The Baxter Neutral Luer Activated Device is intended for single patient use with a vascular access device for the administration of drugs and solutions without needles, thus eliminating the potential for needle-stick injuries during use. This 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. This device may be used with low pressure power injectors.

Device Description

The proposed devices, which are the subject of this Special 510(k) Premarket Notification. consist of a power injectable extension set without the One-Link Needle-free IV connector, extension set codes with the One-Link Needle-free IV connector bonded to the rest of the set, standard bore power injectable extension sets, and a power injectable extension set with a one piece male Luer. They are single use disposable devices intended for use with a vascular access device for the withdrawal of fluids and/or the continuous or intermittent administration of fluids.

AI/ML Overview

The provided document describes a Special 510(k) Premarket Notification for updated configurations of the Neutral Luer Activated Device (One-Link Needle-free IV connector) and Extension Sets. The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (K120443) by adding new set configurations, rather than introducing a completely new device or technology. Therefore, the "study" described focuses on non-clinical performance testing to ensure the new configurations maintain the safety and effectiveness of the predicate device.

Here's a breakdown of the requested information based on the provided text, recognizing that some points are not fully applicable or explicitly detailed for this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All test results meet their acceptance criteria," but does not explicitly list the specific quantitative acceptance criteria for each test. For instance, for the "Tubing bond strength test," the document doesn't specify what minimum bond strength (e.g., in pounds-force) was considered acceptable.

Test Conducted	Reported Device Performance	Acceptance Criteria (Not explicitly quantified in text)
ISO Luer tests on male Luer lock connectors	Met acceptance criteria	Not explicitly quantified
Tubing bond strength test on solvent bonds	Met acceptance criteria	Not explicitly quantified
Solvent bond pressure test	Met acceptance criteria	Not explicitly quantified
Clamp shut-off test	Met acceptance criteria	Not explicitly quantified
Power injector compatibility test	Met acceptance criteria (specifically, compatible with 325 psi, 10 mL/s)	Not explicitly quantified, but device features specify compatibility with 325 psi (2241 kPa) and 10 mL/s
Connector disengagement test	Met acceptance criteria	Not explicitly quantified
Post sterilization lipid stress test	Met acceptance criteria	Not explicitly quantified
Pressure failure mode simulation	Met acceptance criteria	Not explicitly quantified
Burst pressure test	Met acceptance criteria	Not explicitly quantified

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

Sample Size: The document does not specify the sample size for any of the individual non-clinical tests. It simply states that "all test results meet their acceptance criteria."
Data Provenance: The tests were conducted by Baxter Healthcare Corporation. The document does not specify the country of origin of the data beyond the company's location (Deerfield, Illinois, USA). The tests are inherently non-clinical (laboratory/bench testing) rather than clinical retrospective or prospective studies.

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

This question is not applicable to this type of regulatory submission. The "ground truth" for non-clinical performance tests is typically established by engineering specifications, recognized industry standards (like ISO standards mentioned for Luer tests), and risk analysis, rather than expert consensus on medical images or patient outcomes. The performance is measured against predefined engineering and safety benchmarks.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are common in clinical studies where expert review and consensus are needed to determine an outcome (e.g., presence of a disease). For non-clinical bench testing, the results are typically quantitative measurements compared against predefined acceptance criteria, and thus do not require an adjudication process involving multiple human experts in the same way.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic devices or AI algorithms that assist human readers in interpreting data (e.g., medical images). The submitted device is an IV connector and extension set, which is a medical device for fluid administration, not a diagnostic or AI-assisted interpretation tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical medical product, not an AI algorithm.

7. The Type of Ground Truth Used

For this submission, the "ground truth" is based on engineering specifications, recognized industry standards (e.g., ISO Luer tests), and design verification tests derived from risk analyses. It's about demonstrating that the physical device components (connections, bonds, materials) perform as expected under specified conditions (pressure, flow rate, stress) to ensure safety and effectiveness for its intended use, rather than comparing against pathology, clinical outcomes, or expert consensus on a diagnostic finding.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical device, not an AI model that requires a training set of data.

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

This question is not applicable. As stated above, this submission is for a physical medical device, not an AI model requiring a training set.

Summary

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K132734

Special 510(k) Premarket Notification Neutral Luer Activated Device (One-Link Needle-free IV connector) and Extension Sets with the One-Link Needle-free IV connector

Section 5. 510(k) Summary Page 1 of 4

5. 510(K) SUMMARY

September 24, 2013

OWNER:

Baxter Healthcare Corporation

One Baxter Parkway

Deerfield, Illinois 60015

CONTACT PERSON:

Gary Chumbimune

Manager, Global Regulatory Affairs

32650 N Wilson Road

Round Lake, IL 60073

Telephone: (224) 270-3312

Fax: (224) 270-4900

DEVICE NAME:

Trade name:

Neutral Luer Activated Device (One-Link Needle-free IV connector) and Extension Sets with One-Link Needle-free IV connector

ост о 8 2013

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Table 5-1. Proposed Set Configurations

Codenumber	Name
2N1333	Non-DEHP Standard Bore Catheter Extension Set, Power Injectable (325 psi,2241 kPa)
7N8390	One-Link Non-DEHP Microbore Catheter Extension Set. Bonded Needle-freeIV Connector with Neutral Fluid Displacement, Power Injectable (325 psi,2241 kPa)
7N8391	One-Link Non-DEHP Standard Bore Catheter Extension Set, Bonded Needle-free IV Connector with Neutral Fluid Displacement, Power Injectable (325 psi,2241 kPa)
7N8301	One-Link Non-DEHP Standard Bore Catheter Extension Set, Needle-free IVConnector with Neutral Fluid Displacement, Power Injectable (325 psi, 2241kPa)
7N8310	One-Link Non-DEHP Microbore Catheter Extension Set, Needle-free IVConnector with Neutral Fluid Displacement, Power Injectable (325 psi, 2241kPa)

Common name: IV Administration Set

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

PREDICATE DEVICE:

Table 5-2. Predicate 510(k)

Device	Company	Previous$10(k)	Clearancedate
Neutral Luer Activated Device andExtension Sets with Neutral Lucr ActivatedDevice	Baxter Healthcare	K120443	May 22, 2012

DESCRIPTION OF THE DEVICE:

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device for the withdrawal of fluids and/or the continuous or intermittent administration of fluids, The proposed devices will provide additional set configurations to clinicians that:

1. Require/prefer the larger bore tubing to infuse fluid via gravity at high rates that cannot be achieved with microbore tubing,
1. Request the use of extension sets with a permanently affixed One-Link Needle-free IV connector.
1. Prefer an extension set without the One-Link Needle-free IV connector.

They may be used with low pressure power injectors having a maximum pressure of 325 psi (2241 kPa) and a maximum flow rate of 10 mL/s. These proposed devices are equivalent to the current marketed devices, previously cleared under 510(k) premarket notification K120443 (cleared on May 22, 2012).

The basis for this premarket notification is the addition of five extension sets to the product line to provide additional options to the clinician. The addition of these five set configurations (3 with standard bore tubing and 2 with microbore tubing) to the product line does not impact the intended use or the fundamental scientific technology of the device. No new materials of construction are being introduced into this device as part of this update.

STATEMENT OF INTENDED USE:

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The proposed devices are equivalent to Baxter's currently legally marketed devices cleared on May 22, 2012 (K120443). The addition of five set configurations to the product line does not impact the intended use or the fundamental scientific technology of the device. No new materials of construction are being introduced into this device as part of this update. The intended use, the basic design, function and the materials for the proposed devices are equivalent to the predicate device.

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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 their acceptance criteria, and support that the proposed devices are appropriately designed for their intended use.

Performance Data: The following tests were conducted to evaluate the addition of five set configurations to the product line:

ISO Luer tests on male Luer lock connectors
. Tubing bond strength test on solvent bonds
. Solvent bond pressure test
. Clamp shut-off test
� Power injector compatibility test
. Connector disengagement test
� Post sterilization lipid stress test
. Pressure failure mode simulation
. Burst pressure test

All tests met the acceptance criteria.

Biocompatibility: No new materials of construction are being introduced into these devices as part of this Special 510(k) premarket submission. Biocompatibility assessment has been conducted based on ISO-10993, Biological Evaluation of Medical Devices for prolonged duration, external communicating, indirect blood path and Blue Book Memorandum G95-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," as recommended in the I.V. Administration sets guidance.

CONCLUSION:

The data from the non-clinical tests demonstrate that the proposed devices are as safe and effective, and perform as well as or better to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the United States. The logo consists of two main elements: the department's name arranged in a circular fashion around the perimeter and a stylized symbol in the center. The symbol is a stylized representation of a human figure embracing a bird, which is meant to symbolize the department's mission of protecting and promoting the health and well-being of Americans.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

October 8, 2013

Baxter Health Corporation Mr. Gary Chumbimune Manager, Global Regulatory Affairs 32650 North Wilson Road ROUND LAKE IL 60073

Re: K132734

Trade/Device Name: Neutral Luer Activated Device (One-Link Needle-free IV Connector) and Extension Sets with One-Link Needle-free IV Connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Il Product Code: FPA Dated: August 30, 2013 Received: September 3, 2013

Dear Mr. Chumbimune:

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 for ase stated in the More 28, 1976, the enactment date of the Medical Device Amendments. or 10 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 I he general variable 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 If your device is blussined (beourols. Existing major regulations affecting your device can be may be subject to additions. Title 21. Parts 800 to 898. In addition. FDA may round in ther announcements concerning your device in the Eederal Register.

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Page 2 - Mr. Chumbimune

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

Mary S.B.Dyner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. INDICATIONS FOR USE

510(k) Number (if known): K (32734

Device Name:

Neutral Luer Activated Device (One-Link Needle-free IV connector) and Extension Sets with the One-Link Needle-free IV connector

Indications for Use:

Prescription Use	X
AND/OR
Over-The-Counter Use

(Part 2) CFR 801 Subparı 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)

FDA
21 CFR Part 11

Richard C. Chapman 2013.10.03 12:12:15 04'00

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

510(k) Number: K132734

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.