Ivenix Infusion System (IIS)

K183311 · Ivenix, Inc. · FRN · Jun 7, 2019 · General Hospital

Device Facts

• Record ID: K183311
• Device Name: Ivenix Infusion System (IIS)
• Applicant: Ivenix, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Jun 7, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Ivenix Infusion System is indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration: intra-arterial, epidural, and subcutaneous, to adults, pediatric and neonate patients. Administered fluids may be pharmaceutical drugs, red blood cells, platelets, plasma, and other mixtures required for patient therapy. The Ivenix Large Volume Pump (LVP) is indicated for use only with the Ivenix sterile, single use, disposable administration sets, including: Primary dual inlet, single outlet, 1 Y-site Primary single inlet, single outlet Blood Set, dual inlet, single outlet, 1 Y-site, for administration of red blood cells, platelets and plasma Microbore single inlet, single outlet, for administration of epidural fluids Microbore dual inlet, single outlet, 1 Y-site Infusion Management System (IMS): The IMS provides information to the clinician regarding the use of the Ivenix Large Volume Pump (LVP) by way of a drug library, LVP configurations, and by providing remote information regarding LVP status. It also provides information on pump usage data reports to various functions within an institution.

Device Story

Ivenix Infusion System (IIS) comprises a single-channel large volume pump (LVP), sterile single-use administration sets, and an Infusion Management System (IMS) server. The LVP uses a pneumatically driven, closed-loop diaphragm mechanism; negative pressure draws fluid into an intermediate pumping chamber (IPC); positive pressure delivers it to the patient. The system calculates volume using the ideal gas law (P1V1=P2V2) via pressure measurements during fill/empty cycles; it adjusts drive pressure and fluidic resistance to maintain target flow rates. The LVP supports dual-inlet, single-outlet delivery for intermittent/piggy-back infusions. The IMS provides a centralized drug library, remote status dashboards, and clinical analytics. Operated by clinicians in hospitals/outpatient settings, the system integrates with Bar Code Medication Administration (BCMA) for auto-programming. Output includes real-time infusion status and usage reports. Benefits include precise flow control, dose error reduction via drug libraries, and remote monitoring capabilities.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including software validation (IEC 62304), electrical safety (AAMI/ANSI ES 60601-1), EMC (IEC 60601-1-2), wireless coexistence, human factors engineering, biocompatibility (ISO 10993), and microbial ingress testing. Blood product compatibility testing showed no degradation of red blood cells, platelets, or plasma.

Technological Characteristics

Pneumatically driven diaphragm pump; aluminum, polycarbonate, ABS construction. Administration sets: PE-lined PVC, polycarbonate, silicone. Power: 100-240 VAC or Li-ion battery. Connectivity: Wireless for IMS data transmission. Software: Major level of concern. Sterilization: Radiation (ISO 11137). Ingress protection: IPX3.

Indications for Use

Indicated for controlled fluid administration (pharmaceuticals, blood products, plasma) via intra-arterial, epidural, or subcutaneous routes in adult, pediatric, and neonate patients in hospital or outpatient settings.

Regulatory Classification

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.

Predicate Devices

• Baxter SIGMA Spectra Infusion Pump (K173084)
• Hospira Inc. Plum 360 Infusion System (K161469)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.

June 7, 2019

Ivenix, Inc. John Sokolowski Vice President, Regulatory Affairs 50 High St., Suite 50 North Andover, Massachusetts 01845

Re: K183311

Trade/Device Name: Invenix Infusion System (IIS) Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: FRN, FPA, PHC Dated: November 28, 2018 Received: November 29, 2018

Dear John Sokolowski:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Tina Kiang, Ph.D. Director

DHT3C: Division of Drug Delivery and General Hospital Devices and Human Factors | OHT3: Office of Gastrorenal, OB/GYN, General Hospital, and Urology Devices | Office of Product Evaluation and Quality CDRH | Food and Drug Administration

Enclosure

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### Indications for Use

510(k) Number (if known)

K183311

Device Name Ivenix Infusion System (IIS)

#### Indications for Use (Describe)

The Ivenix Infusion System is indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration: intra-arterial, epidural, and subcutaneous, to adults, pediatric and neonate patients. Administered fluids may be pharmaceutical drugs, red blood cells, platelets, plasma, and other mixtures required for patient therapy.

The Ivenix Large Volume Pump (LVP) is indicated for use only with the Ivenix sterile, single use, disposable administration sets, including:

Primary dual inlet, single outlet, 1 Y-site Primary single inlet, single outlet Blood Set, dual inlet, single outlet, 1 Y-site, for administration of red blood cells, platelets and plasma Microbore single inlet, single outlet, for administration of epidural fluids Microbore dual inlet, single outlet, 1 Y-site

Infusion Management System (IMS):

The IMS provides information to the clinician regarding the use of the Ivenix Large Volume Pump (LVP) by way of a drug library, LVP configurations, and by providing remote information regarding LVP status. It also provides information on pump usage data reports to various functions within an institution.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> 区 Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# K183311 510(K) SUMMARY

| Preparation Date: | June 7, 2019 |
|-------------------------|-----------------------------------------------------------------------------------------------|
| Manufacturer's Name: | Ivenix, Inc.<br>50 High Street, North Andover, MA 01845 |
| Corresponding Official: | John J. Sokolowski<br>Vice President, Regulatory Affairs |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| E-mail Address: | [e-mail] |
| Trade Name: | Ivenix Infusion System (IIS) |
| Common or Usual Name: | Large Volume Infusion Pump, Infusion Safety<br>Management Software |
| Regulation Name: | Infusion Pump |
| Regulation Number: | 21 CFR 880.5725 |
| Product Codes: | FRN, PHC, FPA |
| Device Class: | Class II |
| Predicate Device: | K173084, Baxter SIGMA Spectra Infusion Pump<br>K161469, Hospira Inc. Plum 360 Infusion System |

### Device Description

The Ivenix Infusion System (IIS) consists of three primary components:

- 1. Single channel large volume pump (LVP),
- 2. Single use, sterile, disposable fluid administration sets, and
- 3. Infusion Management System (IMS) server applications.

The Large Volume Infusion Pump (LVP) is built around a closed-loop, pneumatically driven fluid delivery mechanism. Negative pressure is used to draw liquid from the source container into an intermediate pumping chamber (IPC). Positive pressure is then used to push the liquid out of the IPC and to the patient. The pneumatic drive allows for direct measurement of volume changes in the IPC.

The pump used the ideal gas equation, P1V1 = P2V2, to accurately calculate volume of fluid delivered. Using a known reference volume, pressure measurements are taken at various intervals during the fill and empty cycles to allow the system to determine flow rate to the patient. The LVP then adjusts drive pressure and/or fluidic resistance through a variable fluidic resistor to bring the actual flow rate to match the target flow rate.

The LVP System is a dual-inlet, single-outlet delivery system that can selectively draw from up to two fluid sources and deliver either of those fluids to the patient through a single outlet. Active delivery from two inlets provides for managed intermittent and "piggy-back" infusions. The system does not support concurrent delivery of the same time. The LVP can use 5 ml to 60 ml syringes, manufactured by Becton Dickinson, B. Braun, or Covidien, directly connected to the secondary inlet of the primary and microbore administration sets as a fluid source.

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The system delivers fluid through a single-use, dual-inlet, single-outlet, disposable administration set. There are five varieties of administration sets:

- 1. Primary dual inlet, single outlet, 1 Y-site
- 2. Primary single inlet, single outlet
- Blood Set, dual inlet, single outlet. 1 Y-site, for administration of red blood cells, platelets and plasma 3.
- Microbore single inlet, single outlet, for administration of epidural fluids 4.
- 5. Microbore dual inlet, single outlet, 1 Y-site

The Infusion Management System (IMS) allows the pump to share information with other pumps and applications provided by Ivenix, such as an infusate library, or other systems that reside within the hospital. In addition, the IMS provides other features, such as remote viewing dashboards, clinical analytics, and advisories that provide information about the infusion delivery both at, and away from, the point of care.

### Indications for Use

The Ivenix Infusion System is indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration: intra- arterial, epidural, and subcutaneous to adults, pediatric and neonate patients. Administered fluids may be pharmaceutical drugs, red blood cells, platelets, plasma, and other mixtures required for patient therapy.

The Ivenix Large Volume Pump (LVP) is indicated for use only with the Ivenix sterile, single use, disposable administration sets, including:

- 1. Primary dual inlet, single outlet, 1 Y-site
- 2. Primary single inlet, single outlet
- 3. Blood Set, dual inlet, single outlet, 1 Y-site, for administration of red blood cells, platelets and plasma
- 4. Microbore single inlet, single outlet, for administration of epidural fluids
- 5. Microbore dual inlet, single outlet, 1 Y-site

#### Infusion Management System (IMS):

The IMS is intended to provide information to the clinician regarding the use of the Ivenix Large Volume Pump (LVP) by way of a drug library, LVP configurations, and by providing remote information regarding LVP status. It is also intended to provide information on pump usage data reports to various functions within an institution.

The device is prescription only.

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# Substantial Equivalence Discussion

### Intended Use Comparison

The table below includes a comparison of the intended use between the new device and those of the predicate device:

| Characteristic | Predicate Device<br>Baxter SIGMA Spectrum<br>K173084 | Subject Device<br>Ivenix Infusion System<br>K183311 | Discussion |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Ivenix Infusion System is<br>indicated for use in a hospital and<br>in outpatient care environments for<br>the controlled administration of<br>fluids through clinically accepted<br>routes of administration:<br>intravenous, intra-arterial, epidural,<br>and subcutaneous. Administered<br>fluids may be pharmaceutical<br>drugs, red blood cells, platelets,<br>plasma, and other mixtures required<br>for patient therapy. | The Baxter SIGMA<br>Spectrum Infusion Pump<br>with Master Drug Library is<br>intended to be used for the<br>controlled administration of<br>fluids. These may be<br>pharmaceutical drugs,<br>blood, blood products and<br>mixtures of required patient<br>therapy. The intended routes<br>of administration consist of<br>the following clinically<br>accepted routes:<br>intravenous, arterial,<br>subcutaneous, epidural or<br>irrigation of fluid space. | The subject device and<br>predicate device deliver<br>medications and other<br>fluids to a patient by<br>clinically accepted routes<br>of administration.<br>The difference is that the<br>Ivenix Infusion System is<br>not indicated for whole<br>blood, since whole blood<br>is rarely used for<br>transfusion. |
| Prescription Only or<br>Over the Counter | Prescription Only | Prescription Only | No differences between<br>the devices. |
| Intended Population | Adult, pediatric, neonate | Adult, pediatric, neonate | No differences between<br>the devices. |
| Environment of Use | Hospital or out-patient setting | Not specified | Both devices are intended<br>to be used by licensed<br>health care providers. |
| Item | Ivenix Infusion System –<br>LVP (K183311) | SIGMA Spectrum Pump<br>K173084 | Discussion |
| Mechanism of action | Pneumatically driven<br>diaphragm pump | Peristaltic pump action on<br>the administration set<br>tubing. | Both the subject and predicate<br>device deliver infusion fluid to<br>the patient in a controlled<br>manner at a programmed flow<br>rate.<br><br>Although different pumping<br>technologies are employed by<br>the subject device and the<br>predicate device, verification of<br>the subject device demonstrates<br>that it meets its intended use of<br>delivering fluids to a patient in a<br>controlled manner |
| Infusion accuracy | +/- 5% @ 0.5 - 1000 ml/hr. | +/- 5% @ 2 – 999 ml/hr,<br>+/- 0.1 ml/hr for rates < 2<br>ml/hr. | The subject device's flow rate<br>accuracy is consistent at all flow<br>rates as verified through<br>performance testing. |
| Maximum infusion<br>pressure | 931 mm Hg | 1488 mm Hg | Maximum pump pressures differ<br>because of the pumping<br>mechanisms of the two devices.<br>Both maximum pressures are<br>greater than the maximum<br>occlusion pressure alarm<br>threshold settings. |
| Programmable<br>flow rate range | 0.5 – 1000 ml/hr. | 0.5 - 999 ml/hr. | Essentially the same. The 1<br>ml/hr. difference at the high end<br>of the flow range is not<br>clinically significant. |
| Time to occlusion<br>alarm | Approximately 9 seconds to<br>30 minutes, depending on<br>flow rate, pressure threshold<br>setting, and distal tubing<br>type. | Approximately 50 seconds<br>to 3 hours, depending on<br>flow rate and pressure<br>threshold setting. | The subject device in general has<br>a more sensitive detection of<br>occlusions and raises an<br>occlusion alarm in a shorter<br>period of time than the predicate<br>device. This does not raise<br>different questions of safety or<br>effectiveness. |
| Item | Ivenix Infusion System –<br>LVP (K183311) | SIGMA Spectrum Pump<br>K173084 | Discussion |
| Post-occlusion<br>bolus | Less than 0.5 mL at<br>maximum occlusion<br>detection pressure and all<br>rates. | Less than 0.8 mL at<br>maximum occlusion<br>detection pressure and 25<br>mL/hr. | The maximum unintended bolus<br>of the Spectrum is 0.8 mL as<br>tested by Ivenix. The Ivenix LVP<br>is constant at 0.5 mL at any flow<br>rate. |
| Alarms & Alerts | • Air-in-line<br>• Battery low<br>• Battery depleted<br>• Bolus complete<br>• KVO<br>• Infusion complete<br>• Infusion not started<br>• Restricted flow Infusion<br>paused<br>• Occlusion (upstream or<br>downstream)<br>• Pump problem<br>• Tubing set problem<br>• Tubing set removed<br>• Dose limits exceeded | • Air-in-line<br>• Battery low<br>• Battery depleted<br>• Bolus complete<br>• KVO<br>• Infusion complete<br>• Inactivity alarm<br>• Occlusion (upstream or<br>downstream)<br>• System error Door open<br>• Dose limits exceeded | Alarms were validated based on<br>the intended use of the device<br>and the unique technological<br>characteristics. Alarm priorities<br>are similar for both devices. |
| Device service life | 5 years | Not specified | The device was evaluated<br>through performance testing to<br>meet the essential performance<br>throughout the service life. |
| Item | Ivenix Infusion System – LVP<br>(K183311) | SIGMA Spectrum Pump<br>K173084 | Discussion |
| Dimensions and<br>weight | 7.5"H x 8.5" W x 3.5" D<br>6.8 lbs. | 6.3"H x 6.4"W x 4.7"D<br>3.2 lbs.<br>(with wireless battery) | The Ivenix device is larger<br>and heavier than the Baxter<br>SIGMA Spectrum. This does<br>not raise different questions |
| Materials | Pump: aluminum, polycarbonate,<br>ABS<br>Administration set: PE lined PVC<br>tubing, polycarbonate, silicone<br>rubber | Pump: not specified<br>Administration sets: PVC<br>or PE tubing | of safety or effectiveness.<br>Materials are well-<br>characterized in both devices.<br>Biocompatibility and<br>Performance testing support<br>substantial equivalence of the<br>difference in materials. |
| Environment of<br>use | Hospital or out-patient setting | Presumed hospital or out-<br>patient setting | The use environment is the<br>same for both devices. |
| Ingress protection | IPX3 Spraying water | IPX0 – None | The predicate device does not<br>protect against water ingress.<br>The Ingress Protection level<br>was verified through<br>performance testing. |
| Power source | 100 - 240 VAC, 50/60 Hz, 2.0 A<br>or on-board rechargeable Lithium-<br>ion battery. | 115 VAC, 50 to 60 Hz,<br>300 mA, or attached<br>lithium-ion battery | Both devices use essentially<br>the same power sources. |
| Storage conditions | -20 to +60°C (-4 to +140°F), 20 to<br>90% RH non-condensing | -10 to +49°C (14 -<br>120°F), 10 to 90% RH<br>non-condensing | Both devices have similar<br>storage conditions. |
| Operating<br>Conditions | +5 to +35°C (+41 to +95°F), up to<br>90% RH non-condensing | 15.6 to 26.7°C (60 to<br>80°F, 20 to 90% RH non-<br>condensing | Both devices meet the<br>operating condition expected<br>in the use environment. |

### Discussions of differences in Indications for Use statement

The Ivenix Infusion System is not indicated for transfusion of whole blood, since whole blood is rarely used for transfusion.

### Discussions of differences in intended population

The intended population for the subject device is identical to the predicate device.

### Discussions of differences in environment of use

Although not specified, the Baxter SIGMA Spectrum pump is predominately used in the hospital or out-patient clinical environment, which is the same as the Ivenix Infusion System.

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#### Technological Characteristics

The table below includes a comparison of the technological characteristics between the new device and those of the predicate device:

The IIS LVP and the SIGMA Spectrum pump have equivalent technological characteristics as described in the table below.

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### Administration Sets:

The Ivenix Infusion System administration sets are similar to the Plum 360™ Infusion System, marketed under K161469. Both systems use sterile, single use disposable administration sets to deliver fluids to the patient. These sets have equivalent technological characteristics, as described below, and support substantial equivalence.

| Item | Ivenix Infusion System -<br>administration set | Plum 360 administration<br>set | Discussion |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Upstream air<br>management | The Ivenix pump has an<br>upstream air elimination<br>feature. | Air Trap allows 1 mL of air<br>in either A or B line before<br>the infuser sounds a cassette<br>alarm. | Both devices attempt to<br>purge or trap excess air in the<br>upstream portion of the<br>administration set. |
| Flow<br>dial/regulator | The Flow Dial integrates with<br>the LVP to maintain flow<br>accuracy. It also manually<br>controls flow during priming<br>or gravity infusion | The flow regulator manually<br>controls flow during priming<br>or gravity infusion. | The functions are similar in<br>both devices and were<br>verified through performance<br>testing for the intended use. |
| Connector | The connector that attaches<br>the downstream outlet tubing<br>to the patient access device<br>has a 2-piece luer lock. | The connector that attaches<br>the distal line to the patient<br>access device has a luer<br>connector with a locking<br>collar. | Both devices use standard<br>luer connections. |
| Outlet Tubing /<br>Distal Line<br>(Patient Line) | Runs from the cassette to the<br>patient. | Runs from the cassette to the<br>patient. | No differences between the<br>devices. |
| Lines | Ivenix IIS Administration Sets<br>have two lines referenced as<br>Primary and Secondary. | Hospira Plum Sets have two<br>lines referenced as Line A<br>and Line B. Manual also<br>references Secondary Ports. | Essentially the same between<br>both devices. |
| Syringe Use | Syringes (size 5 ml to 60 ml)<br>may be directly connected to<br>the secondary inlet of the<br>cassette as a fluid source. | Syringes (size 3 ml to 60 ml)<br>may be directly connected to<br>the secondary inlet of the<br>cassette as a fluid source. | Essentially the same between<br>both devices. The Ivenix<br>device's minimum syringe<br>size is 5 ml. |

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#### Infusion Management System:

The Ivenix Infusion Management System is similar to the Plum 360™ Infusion System with MedNet/ Smart Card Plug 'n' Play Module, K161469. Both systems employ a drug library to provide dose error reduction support to the clinician. These systems have equivalent features as described below, which support a finding of substantial equivalence.

| Feature | Subject Device - Ivenix<br>Infusion System - IMS | Primary Predicate -Plum<br>360 Infusion System -<br>MedNet/Smart Card Plug<br>'n' Play Module | Discussion |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Technology | Local server | Local server | No differences between the<br>devices. |
| Pump data<br>transmission | Wireless | Wireless | No differences between the<br>devices. |
| Dashboard (clinical,<br>biomedical.<br>pharmacy) | Independent of EMR, resides<br>on multiple platforms (laptop,<br>tablet, smart phone) | Single pump data available<br>for upload. | The Hospira system does<br>not have a dashboard<br>feature. |
| Auto programming | Supports interfaces to a Bar<br>Code Medication<br>Administration (BCMA) | Supports interface to BCMA | Both device support<br>BCMA. |
| Drug libraries | Customizable through an<br>editor | Customizable through an<br>editor | No differences between the<br>devices. |
| Drug library updates | Changes published and made<br>available to pump. Pump<br>initiates download and inserts<br>in drug library database. | Entire drug library pushed to<br>pump when pump not in use.<br>Different drug library replaces<br>previous one. | The Ivenix system updates the<br>pump fleet simultaneously<br>when an update is deployed. |
| Drug library<br>validation | Pump emulation software<br>within the drug library module. | Download to designated<br>pump or pumps for validation. | The Ivenix system uses a<br>simulated pump interface<br>to validate the drug library<br>content. |

### Discussions of differences in technological characteristics

The following minor technological differences exist between the subject and predicate devices, none of which raises different questions of safety or effectiveness:

- The Ivenix LVP device uses pneumatic pressure to move a flexible diaphragm to move fluid through the administration set. The Spectrum device utilizes peristaltic pump action on the straight tubing of the administration set to move fluid.
- The Ivenix LVP has the same flow rate range as the Spectrum pump. The accuracy of the Ivenix LVP is 5% across the full flow rate range. The Baxter device has a wider tolerance range at flow rates less than 2 ml/hr.
- Times to occlusion alarms of the Ivenix Infusion System LVP are less than the Spectrum pump, but provide the same functionality as the Spectrum pump, with variability depending on flow rates, pressure threshold settings, distal tubing characteristics, and other factors.
- The Ivenix LVP is slighter heavier than the Spectrum pump. ●
- The Ivenix LVP has a higher fluid ingress protection rating than the Baxter device.

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These differences between the subject device and the predicate devices are minor and do not raise different questions of safety or effectiveness.

# Performance Testing

The following bench testing was performed and reviewed to support the substantial equivalence of the subject device:

A safety assurance case was provided for the Ivenix Infusion System, as recommended in the FDA guidance document, Infusion Pumps Total Product Life Cycle.

The stated goal of the safety assurance case is: "The Ivenix Infusion System is reasonably safe for its intended use"

The safety assurance case addressed the system in its intended use environment. The supporting assurance arguments covered the following attributes:

- All hazards associated with the system have been identified and adequately addressed
- . Device reliability is adequate
- . The device design requirements are adequately verified and validated.
- . The system adequately secures data
- . The pump system functions under all anticipated conditions of use

The following specific evidence was included within the assurance case to demonstrate that the subject device is verified and validated for its intended use and to demonstrate substantial equivalence to the predicate devices:

| Software & Cybersecurity | • Software documentation is included per FDA's Guidance for the Content of Premarket<br>Submissions for Software Contained in Medical Devices for Major level of concern for the<br>software embedded in the Ivenix Infusion System.<br>• Software validation was conducted per IEC 62304 and the FDA guidance document<br>General Principles of Software Validation – Final Guidance for Industry and FDA Staff.<br>• Cybersecurity risks were assessed and documentation is included based on the FDA's<br>Guidance of Premarket Submissions for Management of Cybersecurity in Medical Device.<br>• AAMI ANSI IEC 62304:2006 Medical Device Software - Software Life Cycle Process |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety | • AAMI/ANSI ES 60601-1:2005/(R)2012 + A1:2012, C1:2009/(R)2012 + A2:2010/(R)<br>2012 Medical electrical equipment – Part 1: General requirements for basic safety and<br>essential performance |
| EMC | • IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1: General Requirements for<br>Safety-2-Collateral Standard: Electromagnetic Compatibility-Requirements & Tests |
| Wireless Coexistence &<br>RF Wireless testing | • FDA Guidance Document "Radio Frequency Wireless Technology in Medical Devices -<br>Guidance for Industry and Food and Drug Administration Staff"<br>• ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence<br>• AIM 7351731 Rev. 2.00 RFID Immunity |
| Administration Set<br>Compatibility | • Verification of the pump essential performance was completed with the indicated<br>administration sets |
| Device performance | • The essential performance requirements of the device were verified through performance testing in accordance with the intended use of the device and in accordance with the FDA Guidance "Infusion Pumps Total Product Life Cycle" |
| Syringe compatibility | • Performance testing was conducted on 5 ml to 60 ml syringes manufactured by B. Braun, Becton Dickinson, and Covidien at flow rates from 0.5 ml/hr to 20 ml/hr. The pump maintained flow accuracy with all syringe sizes and manufacturers tested, with no occlusions observed. |
| Battery testing | • Li-ion battery safety successfully tested per IEC 62133 |
| Human Factors | • Human factors studies per the FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016). The human factors studies were conducted with the intended user population, use environment and use scenarios to simulate clinical conditions. Results of the human factors testing demonstrate validation of the device per the intended use. |
| Reprocessing, Cleaning,<br>Sterility | • ISO 11137-1:2006 + A1:2013 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices<br>• ISO 11607-1:2006 + A1:2014 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems<br>• Validation per the FDA Guidance for Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (March 17, 2015) confirmed cleaning and disinfection instruction provided in instructions for use |
| Microbial Ingress | • The sterile fluid path of the administration set was challenged, under simulated worst case conditions, at the needless access ports, the spike connection to the fluid source, and the luer connection to the patient access device, with four strains of bacteria (2 gram positive, 2 gram negative). Test results showed no growth of microorganism in any test article, demonstrating the integrity of the sterile fluid path under simulated conditions of use. |
| Biocompatibility | • The materials used for in the Ivenix Administration Sets comply with biocompatibility requirements outlined in ISO 10993-1:2009 and the Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process and are considered to be biocompatible.<br>• Testing was conducted for cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, and hemocompatibility.<br>• $USP <661>$ Physicochemical properties<br>• AAMI ST72: 2011 Bacterial Endotoxins - Test methods, routine monitoring, and alternatives to batch testing<br>• $USP 39 <788>:2016$ Particulate Matter in Injections and ISO 8536-4. |
| Blood products<br>compatibility | • Packed red blood cells, platelets, and plasma were pumped through the Ivenix device at 14 ml/hr, 350 ml/hr, and 500 ml/hr flow rates. No appreciable degradation of any of the blood products was observed. |

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No testing was performed regarding use with magnetic resonance imaging (MRI) equipment. The pump is MR Unsafe.

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## Clinical Tests

Clinical evaluation is not required for this submission to support substantial equivalence. Similarly, the predicate devices did not undergo clinical evaluation to support substantial equivalence.

### Conclusions

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Ivenix Infusion System is substantially equivalent to the Baxter SIGMA Spectrum Infusion Pump cleared under K173084 with respect to the indications for use, target populations, treatment method, and technological characteristics.