The proposed devices consist of Intravascular Administration Sets. 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 proposed devices consist of a spike tip protector, non-vented spike, drip chamber, tubing, check valve, slide clamp, regulating roller clamp, Clearlink Luer activated valve (LAV), Interlink injection site, 3 Port Manifold, Stopcock, female Luer, two-piece male Luer lock and male Luer cap. The proposed devices are used to administer solution directly from a container to a patient vascular system. These sets can be used with or without a Baxter infusion pump.

AI/ML Overview

This document is a 510(k) summary for the Baxter Healthcare Corporation's Intravascular Administration Sets with Stopcock and Manifold (K223175). It does not contain information about a study comparing device performance against specific acceptance criteria in the context of an AI/human-in-the-loop setting. This type of submission is for medical devices that are substantially equivalent to a predicate device, and the focus is on demonstrating that the new device's technological characteristics do not raise new questions of safety or effectiveness.

Therefore, many of the requested items (e.g., reporting device performance against acceptance criteria, sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not present in this document because they are generally applicable to the evaluation of AI/ML-enabled medical devices or those requiring de novo classification, not typical 510(k) submissions for physical devices like administration sets.

However, I can extract information related to the device's performance testing which demonstrates its safety and effectiveness, as well as the types of studies conducted for substantiation.

Here's an attempt to answer based on the provided text, acknowledging that many requested fields are not applicable:

1. A table of acceptance criteria and the reported device performance

The document states: "All test results meet their acceptance criteria and support that the proposed devices are appropriately designed for their intended use." However, specific quantitative acceptance criteria and corresponding reported device performance values are not explicitly provided in a table format in this summary. Instead, it lists the types of tests performed and the standards they conform to.

Test Type	Standard / Description	Acceptance Status (as stated in document)
Luer Tests	ISO 80369-7 "Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications"	Met Acceptance Criteria
	ISO 594-1 "Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements"	Met Acceptance Criteria
	ISO 594-2 "Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings"	Met Acceptance Criteria
Biocompatibility	ISO 10993-1, Biological Evaluation of Medical Devices and FDA-2013-D-0350 Guidance for Industry and FDA Staff. Tests included: Cytotoxicity, Sensitization, Intracutaneous (Irritation) Reactivity, Acute Systemic Toxicity, 30 Day Systemic Repeat Dose Toxicity Study, Material Mediated Pyrogen, Hemolysis.	"Biocompatible and appropriate for its intended use"
Particulate Matter	USP <788> Particulate Matter in Injections	Met USP Acceptance criteria
Sterility	ANSI/AAMI/ISO 11137-2, "Sterilization of health care products - Radiation-Part 2: Establishing the sterilization dose." Doses typically 14.3 - 22.4 kGy, validated for 10^-6 SAL.	Met Acceptance Criteria
Shelf Life	Aging testing performed.	Supported a 2-year shelf-life claim
Microbial Ingress Testing	Baxter's testing strategy (previously cleared under K203609) simulating clinical use for spike, injection sites, and Luer Connector Sites.	Met Acceptance Criteria

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the various bench tests. Data provenance in terms of country of origin is not mentioned, and the tests are described as non-clinical bench tests or evaluations of materials. This is not a study involving human patient data, so "retrospective or prospective" doesn't apply in the same way as for AI/clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not an AI/ML device requiring expert ground truth for image/data interpretation. Ground truth for these tests is based on adherence to established international standards (ISO, USP) and validated testing protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML device requiring adjudication of expert interpretations for ground truth.

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 not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance of these Intravascular Administration Sets is established through adherence to recognized international standards and validated scientific testing protocols. For example:

Luer connectors: Conformance to ISO 80369-7, ISO 594-1, ISO 594-2.
Biocompatibility: Conformance to ISO 10993-1 and FDA guidance.
Particulate matter: Conformance to USP <788>.
Sterility: Conformance to ANSI/AAMI/ISO 11137-2.
Microbial ingress: Baxter's internally validated "testing strategy."

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set."

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

Not applicable. This is not an AI/ML device.

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). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 10, 2023

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

Re: K223175

Trade/Device Name: Intravascular Administration Sets with Stopcock and Manifold Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FMG Dated: January 31, 2023 Received: February 9, 2023

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 (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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).

Sincerely,

Danil Walloschek

David Wolloscheck, Ph.D. Acting 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

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Indications for Use

510(k) Number (if known) K223175

Device Name

Intravascular Administration Sets with Stopcock and Manifold

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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K223175- 510(k) Summary

OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

CONTACT PERSON:

Meaghan Bonn Principal Specialist, Regulatory Affairs 25212 West Illinois Route 120 Round Lake, IL 60073 Telephone: (847) 217 6197 Fax: (224) 270 4119

DATE PREPARED: March 10, 2023

IDENTIFICATION OF THE DEVICE:

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

PREDICATE DEVICE:

Table 1. Predicate Device

Device	Company	Predicate 510(k)	Clearance Date
Stopcock and I.V.Solution AdministrationSets with Stopcocks	Baxter HealthcareCorporation	K130245 (Codes:2C6607 and 2C6255)	March 1, 2013

REASON FOR SUBMISSION:

The basis for this premarket notification is a change which involves the inclusion of an expiry date on all packaging configuration of the proposed devices and update to the two

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piece luer to be dimensionally compliant to ISO80369-7. Additionally, updates are being made to the product labels, including a minor rewording of the indications for use, an update to the pump compatibility statement and implementation of other clarifying information to comply with Baxter's labeling standards. These modifications do not impact the intended use or the fundamental scientific technology of the devices.

DESCRIPTION OF THE DEVICE:

These sets were previously cleared under 510(k) premarket notification K932512 on Feb 22, 1994. The devices covered in this submission are substantially equivalent to the predicate devices, previously cleared under 510(k) premarket notification K130245 on March 1, 2013. The intended use and function of the proposed devices are equivalent to the predicate devices.

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 K130245 (Codes 2C6607 and 2C6255), previously cleared under 510(k) premarket notification on March 1, 2013. The intended use and function of the proposed devices are equivalent to the predicate devices.

Table 2 is a device comparison table outlining the differences between the predicate and proposed devices.

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Features	Predicate DevicesStopcock and I.V.Solution AdministrationSets with Stopcocks.K130245(Codes: 2C6607 and2C6255)	Proposed DevicesIntravascularAdministration Setwith Manifold andStopcockK223175	Assessment of Differences
Indication forUse	To administer fluidsfrom a container into thepatient's vascular systemthrough a vascular accessdevice.	For the administration offluids from a containerinto the patient'svascular system througha vascular access device.	Similar - See Comment # 1
RegulationNumber	21 CFR 880.5440	Same	N/A
Product Code	FMG	Same	N/A
Sterility	Sterile; GammaIrradiation	Same	N/A
SterilityAssuranceLevel	10-6	Same	N/A
Non-Pyrogenic	Yes	Same	N/A
Single Use	Yes	Same	N/A
Length	41" (103 cm) - 123" (316cm)	40" (101 cm) - 130" (333cm)	Different- See Comment # 2
PrimingVolume	6.2 mL - 19.8 mL	6.2 mL - 21.8 mL	Different - See Comment # 3
InnerDiameter	0.102" (0.26 cm) -0.111" (0.28cm)	Same	N/A
OuterDiameter	0.133" (0.34 cm) - 0.152"(0.39 cm)	Same	N/A
Fluid path Components/Materials
Spike & DripChamberAssembly	Acrylonitrile butadienestyrene (Spike)	Same (Spike)	N/A
	Polyvinyl Chloride(PVC) (Drip Chamber)	Same (Drip Chamber)	N/A
Tubing	Polyvinyl chloride (PVC)	Same	N/A
Check Valve	Polymethyl methacrylate(acrylic) (PMMA)(Inlet/Outlet)	Same	N/A
	Silicone rubber (SI)(Disk)
	Copolyester(Housing)
InterlinkInjection Site	Silicone lubricant,(Lubricant)	Same	N/A
	Natural syntheticpolyisoprene rubber,(Septum)
	Polycarbonate(Inlet/Outlet)
Clearlink	Silicone (Gland)	Same	N/A
	Polycarbonate (CenterPost)
	Polysulfone (Housing)
4-waystopcock(Large Bore)	Polyethylene (Handle)	Same	N/A
	Polycarbonate (LuerLock Nut)
	N/A	Polyester (Housing)	Different - See Comment #4
3-PortManifold	N/A	Silicone rubber (SI)(Disk)
	N/A	Acrylonitrile butadienestyrene (Collar)
Male Luer	Acrylonitrile butadienestyrene (ABS)(Luer Body)	Same	N/A
Female Luer	Polyester (PES)	Same	N/A

Table 2. Device Comparison

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Discussion of difirences in technological characteristics.

Comment# 1- Minor rewording of the Indications for Use statement has been made to better align with 21 CFR 880.5440 and for the purpose of streamlining the information provided to the user. This minor modification does not alter the disease or condition the device will diagnose, treat, prevent, cure/mitigate, or the patient population for which the

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device is intended to be used. In addition, the minor rewording does not reflect a different anatomical site from which a disease state or population may be inferred.

Comment # 2: The proposed devices offer sets with different lengths and injection sites. allowing the clinician to select the appropriate one for the administration of the intended therapy. Design control activities have been conducted and have confirmed that the different technological characteristics of the proposed devices do not raise different questions of safety and effectiveness.

Comment # 3: The proposed devices offer sets with different lengths and injection sites, allowing the clinician to select the appropriate one for the administration of the intended therapy. Design control activities have been conducted and have confirmed that the different technological characteristics of the proposed devices do not raise different questions of safety and effectiveness.

Comment # 4: This material has been used in another Baxter cleared device (cleared in K932512 (22/02/1994)) with the same/similar intended use and with the same type and duration of contact. Design control activities have been conducted and confirmed that there is no impact to safety or effectiveness for this application.

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 bench tests (Table 3) were conducted for the Intravascular Administration Sets with Stopcock and Manifold and were found to be in conformance with the following FDA recognized standards:

Test
ISO 80369-7 Luer Tests on male Luer Lock Connector
"Small-bore connectors for liquids and gases in healthcare applications - Part7: Connectors for intravascular or hypodermic applications"
ISO 594-1
"Conical fittings with a 6% (Luer) taper for syringes, needles and certainother medical equipment - Part 1: General requirements"
ISO 594-2

Table 3. Performance Data

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Test
"Conical fittings with a 6% (Luer) taper for syringes, needles and certainother medical equipment - Part 2: Lock fittings"

Biocompatibility:

In accordance with ISO 10993-1, the IV Administration Set with stopcock and manifold is 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
Intracutaneous (Irritation) Reactivity
Acute Systemic Toxicity
30 Day Systemic Repeat Dose Toxicity Study
Material Mediated Pyrogen
Hemolysis

Particulate matter testing was conducted in accordance with USP <788>Particulate Matter in Injections and met the USP Acceptance criteria.

Sterility:

The proposed devices are sterilized with gamma radiation. The products are in the bioburden (sub) category "General Sets Labeled Sterile" or "General Small Devices Labeled Sterile". The Minimum Sterilizing Dose (MSD) required to provide a 10° Sterility Assurance Level (SAL) for these (sub) categories was established and validated at the manufacturing facility as described in ANSI/AAMI/ISO 11137-2, "Sterilization of health care products - Radiation-Part 2: Establishing the sterilization dose." The dose setting method used includes, but is not limited to, Method 1 or VDmax. Generally, the MSDs are between 14.3 - 22.4 kGy. The continued validity of the MSD for each (sub)

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category is confirmed via periodic dose audit studies. In addition, routine periodic presterilization bioburden testing is performed for each (sub) category.

Shelf Life:

Baxter has performed aging testing to support a shelf-life claim of 2 (two) years.

Microbial Ingress Testing:

Baxter has conducted testing on all potential points of microbial entry into the sterile fluid pathway of the proposed devices subject to this premarket notification. The spike, injection sites and Luer Connector Sites were tested following Baxter's testing strategy (as previously cleared under K203609 (cleared on Sept 30, 2021)) 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.

CONCLUSION:

The non-clinical data demonstrate that the subject devices are substantially equivalent and perform comparably to the predicate devices that are legally marketed for the same intended use.

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.