GORE Molding and Occlusion Balloon Catheter

K172567 · W. L. Gore and Associates, Inc. · MJN · Jan 31, 2018 · Cardiovascular

Device Facts

• Record ID: K172567
• Device Name: GORE Molding and Occlusion Balloon Catheter
• Applicant: W. L. Gore and Associates, Inc.
• Product Code: MJN · Cardiovascular
• Decision Date: Jan 31, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GORE Molding and Occlusion Balloon Catheter is intended for temporary occlusion of large vessels or to assist in the expansion of self-expanding endovascular prostheses (stent grafts).

Device Story

Sterile, single-use, single-lobed compliant polyurethane balloon catheter; 3-lumen shaft (two inflation, one guidewire). Used in clinical settings under fluoroscopic guidance by physicians. Input: manual syringe inflation via dual-port y-arm. Output: balloon expansion (10mm to 37mm diameter) for vessel occlusion or stent graft molding. Radiopaque markers indicate balloon position. Benefits: facilitates endovascular procedures by providing temporary flow control or ensuring proper stent graft apposition.

Clinical Evidence

No clinical evaluations or animal studies were performed. Substantial equivalence is supported by bench testing, including design verification for device profile, sheath compatibility, inflation/deflation performance, burst volume, leakage, tensile strength, shelf life, and biocompatibility.

Technological Characteristics

Single-lobed compliant polyurethane balloon; Pellethane catheter shaft; 3-lumen design (2 inflation, 1 guidewire); 10 Fr introducer sheath compatible; 0.035" guidewire compatibility; radiopaque marker bands; manual hydraulic inflation; Ethylene Oxide (EtO) sterilization.

Indications for Use

Indicated for temporary occlusion of large vessels or to assist in the expansion of self-expanding endovascular prostheses (stent grafts) in patients requiring endovascular intervention.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• QXMédical, Q50® PLUS Stent Graft Balloon Catheter (K120381)

Submission Summary (Full Text)

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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 in blue and includes the letters "FDA" and the words "U.S. Food & Drug Administration."

January 31, 2018

W.L Gore and Associates Inc. Jeremiah Andrews Regulatory Affairs Associate 1505 N. Fourth Street Flagstaff, Arizona 86004

Re: K172567

Trade/Device Name: GORE Molding and Occlusion Balloon Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: December 21, 2017 Received: December 28, 2017

Dear Jeremiah Andrews:

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 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);

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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 medical devices and radiation-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,

Nicole G. Ibrahim -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) K172567

Device Name GORE Molding and Occlusion Balloon

Indications for Use (Describe)

The GORE Molding and Occlusion Balloon Catheter is intended for temporary occlusion of large vessels or to assist in the expansion of self-expanding endovascular prostheses (stent grafts).

| Type of Use (Select one or both, as applicable) | | |
|-------------------------------------------------|--|--|
| <table><tr><td></td><td></td></tr></table> | | |
| | | |

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 510(k) SUMMARY (Per 21CFR807.92)

#### 510(k) Owner:

W.L. Gore & Associates, Inc. Medical Products Division 1505 North Fourth Street Flagstaff, Arizona 86004 - U.S.A.

Regulatory Contact: Jeremiah Andrews W. L. Gore & Associates, Inc 32360 N. North Valley Parkway Phoenix, AZ 85085

Phone: [phone] Fax: [phone] Email: [e-mail]

January 25, 2018 Date Prepared:

## Device Names/Classification

| Trade Name: | GORE® Molding and Occlusion Balloon |
|-------------|-------------------------------------|
| Catheter: | |

| Product Code: | MJN |
|---------------|-----|
|---------------|-----|

21CFR 870.4450

Classification Panel: Cardiovascular Devices

Device Class: Class II

#### Predicate Devices

| Device Name | 510(k) Number |
|------------------------------------------------------|---------------|
| QXMédical, Q50® PLUS Stent Graft Balloon<br>Catheter | K120381 |

This predicate device has not been subject to a design-related recall.

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#### Device Description

The GORE® Molding and Occlusion Balloon Catheter is a sterile (EtO), single use, single-lobed polyurethane balloon catheter. The compliant polyurethane balloon is mounted on the leading end of a 3 lumen catheter shaft (two inflation lumens and one quidewire lumen). Termination of the leading end of the catheter is an atraumatic catheter leading tip for smooth transition from the quidewire to catheter transition. Radiopaque markers (approximately 40 mm apart) indicate the proximal and distal end of the balloon which aid in proper balloon placement under fluoroscopy. Both of the (2) inflation lumens are in communication with each end of the balloon to facilitate balloon catheter preparation, inflation and deflation. At the trailing end of the balloon catheter is a dual port (balloon inflation and quidewire) yarm. The inflation port of the y-arm is in communication with both of the balloon inflation lumens and is affixed with a luer lock and three way stopcock via an extension tube. The quidewire lumen of the v-arm allows introduction of a 0.035" (0.89 mm) diameter guidewire for over-the-wire access. The trailing end of the quidewire lumen is affixed with a flushing / guidewire port with luer lock used for flushing the guidewire lumen. The balloon catheter proximal y-arm is provided within a housing which contains markings of the balloon length and inflation range diameter. The balloon can be inflated to diameters of 10 mm to a maximum inflation diameter of 37 mm. The balloon catheter profile is 10 Fr introducer sheath compatible.

#### Indications for Use

The GORE® Molding and Occlusion Balloon Catheter is intended for temporary occlusion of large vessels or to assist in the expansion of selfexpanding endovascular prostheses (stent grafts).

## Summary of Similarities and Differences in Technological Characteristics

Technical Equivalence is established through similar design of single lobed balloon catheter and profile, principal of operation by hydraulic, manual syringe inflation, specification of operating/treatment diameter ranges, fundamental technology and material properties, and user interface.

A comparison of the technical characteristics of the subject and predicate devices is provided in the following table.

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#### Comparison of the GORE® Molding and Occlusion Balloon Catheter to Predicate Device

| | GORE® Molding and<br>Occlusion Balloon<br>Catheter | Q50® PLUS Stent Graft<br>Balloon Catheter | Difference Comparison |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating<br>Principal | Device is inserted and<br>withdrawn over a guidewire<br>and through an introducer<br>sheath to the treatment<br>site, via fluoroscopic<br>guidance with the aid of<br>balloon radiopaque marker<br>bands. Device hub allows<br>inflation/deflation of the<br>balloon via a manual<br>syringe. | Device is inserted and<br>withdrawn over a guidewire<br>and through an introducer<br>sheath to the treatment<br>site, via fluoroscopic<br>guidance with the aid of<br>balloon radiopaque marker<br>bands. Device hub allows<br>inflation/deflation of the<br>balloon via a manual<br>syringe. | |
| Max Inflation<br>Volume | 48ml | 60ml | Subject device does not<br>exceed maximum inflation<br>volume of predicate. |
| Treatment<br>Diameter | 10mm - 37mm | 10mm - 50mm | Subject device is within the<br>range of treatment diameter of<br>the predicate device. |
| Design of<br>Construction | Single-lobed balloon | Single-lobed balloon | |
| Catheter<br>shaft | 3 lumen | 3 lumen | |
| Working<br>Length | 90cm | 65cm, 100cm | Subject device is within the<br>range of lengths offered for<br>the predicate device. |
| Profile | 10 Fr | 12 Fr | Subject device does not<br>exceed the profile of the<br>predicate device. |
| Guidewire<br>Compatibility | 0.035" | 0.035" | |
| Radiopacity | Dual balloon marker bands<br>on catheter | Dual balloon marker bands<br>on catheter | |
| Balloon<br>diameter<br>versus<br>volume | 10mm - 2ml<br>20mm - 7ml<br>30mm - 16ml<br>37mm - 35ml | 10mm - 3ml<br>20mm - 6ml<br>30mm - 16ml<br>40mm - 32ml<br>50mm - 60ml | Balloon Diameter vs Volume<br>of the devices are similar, but<br>not identical. Predicate device<br>maximum balloon diameter vs<br>volume does not exceed that<br>of the predicate device. |
| User<br>Interface | 2 port y-arm | 2 port y-arm | |
| Balloon<br>Materials of<br>Construction | Compliant Polyurethane | Compliant Polyurethane | |
| Catheter<br>Materials of<br>Construction | Pellethane | Pebax | Catheter materials of<br>construction are different. |
| Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide | |

#### (NOTE: Shaded table cells indicate characteristics that are identical)

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## Performance Data

Bench study: Design verification testing (listed below) demonstrated the subject device performed as intended and was substantially equivalent to the predicate device.

| Design Verification Testing | |
|---------------------------------------|--------------------------------------------|
| Device Profile / Sheath Compatibility | Guidewire Compatibility |
| Repeat Inflation / Deflation | Balloon & Marker Band Position &<br>Length |
| Inflation Time | Catheter Effective Length |
| Deflation Time | Visual Inspection Mechanical Defects |
| Occlusion | Tip Durability |
| Balloon Inflation Diameter | Tensile Strength |
| Burst Volume | Shelf Life Testing |
| Leakage | Packaging Validation Testing |
| Aspiration | Sterilization Validation Testing |
| Accessory Compatibility | Biocompatibility |

Animal study: No animal studies were performed.

Clinical: No clinical evaluations of this product have been conducted.

# Conclusion

W.L. Gore & Associates concludes that the subject GORE® Molding and Occlusion Balloon Catheter is substantially equivalent to the predicate device.