The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

Device Description

IV Administration Sets are gravity, single use, disposable, intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, luer access device, stopcock, manifold, tubing, luer connections (connector, adaptor), filter, and hand pump. IV Administration sets are configured to ensure the intended use of the device is met.

AI/ML Overview

The provided text is a 510(k) summary for an IV Administration Set (K213778). It describes the device, its intended use, comparison to a predicate device, and nonclinical testing performed to demonstrate substantial equivalence.

However, the request primarily asks about acceptance criteria and a study proving a device meets acceptance criteria, specifically in the context of an AI/Software as a Medical Device (SaMD). The document furnished details on a physical medical device (IV Administration Set) and its substantial equivalence to a predicate through bench testing and adherence to ISO standards.

Therefore, the information required to answer the prompt regarding AI/SaMD acceptance criteria and proof of performance (e.g., sample size, expert ground truth, MRMC study, standalone performance) is not present in the provided text. The document clearly states: "No clinical testing was performed as these devices does not require clinical studies to demonstrate substantial equivalence with the predicate device."

To reiterate, the provided document does not contain the information requested in your prompt regarding AI/SaMD performance studies and acceptance criteria. This device is a physical IV administration set, not an AI/SaMD.

If you can provide a document related to an AI/SaMD, I would be happy to help answer your questions.

Summary

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March 3, 2022

B.Braun Medical Inc. Tracy Larish Sr. Regulatory Affairs Specialist 901 Marcon Blvd. Allentown, Pennsylvania 18109

Re: K213778

Trade/Device Name: IV Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: November 24, 2021 Received: December 3, 2021

Dear Tracy Larish:

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,

Gang Peng for Payal Patel 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) K213778

Device Name IV Administration Set

Indications for Use (Describe)

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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K213778 510(k) SUMMARY

SUBMITTER INFORMATION:

Name:	B. Braun Medical Inc.
Address:	901 Marcon Boulevard
	Allentown, PA 18109-9341
Telephone Number:	610-266-0500, ext. 2966
Contact Person:	Tracy Larish, Sr. Regulatory Affairs Specialist
Telephone Number:	(610) 596-2941
Fax Number:	(610) 849-9286
Email:	tracy.larish@bbraunusa.com
Date Prepared:	February 3, 2021

DEVICE NAME:

Device Trade Name:	IV Administration Set
Common Name:	Intravascular Administration Set
Classification Name:	Intravascular administration set, 21 CFR §880.5440Class II, Product code FPA

PREDICATE DEVICES:

· K173361 IV Administration Set, B. Braun Medical Inc.

DEVICE DESCRIPTION

INDICATIONS FOR USE:

TECHNOLOGICAL CHARACTERISTICS:

The IV Administration Set is substantially equivalent to the B. Braun Medical Inc. IV Administration Set (K173361). The predicate device used for comparison to the IV Administration Set was utilized to demonstrate the substantial equivalence in Indications for Use, intended use, and design between the proposed device and the predicate devices.

The IV Administration Set has the same intended use, the same principle of operation, the same fundamental scientific technology and Indications for Use as the predicate device. It comprised of similar component types and meet the same relevant performance specifications as the predicate devices.

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The fundamental technology of the proposed set is unchanged when compared to the predicate device. The differences between the proposed IV Administration Set and predicate device are listed below. These differences do not raise new issues of safety and effectiveness.

The Spin lock Luer connector with primestop cap has been modified to be a fixed male luer lock and the material of construction have been changed.
The roller clamp design has been modified to include a docking location for the insertion spike and the materials of construction have been changed.
An in-line filter was added to the set. ●

A table summarizing the comparison between the IV Administration Sets and the predicate devices is provided below:

	Proposed IV Administration Set(K213778)	Predicate Device (K173361) IVAdministration Set with HCO tubing	Differences
Indications forUse	The IV Administration Sets areintravenous administration setsintended for delivery of fluids from acontainer into a patient's vascularsystem.These devices may be used for anypatient population with considerationgiven to adequacy of vascular anatomyand appropriateness for the solutionbeing infused and duration of therapy	The IV Administration Sets areintravenous administration sets intendedfor delivery of fluids from a containerinto a patient's vascular system.These devices may be used for anypatient population with considerationgiven to adequacy of vascular anatomyand appropriateness for the solutionbeing infused and duration of therapy	Same
Intended Use	Delivery of fluids from a containerinto a patient's vascular system.	Delivery of fluids from a container intoa patient's vascular system.	Same
Mode of FluidDelivery	Gravity	Gravity	Same
AdministrationSet Components/materials	Drip chamber PVCInsertion spike-ABSRoller Clamp-ABSTubing- PVC w/ DEHT and HCOLuer connection- MABS/PPIn line filters-MABS/ABSPPSU/PVP/PTFE	Drip chamber-PVCInsertion spike-ABSRoller clamp-ABSTubing -PVC w/ DEHT and HCOLuer connections-MABS/PCInjection site-Acryllic/PolyisopreneNeedleless Y-site - PCBack check valve- MABS	Design and materialchange to the roller clampand luer connector.Addition of in-line filter.Biocompatibility andperformance testing wereperformed to demonstratesubstantial equivalence(see below).
Summary ofnonclinical testsfor determinationof substantialequivalence	ISO 8536-4 Physical Requirements● Particulate● Leakage● Flow Rate● Tensile Strength● Closure-piercing device● Air-inlet device● Tubing● Drip chamber● Flow Regulator● Male Conical Fitting● Protective CapsISO 8536-8ISO 80369-7:2016ISO 80369-20:2015Internal Testing● Microbial Ingress● Particulate Testing per USP <788>● Stress Cracking● Roller Clamp function● Joint testing● Simulated use Testing● Lipid Compatibility	ISO 8536-4 Physical Requirements● Particulate● Leakage● Flow Rate● Tensile Strength● Closure-piercing device● Air-inlet device● Tubing● Drip chamber● Flow Regulator● Male Conical Fitting● Protective Caps	Additional tests performedto confirm substantialequivalence
Patient Contactcategory/Duration	Externally Communicating, BloodPath Indirect prolonged exposure	Externally Communicating, Blood PathIndirect prolonged exposure	Same
	Proposed IV Administration Set(K213778)	Predicate Device (K173361) IVAdministration Set with HCO tubing	Differences
Biocompatibility	Conforms to ISO 10993	Conforms to ISO 10993	Same
Pyrogenicity	Pyrogenicity <0.5 EU/mL	Pyrogenicity <0.5 EU/mL	Same
Sterilization	Ethylene Oxide SAL 10-6	Ethylene Oxide SAL 10-6	Same

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NONCLINICAL TESTING

Bench testing performed on IV Administration Sets to demonstrates that the device performs as intended. No clinical testing was performed as these devices does not require clinical studies to demonstrate substantial equivalence with the predicate device. The test results demonstrated that the proposed device complies with the following standards:

· ISO 8536-4: "Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed"
· ISO 8536-8: "Infusion equipment for medical use Part 8: Infusion sets for single use with pressure infusion apparatus"
· ISO 10993-1: "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process"
· ISO 10993-7 2nd Edition 2008-10-15 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009)]
· ISO 11135, "Sterilization of health care products Ethylene oxide Requirements for development, validation and routine control of a sterilization process for medical devices"
· ISO 80369-7: "Small-bore connectors for liquids and gases in healthcare applications
· ISO 80369-20: "Small-bore connectors for liquids and gases in healthcare applications-Part 20:Common test methods

CONCLUSION:

Results of the functional and performance testing conducted on the proposed devices demonstrate that the IV Administration Set is equivalent to the predicate device. The differences, between subject device and predicate device, do not raise any new issues of safety and effectiveness. The subject IV Administration Set has demonstrated to be substantially equivalent to the predicate device.

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.