IVX Fluid Transfer Set

{0}------------------------------------------------ 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. 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You must comply with all the Act's {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 Drive<br>Cranberry, PA 16066 | | Contact Person: | David J. Vanella<br>Vice 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 | | Secondary<br>Product 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 | {4}------------------------------------------------ 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 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. ### 5. Indication for Use/ Intended Use ### Indication for Use: 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. #### 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. {5}------------------------------------------------ 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 for<br>Comparison | Subject Device<br>IVX Fluid Transfer Set | Predicate Device<br>KIRO Set | Comparison | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code and<br>Regulation | LHI<br>21 CFR 880.5440<br>Secondary: NEP<br>21 CFR 880.5440 | LHI<br>21 CFR 880.5440<br>Secondary: NEP<br>21 CFR 880.5440 | Identical | | 510(k) Number | K212530 | K152441 | --- | | Classification | LHI: Class II (non-<br>exempt)<br>NEP: Class II (exempt) | LHI: Class II (non-<br>exempt)<br>NEP: Class II (exempt) | Identical | | Areas for<br>Comparison | Subject Device<br>IVX Fluid Transfer Set | Predicate Device<br>KIRO Set | Comparison | | Intended Use | This product is used for<br>fluid transfer in the<br>preparation of final<br>medication containers<br>and the reconstitution of<br>drug vials in hospital<br>pharmacies when used<br>with the IVX pharmacy<br>compoundingdevice. | This product is used for<br>fluid transfer in the<br>preparation of final<br>medication containers<br>and the reconstitution of<br>drug vials in hospital<br>pharmacies when used<br>with the KIRO Oncology<br>pharmacy compounding<br>device. | Both devices are<br>intended for fluid<br>transfer and<br>reconstitution of drug<br>vials within their<br>respective pharmacy<br>compounding station. | | Indication for Use | The IVX Fluid Transfer<br>Set is a single use device<br>indicated for use with the<br>IVX Station Pharmacy<br>Compounding System.<br>The IVX Fluid Transfer<br>device contains three<br>separate tubing<br>configurations and is<br>indicated for the following<br>applications:<br>• Aseptic withdraw of<br>fluid from I.V. bag(s) in<br>preparation for<br>compounding,<br>• aseptic reconstitution of<br>lyophilized drug in vial(s)<br>from an I.V. bag source<br>and<br>• aseptic transfer of fluid<br>from an I.V. bag of<br>compounded drug into a<br>final container(s)<br>for use in the preparation<br>of final compounded<br>drugs for patient infusion<br>administration. | The KIRO Set is a sterile,<br>single-use disposable<br>ancillary device used<br>with the peristaltic pump<br>in the KIRO Oncology<br>pharmacy compounding<br>device for the transfer of<br>fluids into sterile powder<br>drug vials or into sterile<br>medication containers for<br>intravenous drug<br>administration.<br>The device is for<br>prescription use only. | The differences are<br>minimal and do not<br>impact the risk to<br>patient or user. Both<br>devices are sterile,<br>single use devices<br>indicated for the<br>transfer of fluids into<br>drug vials or other<br>containers and<br>reconstitution of<br>drugs within their<br>respective pharmacy<br>compounding<br>stations. | | Type of Use | Prescription use only | Prescription use only | Identical | | Conditions of Use | Single use only | Single use only | Identical | | Areas for<br>Comparison | Subject Device<br>IVX Fluid Transfer Set | Predicate Device<br>KIRO Set | Comparison | | Sterilization<br>Method | Gamma radiation | Gamma radiation | Identical | | Intended for<br>Direct Connection<br>to Patient | No | No | Identical | | Use Environment | Hospital pharmacy inside<br>the IVX Station ISO 5<br>environment | Hospital pharmacy inside<br>the KIRO Oncology PCD<br>ISO 5 environment | Both are used in their<br>respective pharmacy<br>compounding<br>stations in an ISO 5<br>environment | | Target Users | Trained health-care<br>personnel | Trained health-care<br>personnel | Identical | | Primary Fluid<br>Contact<br>Material—Tubing | Polycarbonate,<br>Polyvinylchloride,<br>Acrylonitrile Butadiene<br>Styrene, Medical Grade<br>Silicone, Polypropylene | Medical Grade Silicone | The differences are<br>minimal and do not<br>impact the risk to<br>patient or user. Both<br>devices are made of<br>plastics commonly<br>used in I.V. sets. | | Fluid Transfer<br>Mechanism | External Peristaltic<br>Pump<br>— Single Channel for the<br>Withdraw Transfer Set<br><br>Reconstitution Transfer<br>Set and Stock Solution<br>Transfer Set utilize a<br>syringe for the pump | External Peristaltic<br>Pump<br>— Double Channel | The Withdraw<br>Transfer Set is used<br>with a peristaltic<br>pump, which is<br>identical to the KIRO<br>Set.<br><br>The Reconstitution<br>and Stock Solution<br>Transfer Sets utilize<br>a syringe. The<br>differences are<br>minimal and do not<br>impact the risk to<br>patient or user. | | Final Containers | Reconstitution Transfer<br>Set: Vial<br>Stock Solution Transfer<br>Set: Syringe | Vials, Infusion Bags,<br>Cassettes, Elastomeric<br>pumps | The subject device<br>includes two of the<br>four final containers<br>used with the<br>predicate device. | #### Table 1: Comparison of Technological Characteristics with the Predicate Device {6}------------------------------------------------ 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. C {7}------------------------------------------------ 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. {8}------------------------------------------------ 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: | Biocompatibility<br>Test | Standard Number | Standard Description | |--------------------------------------|-------------------|------------------------------------------------------------------------------------------------------------| | Hemolysis | ISO 10993-4:2017 | Biological evaluation of<br>medical devices - Part 4:<br>Selection of tests for<br>interactions with blood | | Cytotoxicity | ISO 10993-5:2009 | Biological evaluation of<br>medical devices - Part 5: Tests<br>for in vitro cytotoxicity | | Irritation and<br>Sensitization | ISO 10993-10:2010 | Biological evaluation of<br>medical devices - Part 10:<br>Tests for irritation and skin<br>sensitization | | Acute Systemic<br>Toxicity | ISO 10993-11:2017 | Biological evaluation of<br>medical devices - Part 11:<br>Tests for systemic toxicity | | Material Mediated<br>Pyrogen Testing | USP <151> | Rabbit Pyrogen Test | | Bench Test | Standard Number | Standard Description | | Performance Testing | ISO 22413:2021 | Transfer sets for<br>pharmaceutical preparations –<br>Requirements and test methods | | | ISO 8536-4:2019 | Infusion equipment for medical<br>use - Part 4: Infusion sets for<br>single use, gravity feed | | | ISO 80369-7:2021 | Infusion equipment for medical<br>use - Part 4: Infusion sets for<br>single use, gravity feed | | | ISO 80369-20:2015 | Small-bore connectors for<br>liquids and gases in healthcare<br>applications | | | USP<788> | Particulate Matter in Injections | | | --- | Microbial Ingress Testing | {9}------------------------------------------------ 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 {10}------------------------------------------------ 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.