The GORE Balloon Sheath is indicated for temporary occlusion, selective angiography, and/or facilitating the introduction and placement of intravascular devices into selected blood vessels in the peripheral and neurovascular systems.

Device Description

The GORE Balloon Sheath consists of a dual lumen catheter shaft with a compliant balloon mounted at the distal-most tip of the shaft. The GORE Balloon Sheath is provided with compatible dilator which facilitates a gradual transition from the guide wire diameter to the sheath internal diameter. The first lumen acts as the inflation lumen while the second lumen acts as the working channel, accommodating diagnostic and therapeutic interventional devices. The sheath hub consists of four ports. The first port ("balloon inflation port") has a female luer thread, allowing assembly of a syringe and stopcock for balloon inflation. The second port ("fluid port") has a flexible tubing extension, which permits access to the working channel to subsequently allows fluid (e.g. contrast agent) injections and / or blood aspiration. The third port ("auxiliary port") allows side access to the working channel to introduce interventional devices. The fourth port ("main port") provides linear access to the working channel, functioning primarily as the delivery port for diagnostic and therapeutic devices.

AI/ML Overview

The provided document is a 510(k) summary for the GORE Balloon Sheath and Dilator, focusing on establishing substantial equivalence to predicate devices for regulatory clearance. It does not contain information about a study proving the device meets specific performance acceptance criteria in the manner of a clinical trial or algorithm performance study.

Instead, the "Testing" section describes conformity to established standards for medical devices.

Here's the breakdown of the requested information based on the provided text:

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

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Verified in accordance with ISO 10993-1. Confirmed as an external communicating blood contact short duration (<24 hours) device.
Dimensional Verification	Testing performed in accordance with ISO 10555.
Force to Break	Testing performed in accordance with ISO 10555.
Freedom from Leakage	Testing performed in accordance with ISO 10555.
Balloon Integrity	Testing performed in accordance with ISO 10555.
Overall Performance	`Testing demonstrates that the device meets or exceeds the requirements of the standard and performs substantially equivalent to the predicate devices.`

Note: The document states that testing was done "in accordance with ISO 10555" for several performance criteria and that the device "meets or exceeds the requirements of the standard." However, it does not provide specific numerical acceptance criteria or numerical reported device performance values for these tests. The standards themselves would contain the specific thresholds.

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

Sample Size: Not specified for any of the performance tests.
Data Provenance: Not specified. The testing seems to be internal verification by the manufacturer (W. L. Gore & Associates, Inc.) as part of the regulatory submission process. It is a pre-market submission, implying this testing was done before the device entered the market.

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

This type of information is not applicable to the testing described. The "ground truth" here is defined by compliance with ISO standards for physical and biological characteristics, not expert interpretation of outputs like in a diagnostic AI study.

4. Adjudication method for the test set

This is not applicable. No adjudication method involving human experts interpreting test results is described. The tests are standard engineering and biological performance evaluations.

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

No, an MRMC comparative effectiveness study was not done. This document describes a medical device (balloon sheath and dilator), not an AI-powered diagnostic or assistive tool.

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

This is not applicable. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used

For biocompatibility: Ground truth is defined by the ISO 10993-1 standard and its associated testing methodologies.
For performance characteristics (dimensional verification, force to break, freedom from leakage, balloon integrity): Ground truth is defined by the ISO 10555 standard and its associated testing methodologies.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

This is not applicable. As above, there's no training set or machine learning model involved.

Summary

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JUN 2 9 2007 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

Regulatory Authority:

Safe Medical Devices Act of 1990, 21 CFR 807.92

GORE Balloon Sheath and Dilator Proprietary Name: Occlusion Balloon Common Name: Classification Name: Catheter, Intravascular Occluding, Temporary Class II Device Classification: Product Classification and Code: 870.4450, MJN General and Plastic Surgery Classification Panel: 2017233 Establishment Registration Number: Timothy Rynn Contact Person: Regulatory Affairs Medical Products Division W. L. Gore & Associates, Inc. 3450 West Kiltie Lane Flagstaff, AZ 86002-0500 Telephone: (928) 864-3714 Facsimile: (928) 864-2735 E-mail: trynn@wlgore.com

Image /page/0/Picture/7 description: The image contains the Gore logo on the left side and the word "Confidential" on the right side. The Gore logo consists of the word "GORE" in bold letters with a stylized arrow pointing to the right. Below the word "GORE" are smaller words that are difficult to read. The word "Confidential" is written in a simple, sans-serif font.

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6070770 0.2042

Indications for Use:

Device Description:

The second port ("fluid port") has a flexible tubing extension, which permits access to the working channel to subsequently allows fluid (e.g. contrast agent) injections and / or blood aspiration.

The third port ("auxiliary port") allows side access to the working channel to introduce interventional devices.

The fourth port ("main port") provides linear access to the working channel, functioning primarily as the delivery port for diagnostic and therapeutic devices.

Testing:

Biocompatibility of the GORE Balloon Sheath and Dilator were verified in accordance with ISO 10993-1. Biological Evaluation of Medical Devices. Testing confirmed the biocompatibility of the GORE Balloon Sheath as an external communicating blood contact short duration (<24 hours) device.

Performance testing was conducted in accordance with ISO 10555 Sterile, single use intravascular catheter. Part 1. Tests included biocompatibility, dimensional verification, force to break, freedom from leakage, and balloon integrity. Testing demonstrates that the device meets or exceeds the requirements of the standard and performs substantially equivalent to the predicate devices.

Predicate Devices:

ArteriA Medical ParCA Catheter K001917 .
ArteriA Medical Occlusion Balloon K002286 .
Concentric, Concentric Guide Catheter K003085 .

Summary of Substantial Equivalence:

The GORE Balloon Sheath and Dilator are substantially equivalent to the predicate devices in technological characteristics and indications for use.

Image /page/1/Picture/18 description: The image contains the Gore logo on the left and the word "Confidential" on the right. The Gore logo is a stylized design with the word "GORE" in bold letters. The word "Confidential" is written in a simple, sans-serif font. The text is black and the background is white.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2007

W.L. Gore & Associates c/o Mr. Alan Curtis AEC Consulting 2647 Lin Gate Court Pleasanton, CA 94566

Re: K070770

GORE Balloon Sheath Regulation Number: 21 CFR 870.4450 Regulation Name: Catheter, Intravascular Occluding, Temporary Regulatory Class: Class II Product Code: MJN Dated: May 5, 2007 Received: May 6, 2007

Dear Mr. Curtis:

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.

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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); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.

Duna R. Varner

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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GORE BALLOON SHEATH

INDICATION FOR USE

510(k) Number (if known):

Device Name:

GORE BALLOON SHEATH

K070770

Intended Use / Indication For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

sumna R. Holmes

ardiovascular Devices

510(k) Number Fo

Image /page/4/Picture/16 description: The image shows the Gore logo on the left and the word "Confidential" on the right. The Gore logo is a black square with the word "GORE" in white letters and a white arrow pointing to the right. Below the logo is some smaller text that is difficult to read. The word "Confidential" is in black letters and is slightly larger than the text in the logo.

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).