The GORE Flow Reversal System is intended to provide embolic protection during carotid artery angioplasty and stenting for the patients diagnosed with carotid artery stenosis and who have the appropriate anatomy described below:

Adequate iliac/femoral access
Common carotid artery diameters between 6 and 12 mm
External carotid artery diameters less than 6 mm

Device Description

The GORE Flow Reversal System consists of three primary components:

GORE Balloon Sheath
GORE Balloon Wire, and
GORE External Filter
When assembled together, the GORE Flow Reversal System reverses the flow of blood at the treatment site of the internal carotid artery (ICA), directing embolic particles away from the neurovascular circulation and removing them through an external filter.

AI/ML Overview

The GORE Flow Reversal System was evaluated in the Gore EMPiRE Clinical Trial, a prospective, multicenter, nonrandomized, single-arm study. The study compared the 30-day safety and efficacy of the GORE Flow Reversal System (used with FDA-approved carotid stents) to an objective performance criterion (OPC) derived from prior carotid artery stenting studies that used distal embolic protection devices.

1. A table of acceptance criteria and the reported device performance

The provided text only explicitly states that the GORE Flow Reversal System "met the OPC hypothesis defined for the study." It does not detail the specific numerical acceptance criteria or the precise reported device performance metrics against those criteria. The acceptance criteria were an "objective performance criteria (OPC) determined from prior carotid artery stenting studies where distal embolic protection devices were used." Without the specifics of the OPC, a direct comparison table cannot be generated.

2. Sample size used for the test set and the data provenance

Sample size used for the test set: 245 pivotal subjects.
Data provenance: Prospective, multicenter, nonrandomized, single-arm study conducted across 29 US sites.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide information on the number of experts used to establish the ground truth, nor their qualifications. The study focused on clinical outcomes compared to an Objective Performance Criteria (OPC), rather than subjective expert interpretation for ground truth establishment.

4. Adjudication method for the test set

The document does not describe any specific adjudication method for establishing ground truth for the test set. Given it was a clinical trial, outcomes would likely be assessed by the treating physicians and potentially reviewed by a clinical events committee, but the details of this are not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study was a single-arm clinical trial evaluating the GORE Flow Reversal System itself, not comparing human readers' performance with and without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The GORE Flow Reversal System is a medical device (an embolic protection system), not an AI algorithm. A "standalone" performance assessment for an algorithm is therefore not relevant in this context. The study evaluated the standalone performance of the physical device in a clinical setting.

7. The type of ground truth used

The ground truth was based on the safety and efficacy outcomes of the 245 pivotal subjects at 30 days, compared against a pre-defined Objective Performance Criteria (OPC) derived from historical clinical studies of similar devices. This is effectively a form of outcomes data compared against a benchmark.

8. The sample size for the training set

This question is not applicable. The GORE Flow Reversal System is a physical medical device, not an AI algorithm that requires a "training set."

9. How the ground truth for the training set was established

This question is not applicable as there was no training set for an AI algorithm.

Summary

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K08 3300

W. L. Gore & Associates, Inc. Original 510(k) GORE Flow Reversal System Embolic protection system indication

FEB - 4 2009

510(k) SUMMARY [21 CFR 807.92(a)(1)]

1. 510(k) Owners Contact Information: name, address, phone and fax numbers, name of contact person, and date the summary was prepared [807.92(a)(1)]

Applicant:	W. L. Gore & Associates, Inc.4250 W. Kiltie LaneFlagstaff, AZ 86001
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Contact:

Michelle Ann Wells, RAC Requiatory Affairs W. L. Gore & Associates, Inc. Medical Products Division P.O. Box 2400 Flagstaff AZ 86003-2400

Toll Free: (800) 437-8181 Facsimile: (928) 864-4957 mwells@wlgore.com

November 7, 2008 Date Prepared:

1. Name of the Device: including the trade or proprietary name, if applicable, the common or usual name, and the classification name, if known [807.92(a)(2)]
- Trade name GORE Flow Reversal System .
- Common name Occlusion catheter .
- Classification name Catheter, carotid, temporary, for embolization capture .
- Classification 21CFR 870.1250, NTE Class II .
1. Device Predicates [807.92(a)(3)]

K021210 Arteria Occlusion Balloon

K021293 Arteria Blood Filter

K070770 GORE Balloon Sheath

K072990 Guardwire Temporary Occlusion and Aspiration System

1. Description of the Device [807.92(a)(4)]
  The GORE Flow Reversal System consists of three primary components:
GORE Balloon Sheath .
GORE Balloon Wire, and .

Image /page/0/Picture/24 description: The image shows a logo with the word "GORE" in bold, stylized letters. Below the word "GORE" are the words "Creative Technologies Worldwide" in a smaller font. The logo is contained within a rectangular box. To the right of the logo is the letter "C".

CONFIDENTIAL

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510(k) SUMMARY [21 CFR 807.92(a)(1)]

· GORE External Filter
When assembled together, the GORE Flow Reversal System reverses the flow of blood at the treatment site of the internal carotid artery (ICA), directing embolic particles away from the neurovascular circulation and removing them through an external filter.
1. Intended Use [807.92(a)(4)]
  The GORE Flow Reversal System is intended to provide embolic protection during carotid artery angioplasty and stenting for the patients diagnosed with carotid artery stenosis and who have the appropriate anatomy described below:
Adequate iliac/femoral access .
Common carotid artery diameters between 6 and 12 mm .
External carotid artery diameters less than 6 mm ●
1. Predicate Device Comparison [807.92(a)(6)]

Non-Clinical: Testing of the GORE Flow Reversal System consisted of biocompatibility, sterilization, packaging, product shelf life and performance testing. These tests demonstrated that the technological characteristics such as product performance, design and intended use are substantially equivalent to the currently marketed predicate devices.

Clinical: The Gore EMPiRE Clinical Trial was a prospective, multicenter, nonrandomized, single-arm study designed to compare 30-day safety and efficacy of the GORE Flow Reversal System used with FDA-approved carotid stents to an objective performance criteria (OPC) determined from prior carotid artery stenting studies where distal embolic protection devices were used. Twentynine (29) US sites participated in the study and enrolled 245 pivotal subjects. Statistical analysis confirms that the GORE Flow Reversal System met the OPC hypothesis defined for the study, demonstrating the safety and efficacy of the GORE Flow Reversal System for use in carotid artery stenting when used in accordance with the Instructions for Use.

Conclusion: The GORE Flow Reversal System is substantially equivalent to the predicate devices in terms of material composition, design, intended use, and performance attributes.

ONFIDENTIAL

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 4 2009

W.L. Gore and Associates, Inc. c/o Ms. Michelle Ann Wells. RAC Regulatory Affairs 4250 West Kiltie Lane Flagstaff, AZ 86001

Re: K083300

Trade/Device Name: Gore Flow Reversal System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: January 14, 2009 Received: January 15, 2009

Dear Ms. Wells:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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Page 2 - Ms. Michelle Wells

CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

1 1 . . . . . . . . . .

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

una R. bichner

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

Enclosure

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W. L. Gore & Associates, Inc. Original 510(k) GORE Flow Reversal System Embolic protection system indication

INDICATIONS FOR USE STATEMENT

Indications for Use

510(k) Number (if known):

Fobe assigned K003300

Device Name:

GORE Flow Reversal System

Indications for Use:

Adequate iliac/femoral access
Common carotid artery diameters between 6 and 12 mm
External carotid artery diameters less than 6 mm �

Prescription Use × Over-The-Counter Use (Part 21 CFR 801 Subpart D) AND/OR (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)

sumner R. Luchner

(Division Sirin-Off) Division Sign-Om)
Cardiovascular Devices

510(K) Number K083300

Image /page/4/Picture/18 description: The image contains the GORE logo on the left side. To the right of the logo, the word "CONFIDENTIAL" is written in large, bold, sans-serif font. The logo is a stylized design with the word "GORE" in a distinctive typeface. The word confidential indicates that the document is private.

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Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).