The IVX Fluid Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding System. The IVX Fluid Transfer device contains three separate tubing configurations and is indicated for the following applications:

Aseptic withdraw of fluid from I.V. bag(s) in preparation for compounding,
aseptic reconstitution of lyophilized drug in vial(s) from an I.V. bag source and
aseptic transfer of fluid from an I.V. bag of compounded drug into a final container(s) for use in the preparation of final compounded drugs for patient infusion administration.

Device Description

The IVX Fluid Transfer Set is a sterile, single-use fluid transfer tubing set that contain three separate tubing configurations, Withdraw Transfer Set, Reconstitution Transfer Set and Stock Solution Transfer Set.

The Withdraw Transfer Set is used to remove excess fluid from an I.V. bag and place the fluid in a waste container for disposal.
The Reconstitution Transfer Set is used to withdraw fluid from an I.V. bag and transfer the fluid to a vial that contains powdered drug so that the drug can be reconstituted.
The Stock Solution Transfer Set is used to transfer fluid from an I.V. bag of a compounded drug into a final container, which is a syringe.

Each process is performed using aseptic technique within the ISO 5 environment using the IVX Pharmacy Compounding Station.

The IVX Fluid Transfer Set is intended to be used by trained healthcare personnel and is not intended to be used for direct patient contact.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from Omnicell, Inc. for the IVX Fluid Transfer Set. It focuses on demonstrating substantial equivalence to a predicate device (KIRO Set) primarily through performance bench testing and biocompatibility testing, rather than clinical studies involving human readers or AI algorithms.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device (referring to MRMC studies, ground truth, expert adjudication, training/test sets, etc.) is largely not applicable to this specific device (IVX Fluid Transfer Set). This is a physical fluid transfer device, not a software or AI/ML product.

However, I can extract the relevant "acceptance criteria" and "device performance" in the context of this physical medical device as presented in the document.

Here's a breakdown based on the provided text, addressing what is applicable and noting what is not:

Acceptance Criteria and Device Performance (for a physical medical device)

The document states that "The IVX Fluid Transfer Set has met all established acceptance criteria for performance testing and design verification testing." While specific numerical acceptance criteria values are not explicitly laid out in a table with corresponding measured performance alongside, the types of tests performed serve as the basis for demonstrating that the device meets its intended use and is safe and effective.

Here's how the general concept of "acceptance criteria" and "device performance" can be interpreted from the text for this physical medical device:

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

The document lists various tests performed. The "acceptance criterion" for each would generally be "compliance with the standard" or "no adverse findings." The "reported device performance" is implicitly "met the standard" or "passed the test."

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Biocompatibility:
Hemolysis (ISO 10993-4:2017) acceptable limits	Passed (supports substantial equivalence, does not raise new questions of safety and effectiveness)
Cytotoxicity (ISO 10993-5:2009) acceptable limits	Passed (supports substantial equivalence, does not raise new questions of safety and effectiveness)
Irritation and Sensitization (ISO 10993-10:2010) acceptable limits	Passed (supports substantial equivalence, does not raise new questions of safety and effectiveness)
Acute Systemic Toxicity (ISO 10993-11:2017) acceptable limits	Passed (supports substantial equivalence, does not raise new questions of safety and effectiveness)
Material Mediated Pyrogen Testing (USP <151>) acceptable limits	Passed (supports substantial equivalence, does not raise new questions of safety and effectiveness)
Bench Performance Testing:
Performance (ISO 22413:2021) compliance	Passed (No new questions of safety and effectiveness)
Performance (ISO 8536-4:2019) compliance	Passed (No new questions of safety and effectiveness)
Performance (ISO 80369-7:2021) compliance	Passed (No new questions of safety and effectiveness)
Performance (ISO 80369-20:2015) compliance	Passed (No new questions of safety and effectiveness)
Particulate Matter in Injections (USP<788>) acceptable limits	Passed (No new questions of safety and effectiveness)
Microbial Ingress Testing acceptable limits	Passed (No new questions of safety and effectiveness)
Dose accuracy with representative fluids (when used with IVX Pharmacy Compounding Station) acceptable limits	Evaluated and met (No new questions of safety and effectiveness)

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

Sample Size: Not explicitly stated in terms of number of devices tested for each performance or biocompatibility test. The document refers to "Performance bench testing was conducted," implying a sufficient number of samples were tested to meet the requirements of the standards.
Data Provenance: The tests were conducted internally by Omnicell, Inc. or by a contracted lab following established medical device testing standards (ISO, USP). The document indicates these are "bench tests," not clinical studies. Therefore, specific country of origin or retrospective/prospective designation for data from human subjects is not applicable.

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 a physical device, not an AI/ML diagnostic tool. Ground truth in this context would be established by validated laboratory equipment and protocols, not expert human readers.

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

Not Applicable. This concept applies to human expert review for establishing ground truth in diagnostic studies, not to bench testing of a physical device.

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. "No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate 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 concensus, pathology, outcomes data, etc.):

Bench Testing Standards/Validated Methods: For biocompatibility, ground truth is established by the results of standardized biological tests (e.g., cell viability assays for cytotoxicity, hemolytic index for hemolysis). For performance, ground truth is established by direct measurement against specified engineering requirements and compliance with international standards (e.g., flow rates, pressure resistance, particulate matter counts).

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device. Training sets are relevant for machine learning algorithms.

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

Not Applicable. As above, training sets and their ground truth are concepts for AI/ML development.

Summary regarding the nature of this submission:

This 510(k) submission is for a Class II physical medical device (IVX Fluid Transfer Set). The primary pathway for clearance is demonstrating substantial equivalence to an existing predicate device (KIRO Set) through benchtop performance testing and biocompatibility testing. The concepts of AI/ML performance, human reader studies, and training/test set ground truth as typically discussed for software as a medical device (SaMD) are not relevant to this specific submission. The "acceptance criteria" and "performance" here refer to meeting engineering specifications and safety standards.

Summary

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Image /page/0/Picture/0 description: The image contains 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 the FDA logo, which 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.

April 24, 2022

Omnicell, Inc. David Vanella VP Quality and Product Regulatory Affairs 500 Cranberry Woods Drive Cranberry, Pennsylvania 16066

Re: K212530

Trade/Device Name: IVX Fluid Transfer Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI, NEP Dated: March 24, 2022 Received: March 25, 2022

Dear David Vanella:

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

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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 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 (OS) 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,

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) K212530

Device Name IVX Fluid Transfer Set

Indications for Use (Describe)

The IVX Fluid Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding System.

The IVX Fluid Transfer device contains three separate tubing configurations and is indicated for the following applications:

· Aseptic withdraw of fluid from I.V. bag(s) in preparation for compounding,

· aseptic reconstitution of lyophilized drug in vial(s) from an I.V. bag source and
· aseptic transfer of fluid from an I.V. bag of compounded drug into a final container(s)

for use in the preparation of final compounded drugs for patient infusion administration.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Omnicell. The logo consists of a green circle with a smaller circle cut out of the top right quadrant. Below the circle is the word "Omnicell" in a green sans-serif font.

Image /page/3/Picture/1 description: The image shows a series of green shapes, including circles and rounded rectangles, arranged horizontally across a white background. The shades of green vary, with some shapes appearing darker and others lighter. The shapes are not uniformly spaced, and their sizes differ, creating a pattern that resembles a visual code or abstract representation of data.

K212530 - 510(k) SUMMARY

1. Submitter Information

Name:	Omnicell, Inc.
Address:	500 Cranberry Woods DriveCranberry, PA 16066
Contact Person:	David J. VanellaVice President, Quality and Product Regulatory Affairs
Telephone Number:	(724) 741-8115
E-mail:	david.vanella@omnicell.com
Date Prepared:	March 23, 2022

2. Device Name and Classification

Device Trade Name:	IVX Fluid Transfer Set
Common Name:	Set, I.V. Fluid Transfer
Classification Name:	21 CFR 880.5440
Regulatory Class:	II
Product Code:	LHI
SecondaryProduct Code:	NEP

3. Predicate Device

Device Trade Name:	KIRO Set
Common Name:	IV Fluid Transfer Set
Classification Name:	21 CFR 880.5440 Set, I.V. Fluid Transfer
Regulatory Class:	II
Product Code:	LHI
Secondary Product Code:	NEP
510(k) Number:	K152441

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Image /page/4/Picture/0 description: The image shows the logo for Omnicell. The logo consists of a green circle with a smaller circle cut out of the top right quadrant. Below the circle is the word "Omnicell" in a sans-serif font, also in green. The logo is simple and modern, with a focus on the company name.

Image /page/4/Figure/1 description: The image shows a pattern of green circles and rounded rectangles of varying sizes and shades of green. The shapes are scattered across a white background, creating a somewhat random yet visually cohesive design. The arrangement of the shapes does not appear to follow a specific grid or structure, giving it an organic feel. The different shades of green add depth and visual interest to the composition.

4. Device Description

The Withdraw Transfer Set is used to remove excess fluid from an I.V. bag and place the fluid ● in a waste container for disposal.
The Reconstitution Transfer Set is used to withdraw fluid from an I.V. bag and transfer the ● fluid to a vial that contains powdered drug so that the drug can be reconstituted.
The Stock Solution Transfer Set is used to transfer fluid from an I.V. bag of a compounded ● drug into a final container, which is a syringe.

Each process is performed using aseptic technique within the ISO 5 environment using the IVX Pharmacy Compounding Station.

The IVX Fluid Transfer Set is intended to be used by trained healthcare personnel and is not intended to be used for direct patient contact.

5. Indication for Use/ Intended Use

Indication for Use:

· Aseptic withdraw of fluid from I.V. bag(s) in preparation for compounding,
· aseptic reconstitution of lyophilized drug in vial(s) from an I.V. bag source and
· aseptic transfer of fluid from an I.V. bag of compounded drug into a final container(s)

for use in the preparation of final compounded drugs for patient infusion administration.

Intended Use:

The IVX Fluid Transfer Set is used for fluid transfer in the preparation of final medication containers and the reconstitution of drug vials in hospital pharmacies when used with the IVX Pharmacy Compounding Station.

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Image /page/5/Picture/0 description: The image shows the logo for Omnicell. The logo consists of a green circle with a smaller white circle inside, resembling an eye. Below the circle is the word "Omnicell" in a simple, sans-serif font, also in green. The logo is clean and modern, suggesting a focus on technology and healthcare.

Image /page/5/Picture/1 description: The image shows a pattern of green circles and rounded rectangles scattered across a white background. The shapes vary in size and shade of green, with some being darker and others lighter. The arrangement appears random, without any clear structure or alignment.

6. Comparison of the Technological Characteristics with the Predicate Device

The technological characteristics of the subject device, IVX Fluid Transfer Set, are substantially equivalent to those of the predicate device, KIRO Set, in regard to the following technological characteristics:

Principle of operation and conditions of use of the subject device are similar to those of the predicate device.
Material composition of the subject device is equivalent to that of the predicate device . in that both devices are made from plastics used in medical devices of this type. Material composition of the proposed device does not raise new questions of safety and effectiveness, as demonstrated by performance testing and biocompatibility evaluation.
Physical specifications of the subject device are equivalent to those of the predicate ● device. The IVX Fluid Transfer Set does not raise new questions of safety and effectiveness, as demonstrated by performance testing.
Design features and interfaces are equivalent in that both devices are used to provide a ● pathway through which fluid is transferred from one source container into another suitable container within in a pharmacy compounding station. The subject and predicate devices are limited to use within their respective pharmacy compounding stations. Performance verification of the subject device does not raise new questions of safety and effectiveness.
Sterilization method and SAL level are identical between the subject and predicate device.

A comparison between the predicate device and the subject device is provided in Table 1:

Areas forComparison	Subject DeviceIVX Fluid Transfer Set	Predicate DeviceKIRO Set	Comparison
Product Code andRegulation	LHI21 CFR 880.5440Secondary: NEP21 CFR 880.5440	LHI21 CFR 880.5440Secondary: NEP21 CFR 880.5440	Identical
510(k) Number	K212530	K152441	---
Classification	LHI: Class II (non-exempt)NEP: Class II (exempt)	LHI: Class II (non-exempt)NEP: Class II (exempt)	Identical
Areas forComparison	Subject DeviceIVX Fluid Transfer Set	Predicate DeviceKIRO Set	Comparison
Intended Use	This product is used forfluid transfer in thepreparation of finalmedication containersand the reconstitution ofdrug vials in hospitalpharmacies when usedwith the IVX pharmacycompoundingdevice.	This product is used forfluid transfer in thepreparation of finalmedication containersand the reconstitution ofdrug vials in hospitalpharmacies when usedwith the KIRO Oncologypharmacy compoundingdevice.	Both devices areintended for fluidtransfer andreconstitution of drugvials within theirrespective pharmacycompounding station.
Indication for Use	The IVX Fluid TransferSet is a single use deviceindicated for use with theIVX Station PharmacyCompounding System.The IVX Fluid Transferdevice contains threeseparate tubingconfigurations and isindicated for the followingapplications:• Aseptic withdraw offluid from I.V. bag(s) inpreparation forcompounding,• aseptic reconstitution oflyophilized drug in vial(s)from an I.V. bag sourceand• aseptic transfer of fluidfrom an I.V. bag ofcompounded drug into afinal container(s)for use in the preparationof final compoundeddrugs for patient infusionadministration.	The KIRO Set is a sterile,single-use disposableancillary device usedwith the peristaltic pumpin the KIRO Oncologypharmacy compoundingdevice for the transfer offluids into sterile powderdrug vials or into sterilemedication containers forintravenous drugadministration.The device is forprescription use only.	The differences areminimal and do notimpact the risk topatient or user. Bothdevices are sterile,single use devicesindicated for thetransfer of fluids intodrug vials or othercontainers andreconstitution ofdrugs within theirrespective pharmacycompoundingstations.
Type of Use	Prescription use only	Prescription use only	Identical
Conditions of Use	Single use only	Single use only	Identical
Areas forComparison	Subject DeviceIVX Fluid Transfer Set	Predicate DeviceKIRO Set	Comparison
SterilizationMethod	Gamma radiation	Gamma radiation	Identical
Intended forDirect Connectionto Patient	No	No	Identical
Use Environment	Hospital pharmacy insidethe IVX Station ISO 5environment	Hospital pharmacy insidethe KIRO Oncology PCDISO 5 environment	Both are used in theirrespective pharmacycompoundingstations in an ISO 5environment
Target Users	Trained health-carepersonnel	Trained health-carepersonnel	Identical
Primary FluidContactMaterial—Tubing	Polycarbonate,Polyvinylchloride,Acrylonitrile ButadieneStyrene, Medical GradeSilicone, Polypropylene	Medical Grade Silicone	The differences areminimal and do notimpact the risk topatient or user. Bothdevices are made ofplastics commonlyused in I.V. sets.
Fluid TransferMechanism	External PeristalticPump— Single Channel for theWithdraw Transfer SetReconstitution TransferSet and Stock SolutionTransfer Set utilize asyringe for the pump	External PeristalticPump— Double Channel	The WithdrawTransfer Set is usedwith a peristalticpump, which isidentical to the KIROSet.The Reconstitutionand Stock SolutionTransfer Sets utilizea syringe. Thedifferences areminimal and do notimpact the risk topatient or user.
Final Containers	Reconstitution TransferSet: VialStock Solution TransferSet: Syringe	Vials, Infusion Bags,Cassettes, Elastomericpumps	The subject deviceincludes two of thefour final containersused with thepredicate device.

Table 1: Comparison of Technological Characteristics with the Predicate Device

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Image /page/6/Picture/0 description: The image shows the logo for Omnicell. The logo consists of a green circle with a smaller circle cut out of the top right portion of the larger circle. Below the circle is the word "Omnicell" in a sans-serif font, also in green.

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Image /page/7/Picture/0 description: The image contains the logo for Omnicell. The logo features a green circular graphic with a smaller, partial circle overlapping it, positioned above the company name. The word "Omnicell" is written in a simple, sans-serif font, also in green, directly below the circular graphic.

Image /page/7/Figure/6 description: The image shows a pattern of green shapes on a white background. The shapes are mostly circles and rounded rectangles, and they vary in size and shade of green. The shapes are scattered across the image, with some overlapping and others isolated.

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Image /page/8/Picture/0 description: The image shows the logo for Omnicell. The logo consists of a green circle with a smaller white circle inside, positioned above the word "Omnicell" in green font. The logo is simple and modern, with a focus on the company name.

Image /page/8/Figure/1 description: The image shows a pattern of green circles and rounded rectangles of varying sizes and shades of green. The shapes are scattered across a white background, creating a somewhat random yet visually interesting composition. The darker shades of green provide contrast against the lighter shades, adding depth to the pattern.

7. Performance Testing

Performance Testing-Bench

Performance bench testing was conducted to demonstrate that the IVX Fluid Transfer Set performs as intended. No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device.

The following performance testing was conducted to support the substantial equivalence determination:

BiocompatibilityTest	Standard Number	Standard Description
Hemolysis	ISO 10993-4:2017	Biological evaluation ofmedical devices - Part 4:Selection of tests forinteractions with blood
Cytotoxicity	ISO 10993-5:2009	Biological evaluation ofmedical devices - Part 5: Testsfor in vitro cytotoxicity
Irritation andSensitization	ISO 10993-10:2010	Biological evaluation ofmedical devices - Part 10:Tests for irritation and skinsensitization
Acute SystemicToxicity	ISO 10993-11:2017	Biological evaluation ofmedical devices - Part 11:Tests for systemic toxicity
Material MediatedPyrogen Testing	USP <151>	Rabbit Pyrogen Test
Bench Test	Standard Number	Standard Description
Performance Testing	ISO 22413:2021	Transfer sets forpharmaceutical preparations –Requirements and test methods
	ISO 8536-4:2019	Infusion equipment for medicaluse - Part 4: Infusion sets forsingle use, gravity feed
	ISO 80369-7:2021	Infusion equipment for medicaluse - Part 4: Infusion sets forsingle use, gravity feed
	ISO 80369-20:2015	Small-bore connectors forliquids and gases in healthcareapplications
	USP<788>	Particulate Matter in Injections
	---	Microbial Ingress Testing

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Image /page/9/Picture/0 description: The image shows the logo for Omnicell. The logo consists of a green circle with a smaller, curved shape inside, resembling a stylized "O". Below the circle is the word "Omnicell" in a simple, sans-serif font, also in green. The logo is clean and modern in appearance.

Image /page/9/Picture/1 description: This image is a table that describes sterilization and packaging standards. The table has three columns: Sterilization and Packaging, Standard Number, and Standard Description. The first section of the table describes sterilization standards, including ISO 11137-1: 2018, ISO 11137-2: 2013, ISO 11137-3: 2017, ISO 11737-1:2018, and ISO 11737-2: 2019. The second section of the table describes bacterial endotoxins and packaging standards, including USP <161>, USP<85>, ANSI/AAMI ST72: 2019, F88/F88M-15, F1980-16, and F2096-11 (Reapproved 2019).

In addition, compatibility of the IVX Fluid Transfer Set with the IVX Pharmacy Compounding Station was evaluated for dose accuracy with representative fluids.

Omnicell.com

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Image /page/10/Picture/0 description: The image shows the logo for Omnicell. The logo features the word "Omnicell" in a sans-serif font, with the "O" in "Omnicell" being green. Above the word "Omnicell" is a green circle with a white design inside.

Image /page/10/Picture/1 description: The image shows a pattern of green shapes against a white background. The shapes are mostly circles and rounded rectangles, varying in size and shade of green. The shapes are scattered across the image, creating a random, abstract design.

Conclusion:

The IVX Fluid Transfer Set has met all established acceptance criteria for performance testing and design verification testing. Results of performance and biocompatibility testing conducted with the IVX Fluid Transfer Set demonstrate that the subject device supports a substantial equivalence determination to the predicate device, KIRO Set.

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.