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).

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the GORE Molding and Occlusion Balloon Catheter:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes a series of "Design Verification Testing" activities as the performance data. While specific pass/fail criteria (e.g., a numerical range for "Inflation Time") are not explicitly listed in this summary, the document states that these tests "demonstrated the subject device performed as intended and was substantially equivalent to the predicate device." This implies that the device met internal specifications and expectations derived from the predicate device's performance.

Acceptance Criterion (Test Name)	Reported Device Performance
Device Profile / Sheath Compatibility	Performed as intended, substantially equivalent to predicate device.
Guidewire Compatibility	Performed as intended, substantially equivalent to predicate device.
Repeat Inflation / Deflation	Performed as intended, substantially equivalent to predicate device.
Balloon & Marker Band Position & Length	Performed as intended, substantially equivalent to predicate device.
Inflation Time	Performed as intended, substantially equivalent to predicate device.
Catheter Effective Length	Performed as intended, substantially equivalent to predicate device.
Deflation Time	Performed as intended, substantially equivalent to predicate device.
Visual Inspection Mechanical Defects	Performed as intended, substantially equivalent to predicate device.
Occlusion	Performed as intended, substantially equivalent to predicate device.
Tip Durability	Performed as intended, substantially equivalent to predicate device.
Balloon Inflation Diameter	Performed as intended, substantially equivalent to predicate device.
Tensile Strength	Performed as intended, substantially equivalent to predicate device.
Burst Volume	Performed as intended, substantially equivalent to predicate device.
Shelf Life Testing	Performed as intended, substantially equivalent to predicate device.
Leakage	Performed as intended, substantially equivalent to predicate device.
Packaging Validation Testing	Performed as intended, substantially equivalent to predicate device.
Aspiration	Performed as intended, substantially equivalent to predicate device.
Sterilization Validation Testing	Performed as intended, substantially equivalent to predicate device.
Accessory Compatibility	Performed as intended, substantially equivalent to predicate device.
Biocompatibility	Performed as intended, substantially equivalent to predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the exact sample sizes for each of the "Design Verification Testing" activities. It only references "bench study" data.

Sample Size: Not specified.
Data Provenance: The studies were "bench studies," which are laboratory-based tests. The country of origin is not explicitly stated, but the company (W.L. Gore & Associates) is based in the U.S. (Flagstaff, Arizona), suggesting the studies were likely conducted in the U.S. These are retrospective tests performed to verify design specifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This device is a physical medical device, and the "ground truth" for its performance is established through objective engineering and materials testing, not through expert human interpretation of data like in an AI/imaging device.

4. Adjudication Method for the Test Set:

Not applicable, as the tests are objective bench tests.

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 a physical medical device, not an AI or imaging diagnostic tool that would involve 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.

7. The Type of Ground Truth Used:

The ground truth used for this device's performance evaluation is based on objective engineering specifications, material properties, and functional requirements for a balloon catheter intended for occlusion and stent graft expansion. These are derived from established medical device standards and comparison to a predicate device. For example, "Burst Volume" would have a defined expected value, and the tested device's performance would be compared against that.

8. The Sample Size for the Training Set:

Not applicable. There is no concept of a "training set" for physical medical device bench testing in the same way there would be for an AI algorithm. The design and manufacturing processes are refined based on general engineering principles and iterative development, not a specific training dataset.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set in the context of this device. The "ground truth" for the device's design and manufacturing is derived from industry standards, regulatory requirements, scientific principles, and iterative design and testing.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

|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: 928-814-6823 Fax: 623-234-5105 Email: jeandrew@wlgore.com

January 25, 2018 Date Prepared:

Device Names/Classification

Trade Name:	GORE® Molding and Occlusion Balloon
Catheter:

Product Code:	MJN
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21CFR 870.4450

Classification Panel: Cardiovascular Devices

Device Class: Class II

Predicate Devices

Device Name	510(k) Number
QXMédical, Q50® PLUS Stent Graft BalloonCatheter	K120381

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

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Device Description

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 andOcclusion BalloonCatheter	Q50® PLUS Stent GraftBalloon Catheter	Difference Comparison
OperatingPrincipal	Device is inserted andwithdrawn over a guidewireand through an introducersheath to the treatmentsite, via fluoroscopicguidance with the aid ofballoon radiopaque markerbands. Device hub allowsinflation/deflation of theballoon via a manualsyringe.	Device is inserted andwithdrawn over a guidewireand through an introducersheath to the treatmentsite, via fluoroscopicguidance with the aid ofballoon radiopaque markerbands. Device hub allowsinflation/deflation of theballoon via a manualsyringe.
Max InflationVolume	48ml	60ml	Subject device does notexceed maximum inflationvolume of predicate.
TreatmentDiameter	10mm - 37mm	10mm - 50mm	Subject device is within therange of treatment diameter ofthe predicate device.
Design ofConstruction	Single-lobed balloon	Single-lobed balloon
Cathetershaft	3 lumen	3 lumen
WorkingLength	90cm	65cm, 100cm	Subject device is within therange of lengths offered forthe predicate device.
Profile	10 Fr	12 Fr	Subject device does notexceed the profile of thepredicate device.
GuidewireCompatibility	0.035"	0.035"
Radiopacity	Dual balloon marker bandson catheter	Dual balloon marker bandson catheter
Balloondiameterversusvolume	10mm - 2ml20mm - 7ml30mm - 16ml37mm - 35ml	10mm - 3ml20mm - 6ml30mm - 16ml40mm - 32ml50mm - 60ml	Balloon Diameter vs Volumeof the devices are similar, butnot identical. Predicate devicemaximum balloon diameter vsvolume does not exceed thatof the predicate device.
UserInterface	2 port y-arm	2 port y-arm
BalloonMaterials ofConstruction	Compliant Polyurethane	Compliant Polyurethane
CatheterMaterials ofConstruction	Pellethane	Pebax	Catheter materials ofconstruction are different.
SterilizationMethod	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 &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.

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).