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 Description

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

1. Single channel large volume pump (LVP),
1. Single use, sterile, disposable fluid administration sets, and
1. 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.

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
1. 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.
1. 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.

AI/ML Overview

The medical device described in the provided text is an infusion pump, and the document is a 510(k) summary for its premarket notification. Infusion pumps are typically subject to performance testing against established standards, rather than clinical studies with "acceptance criteria" and "ground truth" as might be seen for diagnostic AI devices.

Based on the provided information, I can answer your questions, specifically pointing out where the concepts you've asked about (like "acceptance criteria" for accuracy, "ground truth" for training, etc.) are addressed in the context of an infusion pump's regulatory submission.

1. A table of acceptance criteria and the reported device performance

For an infusion pump, "acceptance criteria" primarily relate to engineering and performance specifications outlined in recognized standards and internal validation. The document compares the subject device (Ivenix Infusion System) to a predicate device (Baxter SIGMA Spectrum Infusion Pump) on various technological characteristics, which act as de-facto performance criteria for achieving substantial equivalence.

Acceptance Criteria (Characteristic)	Reported Device Performance (Ivenix Infusion System - IIS)	Discussion/Comparison to Predicate
Infusion Accuracy	+/- 5% @ 0.5 - 1000 ml/hr. (Subject)	Predicate: +/- 5% @ 2 – 999 ml/hr, +/- 0.1 ml/hr for rates < 2 ml/hr. IIS flow rate accuracy is consistent at all flow rates, while the predicate has wider tolerance at rates < 2 ml/hr. Considered substantially equivalent.
Maximum Infusion Pressure	931 mm Hg (Subject)	Predicate: 1488 mm Hg. Differences due to pumping mechanisms; both greater than max occlusion pressure alarm thresholds. No new safety/effectiveness questions.
Programmable Flow Rate Range	0.5 – 1000 ml/hr. (Subject)	Predicate: 0.5 - 999 ml/hr. Essentially the same; 1 ml/hr difference at high end not clinically significant.
Time to Occlusion Alarm	Approximately 9 seconds to 30 minutes, depending on flow rate, pressure threshold setting, and distal tubing type. (Subject)	Predicate: Approximately 50 seconds to 3 hours. IIS generally has more sensitive detection and raises alarm faster. No new safety/effectiveness questions.
Post-occlusion Bolus	Less than 0.5 mL at maximum occlusion detection pressure and all rates. (Subject)	Predicate: Less than 0.8 mL at maximum occlusion detection pressure and 25 mL/hr. IIS is constant at 0.5mL at any flow rate.
Alarms & Alerts	Air-in-line, Battery low, Battery depleted, Bolus complete, KVO, Infusion complete, Infusion not started, Restricted flow, Infusion paused, Occlusion (upstream or downstream), Pump problem, Tubing set problem, Tubing set removed, Dose limits exceeded.	Alarms validated based on intended use and unique characteristics. Alarm priorities similar. No new safety/effectiveness questions.
Device Service Life	5 years (Subject)	Predicate: Not specified. IIS evaluated through performance testing to meet essential performance throughout service life.
Ingress Protection	IPX3 Spraying water (Subject)	Predicate: IPX0 – None. IIS has higher protection, verified through performance testing. Does not raise new safety/effectiveness questions.
Upstream Air Management	Air elimination feature. (Subject)	Predicate: Air Trap allows 1 mL of air in either A or B line before infuser sounds cassette alarm. Both attempt to purge or trap excess air.
Cannula/Connector Type	2-piece luer lock. (Subject)	Predicate: Luer connector with a locking collar. Both use standard luer connections.
Syringe Compatibility	5 ml to 60 ml syringes (Becton Dickinson, B. Braun, Covidien) (Subject)	Predicate: 3 ml to 60 ml syringes. IIS minimum syringe size is 5 ml. Essentially the same.
General Safety (Elec., EMC, Wireless)	Complies with AAMI/ANSI ES 60601-1, IEC 60601-1-2, FDA Guidance "Radio Frequency Wireless Technology," ANSI C63.27-2017, AIM 7351731 Rev. 2.00 RFID Immunity.	Standard safety and performance criteria for medical devices. Demonstrated compliance.
Biocompatibility	Complies with ISO 10993-1, testing for cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility. USP <661>, AAMI ST72, USP 39 <788>, ISO 8536-4.	Standard biocompatibility criteria for patient-contacting materials. Demonstrated compliance.
Microbial Ingress	No growth of microorganism showed under simulated worst-case conditions. (Subject)	Standard for sterile fluid path. Demonstrated integrity of sterile fluid path.
Blood Products Compatibility	No appreciable degradation of packed red blood cells, platelets, plasma observed when pumped at various flow rates. (Subject)	Demonstrated compatibility with various blood products.
Software & Cybersecurity	Complies with FDA's Guidance for "Software Contained in Medical Devices," IEC 62304, FDA Guidance "General Principles of Software Validation," FDA Guidance "Cybersecurity in Medical Device."	Standard for software validation and cybersecurity. Demonstrated compliance for a "Major" level of concern software.
Human Factors	Complies with FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices." Studies conducted with intended user population/environment/scenarios.	Standard for human factors validation. Demonstrated validation of device per intended use.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

For the performance testing of an infusion pump, "sample size" refers to the number of devices or components (e.g., administration sets, syringes) tested under various conditions to ensure they meet their specifications. The document details that various tests were performed, but does not specify quantitative sample sizes (e.g., N=X devices tested) or the provenance of this test data (e.g., conducted internally, by a third-party lab). These are typically highly controlled engineering tests, not based on real-world patient data in the way an AI diagnostic device would be.

Administration Set Compatibility: "Verification of the pump essential performance was completed with the indicated administration sets"
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 specific number of syringes or tests is not given.
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..."
Blood products 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." The number of samples or trials for each condition is not stated.
Human Factors: "The human factors studies were conducted with the intended user population, use environment and use scenarios to simulate clinical conditions." The number of participants is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This question is not applicable in the context of an infusion pump's performance testing for regulatory clearance. Infusion pump performance is verified against technical specifications and recognized standards, not "ground truth" established by human experts in the diagnostic sense. For example, flow rate accuracy is measured by calibrated instruments, not by an expert's assessment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This concept is not applicable. Adjudication methods like 2+1 or 3+1 are used in medical imaging studies to establish accurate labels (ground truth) for complex diagnostic tasks. For an infusion pump, performance is measured objectively against predefined engineering standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. MRMC studies are used to evaluate human reader performance with and without AI assistance for diagnostic tasks. This device is an infusion pump, not a diagnostic AI system, and therefore, such a study would not be performed for its clearance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The device is an infusion pump with an "Infusion Management System (IMS)" that includes a drug library and remote monitoring features. The performance tests ("Device performance", "Software & Cybersecurity") implicitly cover the "standalone" performance of the pump's mechanical and software components in delivering fluids accurately. The "Human Factors" study assesses the human-in-the-loop performance, but this is about usability and safety, not diagnostic accuracy improvement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

As discussed, the concept of "ground truth" for an infusion pump's performance is different from that of a diagnostic algorithm. The "ground truth" or reference for the infusion pump's performance testing consists of:

Established engineering specifications: E.g., flow rate accuracy within +/- 5%.
Validated measurement methods and equipment: Use of calibrated sensors and experimental setups to objectively measure parameters like flow rate, pressure, and bolus volume.
Recognized industry standards: Compliance with standards like IEC 60601 (electrical safety), ISO 10993 (biocompatibility), IEC 62304 (software life cycle), etc.

8. The sample size for the training set

This question is not applicable since the device is an infusion pump, which is not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves its design, engineering, and manufacturing processes to meet predefined specifications.

9. How the ground truth for the training set was established

Not applicable, as it's not an AI/ML device with a "training set." The "ground truth" for its development is based on engineering principles, clinical requirements for fluid delivery, and regulatory standards.

Summary

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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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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.

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

Infusion Management System (IMS):

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

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K183311 510(K) SUMMARY

Preparation Date:	June 7, 2019
Manufacturer's Name:	Ivenix, Inc.50 High Street, North Andover, MA 01845
Corresponding Official:	John J. SokolowskiVice President, Regulatory Affairs
Telephone Number:	(978) 775-8050
Fax Number:	(978) 775-8052
E-mail Address:	jsokolowski@ivenix.com
Trade Name:	Ivenix Infusion System (IIS)
Common or Usual Name:	Large Volume Infusion Pump, Infusion SafetyManagement 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 PumpK161469, 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),
1. Single use, sterile, disposable fluid administration sets, and
1. Infusion Management System (IMS) server applications.

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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
1. 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.
1. Microbore dual inlet, single outlet, 1 Y-site

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
1. Primary single inlet, single outlet
1. Blood Set, dual inlet, single outlet, 1 Y-site, for administration of red blood cells, platelets and plasma
1. Microbore single inlet, single outlet, for administration of epidural fluids
1. 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 DeviceBaxter SIGMA SpectrumK173084	Subject DeviceIvenix Infusion SystemK183311	Discussion
Indications for Use	The Ivenix Infusion System isindicated for use in a hospital andin outpatient care environments forthe controlled administration offluids through clinically acceptedroutes of administration:intravenous, intra-arterial, epidural,and subcutaneous. Administeredfluids may be pharmaceuticaldrugs, red blood cells, platelets,plasma, and other mixtures requiredfor patient therapy.	The Baxter SIGMASpectrum Infusion Pumpwith Master Drug Library isintended to be used for thecontrolled administration offluids. These may bepharmaceutical drugs,blood, blood products andmixtures of required patienttherapy. The intended routesof administration consist ofthe following clinicallyaccepted routes:intravenous, arterial,subcutaneous, epidural orirrigation of fluid space.	The subject device andpredicate device delivermedications and otherfluids to a patient byclinically accepted routesof administration.The difference is that theIvenix Infusion System isnot indicated for wholeblood, since whole bloodis rarely used fortransfusion.
Prescription Only orOver the Counter	Prescription Only	Prescription Only	No differences betweenthe devices.
Intended Population	Adult, pediatric, neonate	Adult, pediatric, neonate	No differences betweenthe devices.
Environment of Use	Hospital or out-patient setting	Not specified	Both devices are intendedto be used by licensedhealth care providers.
Item	Ivenix Infusion System –LVP (K183311)	SIGMA Spectrum PumpK173084	Discussion
Mechanism of action	Pneumatically drivendiaphragm pump	Peristaltic pump action onthe administration settubing.	Both the subject and predicatedevice deliver infusion fluid tothe patient in a controlledmanner at a programmed flowrate.Although different pumpingtechnologies are employed bythe subject device and thepredicate device, verification ofthe subject device demonstratesthat it meets its intended use ofdelivering fluids to a patient in acontrolled manner
Infusion accuracy	+/- 5% @ 0.5 - 1000 ml/hr.	+/- 5% @ 2 – 999 ml/hr,+/- 0.1 ml/hr for rates < 2ml/hr.	The subject device's flow rateaccuracy is consistent at all flowrates as verified throughperformance testing.
Maximum infusionpressure	931 mm Hg	1488 mm Hg	Maximum pump pressures differbecause of the pumpingmechanisms of the two devices.Both maximum pressures aregreater than the maximumocclusion pressure alarmthreshold settings.
Programmableflow rate range	0.5 – 1000 ml/hr.	0.5 - 999 ml/hr.	Essentially the same. The 1ml/hr. difference at the high endof the flow range is notclinically significant.
Time to occlusionalarm	Approximately 9 seconds to30 minutes, depending onflow rate, pressure thresholdsetting, and distal tubingtype.	Approximately 50 secondsto 3 hours, depending onflow rate and pressurethreshold setting.	The subject device in general hasa more sensitive detection ofocclusions and raises anocclusion alarm in a shorterperiod of time than the predicatedevice. This does not raisedifferent questions of safety oreffectiveness.
Item	Ivenix Infusion System –LVP (K183311)	SIGMA Spectrum PumpK173084	Discussion
Post-occlusionbolus	Less than 0.5 mL atmaximum occlusiondetection pressure and allrates.	Less than 0.8 mL atmaximum occlusiondetection pressure and 25mL/hr.	The maximum unintended bolusof the Spectrum is 0.8 mL astested by Ivenix. The Ivenix LVPis constant at 0.5 mL at any flowrate.
Alarms & Alerts	• Air-in-line• Battery low• Battery depleted• Bolus complete• KVO• Infusion complete• Infusion not started• Restricted flow Infusionpaused• Occlusion (upstream ordownstream)• Pump problem• Tubing set problem• Tubing set removed• Dose limits exceeded	• Air-in-line• Battery low• Battery depleted• Bolus complete• KVO• Infusion complete• Inactivity alarm• Occlusion (upstream ordownstream)• System error Door open• Dose limits exceeded	Alarms were validated based onthe intended use of the deviceand the unique technologicalcharacteristics. Alarm prioritiesare similar for both devices.
Device service life	5 years	Not specified	The device was evaluatedthrough performance testing tomeet the essential performancethroughout the service life.
Item	Ivenix Infusion System – LVP(K183311)	SIGMA Spectrum PumpK173084	Discussion
Dimensions andweight	7.5"H x 8.5" W x 3.5" D6.8 lbs.	6.3"H x 6.4"W x 4.7"D3.2 lbs.(with wireless battery)	The Ivenix device is largerand heavier than the BaxterSIGMA Spectrum. This doesnot raise different questions
Materials	Pump: aluminum, polycarbonate,ABSAdministration set: PE lined PVCtubing, polycarbonate, siliconerubber	Pump: not specifiedAdministration sets: PVCor PE tubing	of safety or effectiveness.Materials are well-characterized in both devices.Biocompatibility andPerformance testing supportsubstantial equivalence of thedifference in materials.
Environment ofuse	Hospital or out-patient setting	Presumed hospital or out-patient setting	The use environment is thesame for both devices.
Ingress protection	IPX3 Spraying water	IPX0 – None	The predicate device does notprotect against water ingress.The Ingress Protection levelwas verified throughperformance testing.
Power source	100 - 240 VAC, 50/60 Hz, 2.0 Aor on-board rechargeable Lithium-ion battery.	115 VAC, 50 to 60 Hz,300 mA, or attachedlithium-ion battery	Both devices use essentiallythe same power sources.
Storage conditions	-20 to +60°C (-4 to +140°F), 20 to90% RH non-condensing	-10 to +49°C (14 -120°F), 10 to 90% RHnon-condensing	Both devices have similarstorage conditions.
OperatingConditions	+5 to +35°C (+41 to +95°F), up to90% RH non-condensing	15.6 to 26.7°C (60 to80°F, 20 to 90% RH non-condensing	Both devices meet theoperating condition expectedin 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 -administration set	Plum 360 administrationset	Discussion
Upstream airmanagement	The Ivenix pump has anupstream air eliminationfeature.	Air Trap allows 1 mL of airin either A or B line beforethe infuser sounds a cassettealarm.	Both devices attempt topurge or trap excess air in theupstream portion of theadministration set.
Flowdial/regulator	The Flow Dial integrates withthe LVP to maintain flowaccuracy. It also manuallycontrols flow during primingor gravity infusion	The flow regulator manuallycontrols flow during primingor gravity infusion.	The functions are similar inboth devices and wereverified through performancetesting for the intended use.
Connector	The connector that attachesthe downstream outlet tubingto the patient access devicehas a 2-piece luer lock.	The connector that attachesthe distal line to the patientaccess device has a luerconnector with a lockingcollar.	Both devices use standardluer connections.
Outlet Tubing /Distal Line(Patient Line)	Runs from the cassette to thepatient.	Runs from the cassette to thepatient.	No differences between thedevices.
Lines	Ivenix IIS Administration Setshave two lines referenced asPrimary and Secondary.	Hospira Plum Sets have twolines referenced as Line Aand Line B. Manual alsoreferences Secondary Ports.	Essentially the same betweenboth devices.
Syringe Use	Syringes (size 5 ml to 60 ml)may be directly connected tothe secondary inlet of thecassette as a fluid source.	Syringes (size 3 ml to 60 ml)may be directly connected tothe secondary inlet of thecassette as a fluid source.	Essentially the same betweenboth devices. The Ivenixdevice's minimum syringesize 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 - IvenixInfusion System - IMS	Primary Predicate -Plum360 Infusion System -MedNet/Smart Card Plug'n' Play Module	Discussion
Technology	Local server	Local server	No differences between thedevices.
Pump datatransmission	Wireless	Wireless	No differences between thedevices.
Dashboard (clinical,biomedical.pharmacy)	Independent of EMR, resideson multiple platforms (laptop,tablet, smart phone)	Single pump data availablefor upload.	The Hospira system doesnot have a dashboardfeature.
Auto programming	Supports interfaces to a BarCode MedicationAdministration (BCMA)	Supports interface to BCMA	Both device supportBCMA.
Drug libraries	Customizable through aneditor	Customizable through aneditor	No differences between thedevices.
Drug library updates	Changes published and madeavailable to pump. Pumpinitiates download and insertsin drug library database.	Entire drug library pushed topump when pump not in use.Different drug library replacesprevious one.	The Ivenix system updates thepump fleet simultaneouslywhen an update is deployed.
Drug libraryvalidation	Pump emulation softwarewithin the drug library module.	Download to designatedpump or pumps for validation.	The Ivenix system uses asimulated pump interfaceto validate the drug librarycontent.

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 PremarketSubmissions for Software Contained in Medical Devices for Major level of concern for thesoftware embedded in the Ivenix Infusion System.• Software validation was conducted per IEC 62304 and the FDA guidance documentGeneral Principles of Software Validation – Final Guidance for Industry and FDA Staff.• Cybersecurity risks were assessed and documentation is included based on the FDA'sGuidance of Premarket Submissions for Management of Cybersecurity in Medical Device.• 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)2012 Medical electrical equipment – Part 1: General requirements for basic safety andessential performance
EMC	• IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1: General Requirements forSafety-2-Collateral Standard: Electromagnetic Compatibility-Requirements & Tests
Wireless Coexistence &RF Wireless testing	• FDA Guidance Document "Radio Frequency Wireless Technology in Medical Devices -Guidance for Industry and Food and Drug Administration Staff"• ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence• AIM 7351731 Rev. 2.00 RFID Immunity
Administration SetCompatibility	• Verification of the pump essential performance was completed with the indicatedadministration 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,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• ISO 11607-1:2006 + A1:2014 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems• 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.• Testing was conducted for cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, and hemocompatibility.• $USP <661>$ Physicochemical properties• AAMI ST72: 2011 Bacterial Endotoxins - Test methods, routine monitoring, and alternatives to batch testing• $USP 39 <788>:2016$ Particulate Matter in Injections and ISO 8536-4.
Blood productscompatibility	• 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.

Regulation Number and Section

§ 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).