Intended for use with a vascular access device for the administration of drugs and solutions. The CLEARLINK 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 CLEARLINK Antimicrobial Luer Activated Device contains an antimicrobial agent (metallic silver) that may inhibit the growth of microorganisms on the coated surfaces of the CLEARLINK device. The antimicrobial agent is intended to reduce the possibility that the device may become microbially contaminated. The antimicrobial agent is not intended to be used as a treatment for existing infections.

Device Description

The CLEARLINK 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 syringefluer 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 antiscptic before each connection.

The hard surfaces of the CLEARLINK Antimicrobial Luer Activated Device are coated with a proprietary silver technology that may destroy or inhibit the growth of microorganisms on the coated surfaces of the CLEARLINK device. The antimicrobial agent is intended to reduce the possibility that the device may become microbially compromised.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to existing legally marketed devices rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way one might find for a novel device or AI algorithm.

Due to the nature of a 510(k) summary, which often relies on non-clinical testing and comparison to predicates, many of the requested details (like sample sizes for test/training sets, expert qualifications, MRMC studies, and detailed quantitative performance metrics) are not present in the provided document.

Here's an analysis based on the available information:

1. Table of acceptance criteria and reported device performance:

The document broadly states: "All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use." However, it does not specify what those acceptance criteria are, nor does it provide quantitative reported device performance against those criteria. It focuses on the presence of an antimicrobial agent (metallic silver) and its intended function to inhibit microbial growth on coated surfaces.

Acceptance Criteria	Reported Device Performance
Not specified in document	"All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use."
Reduced possibility of microbial contamination on coated surfaces	Device contains metallic silver intended to inhibit growth of microorganisms on coated surfaces, thereby reducing microbial contamination.

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

Sample Size for Test Set: Not specified. The document mentions "nonclinical tests" but does not provide details on the number of units tested.
Data Provenance: Not specified, but given it's a 510(k) for a physical medical device (IV administration set), the testing would likely be performed in a laboratory setting by the manufacturer, or contracted labs, rather than involving patient data in the typical sense of a clinical study for an AI algorithm.

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

Not applicable as this is not a study requiring expert-established ground truth in the context of diagnostic interpretation (e.g., radiology reads). The "testing" referred to is non-clinical, likely engineering and microbiology testing.

4. Adjudication method for the test set:

Not applicable. This type of non-clinical testing typically involves objective measurements against established standards, not interpretation or adjudication by human experts for a "ground truth" derived from consensus.

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 an AI/software device that would involve human readers or MRMC studies. The device is a physical IV administration set with an antimicrobial coating.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

For the antimicrobial aspect, the "ground truth" would be established through microbiological assays demonstrating the inhibition of microbial growth on the coated surfaces under controlled laboratory conditions, likely comparing against non-coated versions or established controls.
For the functional aspects (e.g., fluid administration, luer activation), the ground truth would be established through engineering and performance standards for IV administration sets to ensure proper sealing, flow rates, and connection integrity.

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" in the context of this device, as it is a physical medical device and not a machine learning model.

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

Not applicable for the reason above.

In summary:

The provided 510(k) summary for the CLEARLINK Antimicrobial Luer Activated Device and Extension Sets focuses on demonstrating substantial equivalence through non-clinical risk analyses and design verification tests. While it states that acceptance criteria were met, it lacks the detailed quantitative performance metrics, sample sizes, expert qualifications, or study designs often associated with clinical trials or AI/software validation studies. This is typical for a 510(k) submission for a physical device where the primary change is the addition of a well-understood feature (antimicrobial coating) similar to those already cleared in predicate devices.

Summary

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K072576

5. 510(k) SUMMARY

October 18, 2007

OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

NOV 0 6 2007

CONTACT PERSON:

Nanette Hedden Manager, Global Regulatory Affairs 1620 Waukegan Rd. MPGR-AL McGaw Park. IL 60085 Telephone: (847) 473-6281 Fax: (847) 784-5116

DEVICE NAME:

Trade name:

CLEARLINK Antimicrobial Luer Activated Device and Extension Sets with CLEARLINK Antimicrobial Luer Activated Device

6N8399	Luer Activated System1Luer Activated Device with Silver for IV Access
6N8378	Luer Activated SystemNon-DEHP Catheter Extension Set
6N8374	Luer Activated SystemNon-DEHP Catheter Extension Set
6N8377	Luer Activated SystemNon-DEHP Y-Type Catheter Extension Set
6N8371	Luer Activated SystemNon-DEHP Y-Type Catheter Extension Set

Table 5-1. Product Codes for CLEARLINK Antimicrobial Lucr Activated Device

' Clearlink is a trademark of Baxter, Intl., Inc.

Other trademarks are the properties of their respective owners.

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1 Baxter Healthcare Corporation will be applying a brand name to replace Luer Activated System for the antimicrobial product prior to market release.

Common name: 1V Administration Set

Classification name:

1V Administration Set (21 CFR 880.5440. Product Code FPA)

PREDICATE DEVICE(S):

Device	Company	Previous 510(k)	Clearance date
ON-Q Silver SoakerAntimicrobialCatheter (Coating)	I-Flow	K051401	November 30, 2005
Modification toSolutionAdministration Setwith Capped LuerActivated Device	Baxter Healthcare	K003225	October 19, 2000
NP Medical CaplessLuer ActivatedValve	NP Medical	K973916	March 9, 1998
ElcamAntimicrobialStopcock (orManifold) (Coating)	Elcam Medical	K053405	May 11, 2006

Table 5-2. Previous 510(k)s

DESCRIPTION OF THE DEVICE:

The hard surfaces of the CLEARLINK Antimicrobial Luer Activated Device are coated with a proprietary silver technology that may destroy or inhibit the growth of

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microorganisms on the coated surfaces of the CLEARLINK device. The antimicrobial agent is intended to reduce the possibility that the device may become microbially compromised.

STATEMENT OF INTENDED USE:

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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The Baxter CLEARLINK Antimicrobial Luer Activated Device is substantially equivalent to Baxter's current legally marketed CLEARLINK Luer Activated Device cleared by 510(k) K003225 and NP Medical's 510(k) K973916. Baxter's current CLEARI.INK Luer Activated Device does not include the antimicrobial feature. The CLEARLINK Antimicrobial Luer Activated Device utilizes an antimicrobial agent equivalent to the coating in the 510(k) cleared on the I-Flow ON-Q SilverSoaker Catheter (K051401) and is similar to the antimicrobial agent (silver ions) used in Elcam Medical's Antimicrobial Stopcock (K053405).

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 CLEARLINK Antimicrobial Luer Activated Device is substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 6 2007

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

Re: K072576

Trade/Device Name: CLEARLINK Antimicrobial Luer Activated Device and Extension Sets with CLEARLINK Antimicrobial Luer Activated Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 12, 2007 Received: September 14, 2007

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.

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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 (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) 276-0115. 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 yours,

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);

Device Name: CLEARLINK Antimicrobial Luer Activated Device and Extension Sets with CLEARLINK Antimicrobial Luer Activated Device

Indications for Use:

Prescription Use __ X ________________________________________________________________________________________________________________________________________________________ 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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:	K472516
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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.