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

Device Description

The proposed devices, which are the subject of this Special 510(k) Premarket Notification, consist of the Clearlink Luer Activated Valve, Intravenous (IV) administration and IV extension sets with the Clearlink Luer Activated Valve. They are single use disposable devices intended for use with a vascular access device for continuous or intermittent fluid administration or withdrawal of fluids. These devices are the same as the current marketed devices, previously cleared on October 19, 2000 under 510(k) premarket notification "Modification to Solution Administration Set with Capped Luer Activated Device (Clearlink)" by Baxter Healthcare Corporation (K003255).

The Clearlink Luer Activated Valve is an in-line access site and can be connected to male Luer adapters (e.g., syringes or sets) to allow needleless access to the fluid or vascular path.

The IV administration sets with the Clearlink Luer Activated Valve are used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. They contain the Clearlink Luer Activated Valve Y-Site port that can be used for the administration of secondary medication.

The IV extension sets with the Clearlink Luer Activated Valve are used for the administration and withdrawal of fluids. They consist of the Clearlink Luer Activated Valve connected to the IV extension set.

The basis for this premarket notification is a proposed minor design change to Baxter's Clearlink Luer Activated Valve Y-Site design that is integral to the IV administration sets.

AI/ML Overview

This document describes a Special 510(k) Premarket Notification for a minor design change to an existing medical device, the Clearlink Luer Activated Valve and associated IV administration and extension sets. This type of submission focuses on demonstrating that the modified device remains substantially equivalent to the previously cleared predicate device, rather than proving efficacy or a new clinical benefit. Therefore, the information provided focuses on engineering and performance testing to confirm the design change does not negatively impact safety or function.

Given this context, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" will be interpreted in terms of the non-clinical bench testing performed for this 510(k) submission. Many of the requested specific points (e.g., sample size for test set, data provenance, ground truth experts, MRMC studies, standalone algorithm performance, training set details) are typically relevant for AI/ML device submissions or clinical trials, which are not applicable to this type of device and submission.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use." However, it does not explicitly list the quantitative acceptance criteria for each test. The "reported device performance" is implicitly stated as meeting these unquantified criteria.

Acceptance Criteria (Not explicitly quantified in the document)	Reported Device Performance
The device should demonstrate appropriate visual characteristics.	All visual inspections passed, implying device meets visual quality standards.
The device should maintain appropriate pressure differentials.	Testing confirmed appropriate pressure differential performance.
The device should be resistant to lipids.	Testing confirmed lipid resistance.
The device should withstand back pressure in a closed position.	Testing confirmed performance under back pressure (closed position).
The device should withstand back pressure with a male Luer in (open position).	Testing confirmed performance under back pressure (open position).
The device should prevent seepage at 6 psi low water pressure.	Testing confirmed no seepage at 6 psi low water pressure.
The ultrasonic weld joints should perform as expected.	Testing confirmed ultrasonic weld joint performance.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size for each bench test conducted.
Data Provenance: The tests were non-clinical bench tests conducted by Baxter Healthcare Corporation to evaluate a minor design modification. The location of the testing is not specified beyond Baxter Healthcare Corporation. The data is prospective in the sense that it was generated specifically for this regulatory submission to evaluate the new design. There is no mention of country of origin for the "data" in a clinical/patient sense, as it's bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable. For bench tests of this nature, "ground truth" is typically established by engineering specifications, published standards, or validated internal test methods rather than expert clinical consensus.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The results of bench tests are typically assessed against pre-defined engineering specifications or performance standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices and AI algorithms, not for a modified IV administration set.

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

Standalone Performance Study: Not applicable. This device is a mechanical medical device, not an AI/ML algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for the bench tests would have been established by engineering specifications, relevant industry standards (e.g., ISO, AAMI standards for IV sets), or internal validated test protocols that define acceptable performance limits for the characteristics being tested (e.g., pressure, leak rate, material integrity).

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is a mechanical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Ground Truth Establishment for Training Set: Not applicable. No training set was used.

Summary

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Special 510(k) Premarket Notification Clearlink Luer Activated Valve, IV Administration and IV Extension Sets with Clearlink Luer Activated Valve Section 5, 510(k) Summary

OCT 1 8 2011

K112 893

5. 510(k) SUMMARY

September 29, 2011

OWNER:

。

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

CONTACT PERSON:

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

DEVICE NAME:

Trade name: Clearlink Luer Activated Valve, Intravenous (IV) administration and IV extension sets with the Clearlink Luer Activated Valve

Clearlink Luer Activated Valve, Representative Intravenous (IV) administration and IV extension sets with the Clearlink Luer Activated Valve

Table 5-1.

Code number	Name
2N8399	Clearlink System Luer Activated Valve for IV Access, Vol. 0.25 mL
2N8378	Clearlink System Non-DEHP Catheter Extension Set, 7.6" (19.3 cm),Vol. 0.9 mL
2N8377	Clearlink System Non-DEHP Y-Type Catheter Extension Set, 6.5'' (16.5cm), Vol. 1.2 mL
2N8374	Clearlink System Non-DEHP Catheter Extension Set, 8.2" (21.0 cm),Vol. 0.5 mL
2N8371	Clearlink System Non-DEHP Y-Type Catheter Extension Set, 6.0" (15.2cm), Vol. 1.0 mL
2H8401	Clearlink System Non-DEHP Solution Set, 76" (1.9 m)
2C8425s	Clearlink System Solution Set, 100" (2.5 m)

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Special 510(k) Premarket Notification Clearlink Luer Activated Valve, IV Administration and IV Extension Sets with Clearlink Luer Activated Valve

Common name: Clearlink Luer Activated Valve, Intravenous (IV) administration and IV extension sets with the Clearlink Luer Activated Valve

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

. .

PREDICATE DEVICE:

Table 5-2. Previous 510(k)s

Device	Company	Previous510(k)	Clearancedate
Modification to SolutionAdministration Set with Capped LuerActivated Device (Clearlink).	BaxterHealthcare	K003225	October 19,2000

DESCRIPTION OF THE DEVICE:

The Clearlink Luer Activated Valve is an in-line access site and can be connected to male Luer adapters (e.g., syringes or sets) to allow needleless access to the fluid or vascular path.

. .

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Special 510(k) Premarket Notification Clearlink Luer Activated Valve, IV Administration and IV Extension Sets with Clearlink Luer Activated Valve

The basis for this premarket notification is a proposed minor design change to Baxter's Clearlink Luer Activated Valve Y-Site design that is integral to the IV administration sets.

STATEMENT OF INTENDED USE:

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The proposed devices consist of the Clearlink Luer Activated Valve, Intravenous (IV) administration and IV extension sets with the Clearlink Luer Activated Valve. These devices are the same as the current marketed devices, previously cleared on October 19, 2000 under 510(k) premarket notification "Modification to Solution Administration Set with Capped Luer Activated Device (Clearlink)" by Baxter Healthcare Corporation (K003255). A minor design change will be made to the Clearlink Luer Activated Valve Y-Site design that is integral to the IV administration sets in order to optimize the manufacturing assembly process. The intended use, the basic design, function and the materials for the proposed device are equivalent to the predicate device.

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Section 5, 510(k) Summary

Special 510(k) Premarket Notification Clearlink Luer Activated Valve, IV Administration and IV Extension Sets with Clearlink Luer Activated Valve

ﺎ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

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. The following bench tests were conducted to evaluate the effect of the design modification on the functional performance of the Clearlink Luer Activated Valve:

Visual inspection ●
. Pressure differential test
Lipid resistance test ●
. Back pressure test (closed position)
Back pressure test with male Luer in (open position) ●
6 psi low water pressure seepage test .
Ultrasonic weld joint performance .

CONCLUSION:

The proposed devices are substantially equivalent to the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

OCT 1 8 2011

Re: K112893

Trade/Device Name: Clearlink Luer Activated Valve, Intravenous (IV) administration and IV extension sets with the Clearlink Luer Activated Valve Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 29, 2011 Received: October 3, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson

Anthony D. Watson, B.S., M.S., M.B.A. 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): K11289 3

Device Name: Clearlink Luer Activated Valve, Intravenous (IV) administration and IV extension sets with the Clearlink Luer Activated Valve

Indications for Use:

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use
(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 14: 1 : 1 : 1 : 1 :

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rill C 10/7/4

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K112893

: :

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.