Predicate Devices

Reference Devices

K223175, K180739, K172544, K161808, K153158, K142011, K130245, K123868, K112893, K952074, K160007, K150860

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes basic fluid administration sets and the performance testing focuses on mechanical and physical properties, not computational analysis or algorithms. There are no mentions of AI, ML, or related concepts.

Therapeutic

No
A therapeutic device is one that treats a disease or condition. This device is for administering fluids, which is a supportive function, not a direct treatment for a disease.

Diagnostic

No

Explanation: The device is described as a "Solution Administration Set" for the "administration of fluids from a container into the patient's vascular system." This indicates a therapeutic or administration function, not a diagnostic one. No part of the description suggests it is used to identify or determine the nature of a disease or condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of "Solution Administration Sets" which are described as "single use disposable, non-pyrogenic, sterile devices". The performance studies also detail bench tests related to mechanical, pressure, and material properties, all indicative of a physical hardware device. There is no mention of software as the primary component or function.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "For the administration of fluids from a container into the patient's vascular system through a vascular access device." This describes a device used directly on or in the patient for therapeutic purposes (administering fluids).
Device Description: The description confirms it's a "Solution Administration Set" used for "administration of fluids from a container into the patient's vascular system." This is consistent with a device used for infusion or injection.
IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).

This device is clearly used in vivo (within the living body) for administering substances, not for testing samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For the administration of fluids from a container into the patient's vascular system through a vascular access device.

Product codes

FPA, FMG, FPB

Device Description

The proposed devices consist of Solution Administration Sets. These devices include Basic, Secondary, CONTINU-FLO solution sets, Stand-Alone devices and Chemotherapy devices (see Table 2 for a list of subject device set names per product family). They are single use disposable, non-pyrogenic, sterile devices intended for the administration of fluids from a container into the patient's vascular system.

The Basic solution sets consist of a combination of the following components: spike tip protector, non-vented or DUO-VENT macro or micro spike with a non-DEHP or DEHP drip chamber, DEHP or non-DEHP tubing, slide clamp, regulating roller clamp or On/Off roller clamp. Clearlink Luer activated valve (LAV) or Interlink injection site. 0.2 or 1.2 micron inline filter, and two-piece male Luer lock with cap or one-piece male luer and with cap. The Basic solution sets are used to administer solutions directly from a container to a patient vascular system. These sets can be used with or without a Baxter infusion pump.

The Secondary solution sets consist of a combination of the following components: spike tip protector, non-vented or DUO-VENT spike with a DEHP or non-DEHP drip chamber, non-DEHP or DEHP tubing, regulating roller clamp or On/Off roller clamp, two-piece male Luer lock with cap or one-piece male Luer with cap and hanger. Secondary solution sets are used in conjunction with CONTINU-FLO solution sets to administer intermittent fluids to the patient.

The CONTINU-FLO solution sets consist of a combination of the following components: spike tip protector, non-vented, vented or DUO-VENT macro or micro spike with a DEHP or non-DEHP drip chamber, non-DEHP or DEHP tubing, backcheck valve, slide clamp, regulating roller clamp or On/Off roller clamp. Clearlink Luer activated valve (LAV) or Interlink injection site, 3 port manifold, 4-way large bore stopcock, female Luer Lock and two-piece male Luer lock with cap. The CONTINUFLO solution sets are used to administer fluids from a container to a patient's vascular system. They can be used for gravity or pump infusion of I.V. fluids. CONTINU-FLO solution sets contain the Interlink Injection Site or Clearlink injection site that can be used for the administration of secondary medication. They also contain a check valve which prevents backflow of solution from the secondary medication container into the primary container during the administration of secondary medication.

The Stand-Alone devices are 4-way large bore stopcocks with non-vented female cap, Luer-Lock nut and a vented male Luer cover and 3 port manifolds with male Luer breather cap and Luer Lock Cap. The Stand-Alone devices are used in combination with IV sets to administer solutions directly from a container to a patient's vascular system.

The Chemotherapy devices consist of a combination of the following components: a spike tip protector, vented spike or non-vented spike, non-DEHP drip chamber, PE lined tubing, slide clamp, 0.2-micron filter, roller clamp, Clearlink Luer activated valve (LAV) or Interlink injection site, two-piece male Luer lock with cap or one-piece male Luer with cap. The Chemotherapy sets are used to administer solutions directly from a container to a patient vascular system. These sets can be used with or without a Baxter infusion pump.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's vascular system

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench tests listed were conducted for the Solution Administration Sets and were found to be in conformance with FDA recognized standards ISO 80369-7: 2021 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications. Performance testing includes mechanical (tensile strength) pressure (burst, leakage, backflow, internal), stress cracking, resistance, torque, spike insertion/removal force, drop form accuracy, vacuum, pump / set integrity, DEHP content.

Filter performance testing included particulate retention, integrity, air filter flow. Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP Acceptance criteria.

Microbial Ingress testing was conducted on all potential points of microbial entry into the sterile fluid pathway of the proposed devices subject to this premarket notification following Baxter's testing strategy (as previously cleared under K223175 (cleared on March 10, 2023)) of challenging the connections during simulated clinical use to ensure the absence of microbial ingress into the sterile fluid path. All test results meet their acceptance criteria and support that the proposed devices are appropriately designed for their intended use.

All test results meet their acceptance criteria and support that the proposed devices are appropriately designed for their intended use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K203609

Reference Device(s)

K223175, K180739, K172544, K161808, K153158, K142011, K130245, K123868, K112893, K952074, K160007, K150860

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 14, 2025

Baxter Healthcare Corporation Meaghan Bonn Principal Regulatory Affairs Specialist 25212 W IL Route 120 Round Lake, Illinois 60073

Re: K243529

Trade/Device Name: Solution Administration Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA. FMG. FPB Dated: February 6, 2025 Received: February 12, 2025

Dear Meaghan Bonn:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Porsche Bennett

Porsche Bennett For David Wolloscheck Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K243529

Device Name Solution Administration Sets

Indications for Use (Describe)

For the administration of fluids from a container into the patient's vascular system through a vascular access device.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K243529 - 510(k) Summary

SUBMITTER:

Name: Baxter Healthcare Corporation Address: One Baxter Parkway Deerfield, Illinois 60015 Telephone Number: (224) 948-2000 Date Prepared: March 14, 2025

CONTACT PERSON:

Meaghan Bonn Principal Specialist, Regulatory Affairs 25212 West Illinois Route 120 Round Lake, IL 60073 Telephone: (224) 270 6470 Fax: (224) 270 4119

IDENTIFICATION OF THE DEVICE:

Trade/Device Name: Solution Administration Sets Common/Usual Name: Set, Administration, Intravascular Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FPA

Trade/Device Name: Solution Administration Sets Common/Usual Name: Stopcock, I.V. Set Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FMG

Trade/Device Name: Solution Administration Sets

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Common/Usual Name: Filter, infusion line Classification Panel: 80 General Hospital

Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FPB

PREDICATE DEVICE:

Table 1. Predicate Device
---------------------------

Device	Company	Predicate 510(k)
Intravascular
Administration Sets	Baxter Healthcare
Corporation	K203609	September 30, 2021

SUBJECT DEVICE:

Table 2. Subject Device Set Names per Product Family

Product Family	Product Name
Basic Solution Sets	Solution Set (X5, with varied lengths)
	Basic Solution Set
	Solution Set with DUO-VENT Spike (X2, with
varied lengths)
	INTERLINK System Y-Type Solution Set
	IV Fat Emulsion Administration Set
	Non-DEHP IV Fat Emulsion Administration Set
(X2, with varied lengths)
	INTERLINK System Solution Set with DUO-VENT
Spike
	INTERLINK System Solution Set (X3, with varied
lengths)
	CLEARLINK System Solution Set (X3, with varied
lengths)
	CLEARLINK System Non-DEHP Solution Set with
DUO-VENT Spike
	CLEARLINK System Non-DEHP Solution Set (X4,
with varied lengths)
	Non-DEHP Solution Set with DUO-VENT Spike
CONTINU-FLO Sets	(X2, with varied lengths)
	CONTINU-FLO Solution Set (X4, with varied
lengths)
	CLEARLINK System CONTINU-FLO Solution Set
(X9, with varied lengths)
	CONTINU-FLO Solution Set with DUO-VENT
Spike
	Non-DEHP CONTINU-FLO Solution Set
	CLEARLINK System Vented CONTINU-FLO
Solution Set
	CLEARLINK System Non-DEHP CONTINU-FLO
Solution Set (X11 with varied lengths)
	CLEARLINK System Non-DEHP CONTINU-FLO
Solution Set with DUO- VENT Spike (X3, with
varied lengths)
	INTERLINK System CONTINU-FLO Solution Set
(X2, with varied lengths)
	CLEARLINK System Solution Set with DUO-
VENT Spike (X3, with varied lengths)
Secondary Sets	CLEARLINK System Secondary Medication Set
	CLEARLINK System Secondary Medication Set
with DUO-VENT Spike
	CLEARLINK System Non-DEHP Secondary
Medication Set with DUO-VENT Spike (X2, with
varied lengths)
Chemotherapy Sets	INTERLINK System Vented PE-lined Solution Set
with 0.2 Micron Filter
	INTERLINK System PE-lined Solution Set with 0.2
Micron Filter
	CLEARLINK System Vented PE-lined Solution Set
with 0.2 Micron Filter
	CLEARLINK System PE-lined Solution Set with
0.2 Micron Filter (X2, with varied lengths)
	CLEARLINK System PE-lined Solution Set with
DUO-VENT Spike
	PE lined Solution Set with DUO-VENT Spike
	INTERLINK System PE-lined Solution Set with
DUO-VENT Spike
Stand-Alone Sets	Large Bore Stopcock
	Two Gang Large Bore Stopcock Manifold
	Three Gang Large Bore Stopcock Manifold
	3-Port Manifold with Check Valves

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Code #	Device Description
1C8581	Image: Interlink System Y-Type Solution Set 79" (2.0 m)	1. Spike Tip Protector

Spike
Roller Clamp
Drip Chamber
Slide Clamp
Interlink Y-Site
Male Luer
Male Luer Cap |
| 1C8722 | Image: Clearlink System CONTINU-FLO Solution Set 108" (2.7 m)
Extension Set 20" (50cm) 3.3 mL
Extension Set 5.5" (14cm) 0.74 mL | 1. Spike Tip Protector
Spike
Drip Chamber
Check Valve
Clearlink Y-Site
Pump Compatible Slide Clamp
Roller Clamp
In Line Connection
Slide Clamp
Male Luer
Male Luer Cap |
| 2C6256 | Image: Clearlink System CONTINU-FLO Solution Set 124" (3.12 m) | 1. Spike Tip Protector
Spike
Drip Chamber
Check Valve
Clearlink Y-Site
Pump Compatible Slide Clamp
Roller Clamp
Stopcock Manifold
Slide Clamp
Male Luer
Male Luer Cap |
| 2C6419 | Image: Interlink System Solution Set with DUO-VENT Spike, 92" (2.3m) | 1. Spike Tip Protector
Spike
Air Vent
Drip Chamber
Pump Compatible Slide Clamp
Roller Clamp
Interlink Y-Site
Male Luer
Male Luer Cap |
| 2C8548 | Image: Clearlink System Vented CONTINU-FLO Solution Set 104" (2.6 m) | 1. Spike Tip Protector
Spike
Air Vent |
| Code # | Device Description | |
| | Image: Device Description | 4. Drop Former
Drip chamber
Check Valve
Clearlink Y-site
Pump Compatible Slide Clamp
Roller Clamp
Male Luer
Male Luer Cap |
| 2C8931 | Clearlink System CONTINU-FLO Solution Set 128" (3.21m)
Image: Device | 1. Spike Tip Protector
Spike
Drip Chamber
Check Valve
Clearlink Y-Site
Pump Compatible Slide Clamp
Roller Clamp
Manifold
Stopcock
Slide Clamp
Male Luer
Male Luer Cap |
| 2H7463 | Clearlink System Non – DEHP Secondary Medication Set with DUO-VENT Spike 37" (93 cm)
Image: Device | 1. Spike Tip Protector
Spike
Air Vent
Drop Former
Drip Chamber
Roller Clamp
Male Luer
Male Luer Cap
Hanger |
| 2H8405 | Non - DEHP Solution Set with DUO-VENT Spike 93" (2.4 m)
Image: Device | 1. Spike Tip Protector
Spike
Air Vent
Drip Chamber
Solution Filter
Slide Clamp
Roller Clamp
Male Luer
Male Luer Cap |
| 2R8480 | Clearlink System Non – DEHP Solution Set with DUO-VENT Spike 103" (2.6m)
Image: Device | 1. Spike Tip Protector
Spike
Air Vent
Drip Chamber
Pump compatible Slide Clamp
Roller Clamp
IV Express filter
Slide Clamp |
| Code # | Device Description | |
| | | 9. Clearlink Y-Site
Male Luer
Male Luer Cap |
| 2R8486 | Clearlink System Non-DEHP Solution Set 107" (2.7m)
| 1. Spike Tip Protector
Spike
Drip Chamber
Pump Compatible Slide Clamp
Roller Clamp
Clearlink Y-Site
Filter
Slide Clamp
Male Luer
Male Luer Cap |
| 2R8875 | Clearlink System Solution Set with DUO-VENT Spike 117" (2.9m)
| 1. Spike Tip Protector
Spike
Air Vent
Drip Chamber
Pump Compatible Slide Clamp
Roller Clamp
Clearlink Y-Site
Male Luer
Male Luer Cap |
| ALT2403 | Clearlink System – QuickStay Set
| 1. Spike Tip Protector
Spike
Air Vent
Drip Chamber
Check Valve
Clearlink Y-Site
Roller Clamp
Male Luer
Male Luer Cap |

Table 3. Proposed Representative Solution Administration Set Configurations

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Table 3. Proposed Representative Solution Administration Set Configurations

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Table 3. Proposed Representative Solution Administration Set Configurations

REASON FOR SUBMISSION:

The basis for this premarket notification is (where applicable):

A change to the sterile fluid path distal tip protector (vented to non-vented) and 1. material of construction.
1. A modification to the proximal Luer tip protector design.
1. A modification to the male and female Luers for dimensional compliance to ISO 80369-7: 2021 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

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1. A change in design of the top end spike and chamber and expansion of non-DEHP product portfolio.
1. Updates to product labels, including:
- a. Addition of expiration dating,
- b. Changes in indications for use
- c. Update to the pump compatibility statement and
- d. Implementation of other clarifying information to comply with Baxter's labeling standards.

These modifications do not impact the intended use, fundamental scientific technology of the devices, or impact safety or effectiveness of the devices.

DESCRIPTION OF THE DEVICE:

The proposed devices consist of Solution Administration Sets. These devices include Basic, Secondary, CONTINU-FLO solution sets, Stand-Alone devices and Chemotherapy devices (see Table 2 for a list of subject device set names per product family). They are single use disposable, non-pyrogenic, sterile devices intended for the administration of fluids from a container into the patient's vascular system.

The Basic solution sets consist of a combination of the following components: spike tip protector, non-vented or DUO-VENT macro or micro spike with a non-DEHP or DEHP drip chamber, DEHP or non-DEHP tubing, slide clamp, regulating roller clamp or On/Off roller clamp. Clearlink Luer activated valve (LAV) or Interlink injection site. 0.2 or 1.2 micron inline filter, and two-piece male Luer lock with cap or one-piece male luer and with cap. The Basic solution sets are used to administer solutions directly from a container to a patient vascular system. These sets can be used with or without a Baxter infusion pump.

The Secondary solution sets consist of a combination of the following components: spike tip protector, non-vented or DUO-VENT spike with a DEHP or non-DEHP drip chamber, non-DEHP or DEHP tubing, regulating roller clamp or On/Off roller clamp, two-piece male Luer lock with cap or one-piece male Luer with cap and hanger. Secondary solution sets are used in conjunction with CONTINU-FLO solution sets to administer intermittent fluids to the patient.

The CONTINU-FLO solution sets consist of a combination of the following components: spike tip protector, non-vented, vented or DUO-VENT macro or micro spike with a DEHP or non-DEHP drip chamber, non-DEHP or DEHP tubing, backcheck valve, slide clamp, regulating roller clamp or On/Off roller clamp. Clearlink Luer activated valve (LAV) or Interlink injection site, 3 port manifold, 4-way large bore stopcock, female Luer Lock and two-piece male Luer lock with cap. The CONTINUFLO solution sets are used to administer fluids from a container to

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a patient's vascular system. They can be used for gravity or pump infusion of I.V. fluids. CONTINU-FLO solution sets contain the Interlink Injection Site or Clearlink injection site that can be used for the administration of secondary medication. They also contain a check valve which prevents backflow of solution from the secondary medication container into the primary container during the administration of secondary medication.

The Stand-Alone devices are 4-way large bore stopcocks with non-vented female cap, Luer-Lock nut and a vented male Luer cover and 3 port manifolds with male Luer breather cap and Luer Lock Cap. The Stand-Alone devices are used in combination with IV sets to administer solutions directly from a container to a patient's vascular system.

The Chemotherapy devices consist of a combination of the following components: a spike tip protector, vented spike or non-vented spike, non-DEHP drip chamber, PE lined tubing, slide clamp, 0.2-micron filter, roller clamp, Clearlink Luer activated valve (LAV) or Interlink injection site, two-piece male Luer lock with cap or one-piece male Luer with cap. The Chemotherapy sets are used to administer solutions directly from a container to a patient vascular system. These sets can be used with or without a Baxter infusion pump.

These devices were previously cleared under 510(k) premarket notification K223175 on March 10, 2023, K203609 on September 30, 2021, K180739 on May 28, 2019, K172544 on September 22, 2017, K161808 on June 21, 2017, K153158 on December 28, 2015, K142011 on August 18, 2014, K130245 on March 01, 2013, K123868 on January 8, 2013, K112893 on October 18, 2011 and K952074 on July 27, 1995, K160007 on December 19, 2016, K150860 on April 16, 2015.

INDICATIONS FOR USE:

For the administration of fluids from a container into the patient's vascular system through a vascular access device.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The proposed devices are substantially equivalent to the predicate devices K203609, previously cleared under 510(k) premarket notification on September 30, 2021. The intended use and function of the proposed devices are equivalent to the predicate devices.

Table 4 is a device comparison table outlining the differences between the predicate and proposed devices.

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| Features | Predicate Devices
Cleared under K203609 | Subject Devices, K243529 | Assessment of Differences |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the administration of
fluids from a container into
the patient's vascular
system through a vascular
access device. | Same | N/A |
| Indication for
Use | For the administration of
fluids from a container into
the patient's vascular
system through a vascular
access device. | Same | N/A |
| Regulation
Number | 21 CFR 880.5440 | Same | N/A |
| Product Code | FPA | FPA, FMG, FPB | Addition of stopcocks and
manifolds and Infusion Line
(In-Line) Filter products. |
| Sterility | Sterile; Radiation | Same | N/A |
| Sterility
Assurance
Level | $10^{-6}$ | Same | N/A |
| Non-Pyrogenic | Yes | Same | N/A |
| Single Use | Yes | Same | N/A |
| Shelf Life | 2 years | Same | N/A |
| Priming
Volume | 6.1 mL – 21.2 mL | 0.55 mL – 21.2 mL | The subject devices include a
wider range of priming
volumes.

Table 4. Device Comparison

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Table 4. Device Comparison

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Table 4. Device Comparison

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DISCUSSION OF NONCLINICAL TESTS:

Bench tests listed were conducted for the Solution Administration Sets and were found to be in conformance with FDA recognized standards ISO 80369-7: 2021 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications. Performance testing includes mechanical (tensile strength) pressure (burst, leakage, backflow, internal), stress cracking, resistance, torque, spike insertion/removal force, drop form accuracy, vacuum, pump / set integrity, DEHP content.

Filter performance testing included particulate retention, integrity, air filter flow. Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP Acceptance criteria.

Microbial Ingress testing was conducted on all potential points of microbial entry into the sterile fluid pathway of the proposed devices subject to this premarket notification following Baxter's testing strategy (as previously cleared under K223175 (cleared on March 10, 2023)) of challenging the connections during simulated clinical use to ensure the absence of microbial ingress into the sterile fluid path. All test results meet their acceptance criteria and support that the proposed devices are appropriately designed for their intended use.

All test results meet their acceptance criteria and support that the proposed devices are appropriately designed for their intended use.

BIOCOMPATIBILITY:

In accordance with ISO 10993-1, the Solution Administration Sets are classified as: external communicating device, indirect blood path, prolonged contact duration. The proposed devices are biocompatible and appropriate for its intended use.

Biocompatibility assessments were conducted based on ISO-10993-1, Biological Evaluation of Medical Devices and FDA-2013-D-0350 Guidance for Industry and FDA Staff, "Use of International Standard ISO-10993-1, "Biological evaluation of medical devices – Part 1. Evaluation and testing within a risk management process," All tests were conducted on final, finished device. The biocompatibility tests that were conducted are:

Cytotoxicity ●
Sensitization ●

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Intracutaneous (Irritation) Reactivity ●
Acute Systemic Toxicity
30 Day Systemic Repeat Dose Toxicity Study ●
Material Mediated Pyrogen
Hemolysis ●

STERILITY, PACKAGING AND SHELF-LIFE:

Sterilization process was established per ISO 11137-1: 2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; the devices are sterilized via radiation with a minimum Sterility Assurance Level (SAL) of 106. The Minimum Sterilizing Dose (MSD) required to provide a 10° SAL for the bioburden (sub) categories was established and validated as per ISO 11137-2: 2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose, Method 1. The continued validity of the MSD for these bioburden (sub) categories is confirmed via periodic dose audit studies. In addition, routine periodic pre-sterilization bioburden testing is performed for each (sub) category. Package verification testing was performed on the representative devices is in accordance with ISO 11607-1: 2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (Simulated Distribution performed per ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems) and included the following inspections to verify sterile barrier packaging requirements were met: visual (ASTM F1886 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection), seal strength (ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials), and bubble test (ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test). The products have a 2-year shelf-life that is confirmed via accelerated aging executed via ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices.

CONCLUSION:

The non-clinical data demonstrates that the subject devices are substantially equivalent and perform comparably to the predicate devices that are legally marketed for the same intended use and no new questions of clinical safety and effectiveness was raised.