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 having a maximum pressure of 325 psi (2241 kPa) and a maximum flow rate of 10 mL/s.

Device Description

The Neutral Luer Activated Device (LAD) and Extension Sets with Neutral Luer Activated Device are single use disposable devices intended for use with a vascular access device for continuous or intermittent fluid administration or withdrawal of fluids. The device 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 and is designed to be easy to swab. A saline flush of 10 mL is able to clear the Neutral LAD of blood after sampling blood through the device. The Neutral LAD is clear and allows the clinician to view the fluid path of the device. The Neutral LAD has a low priming volume (0.08 mL) that allows medication to be flushed from the device with small amounts of fluid and is the maximum amount of medication that could potentially remain in the device when administered to a patient prior to flushing. A LAD with a low priming/residual volume is favored for pediatric patients or patients requiring fluid restriction. The device is a neutral fluid displacement LAD and does not require a specific clamping sequence in order to be used safely. This neutral displacement design has the added benefit of helping to reduce the occurrence of thrombotic catheter occlusions by limiting the reflux of blood into the catheter. The Neutral LAD 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.

AI/ML Overview

This 510(k) premarket notification describes a medical device, specifically the "Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated Device," not an AI/ML powered device. As such, the requested information regarding AI/ML study components (such as sample size for test/training sets, ground truth methodology, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable and cannot be extracted from the provided text.

The document focuses on demonstrating the substantial equivalence of the new device to existing predicate devices through non-clinical testing.

Here's the relevant information that can be extracted regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria	Reported Device Performance
Intended Use	Administration of drugs/solutions without needles, eliminating needle-stick injuries. In-line injection site for continuous/intermittent fluid administration/withdrawal.	The device is intended for these uses, aligning with the description. It functions as an in-line access site and allows needleless access.
Power Injection Compatibility	Maximum pressure of 325 psi (2241 kPa) and maximum flow rate of 10 mL/s.	The Neutral LAD 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. Testing supports this use.
Neutral Fluid Displacement	Does not require a specific clamping sequence for safe use; helps reduce thrombotic catheter occlusions by limiting blood reflux.	The device is described as "neutral fluid displacement LAD" which "does not require a specific clamping sequence in order to be used safely" and "has the added benefit of helping to reduce the occurrence of thrombotic catheter occlusions by limiting the reflux of blood into the catheter."
Swabability	Designed to be easy to swab.	The Neutral LAD "is designed to be easy to swab."
Visibility	Clear to allow clinicians to view the fluid path.	The Neutral LAD "is clear and allows the clinician to view the fluid path of the device."
Priming Volume	Low priming volume for pediatric patients or those requiring fluid restriction.	The Neutral LAD "has a low priming volume (0.08 mL)"
Blood Clearance (Saline Flush)	Capable of clearing blood after sampling with a 10 mL saline flush.	A "saline flush of 10 mL is able to clear the Neutral LAD of blood after sampling blood through the device."
Use Duration/Actuations	Not explicitly stated as acceptance criteria, but tested.	"Testing supports use of the device for 7 days and/or 200 actuations."
Sterility & Non-pyrogenic	Sterile and non-pyrogenic.	"The product is sterile and non-pyrogenic."
Functional, Biocompatibility, Microbial Ingress, Ease of Use	Met all acceptance criteria.	"This device met all the acceptance criteria for all functional, biocompatibility, microbial ingress, sterility and ease of use requirements and the data support that the device is appropriately designed for its intended use."

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

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a data test set for performance evaluation in the context of an algorithm's output. The "testing" refers to benchtop or in-vitro tests on the devices themselves.
The provenance of data refers to the specific non-clinical tests performed (e.g., pressure testing, flow rate testing, biocompatibility testing, microbial ingress testing, etc.). These are typically laboratory-based tests and not patient data.

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 a physical device, ground truth is established through adherence to engineering specifications, validated test methods, and regulatory standards for device performance, sterility, and biocompatibility. There is no concept of "expert ground truth" in the way it is used for diagnostic AI.

4. Adjudication method for the test set:

Not applicable. There is no "test set" in the context of human interpretation needing adjudication for an AI algorithm. Device performance is evaluated against predefined pass/fail criteria in laboratory settings.

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:

Not applicable. This is a physical medical device, not an AI/ML diagnostic or assistive tool.

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

Not applicable. This is a physical medical device, not an AI/ML algorithm.

7. The type of ground truth used:

Engineering specifications and regulatory standards. For example, pressure testing would have a ground truth defined by a specific pressure range (e.g., 325 psi maximum), and the device either meets or fails this. Biocompatibility would be determined by established ISO standards. Microbial ingress would have a ground truth of preventing microbial contamination.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. This is a physical medical device, not an AI/ML algorithm.

Summary

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

K120443

Traditional 510(k) Premarket Notification Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated Device Section 5, 510(k) Summary

MAY 2 2 2012

5. 510(k) SUMMARY

February 13, 2012

OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

CONTACT PERSON:

Nanette Hedden Sr. Manager, Global Regulatory Affairs 1620 Waukegan Road McGaw Park, Illinois 60085 Telephone: (847) 270-4871 Fax: (847) 270-4900 Email: Nanette_hedden@baxter.com

DEVICE NAME:

Trade name: Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated Device

Code	Product
7N8399	Neutral Luer Activated Device ,Power Injectable (325 psi, 2241 kPa),
7N8371	Neutral Luer Activated Device Non-DEHP Y-Type Microbore CatheterExtension Set
7N8377	Neutral Luer Activated Device Non-DEHP Y-Type Standard BoreCatheter Extension Set
7N8378	Neutral Luer Activated Device Non-DEHP Standard Bore CatheterExtension Set
7N8300	Neutral Luer Activated Device Non-DEHP Microbore CatheterExtension Set, Power Injectable (325 psi, 2241 kPa),

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

Common name: IV Administration Set

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

PREDICATE DEVICE:

Three predicate devices are cited in support of the substantial equivalence determination:

· Baxter Healthcare Solution Administration Sets with Capped Luer Activated Valve. K003225 cleared on October 19, 2000
· Pressure Rated Extension Sets, K083472 cleared on November 18, 2008
· InVision Plus Injection Port Systems, K991653, cleared June 24, 1999

DESCRIPTION OF THE DEVICE:

A saline flush of 10 mL is able to clear the Neutral LAD of blood after sampling blood through the device. The Neutral LAD is clear and allows the clinician to view the fluid path of the device.

The Neutral LAD has a low priming volume (0.08 mL) that allows medication to be flushed from the device with small amounts of fluid and is the maximum amount of medication that could potentially remain in the device when administered to a patient prior to flushing. A LAD with a low priming/residual volume is favored for pediatric patients or patients requiring fluid restriction.

The device is a neutral fluid displacement LAD and does not require a specific clamping sequence in order to be used safely. This neutral displacement design has the added benefit of helping to reduce the occurrence of thrombotic catheter occlusions by limiting the reflux of blood into the catheter. 1.2

1 Hadaway, Lynn C., "Reopen the Pipeline for IV Therapy," Nursing2005, Volume 33, Number 8, 54-62.

2 Infusion Nursing: An Evidence-Based Approach, ed. Mary Alexander, et al., (St. Louis: Saunders Elsevier, Inc. 2010), 495-515.

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

The Neutral LAD 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.

STATEMENT OF INTENDED USE:

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The Neutral Luer Activated Device and Extension sets with the Neutral Luer Activated Device are substantially equivalent to the predicate devices listed above. The Neutral LAD is a neutral fluid displacement device that does not require a specific clamping technique to work safely and effectively for continuous or intermittent fluid delivery. The Neutral LAD is designed to be easy to swab and is appropriate for use with power injectors having a maximum pressure of 325 psi (2241 kPa) and a maximum flow rate of 10 mL/s. The product is sterile and non-pyrogenic. Testing supports use of the device for 7 days and/or 200 actuations.

DISCUSSION OF NONCLINICAL TESTS:

Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. This device met all the acceptance criteria for all functional, biocompatibility, microbial ingress, sterility and ease of use requirements and the data support that the device is appropriately designed for its intended use.

CONCLUSION:

The Neutral Luer Activated Device (LAD) and Extension Sets with the Neutral Luer Activated Device are substantially equivalent to the predicate devices.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Public Health Service

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

MAY 2 2 2012

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

Re: K120443

Trade/Device Name: Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated Device

Regulation Number: 21 CFR 880.5440

Regulation Name: Set, Administration, Intravenous Regulatory Class: II

Product Code: FPA

Dated: April 27, 2012

Received: May 1, 2012

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.

{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); 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. arut

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

{5}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Neutral Luer Activated Device and Extension Sets with Neutral 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)

Rhl C. Ogen 5/22/12

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

510(k) Number:

-04/43

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.