Intended for use with a vascular access device for the administration of drugs and solutions. The V-Link Antimicrobial Luer Activated Device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids.

The V-Link Antimicrobial Luer Activated Device contains an antimicrobial agent (metallic silver) that may reduce the growth of microorganisms on the coated surfaces of the V-Link device. The antimicrobial agent is not intended to be used as a treatment for existing infections.

Device Description

The V-Link Antimicrobial Luer Activated Device consists of a clear housing encasing a gland and center post. The gland functions as the valve that provides a seal against the syringe/luer connector when the device is being used. The gland has a slit that opens when activated by the syringe/Luer connector. The gland also provides a surface that can be easily swabbed with antiseptic before each connection.

The hard surfaces of the V-Link Antimicrobial Luer Activated Device are coated with a proprietary silver technology that may reduce the growth of microorganisms on the coated surfaces of the V-Link device.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called the "V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device." This document focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study report for the current device's performance against those criteria.

Therefore, the requested information, particularly regarding specific acceptance criteria, detailed study results, sample sizes, expert qualifications, and ground truth establishment, is largely not present in the provided text. The document refers to "supplemental data on the efficacy and durability of the antimicrobial coating" and states that "All test results meet the acceptance criteria," but it does not elaborate on what those criteria or results actually are.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is missing:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Not explicitly stated in the document for this submission)	Reported Device Performance (As stated in the document)
Implied: Efficacy and durability of the antimicrobial coating.	"All test results meet the acceptance criteria"
Implied: Substantial equivalence to the predicate device in terms of safety and effectiveness.	"The V-Link Antimicrobial Luer Activated Device is substantially equivalent to Baxter's current legally marketed V-Link Antimicrobial Luer Activated Device cleared November 6, 2007 (K072576)."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for the test set: Not provided in the document.
Data provenance: Not provided in the document. The general nature of 510(k) submissions suggests the data would likely be from pre-clinical testing (lab-based) rather than clinical studies, and therefore country of origin is typically less relevant unless a clinical trial was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. The "ground truth" concept is more relevant for diagnostic or image-based AI devices where human experts define the truth. For this device (an IV administration set with an antimicrobial coating), "ground truth" would be established through laboratory testing and engineering specifications by qualified personnel (e.g., microbiologists, engineers), but the details are not given.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. Adjudication methods like "2+1" are typically used for establishing ground truth in clinical trials or image interpretation studies, not for the type of testing described (efficacy and durability of an antimicrobial coating on an IV set).

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. This is not applicable to the V-Link Antimicrobial Luer Activated Device. This device is an IV administration set, not an AI-assisted diagnostic tool or system requiring human readers.

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

Not applicable/Not provided in the context of an "algorithm." This device is a physical medical device, not a software algorithm. The "efficacy and durability of the antimicrobial coating" would have been evaluated directly through laboratory tests (e.g., microbiological assays, material durability tests) which are "standalone" in the sense that they evaluate the device itself without human-in-the-loop performance in the way an AI diagnostic tool would be assessed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated, but based on the device description, the "ground truth" for the "efficacy and durability of the antimicrobial coating" would have been established through pre-defined laboratory test standards and methods. This would involve:
- Microbiological assays: To determine the reduction in microbial growth on coated surfaces.
- Durability testing: To assess how long the coating remains effective under simulated use conditions.
- These tests adhere to established scientific protocols and acceptance criteria relevant to antimicrobial claims.

8. The sample size for the training set

Not applicable/Not provided. This device is not an AI/machine learning device that uses a "training set."

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

Not applicable/Not provided. This device is not an AI/machine learning device that uses a "training set."

In summary, the provided 510(k) document is a summary of substantial equivalence for a physical medical device. It states that non-clinical tests were conducted and met acceptance criteria, especially concerning the antimicrobial coating's efficacy and durability, but it does not provide the specific details of those tests, the acceptance criteria, or the results in a manner that would answer the detailed questions about sample sizes, expert involvement, or ground truth establishment relevant to AI/diagnostic studies.

Summary

{0}------------------------------------------------

KOR 1289 1 of 3

Section 5, 510(k) Summary

5. 510(k) SUMMARY

July 28, 2008

OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

CONTACT PERSON:

Nanette Hedden Manager, Global Regulatory Affairs 1620 Waukegan Rd. MPGR-AL McGaw Park, IL 60085 Telephone: (847) 270-4871 Fax: (847) 785-5116

DEVICE NAME:

Trade name:

V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device

6N8399	V-Link Luer Activated Device with VitalShield
6N8378	Non-DEHP Catheter Extension Set withV-Link Luer Activated Device with VitalShield
6N8374	Non-DEHP Catheter Extension Set withV-Link Luer Activated Device with VitalShield
6N8377	Non-DEHP Y-Type Catheter Extension Set withV-Link Luer Activated Device with VitalShield
6N8371	Non-DEHP Y-Type Catheter Extension Set withV-Link Luer Activated Device with VitalShield

Table 5-1. Product Codes for V-Link Antimicrobial Luer Activated Device

AUG - 4 2008

{1}------------------------------------------------

K081287 29

Section 5, 510(k) Summary

Common name: IV Administration Set

Classification name:

IV Administration Set (21 CFR 880.5440, Product Code FPA)

PREDICATE DEVICE:

Table 5-2. Previous 510(k)s

Device	Company	Previous 510(k)	Clearance date
CLEARLINK Antimicrobial LuerActivated Device and Extension Setswith CLEARLINK Antimicrobial LuerActivated Device	BaxterHealthcare	K072576	November 6,2007

DESCRIPTION OF THE DEVICE:

No design changes have been made to the V-Link Antimicrobial Luer Activated Device which was cleared on November 6, 2007. This submission adds supplemental data on the efficacy and durability of the antimicrobial coating.

STATEMENT OF INTENDED USE:

{2}------------------------------------------------

K081289 3 of 3

Section 5, 510(k) Summary

Special 510(k) Premarket Notification V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The Baxter V-Link Antimicrobial Luer Activated Device is substantially equivalent to Baxter's current legally marketed V-Link Antimicrobial Luer Activated Device cleared November 6, 2007 (K072576).

DISCUSSION OF NONCLINICAL TESTS:

Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use.

CONCLUSION:

The V-Link Antimicrobial Luer Activated Device is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. In the center of the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The overall design is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 4 2008

Ms. Nanette Hedden Manager, Global Regulatory Affairs Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, Illinois 60085

Re: K081289

Trade/Device Name: V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA, FMG Dated: May 6, 2008 Received: May 7, 2008

Dear Ms. Hedden:

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.

{4}------------------------------------------------

Page 2 - Ms. Hedden

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 the reporting 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 vours.

Quts

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K081289

Device Name:

V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR AND/OR AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sidn-Um) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

KO8/289 510(k) Number: _

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.