Like other, commercially available vascular irrigation sets and intravascular administration sets, the GORE irrigation system is intended to irrigate vascular tissue intraoperatively.

This includes use of the GORE irrigation system to infuse sterile irrigant solution into a vein to allow visualization of the valve destruction process during vein preparation for in-situ vascular bypass.

Device Description

The GORE irrigation system is composed of biocompatible plastics consistent with those used in other commercially available irrigation systems and intravascular administration sets. All tissue and fluid-path materials will be documented as suitable for intended use per international standards and FDA guidances, prior to commercial distribution and clinical use.

The GORE irrigation system consists of a valve controller, tubing with introducer sheaths, and connections for infusion and drainage of irrigant solution into and from the clamped vein.

AI/ML Overview

Here's the information regarding the acceptance criteria and study as requested, based on the provided text:

Important Note: The provided document is a 510(k) Premarket Notification Summary for the GORE Irrigation System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive de novo clinical trial data with detailed acceptance criteria and performance metrics against a pre-defined ground truth in the way a new, high-risk device might. Therefore, many of the requested points will not be explicitly found in this document. The responses below reflect what can be inferred or explicitly stated from this specific type of regulatory submission.

Acceptance Criteria and Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence Basis)	Reported Device Performance
Biocompatibility: Materials suitable for intended use.	"All tissue and fluid-path materials will be documented as suitable for intended use per international standards and FDA guidances, prior to commercial distribution and clinical use." Also states, "As the same types of biocompatible plastics used in other irrigation sets will be used in the GORE irrigation set, and all materials used in the GORE irrigation set will be appropriately characterized and tested for biocompatibility, no new issues regarding materials are raised by the GORE device."
Technological Characteristics: Operates similarly to predicate devices; no new issues regarding use.	"As the GORE irrigation set operates in a manner similar to other commercially available irrigation sets, and surgical users are very familiar with the use of irrigation sets during vein preparation for in-situ bypass, there are no new issues regarding the technological characteristics or use of the GORE device." And again, "As the GORE irrigation set is structured similarly and operates in a manner similar to other commercially available irrigation sets, and surgical users are very familiar with the use of irrigation sets during vein preparation for in-situ bypass, there are no new issues regarding the technological characteristics or use of the GORE device."
Intended Use: Irrigation of vascular tissue intraoperatively for visualization during vein preparation for in-situ vascular bypass.	The stated intended use directly matches this criterion. The FDA letter confirms the device is "substantially equivalent (for the indications for use stated in the enclosure)."
Safety and Effectiveness: Demonstrate requisite structural, biocompatibility, and mechanical characteristics to function safely and effectively.	"This extensive clinical history demonstrates that GORE is capable of ensuring that its devices possess the requisite structural, biocompatibility and mechanical characteristics to function safely and effectively." (Referring to GORE-TEX Medical Products generally, not specific to this device's clinical study).

Study Details (Based on available information in a 510(k) Summary)

Sample size used for the test set and the data provenance:
- This document does not describe a "test set" in the context of a performance study with a specific sample size. The 510(k) process relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive new clinical data with a dedicated test set.
- Data provenance is not applicable for a traditional test set as no such study is described. The rationale for equivalence is based on material commonality and operational similarity to existing devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No "ground truth" establishment by experts for a test set is described, as the submission focuses on substantial equivalence based on design, materials, and intended use.
Adjudication method for the test set:
- Not applicable. No test set requiring expert adjudication is described in the document.
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 device is a physical irrigation system, not an AI or imaging diagnostic tool. Therefore, an MRMC study is irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device, not an algorithm, so standalone algorithm performance is not relevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For this 510(k) submission, the "ground truth" for acceptance is primarily the established safety and effectiveness of the predicate devices and the GORE Irrigation System's similarity to them in materials, design, and intended use. Biocompatibility testing documentation is mentioned as a component.
The sample size for the training set:
- Not applicable. This document does not describe a machine learning model or a training set.
How the ground truth for the training set was established:
- Not applicable. There is no training set mentioned in this regulatory document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for GORE. The logo has the word "GORE" in bold, block letters. Above and to the right of the word is a black shape that resembles a stylized arrow. Below the word "GORE" are the words "Creative Technologies Worldwide" in a smaller font.

DRE & ASSOCIATES, INC

1505 NORTH FOURTH STREET . P.O. BOX 3000 . FLAGSTAFF, ARIZONA

K 964067

UN - 5 1997

PREMARKET NOTIFICATION SUMMARY

Intravascular administration set

1.	Applicant :	W. L. Gore and Associates, Inc.1505 N. Fourth StreetP.O. Box 3000Flagstaff, Arizona 86003-3000
2.	Applicant Device :	GORE Irrigation System

Irrigation system Common Name :

Classification Name :

Predicate Device : 3.

For the purposes of demonstrating the premarket clearance of other, similarly-classified, devices, GORE cited FDA-issued 510k's.

Applicant Device Description : 4.

The GORE irrigation system consists of a valve controller, tubing with introducer sheaths, and connections for infusion and drainage of irrigant solution into and from the clamped vein. As the same types of biocompatible plastics used in other irrigation sets will be used in the GORE irrigation set, and all materials used in the GORE irrigation set will be appropriately characterized and tested for biocompatibility, no new issues regarding materials are raised by the GORE device. As the GORE irrigation set operates in a manner similar to other commercially available irrigation sets, and surgical users are very familiar with the use of irrigation sets during vein preparation for in-situ bypass, there are no new issues regarding the technological characteristics or use of the GORE device.

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【官网】

Like other commercially available vascular irrigation 5. Intended Use : sets and intravascular administration sets, the GORE irrigation system is intended to irrigate vascular tissue intraoperatively. This includes use for infusion of sterile irrigant solution into a vein to allow visualization of pertinent intravascular structures, venous valves and tributary sites, during vein preparation for in-situ vascular bypass.

ਂ. Technological Characteristics :

As the GORE irrigation set is structured similarly and operates in a manner similar to other commercially available irrigation sets, and surgical users are very familiar with the use of irrigation sets during vein preparation for insitu bypass, there are no new issues regarding the technological characteristics or use of the GORE device.

For the past two decades, GORE-TEX Medical Products have been used in more than 4,000,000 clinical applications for a broad range of indications. This extensive clinical history demonstrates that GORF is capable of ensuring that its devices possess the requirite structural, biocompatibility and mechanical characteristics to function safely and effectively.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Dawn Lopez Requlatory Affairs Associate W.L. Gore & Associate, Inc. Medical Products Division 3750 West Kiltie Lane P.O. Box 900 Flagstaff, Arizona 86002-0900

JUN - 5 1997

Re: % K964067 GORE Irrigation Set Requlatory Class: II (Two) Product Code: 79 FPA Dated: March 6, 1997 Received: March 7, 1997

Dear Ms. Lopez:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Dawn Lopez

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address"dsmo@fdadr.cdrh.fda.gov."

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Set Intravascular Inrigation 800. 5440 +PA

INDICATIONS FOR USE

510k Number (if known):	K 964067
Device Name:	Core Irrigation System

Indications for Use:

Like other, commercially available vascular irrigation sets and intravascular administration sets, the GORE irrigation system is intended to irrigate vascular tissue intraoperatively.

Concurrence of CDRH, Office of Device Evaluation (ODE):

Bata L. Campbell

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K964067

Prescription Use: X (per 21 CFR 801.109)

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Over the Counter Use: ________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.