(413 days)
Not Found
No
The summary describes a standard volumetric infusion pump with programmable features and accessories. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies. The testing focuses on standard medical device performance, safety, and software validation.
Yes.
The device is used for the continuous or intermittent delivery of fluids, medications, blood derivatives, and nutrition, which are all therapeutic interventions designed to treat or manage a patient's condition.
No
Explanation: The device is an infusion system designed for delivering fluids and medications, not for diagnosing medical conditions. Its intended use focuses on administration, not detection or analysis of health states.
No
The device description explicitly states it includes a "Volumetric Infusion Pump," which is a hardware component. The summary also details hardware-related testing like electrical safety and EMC.
Based on the provided information, the Agilia VP Infusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "delivery of parenteral fluids, medications, blood derivatives" through various routes of administration. This describes a device used to administer substances into the body, not to perform tests on samples from the body.
- Device Description: The description details a "programmable electronic medical system dedicated to administering a pre-determined volume of an infusion product at a programmed rate." This aligns with the function of an infusion pump, not an IVD device.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Agilia VP Infusion System's function is to deliver substances to the patient, which is a therapeutic or supportive function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Agilia VP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids, medications, blood and 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 VP 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. These routes of administration include intravenous, intra-arterial, and subcutaneous using dedicated administration sets.
It is intended for use by trained healthcare professionals in healthcare facilities.
Product codes (comma separated list FDA assigned to the subject device)
FRN, MRZ, FPA
Device Description
The Agilia VP Infusion System includes the Agilia VP MC WiFi Volumetric Infusion Pump, which is a programmable electronic medical system dedicated to administering a pre-determined volume of an infusion product at a programmed rate, in combination with Volumat Line administration sets and 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 VP infusion pump to a PC for serial communication.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric, neonatal
Intended User / Care Setting
trained healthcare professionals in healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- Verification testing of product requirements.
- Human factors engineering testing of product requirements associated with critical tasks.
- Testing for the reliability goals of the device.
A safety assurance case was provided as recommended in the FDA Guidance Document, Infusion Pumps Total Product Life Cycle issued December 2, 2014, with the stated goal: "The system design is acceptably safe for its intended use by its intended users and in its intended use environment."
The supporting assurance arguments covered:
- Residual risks are analyzed and determined to be acceptably low using industry-standard risk analysis practices and regulatory guidance
- The Agilia VP Infusion System is at least as safe as an equivalent infusion system.
- The Agilia VP Infusion System is Verified and Validated for its intended use as it relates to safety
- The Agilia VP Infusion System is reliable over the system's expected lifetime.
Evidence included:
- Risk Management File
- Design verification and validation testing confirmed the Agilia VP 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 TIR101 2021.
- Device reliability activities, testing and statistical analysis confirmed the Agilia VP Infusion System met its reliability goal at the system, device subsystem, and subsystem component level.
- 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: Electrical Safety per IEC 60601-1, EMC testing per IEC 60601-1-2.
- Cybersecurity testing performed confirmed the system is effective in addressing cybersecurity threats, following "Content of Premarket Submissions for Management of Cybersecurity, October 2, 2014" and "Postmarket Management of Cybersecurity in Medical Devices, December 28, 2016".
Clinical Testing: Not required for this submission. 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 VP 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 VP Infusion System is substantially equivalent to the predicate Agilia Infusion System (K121613).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Infusion Accuracy: ± 5% under most conditions
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
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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 side of the image 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
Fresenis Kabi AG % Keith Dunn Director Regulatory Affairs Fresenius Kabi LLC, USA 3 Corporate Dr Suite 300 Lake Zurich, Illinois 60047
Re: K210073
Trade/Device Name: Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN, MRZ, FPA Dated: January 8, 2021 Received: January 12, 2021
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) K210073
Device Name Agilia VP Infusion System
Indications for Use (Describe)
The Agilia VP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids, medications, 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 VP Infusion System is also intended for neonatal care for the intermittent or continuous delivery of parenteral fluids for hydration and nutrition, blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, 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)
| ☑ 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/1 description: The image contains the logo for Fresenius Kabi. The logo consists of a blue abstract symbol on the left, resembling three vertical wavy lines. To the right of the symbol, the words "FRESENIUS" and "KABI" are stacked on top of each other, also in blue. The text is in a bold, sans-serif font.
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 VP Infusion System
Common Name/Usual Name:
Infusion Pump and Accessories
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Image /page/4/Picture/1 description: The image shows the Fresenius Kabi logo. The logo consists of a blue graphic on the left and the words "FRESENIUS KABI" on the right. The graphic is made up of three blue, curved lines. The words "FRESENIUS KABI" are in blue, with "FRESENIUS" on top and "KABI" on the bottom.
Classification Name
21 CR 880.5725 Infusion Pump
Product Code and Classification Panel
The Agilia VP 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 Number | Class | Description | Panel | Product
Code |
|-----------------------------------------------|-------------------|-------|---------------------------|-------|-----------------|
| Agilia VP MC WiFi Volumetric
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 |
| Volumat Line administration
sets | 21 CFR 880.5725 | II | Infusion pump accessories | 80 | FPA |
Table 1: Device Classification
Legally Marketed Device Under Which Substantial Equivalence is Being Claimed
Agilia Infusion System (K121613)
Device Description
The Agilia VP Infusion System includes the Agilia VP MC WiFi Volumetric Infusion Pump, which is a programmable electronic medical system dedicated to administering a pre-determined volume of an infusion product at a programmed rate, in combination with Volumat Line administration sets and 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 VP infusion pump to a PC for serial communication.
Statement of Intended Use/Indications For Use
The Agilia VP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids. medications, blood and blood derivatives through clinically accepted parenteral routes of administration. These routes
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Image /page/5/Picture/1 description: The image contains the logo for Fresenius Kabi. The logo consists of a blue graphic on the left, which appears to be three stylized vertical lines. To the right of the graphic are the words "FRESENIUS KABI" in blue, with "FRESENIUS" on top of "KABI". There is a small subscript number 1 next to the letter S in Fresenius.
of administration include intravenous, intra-arterial, subcutaneous and intraosseous using dedicated administration sets.
The Agilia VP 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. These routes of administration include intravenous, intra-arterial, and subcutaneous using dedicated administration sets.
It is intended for use by trained healthcare professionals in healthcare facilities.
Technological Comparison as Compared to the Predicate Device
A comparison between the predicate device and the subject device is provided in the Table 2.
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Image /page/6/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.
| Characteristic | Predicate Device | Subject Device | Comment |
|---|---|---|---|
| K121613 | K210073 | ||
| Intended Use / | |||
| Indications for | |||
| Use | The Agilia Infusion System is | ||
| a transportable equipment | |||
| intended for use by trained | |||
| healthcare professionals in | |||
| healthcare facilities and | |||
| homecare environments on | |||
| adults, pediatrics and | |||
| neonate's human patients to | |||
| administer via a single | |||
| channel or mounted on a | |||
| multiple channels rack | |||
| accessory: | |||
| • Intermittent or continuous | |||
| delivery of parenteral fluids | |||
| (solutions, colloids, | |||
| parenteral nutrition) and | |||
| medications (including but | |||
| not limited to diluted drugs, | |||
| chemotherapy) through | |||
| clinically accepted IV routes | |||
| of administration. | |||
| • Transfusion of blood and | |||
| blood derivatives products. | The Agilia VP Infusion | ||
| System is intended for adult | |||
| and pediatric care for the | |||
| intermittent or continuous | |||
| delivery of parenteral fluids, | |||
| medications, blood and 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 VP 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. These routes | |||
| of administration include | |||
| intravenous, intra-arterial, | |||
| and subcutaneous using | |||
| dedicated administration sets. | |||
| It is intended for use by | |||
| trained healthcare | |||
| professionals in healthcare | |||
| facilities. | Similar | ||
| The intended use | |||
| between the predicate | |||
| and proposed device | |||
| are the same in terms | |||
| of intended patient, | |||
| route of | |||
| administrations, and | |||
| treatment. Per FDA | |||
| guidance, the | |||
| statement was revised | |||
| to specifically name | |||
| the intended routes of | |||
| administration and to | |||
| differentiate the | |||
| intended patient | |||
| population . | |||
| Type of Pump | Volumetric, Linear Peristaltic | ||
| Pump | Volumetric, Linear Peristaltic | ||
| Pump | Same | ||
| Patient | |||
| Population | Adults, pediatrics, neonates | Adults, pediatrics, neonates | Same |
| Delivery | |||
| Modes | Continuous, Intermittent, | ||
| Primary, Secondary, KVO, | |||
| Bolus (Manual and | |||
| Programmable), Loading | |||
| Dose | Continuous, Intermittent, | ||
| Primary, Secondary, KVO, | |||
| Bolus (Manual and | |||
| Programmable), Loading | |||
| Dose, Ramp-up / Ramp | |||
| down, Sequential | Similar | ||
| Performance testing | |||
| demonstrates the | |||
| additional modes do | |||
| not introduce any new | |||
| issues of safety or | |||
| effectiveness. | |||
| Characteristic | Predicate Device | Subject Device | Comment |
| K121613 | K210073 | ||
| Infusion | |||
| Accuracy | $\pm$ 5% | $\pm$ 5% under most conditions | Similar |
| Detailed flow rate | |||
| accuracy disclosed in | |||
| the labeling | |||
| WIFI | No | Yes | Similar |
| Performance testing | |||
| demonstrates the | |||
| addition of WIFI | |||
| functionality does not | |||
| introduce any new | |||
| issues of safety or | |||
| effectiveness. | |||
| Pump Control | Microcontroller controlled | Microcontroller controlled | Same |
| Number of | |||
| Channels | 1 | 1 | Same |
| Mechanical | |||
| Sensors | air, occlusion, temperature, | ||
| pressure, door, set installation | air, occlusion, temperature, | ||
| pressure, door, set installation | Same | ||
| Barcoding | No | No | Same |
| Automated | |||
| Programming | No | No | Same |
| Manual | |||
| Programming | Yes | Yes | Same |
| Piggy back / | |||
| secondary | Yes | Yes | Same |
| Alarms | Air, occlusion, temperature, | ||
| system malfunction, | |||
| set installation, door, | |||
| low drug reservoir volume, | |||
| infusion complete, battery, | |||
| technical | Air, occlusion, temperature, | ||
| system malfunction, | |||
| set installation, door, | |||
| low drug reservoir volume, | |||
| infusion complete, battery, | |||
| technical | Same | ||
| Clinical | |||
| Advisories | Yes | Yes | Same |
| Infusion | |||
| Modes | Basic, continuous, | ||
| intermittent, primary / | |||
| secondary, KVO, Bolus | |||
| (direct and programmed), | |||
| Loading Dose | Basic, continuous, | ||
| intermittent, primary / | |||
| secondary, KVO, Bolus | |||
| (direct and programmed), | |||
| Loading Dose, Ramp-up / | |||
| Ramp Down, Sequential | Similar | ||
| Performance testing | |||
| demonstrates the | |||
| additional infusion | |||
| modes do not | |||
| introduce any new | |||
| issues of safety or | |||
| effectiveness. | |||
| Characteristic | Predicate Device | Subject Device | Comment |
| K121613 | K210073 | ||
| Features | Keypad lock | Keypad lock/automatic lock, | |
| occlusion auto restart | Similar | ||
| Performance testing | |||
| demonstrates the | |||
| additional keypad | |||
| features do not | |||
| introduce any new | |||
| issues of safety or | |||
| effectiveness. | |||
| Dose Error | |||
| Reduction | |||
| Software / | |||
| Drug Library | |||
| Software | |||
| Compatibility | Basic Profile (within pump) | Basic Profile (within pump) | Same |
| Wireless | |||
| Server | |||
| Software | No | Yes | Similar |
| Performance testing | |||
| demonstrates the | |||
| addition of wireless | |||
| server software does | |||
| not introduce any new | |||
| issues of safety or | |||
| effectiveness. | |||
| Administration | |||
| Sets | Volumat Line administration | ||
| sets | Volumat Line administration | ||
| sets | Same | ||
| Racking / | |||
| Organization / | |||
| Power | Link+ Agilia | Agilia Link | Similar |
| Simpler, non- | |||
| communicating | |||
| accessory for proposed | |||
| device | |||
| Agilia Duo | Agilia Duo | Same | |
| Electrical | |||
| Safety | IEC 60601-1: 1998 +A1:1995 | ||
| (2nd edition) | |||
| IEC 60601-1-8: 2003 | |||
| +A1:2006 | |||
| IEC 60601-1-2: 2007 | |||
| ANSI/AAMI ID26: | |||
| 2004/(R)2009 | IEC 60601-1: 2005 | ||
| +A1:2012 (3rd edition) | |||
| IEC 60601-1-8: 2012 | |||
| IEC 60601-1-2: 2014 | |||
| ANSI/AAMI ID26: | |||
| 2004/(R)2009 | Similar | ||
| Performance testing | |||
| demonstrates the | |||
| application of state-of- | |||
| the-art standards does | |||
| not introduce any new | |||
| issues of safety or | |||
| effectiveness. | |||
| Mechanical / | |||
| Power | |||
| Specifications | Pump Size: 5.3 x 7.5 x 6.7 | ||
| inches | |||
| Pump Weight: App. 4.4 lbs. | |||
| Line Power: 100-240 VAC | Pump Size: 5.3 x 7.5 x 6.7 | ||
| inches | |||
| Pump Weight: App. 4.4 lbs. | |||
| Line Power: 100-240 VAC | Same | ||
| Operating | |||
| Environment | Temperature: 41° F to 104° F | ||
| Relative Humidity: 20-90% | Temperature: 41° F to 104° F | ||
| Relative Humidity: 20-90% | Same | ||
| Characteristic | Predicate Device | ||
| K121613 | Subject Device | ||
| K210073 | Comment | ||
| Storage | |||
| Environment | Temperature: 14° F to 140° F | ||
| Relative Humidity: 10-90% | |||
| w/o condensation | Temperature: 14° F to 140° F | ||
| Relative Humidity: 10-90% | |||
| w/o condensation | Same |
Table 2: Predicate Comparison
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Image /page/7/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 curved lines.
8
Image /page/8/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 word "FRESENIUS" is above the word "KABI".
9
Image /page/9/Picture/1 description: The image contains the Fresenius Kabi logo. The logo consists of three blue wavy lines on the left side. To the right of the wavy lines is the text "FRESENIUS KABI" in blue, with "FRESENIUS" on top and "KABI" on the bottom.
To demonstrate substantial equivalence between the subject and predicate device the following non-clinical tests were performed:
- Verification testing of product requirements.
- 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 VP 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 VP Infusion System is at least as safe as an equivalent infusion system.
-
The Agilia VP Infusion System is Verified and Validated for its intended use as it relates to safety
-
The Agilia VP Infusion System is reliable over the system's expected lifetime. ●
The following evidence was included in the safety assurance case:
- Risk Management File ●
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Image /page/10/Picture/1 description: The image contains the logo for Fresenius Kabi. The logo consists of a blue graphic on the left, which is three curved lines stacked on top of each other. To the right of the graphic is the text "FRESENIUS" in blue, with "KABI" in blue below it.
- Design verification and validation testing confirmed the Agilia VP 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 TIR101 2021.
- Device reliability activities, testing and statistical analysis confirmed the Agilia VP Infusion System met its reliability goal at the system, device subsystem, and subsystem component level.
- 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.
- Content of Premarket Submissions for Management of Cybersecurity, October 2, O 2014
- Postmarket Management of Cybersecurity in Medical Devices, December 28, O 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 VP 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.
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Image /page/11/Picture/1 description: The image contains the logo for Fresenius Kabi. The logo consists of a blue abstract symbol on the left, resembling three interconnected wave-like shapes. To the right of the symbol, the words "FRESENIUS" and "KABI" are stacked on top of each other, also in blue. The overall design is clean and corporate, suggesting a company in the healthcare or pharmaceutical industry.
Results of verification and validation activities demonstrate that the Agilia VP Infusion System is substantially equivalent to the predicate Agilia Infusion System (K121613).