 100 cm. The device is compatible with 12Fr (or larger) introducer sheaths and 0.038" diameter (or smaller) guidewires. Two platinum-iridium radiopaque marker bands are placed within the balloon to facilitate balloon placement prior to inflation. The proximal end of the catheter has an integral PEBA bifurcation manifold with female luer ports to allow communication with the balloon inflation lumen and guidewire lumen. A PVC extension tube (with stopcock) is connected to the balloon inflation port to facilitate handling. The device is a single use, sterile device.

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The device models are outlined in the table below:

| Device Models | | | |
|-------------------|------------------|--------------|--------------|
| Description | Balloon Diameter | Shaft Length | Model Number |
| Q50® PLUS (65cm) | 10mm-50mm | 65cm | Q50-65P |
| Q50® PLUS (100cm) | 10mm-50mm | 100cm | Q50-100P |

#### Intended Use/Indications for Use:

The Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.

# Summary of Non-Clinical Testing:

The QXMédical Stent Graft Balloon Catheter underwent mechanical, performance, and biocompatibility assessments to verify that the device functions in a safe and effective manner.

The mechanical tests performed on the QXMédical Stent Graft Balloon Catheter include:

| Visual inspections | Vessel occlusion |
|-----------------------------------------|-----------------------------------|
| Dimensional inspections | Balloon fatigue |
| Freedom from leakage | Kink resistance and radius |
| Luer syringe compatibility | Burst or leak volume |
| Guidewire compatibility | Freedom from fragmentation |
| Introducer sheath compatibility | Tensile strength (hub to shaft) |
| Balloon compliance (volume v. diameter) | Tensile strength (tip to shaft) |
| Deflation time | Tensile strength (extension tube) |
| Balloon inflation characteristics | Torque strength |
| Radiopacity | Shelf life testing |
| Corrosion resistance | Package integrity |
| Shipping/distribution testing | Environment conditioning |

All tests met specifications. These results provide assurance that the device has been designed and evaluated to assure conformance to the requirements for its indications for use.

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# Substantial Equivalence Comparison

The QXMédical Stent Graft Balloon Catheter is substantially equivalent to the predicate device based on a comparison of the indications for use and the technological characteristics. The following table provides a comparison of the technological characteristics of the QXMédical Stent Graft Balloon Catheter and the predicate device:

| | QXMédical Stent Graft Balloon<br>Catheter | Predicate Device<br>Via Biomedical Stent Graft Balloon<br>Catheter<br>(K091624) |
|-------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Shaft Configuration | 0.105" diameter, 3 - lumen,<br>65cm & 100cm effective lengths,<br>PEBA | 0.105" diameter, 3 - lumen,<br>65cm & 100cm effective lengths,<br>PEBA |
| Tip | Tapered,<br>Polyurethane | Tapered,<br>Polyurethane |
| Balloon | 10mm to 50mm range,<br>50mm (60cc) max.<br>Polyurethane | 10mm to 50mm range,<br>50mm (60cc) max.<br>Polyurethane |
| Radiopaque Markers | Two markers,<br>40mm spacing,<br>Pt - Ir | Two markers,<br>40mm spacing,<br>Pt - Ir |
| Manifold | Bifurcation style, with female luer<br>connections to guidewire lumen &<br>inflation lumen<br>PEBA | Bifurcation style, with female luer<br>connections to guidewire lumen &<br>inflation lumen<br>PEBA |
| Strain Relief | Heat shrunk,<br>Polyolefin | Heat shrunk,<br>Polyolefin |
| Extension Tube | Single-lumen,<br>PVC, DEHP-free | Single-lumen,<br>PVC, DEHP-free |
| Stopcock Style | One-Way,<br>Polycarbonate & acetal | Three-Way,<br>Polycarbonate & polyethylene |
| Minimum Sheath | 12 Fr | 12 Fr |
| Maximum Guidewire | 0.038" | 0.038" |
| Vessel Occlusion | Up to 41mm | Up to 41mm |
| Balloon Inflations | Maximum of 20 cycles | Maximum of 20 cycles |
| Packaging Configuration | Double sterile barrier | Double sterile barrier |
| Sterilization | Ethylene Oxide | Ethylene Oxide |

One difference between the QXMédical Stent Graft Balloon Catheter and the predicate device is the style of stopcock attached to extension tube (inflation port). The QXMédical Stent Graft Balloon Catheter has a 1-Way stopcock while the predicate device has a 3-way stopcock. These stopcocks have different designs, materials and methods of operation; however, both styles are well characterized and familiar to users. This difference does not raise any issues of safety or effectiveness.

The testing performed confirms that the QXMédical Stent Graft Balloon Catheter will perform as intended.

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# Conclusion

Based on the successful results from the Non-Clinical Testing performed and the Substantial Equivalence Comparison, we conclude that the device is as safe and effective as the legally marketed predicate device listed above.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

FEB 2 4 2012

QXMedical, LLC c/o Mark Job Responsible Third Party Official Regulatory Technical Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K120381

Trade/Device Name: Q50 PLUS Stent Graft Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, MJN Dated: February 6, 2012 Received: February 7, 2012

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becaon 31 (th) premient ferenced above and nave userings and minent and predicate devices marketed in interstate for use stated in the cherosure) to regars nament date of the Medical Device Amendments, or to commerce prof to May 20, 1970, the enactions of the provisions of the Federal Food, Drug, devices that have been reclassified in accrearies approval application (PMA).).
and Cosmetic Act (Act) that do not require approval of a presisions of the Act, TPMA). and Cosment Act (Act) that do not require apple of the general controls provisions of the Act. The
You may, therefore, market the device, subject to the general controlster You may, therefore, market the device, books of the more in the simply to minute mistereding ond general controls provisions of the rict mercises and prohibitions against mister and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Please note: CDICT does not evaluate incommunisment 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 may be subject to additional confrois: "Entrality and to 898. In addition, FDA may Touria in the Code of I cacial Regarations) concerning your device in the Federal Register.

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### Page 2 - Mr. Mark Job

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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours,

M.A. Hellehenne

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 Statement

510(k) Number (if known): __ |< | 2 @38|

Q50® PLUS Stent Graft Balloon Catheter Device Name:

. Indications for Use:

The Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. A. Hilleleme

(Division Sign-Off) Division of Čardiovascular Devices

510(k) Number_ K12038 |

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