Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable

{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. March 1, 2022 Fresenius Kabi AG % Keith Dunn Director Regulatory Affairs Fresenius Kabi LLC, USA 3 Corporate Dr Suite 300 Lake Zurich, Illinois 60047 Re: K210074 Trade/Device Name: Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN. MRZ Dated: January 31, 2022 Received: February 3, 2022 Dear Keith Dunn: We have reviewed vour 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 {1}------------------------------------------------ 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 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 medical devices and radiation-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, Courtney H. Lias, Ph.D. Director 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) K210074 Device Name Agilia SP Infusion System #### Indications for Use (Describe) The Agilia SP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids, medication, blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, subcutaneous, and intraosseous using dedicated administration sets. The Agilia SP Infusion System is also intended for neonatal care for the intermittent or continuous delivery of parenteral fluids for hydration and nutrition, blood, and blood derivatives through clinically accepted parenteral routes of administration and critical drugs under specific conditions. These routes of administration include intravenous, intraarterial, and subcutaneous using dedicated administration sets. It is intended for use by trained healthcare professionals in healthcare facilities | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The word "FRESENIUS" is on top of the word "KABI". # 510(k) SUMMARY ### Date Prepared February 28, 2022 ### Owner/Operator Fresenius Kabi AG 61346 Bad Homburg Germany Owner/Operator Number: 9027285 #### Contact Person ## Keith Dunn Director, Regulatory Affairs Fresenius Kabi USA, LLC Three Corporate Drive, 2nd Floor Lake Zurich, IL 60047 USA Phone: 224-817-2430 Fax: 847 550 2960 E-mail: keith.dunn(@fresenius-kabi.com ### Secondary Contact Person ### Jason Ma Sr. Manager, Regulatory Affairs Fresenius Kabi USA, LLC Three Corporate Drive, 2nd Floor Lake Zurich, IL 60047 USA Phone: 224-817-4100 847 550 2960 Fax: E-mail: jason.ma01(@fresenius-kabi.com #### Device Trade Name Agilia SP Infusion System ### Common Name/Usual Name: Infusion Pump and Accessories {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the Fresenius Kabi logo. On the left side of the logo are three blue wavy lines stacked on top of each other. To the right of the wavy lines is the text "FRESENIUS" on top of the text "KABI". The text is also in blue. ### Classification Name 21 CR 880.5725 Infusion Pump ## Product Code and Classification Panel The Agilia SP Infusion System (pump, set and accessories) has been classified as Class II under 21 CFR 880.5725, and reviewed by the General Hospital Devices Panel (80). For reference, the product code and classification of each device subsystem is identified in Table 1. | Device Name | Regulation<br>Number | Class | Description | Panel | Produc<br>t Code | |-----------------------------------------|----------------------|-------|---------------------------|-------|------------------| | Agilia SP MC WiFi Syringe Infusion Pump | 21 CFR 880.5725 | II | Infusion Pump | 80 | FRN | | Agilia Link | 21 CFR 880.5725 | II | Infusion pump accessories | 80 | MRZ | | Agilia Duo | 21 CFR 880.5725 | II | Infusion pump accessories | 80 | MRZ | | Agilia USB Cable | 21 CFR 880.5725 | II | Infusion pump accessories | 80 | MRZ | ### Table 1: Device Classification # Legally Marketed Device Under Which Substantial Equivalence is Being Claimed Alaris System with Guardrails Suite MX (K133532) ### Device Description The Agilia SP Infusion System includes the Agilia SP MC WiFi Syringe Infusion Pump which is a programmable electronic medical system dedicated to administering a predetermined volume of an infusion product at a programmed rate, in combination with compatible third-party syringes and extension sets along with optional accessories. The optional accessories are identified as follows: - Agilia Link 4, 6 and 8 Stacking rack system intended to power and organize 4, 6 or ● 8 pumps at the patient bedside. - Agilia Duo - two-channel accessory designed to power two Agilia infusion pumps. - Agilia USB Cable - intended to connect the Agilia SP infusion pump to a PC for serial communication. ### Statement of Intended Use/Indications For Use The Agilia SP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids, medication, blood, and blood derivatives {5}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the logo for Fresenius Kabi. The logo consists of a stylized blue wave-like graphic on the left, followed by the text "FRESENIUS" stacked above "KABI" in a bold, sans-serif blue font. The wave graphic is composed of three parallel, curved lines that resemble flowing water or a stylized representation of veins, which is relevant to the company's focus on pharmaceuticals and medical technology. The overall design is clean and modern, conveying a sense of innovation and reliability. through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, subcutaneous, and intraosseous using dedicated administration sets. The Agilia SP Infusion System is also intended for neonatal care for the intermittent or continuous delivery of parenteral fluids for hydration and nutrition, medication, blood, and blood derivatives through clinically accepted parenteral routes of administration and critical drugs under specific conditions. These routes of administration include intravenous, intra-arterial, and subcutaneous using dedicated administration sets. ## Technological Comparison as Compared to the Predicate Device A comparison between the predicate device and the subject device is provided in the Table 2. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image contains the logo for Fresenius Kabi. The logo consists of a blue abstract wave-like design on the left, followed by the company name "FRESENIUS" in a bold, sans-serif font. Below "FRESENIUS" is the word "KABI", also in a bold, sans-serif font, and in the same blue color. | Characteristic | Predicate Device | Subject Device | Comment | |-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | | K133532 | K210074 | | | Intended Use /<br>Indications for<br>Use | The Alaris® PC Unit is the<br>main user interface unit and<br>power supply of the Alaris®<br>System, a modular system to<br>be used with Alaris®<br>System modules intended<br>for use in today's growing<br>professional healthcare<br>environment for facilities<br>that utilize infusion and/or<br>monitoring devices. The<br>specific intended use for<br>each Alaris® System<br>module is specified in its<br>respective submission.<br><br>The Alaris System with<br>Guardrails Suite MX is<br>intended for use in today's<br>growing professional<br>healthcare environment for<br>facilities that utilize syringe<br>pumps for the delivery of<br>fluids, medications, blood<br>and blood products. It is<br>indicated for use on adults,<br>pediatrics and neonates for<br>continuous or intermittent<br>delivery through clinically<br>acceptable routes of<br>administration such as<br>intravenous (IV), intra-<br>arterial (IA), subcutaneous,<br>epidural, enteral, or<br>irrigation of fluid spaces. | The Agilia SP Infusion<br>System is intended for adult<br>and pediatric care for the<br>intermittent or continuous<br>delivery of parenteral fluids,<br>medication, blood, and<br>blood derivatives through<br>clinically accepted<br>parenteral routes of<br>administration. These routes<br>of administration include<br>intravenous, intra-arterial,<br>subcutaneous, and<br>intraosseous using dedicated<br>administration sets.<br><br>The Agilia SP Infusion<br>System is also intended for<br>neonatal care for the<br>intermittent or continuous<br>delivery of parenteral fluids<br>for hydration and nutrition,<br>medication, blood, and<br>blood derivatives through<br>clinically accepted<br>parenteral routes of<br>administration and critical<br>drugs under specific<br>conditions. These routes of<br>administration include<br>intravenous, intra-arterial,<br>and subcutaneous using<br>dedicated administration<br>sets. | Similar<br>Overall intended<br>use except the<br>proposed device<br>does not include<br>indications for<br>epidural or enteral<br>infusion. | | Type of Pump | Syringe Infusion Pump | Syringe Infusion Pump | Same | | Patient<br>Population | Adults, pediatrics, neonates | Adults, pediatrics, neonates | Same | | Delivery Modes | Continuous, Intermittent,<br>KVO, Bolus (Manual and<br>Programmable), Loading<br>Dose, Basic infusion | Continuous, Intermittent,<br>KVO, Bolus (Manual and<br>Programmable), Loading<br>Dose, Basic infusion (also<br>called Basic Profile) | Same | | Characteristic | Predicate Device | Subject Device | Comment | | | K133532 | K210074 | | | Flow Rate<br>Accuracy | ±5% for flow rates between<br>1 and 999 mL/h<br>±5.5% for flow rates less<br>than 1 mL/h | ±3% under most conditions | Similar<br>Detailed flow rate<br>accuracy disclosed<br>in the labeling | | WIFI | Yes | Yes | Same | | Pump Control | Microcontroller controlled | Microcontroller controlled | Same | | Number of<br>Channels | 1 | 1 | Same | | Mechanical<br>Sensors | occlusion, temperature,<br>pressure, syringe<br>installation, force sensor | occlusion, temperature,<br>pressure, syringe<br>installation, force sensor | Same | | Manual<br>Programming | Yes | Yes | Same | | Alarms | High pressure / occlusion,<br>temperature, system<br>malfunction, empty syringe,<br>plunger disengages, syringe<br>unlocked, infusion near end,<br>infusion complete, low<br>battery, depleted battery,<br>technical | High pressure / occlusion,<br>temperature, system<br>malfunction, empty syringe,<br>plunger disengages, syringe<br>unlocked, infusion near end,<br>infusion complete, low<br>battery, depleted battery,<br>technical | Same | | Clinical<br>Advisories | Yes | Yes | Same | | Infusion Modes | Basic infusion,<br>continuous/intermittent,<br>Volume to be infused, Dose<br>to be infused, KVO, Bolus<br>(direct and programmed),<br>Loading Dose | Basic infusion,<br>continuous/intermittent,<br>Volume to be infused, Dose<br>to be infused, KVO, Bolus<br>(direct and programmed),<br>Loading Dose | Same | | Features | Keypad lock/automatic lock,<br>occlusion auto restart | Keypad lock/automatic lock,<br>occlusion auto restart | Same | | Dose Error<br>Reduction<br>Software / Drug<br>Library | Basic Profile (within pump) | Basic Profile (within pump) | Same | | Wireless Server<br>Software | Yes | Yes | Same | | Characteristic | Predicate Device | Subject Device | Comment | | | K133532 | K210074 | | | Number of<br>Compatible<br>Syringes | 20 | 5 | Similar<br>Compatibility of<br>syringes is<br>dependent on the<br>pump. | | Racking /<br>Organization /<br>Power | Maximum of 4 | Agilia Link (for 4, 6 or 8<br>pumps)<br>Agilia Duo (for 2 pumps) | Similar<br>Accessories<br>provide equivalent<br>functionality. | | Electrical Safety | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1: 2005<br>+A1:2012 (3rd edition)<br>IEC 60601-1-8: 2012<br>IEC 60601-1-2: 2014 | Similar<br>State-of-the-art<br>compliance | | Mechanical /<br>Power<br>Specifications | Pump Size: 8.8 x 6.9 x 9<br>(PC Unit) 15 x 4.5 x 7.5<br>(syringe module) inches<br>Pump Weight: 7.2 lbs. (PC<br>unit) 4.5 lbs. syringe module<br>Line Power: 100-240 VAC | Pump Size:<br>5.3 x 13.6 x 6.7 inches<br>Pump Weight: App. 4.6 lbs.<br>Line Power: 100-240 VAC | Similar<br>System size and<br>weight considered<br>moderately small. | | Operating<br>Environment | Temperature 41 °F to 104°F<br>Relative Humidity: 20-90%<br>w/o condensation | Temperature 41 °F to 104°F<br>Relative Humidity: 20-90%<br>w/o condensation | Same | | Storage<br>Environment | Temperature: 4 °F to 140°F<br>Relative Humidity: 5-90%<br>w/o condensation - | Temperature: 14°F to 140°F<br>Relative Humidity: 10-90%<br>w/o condensation | Similar<br>Functional and<br>expected life<br>testing have found<br>no new issues of<br>safety or<br>effectiveness with<br>this change. | # Table 2: Predicate Comparison {7}------------------------------------------------ Image /page/7/Picture/1 description: The image contains the logo for Fresenius Kabi. The logo consists of three blue, stylized waves on the left side. To the right of the waves, 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 and a visual representation of movement or flow. {8}------------------------------------------------ Image /page/8/Picture/1 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". To demonstrate substantial equivalence between the subject and predicate device the following non-clinical tests were performed: - Verification testing of product requirements. ● {9}------------------------------------------------ Image /page/9/Picture/1 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 vertical wavy lines. The words "FRESENIUS" and "KABI" are stacked on top of each other. - Human factors engineering testing of product requirements associated with critical tasks. - Testing for the reliability goals of the device. . # Non-Clinical Testing A safety assurance case was provided for the Agilia SP Infusion System as recommended in the FDA Guidance document, Infusion Pumps Total Product Life Cycle issued December 2, 2014. The stated goal of the safety assurance case is: - The system design is acceptably safe for its intended use by its intended users and in . its intended use environment. The assurance case defines the device system, including the operational description, system definition, indications for use, patient population, intended users and use environments. The supporting assurance arguments covered the following attributes: - Residual risks are analyzed and determined to be acceptably low using industrystandard risk analysis practices and regulatory guidance - The Agilia SP Infusion System is at least as safe as an equivalent infusion system. - The Agilia SP Infusion System is Verified and Validated for its intended use as it relates to safety - The Agilia SP Infusion System is reliable over the system's expected lifetime. The following evidence was included in the safety assurance case: - Risk Management File - . Design verification and validation testing confirmed the Agilia SP Infusion System met user needs and design inputs. Testing results conformed with acceptance criteria. Flow rate and bolus accuracy testing were conducted by following AAMI TIR 101 2021. - . Device reliability activities, testing and statistical analysis confirmed the Agilia SP Infusion System met its reliability goal at the system, device subsystem, and subsystem component level. {10}------------------------------------------------ Image /page/10/Picture/1 description: The image contains the logo for Fresenius Kabi. The logo consists of two parts: a graphic element on the left and the company name on the right. The graphic element is composed of three blue, stylized, vertical lines that resemble waves or streams. To the right of the graphic, the words "FRESENIUS" and "KABI" are stacked vertically, also in blue. - Software verification and validation were performed per FDA Guidance for the ● Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005. - Human factors evaluation conducted to validate the effectiveness of use-related features/functionality and use error-related mitigations in the associated use environments. IEC 62366-1 Edition 1.0 2015 Medical Devices Part 1: Application of usability engineering to medical devices was followed. - Electrical and Electromagnetic Compatibility testing were conducted. The Infusion System complies with the following standards: - Electrical Safety per IEC 60601-1 O - o EMC testing per IEC 60601-1-2 - Cybersecurity testing performed confirmed the system is effective in addressing ● cybersecurity threats. FDA Cybersecurity Guidance followed include: - Content of Premarket Submissions for Management of Cybersecurity, October 2, O 2014 - O Postmarket Management of Cybersecurity in Medical Devices, December 28, 2016 # Clinical Testing Clinical evaluation is not required for this submission to support substantial equivalence. Human Factors studies have been conducted on the subject device demonstrating passing results. # Conclusion The results of software, electrical safety, system verification and validation testing conclude that the Agilia SP Infusion System is safe and effective for the intended users, uses, and use environments, and that no further clinical investigation or testing is needed. The methods and results described in the verification and human factors evaluation (HFE/UE) reports support this conclusion. Results of verification and validation activities demonstrate that the Agilia SP Infusion System is substantially equivalent to the predicate Alaris System with Guardrails Suite MX (K133532).