Volumat Polyethylene I.V. Administration Set

{0}------------------------------------------------ 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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable. June 16, 2023 Fresenius Kabi % Jason Ma Sr. Manager, Regulatory Affairs Fresenius Kabi USA,LLC 3 Corporate Dr Suite 300 Lake Zurich, Illinois 60047 Re: K221121 Trade/Device Name: Volumat Polyethylene I.V. Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: May 18, 2023 Received: May 18, 2023 Dear Jason Ma: 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 {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, Porsche Bennett For David Wolloscheck, Ph.D. 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) K221121 Device Name Volumat Polyethylene I.V. Administration Set Indications for Use (Describe) I.V. Administration Set for the infusion of parenteral fluids and medications from a container into the patient's vascular system through a vascular access device with Agilia VP MC/Volumat MC Agilia pump or gravity only. Type of Use (Select one or both, as applicable)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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Date Prepared: | June 16, 2023 | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2. Submitter Information | | | Name: | Fresenius Kabi | | Address: | Fresenius Kabi AG<br>61346 Bad Homburg<br>Germany | | Contact Person: | Jason Ma<br>Sr. Manager, Regulatory Affairs<br>Fresenius Kabi USA, LLC<br>Three Corporate Drive, 2nd Floor<br>Lake Zurich, IL 60047 USA<br>Phone: 224-817-4100<br>Fax: 847 550 2960<br>E-mail: Jason.ma01@fresenius-kabi.com | | Secondary Contact Person: | Keith Dunn<br>Director, Regulatory Affairs<br>Fresenius Kabi USA, LLC<br>Three Corporate Drive, 2nd Floor<br>Lake Zurich, IL 60047 USA<br>Phone: 224-817-2430<br>Fax: 847 550 2960<br>E-mail: Keith.Dunn@fresenius-kabi.com | ## 3. Device Name and Classification | Device Trade Name: | Volumat Polyethylene I.V. Administration Set | |----------------------|----------------------------------------------| | Common Name: | I.V. Administration Set | | Classification Name: | Intravascular administration set | | Regulation Number | 21 CFR 880.5440 | | Regulatory Class: | Class II | | Product Code: | FPA | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Fresenius Kabi. The logo consists of three blue, wavy lines on the left side. To the right of the lines, the words "FRESENIUS" and "KABI" are stacked on top of each other, also in blue. The logo is simple and modern, with a focus on the company name. hree Cornorate Drive ke Zurich, Illinois 60047 847-550-2300 888-391-6300 ww.fresenius-kabi.us ### 4. Predicate Device | Device Trade Name: | Intravascular Administration Sets | |----------------------|-----------------------------------| | Common Name: | Intravascular Administration Set | | Classification Name: | 21 CFR 880.5440 | | Regulatory Class: | Class II | | Product Code: | FPA | | 510(k) Number: | K203609 | ### 5. Device Description The Volumat Polyethylene I.V. Administration Sets (PE Sets) are available for dedicated use with the Agilia Infusion Pump and the Agilia VP MC Pump, or they can administer parenteral fluids and medications by gravity flow. Both the Agilia Infusion Pump and the Volumat I.V. Administration Sets were cleared under K121613. The Agilia VP MC Pump was cleared under K210073. The PE Sets include a spike, drip chamber, roller clamp, upstream/downstream clamp, backcheck valve, pump segment, needle-free port, rotating male luer lock, and tubing. | Set Number | Description | |------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | M46441395 | Volumat Polyethylene I.V. Administration Set with spike, air vent, drip chamber, roller clamp, pump segment, rotating male luer | | M46441995 | Volumat Polyethylene I.V. Administration Set with spike, air vent, drip chamber, roller clamp, pump segment, downstream clamp, downstream needle-free port, rotating male luer | | M46444495 | Volumat Polyethylene I.V. Administration Set with spike, air vent, drip chamber, upstream clamp, backcheck valve, upstream needle-free port, roller clamp, pump segment, downstream clamp, downstream needle-free port, rotating male luer | | M46445495 | Volumat Polyethylene I.V. Administration Set with spike, air vent, drip chamber, upstream clamp, backcheck valve, upstream needle-free port, roller clamp, pump segment, downstream clamp, downstream needle-free port, rotating male luer | ### 6. Principle of Operation The range of sets provides options for intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but not limited to diluted drugs, chemotherapy) through clinically accepted intravenous (I.V.) routes of administration. The device may be used for Adults and Pediatrics Patients. ### 7. Indication for Use/ Intended Use {5}------------------------------------------------ Image /page/5/Picture/0 description: The image features the logo of Fresenius Kabi, a global healthcare company. On the left side of the logo, there are three stylized, vertical blue lines that resemble waves or abstract shapes. To the right of these lines, the words "FRESENIUS" and "KABI" are stacked on top of each other in a bold, sans-serif blue font. The overall design is clean and corporate, conveying a sense of stability and innovation. w.fresenius-kabi.us #### Indication for Use: I.V. Administration Set for the infusion of parenteral fluids and medications from a container into the patient's vascular system through a vascular access device with Agilia VP MC/Volumat MC Agilia pump or gravity only. #### Intended Use: Volumat Polyethylene I.V. Administration Sets are intended for the administration of drugs and solutions. ### 8. Comparison of the Technological Characteristics with the Predicate Device The technological characteristics of the subject device are substantially equivalent to those of the predicate device in regard to the following technological characteristics: - . Principle of operation and conditions of use of the subject device are the same as those of the predicate device. - Materials of the proposed device do 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. A comparison between the predicate device and the subject device is provided in Table 1 and Table 2 below. | Technological<br>Characteristics | Volumat Polyethylene<br>I.V. Administration<br>Sets (Subject Device) | Baxter Administration<br>Set K203609<br>(Predicate Device) | Assessment of<br>Differences | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use | IV Administration set<br>for the infusion of<br>parenteral fluids and<br>medications from a<br>container into the<br>patient's vascular<br>system through a<br>vascular access device<br>with Agilia VP MC<br>pumps/Volumat MC<br>Agilia pump or gravity<br>only. | For the administration of<br>fluids from a container<br>into the patients'<br>vascular system through<br>a vascular access device. | Similar. Both I.V.<br>administration sets are<br>used to administer fluids<br>from a container to a<br>patient. However, the<br>Subject Device<br>interoperates with<br>infusion systems that<br>have been cleared in<br>other 510(k) submissions<br>including K121613 and<br>K210073.. | | Operating<br>Mechanism | The Volumat<br>administration sets<br>deliver the intravenous | The Baxter<br>administration sets can<br>be used to deliver | Similar, both devices can<br>be used with an infusion<br>pump or by gravity flow. | | Technological<br>Characteristics | Volumat Polyethylene<br>I.V. Administration<br>Sets (Subject Device) | Baxter Administration<br>Set K203609<br>(Predicate Device) | Assessment of<br>Differences | | | infusions via an infusion<br>pump through a<br>pumping mechanism<br>("cassette") or by<br>gravity flow. | solutions for gravity or<br>pump by infusion of I.V.<br>fluids. | The predicate device<br>does not have a pumping<br>mechanism ("cassette").<br>Difference has been<br>verified through<br>performance testing<br>including flow rate<br>accuracy under various<br>environmental conditions<br>(temperature, pressure,<br>humidity) which<br>demonstrate equivalence. | | Sterile | Yes | Yes | Same | | Non-Pyrogenic | Yes | Yes | Same | | Single Use | Yes | Yes | Same | | Length | 75-105 inches | 69-133.5 inches | Similar. The sets<br>included in the subject<br>device range in length<br>from 75 inches to 105<br>inches which is within<br>the range of the predicate<br>device.<br>Difference tested<br>according to ISO 8536-4<br>and flow rate accuracy to<br>demonstrate the subject<br>device performance. | | Priming Volume | 21-27 ml | 6.1 to 21.2 mL | Similar. The Volumat set<br>requires more priming<br>volume than the<br>predicate. Bench testing<br>confirmed that the<br>differences in priming<br>volume do not impact<br>safety or effectiveness. | | Internal Tube<br>Diameter | 0.122 inches | 0.102 to 133 inches | Similar internal and<br>external diameter and<br>approximate range of the<br>predicate device.<br>Difference tested to ISO<br>8536-8 has demonstrated<br>equivalence. | | External Tube<br>Diameter | 0.164 inches | 0.140-0.209 inches | | | Components | | | | | Spike | Yes | Yes | Different. The subject<br>device includes an | | Drip chamber | Yes | Yes | | | Technological<br>Characteristics | Volumat Polyethylene<br>I.V. Administration<br>Sets (Subject Device) | Baxter Administration<br>Set K203609<br>(Predicate Device) | Assessment of<br>Differences | | Backcheck Valve | Yes | Yes | additional pumping | | Pump Segment | Yes | No | segment. However, no | | Needle Free Port | Yes | Yes | significant difference | | Male Luer | Yes | Yes | between the subject and | | Roller Clamp | Yes | Yes | predicate administration | | Connector Luer<br>Lock | Yes | Yes | sets that would raise new<br>issues of safety or<br>efficacy.<br>The differences have<br>been verified in various<br>aspects to demonstrate<br>the subject device's<br>safety and performance<br>including:<br>Biocompatibility testing<br>according to ISO 10993<br>collateral standards,<br>Microbial Ingress<br>Testing, and Particulate<br>Testing; Performance<br>Testing according to ISO<br>8536-4, ISO 80369-20,<br>ISO 8536-8 and ISO<br>8436-14. | #### Table 1: Summary of Substantial Equivalence Comparison {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the Fresenius Kabi logo. The logo consists of a blue abstract symbol on the left and the words "FRESENIUS KABI" in blue on the right. The abstract symbol is made up of three curved lines. **Fresenius Kabi** Fresemius Kabi Thresemius Italia Drive Lake Zurion atabile Drive Lake Zurion 223000 T 888-3991-233000 www.fresenius-kabil.us {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the Fresenius Kabi logo. The logo consists of three blue, wavy lines on the left side. To the right of the lines, the words "FRESENIUS" and "KABI" are written in blue, with "FRESENIUS" on top of "KABI". Fresenius Kabi Theo Corporation Drive Lake Zunich, Illinois 60047 Take Zunich, Illinois 60047 Trad47-5550-2300 www.fresenius-kabi.us #### Table 2: Summary of Material Comparison | Component | Modified Volumat I.V.<br>Administration Set<br>(Subject Device) | Baxter<br>Administration Set<br>K203609<br>(Predicate Device) | Assessment of Differences | |-----------------|-----------------------------------------------------------------|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | Spike | Polystyrene | Acrylonitrile<br>Butadiene Styrene | Similar, testing to<br>biocompatibility and<br>performance standards<br>demonstrated equivalence | | Drip chamber | Polystyrene, styrene-<br>butadiene-copolymer,<br>Polyamide | Polyvinyl Chloride | Different, testing to<br>biocompatibility and<br>performance standards<br>demonstrated equivalence | | Backcheck Valve | Methylmethacrylate-<br>Acrylonitrile-Butadiene-<br>Styrene) | Polymethyl<br>methacrylate (acrylic)<br><br>Silicone Rubber | Similar, testing to<br>biocompatibility and<br>performance standards<br>demonstrated equivalence | | Pump Segment | Methylmethacrylate-<br>Acrylonitrile-Butadiene-<br>Styrene | N/A – predicate<br>device does not have<br>a pump segment | Testing to biocompatibility<br>and performance standards<br>demonstrated equivalence | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the Fresenius Kabi logo. The logo consists of three blue, curved lines on the left side. To the right of the lines, the words "FRESENIUS" and "KABI" are written in blue, with "FRESENIUS" on top of "KABI". 888-391-6300 ww.fresenius-kabi.us | Component | Modified Volumat I.V.<br>Administration Set<br>(Subject Device) | Baxter<br>Administration Set<br>K203609<br>(Predicate Device) | Assessment of Differences | |----------------------------|-------------------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | Needle Free Port | Methylmethacrylate-<br>Acrylonitrile-Butadiene-<br>Styrene, Copolyester | Polyester | Similar, Testing to<br>biocompatibility and<br>performance standards<br>demonstrated equivalence | | Rotating Male Luer<br>Lock | Polyvinylchloride,<br>Acrylonitrile butadiene<br>styrene | Acrylonitrile<br>butadiene styrene | Similar, Testing to<br>biocompatibility and<br>performance standards<br>demonstrated equivalence | | Tubing | Polyvinyl chloride,<br>ethylene-vinyl acetate,<br>polyethylene | Polyvinyl chloride | Similar, Testing to<br>biocompatibility and<br>performance standards<br>demonstrated equivalence | ### 9. Substantial Equivalence #### Intended Use/Indication for Use-Discussion of Differences Both the subject and predicate device have the same intended use and similar indication for use. Both I.V. administration sets are used to administer fluids. #### Technological Characteristics—Discussion of Differences - Both the subject and predicate device can be used with an infusion pump or by gravity flow. The subject device delivers the intravenous infusions via an infusion pump through a pumping mechanism ("cassette") or by gravity flow, and the predicate device does not have a pumping mechanism ("cassette"). - The subject device ranges in length from 75 inches to 105 inches, which is within . the length range of the predicate device. - . The subject device carries more priming volume than the predicate. Bench testing confirmed that the differences in priming volume do not impact safety or effectiveness. - . The subject device includes an additional pumping segment. However, no significant difference between the subject and predicate administration sets that would raise new issues of safety or efficacy. #### Conclusion on Substantial Equivalence {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the logo for Fresenius Kabi. On the left side of the logo are three blue, vertical, wavy lines. To the right of the lines is the text "FRESENIUS KABI" in blue, with "FRESENIUS" on top of "KABI". ee Cornorate Drive Zurich, Illinois 60047 888-391-6300 ww.fresenius-kabi.us The Volumat Polyethylene I.V. Administration Set has the same intended use and equivalent indication for use as the predicate device. The subject device has similar technological characteristics to the predicate, and the descriptive and performance information provided within this premarket notification demonstrates that: - any differences do not raise different questions of safety and . effectiveness compared to the predicate device; and - . the proposed device is at least as safe and effective as the legally marketed predicate device. Based on the comparison of the intended use and the technological characteristics, the subject device is substantially equivalent to the currently marketed predicate device. ### 10.Performance Testing ### Performance Testing-Bench Functional performance bench testing was conducted to demonstrate that the Volumat Polyethylene I.V. Administration Set performs as intended. The following performance testing was conducted to support the substantial equivalence determination: - ISO 8536-8 . - o Leakage - o Tensile Strength - o Storage Tube Volume - ISO 80369-20 ● - o Luer Fittings - Stress Cracking о - Resistance to Separation from Axial Loading o - Resistance to Separation from Unscrewing O - o Resistance to Overriding - ISO 8536-4 ● - o Closure-piercing Device Testing - Air-inlet Device Testing о - Tubing Testing O - Flow Requirements of the Infusion Pump O - Drip Chamber Testing O - Clamp Opening and Closing O - Protective Cap Testing о - Chemical Compatibility Testing O {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the Fresenius Kabi logo. The logo consists of a blue abstract symbol on the left and the words "FRESENIUS KABI" in blue on the right. The abstract symbol is made up of three curved lines that are parallel to each other. w.fresenius-kabi.us - ISO 8536-14 ● - 0 Clamps and Flow Regulators Testing - ISO 11607-1 & 2 and ASTM D4169 ● O Sterile Barrier and Packaging Systems and Simulated Shipping - Particulate USP<788> Particulate Matter in Injections ● - o Particulate Testing - Pump Segment Compatibility Testing with Infusion Pump - Operation under Temperature, Pressure and Humidity - Microbial Ingress Testing ● - . Usability Testing # 11.Biocompatibility Testing Following the FDA Guidance: "Use of International Standard ISO 10993-1, Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process", the tests selected were for prolonged, blood path indirect, externally communicating devices. The following biocompatibility tests were successfully conducted on the Volumat Polyethylene I.V. Administration Set: - Acute Systemic Toxicity - Hemolysis ● - Irritation ● - Sensitization ● - Cytotoxicity ● - Pyrogens ● - Subacute/subchronic toxicity ● ### 12. Sterilization Validation Sterilization was achieved by ethylene oxide and meets the requirements of DIN EN ISO 11135:2020, which is equivalent to ISO 11135 (2014-7) + AMD 1 (2018-10). The ethylene oxide sterilization method achieves a Sterilization Assurance Level (SAL) of 10-6. ### 13. Clinical Testing No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the Fresenius Kabi logo. The logo consists of three blue wavy lines on the left and the words "FRESENIUS KABI" in blue on the right. The word "FRESENIUS" is on top of the word "KABI". Fresenius Kabi Three Corporate Drive Lake Zurich, Illinois 60047 T 847-550-2300 T 888-391-6300 www.fresenius-kabi.us # 14. Conclusion The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The subject device, Volumat Polyethylene I.V. Administration Set is substantially equivalent to the predicate device, I.V. Administration Set, cleared under K203609.