The Unity Subcutaneous Delivery System for Remodulin® (the Unity System) is intended for continuous subcutaneous delivery of Remodulin (treprostinil) injection for use in adults (greater than 22 years of age).

Device Description

The Unity Subcutaneous Delivery System for Remodulin® (Unity System) is a wearable infusion pump designed to deliver Remodulin® for the treatment of pulmonary arterial hypertension (PAH). It is intended for continuous subcutaneous delivery of FDA-approved Remodulin® (treprostimil) (hereinafter referred to as 'Remodulin (treprostinily), NDA 021272. The Unity System consists of several components: a wearable pump assembly, a remote interface, a filling and priming aid, and accessories (e.g., rechargeable batteries, battery charging cable, power adapter). A commercially available subcutaneous infusion set is connected to the pump assembly via a standard Luer connector for the delivery of Remodulin from the Unity System to the patient.

The pump assembly is composed of a reusable pump and a disposable single-use cassette with a user-filled drug reservoir, which infuses Remodulin subcutaneously into the patient based on an individualized programmed rate. Each disposable cassette may be used for up to 72 hours after attachment to the pump. The Unity System utilizes a micro-dosing pump mechanism supplemented with acoustic volume sensor feedback to ensure delivery accuracy.

The device is prescription use only.

AI/ML Overview

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided FDA 510(k) summary for the Unity Subcutaneous Delivery System for Remodulin.

It's important to note that this document is a 510(k) summary, which provides a brief overview of the information submitted to the FDA for a substantial equivalence determination. It does not contain the full details of all studies, such as raw data, complete study protocols, or detailed statistical analyses that would be found in a full study report. Therefore, some information might be less granular than typically expected for a detailed study description.

Acceptance Criteria and Device Performance for Unity Subcutaneous Delivery System for Remodulin

The provided document describes the Unity Subcutaneous Delivery System for Remodulin, an infusion pump. The "acceptance criteria" for a 510(k) device are primarily the demonstration of substantial equivalence to a predicate device. This is achieved by showing that the new device is as safe and effective as the predicate and does not raise new questions of safety or effectiveness. The performance metrics below are compared to the predicate device and justified against the intended use and Remodulin's specific requirements.

1. Table of Acceptance Criteria and Reported Device Performance

For an infusion pump, key performance characteristics related to safety and effectiveness often revolve around accurate and reliable fluid delivery, safety features (e.g., occlusion detection), and robust design. The document highlights various performance aspects and compares them to the predicate device.

Characteristic	Predicate Device (CADD-MS 3 Ambulatory Infusion Pump: K051568)	Proposed Device (Unity Subcutaneous Delivery System for Remodulin: K190182)	Acceptance Criteria (Implicit from Substantial Equivalence Justification)	Reported Device Performance/Justification
Infusion Accuracy	±3% (nominal)	±6%	Meets Remodulin USPI (United States Pharmacopeia) requirements for subcutaneous administration.	"Compliant with Remodulin USPI an infusion accuracy of ±6% satisfies the Remodulin delivery accuracy requirement for administration by subcutaneous injection." Clinical study demonstrated majority of measured data fell within accuracy specification, with brief intervals outside of -6% attributed to measurement uncertainty or air bubbles (within 25%).
Maximum Infusion Pressure	23 psi (159 kPa)	<16.4 psi (<113 kPa)	Acceptable for intended use; verified through performance testing.	"The maximum infusion pressure is less that the predicate; however, the infusion accuracy was verified through performance testing and validated to be appropriate for the intended use."
Programmable Flow Rate Ranges	0.000 mL/hr to 1.000 mL/hr (increments of .002 mL/hr)	16 µl/hr to 225 µl/hr (increments of 1 µl/hr)	Infusion accuracy maintained within specification across flow rates relevant to Remodulin delivery; appropriate for intended use.	"Infusion accuracy was maintained within specification across flow rates that span the programmable flow rates of the device through bench testing and is appropriate based on the intended use."
Time to Occlusion Alarm	Max: 12-15 min at 124 µl/hr; 9.5-19 hr at 2 µl/hr	Max: <12 min at rates ≥ 100 µl/hr; within 8 hr at rates < 100 µl/hr	Similar to predicate; differences evaluated through risk-based approach to be appropriate for intended use.	"Time to occlusion is similar to the predicate. Differences were evaluated through a risk based approach to be appropriate for the intended use."
Post-occlusion Bolus	Approx. 40 µl (min rate); Approx. 210 µl (intermediate rate)	<40 µl at all rates	Tailored for Remodulin delivery; differences do not raise different questions of safety and effectiveness.	"The range for the Unity System is tailored for the delivery of Remodulin. These differences do not raise different questions of safety and effectiveness and have been verified through performance testing."
Alarms & Alerts	List of 13 alarms	List of 21 alarms	Validated based on intended use and unique technological characteristics.	"Alarms were validated based on the intended use of the device and the unique technological characteristics." (Specific performance limits for each alarm type are not detailed in this summary, but would have been part of the validation.)
Device Service Life	Not stated	3 years	Essential performance maintained throughout service life via testing.	"The device was evaluated through performance testing to meet the essential performance throughout the service life." (Specific tests and their pass/fail criteria for this are not detailed, but standard for medical devices).
Biocompatibility	Cartridge: Polypropylene (other materials unknown)	Cassette fluid path: Polycarbonate, Bromobutyl, SEBS, polyurethane; Pump: ABS, Polycarbonate, Aluminum; Cartridge: Polycarbonate, Acrylic, polyurethane	Materials comply with ISO 10993-1 and FDA guidance; considered biocompatible.	"The materials used for the Unity System comply with biocompatibility requirements outlined in ISO 10993-1:2009 and the Guidance for Industry and Food and Drug Administration Staff... Testing was conducted for cytotoxicity, sensitization, irritation, pyrogenicity, and hemolysis. The acute systemic toxicity, subchronic systemic toxicity, and genotoxicity endpoints were addressed through the extractables/leachables study with a toxicological risk assessment."
Ingress Protection	IPX8 (pump's labels and outer shell intact)	IP58 (when connected to reservoir)	Provides protection against particle ingress and moisture, appropriate for intended use.	"The Unity System provides protection against particle ingress in addition to moisture protection. This is appropriate based on the intended use of the device."
Electrical Safety	N/A (implied by predicate)	AAMI/ANSI ES 60601-1; IEC 60601-1-2	Compliance with relevant standards.	Successful testing per AAMI/ANSI ES 60601-1:2005/(R)2012 and IEC 60601-1-2:2014.
Wireless Coexistence & RF Testing	N/A (implied by predicate)	FDA Guidance Document "Radio Frequency Wireless Technology in Medical Devices"; ANSI C63.27-2017	Compliance with relevant standards and guidance.	Successful testing per FDA Guidance and ANSI C63.27-2017.
Human Factors	N/A (implied by predicate)	FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices	Validation of device per intended use with intended user population/environment/scenarios.	"Human factors studies... were conducted with the intended user population, use environment and use scenarios to simulate clinical conditions. Results... demonstrate validation of the device per the intended use."
Reprocessing, Cleaning, Sterility	N/A (implied by predicate)	ISO 11137-1; ISO 11607-1; FDA Guidance for Reprocessing Medical Devices	Validation of cleaning/disinfection instructions and terminal sterilization.	"Validation per the FDA Guidance... confirmed cleaning and disinfection instruction provided in instructions for use." and compliance with ISO 11137-1 and ISO 11607-1.

2. Sample Size Used for the Test Set and Data Provenance

Test Set (Clinical Study): "All participants were healthy subjects between 18 and 55 years of age, inclusive, at the time of informed consent." The exact sample size (N) is not explicitly stated in this summary for the clinical test set. It's common in 510(k) summaries for the detailed sample size to be omitted, but it would be present in the full study report.
Data Provenance: The document does not specify the country of origin. It indicates it was a "Performance Assessment of The Unity Infusion System with 0.9% Sodium Chloride Injection in Healthy Volunteers study." It was a prospective study, as it involved healthy volunteers being infused and monitored.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For this device (an infusion pump), the "ground truth" for the clinical study was the actual volumetric flow rate of the saline infusion compared to the programmed flow rate. This "ground truth" is established by the calibrated measurement equipment used in the study, not by human experts adjudicating images or diagnoses.
Therefore, the concept of "experts establishing ground truth" as it applies to medical imaging AI (e.g., radiologists) is not applicable here. The accuracy of the device's delivery is measured physically.

4. Adjudication Method for the Test Set

Since the ground truth for infusion accuracy is based on objective, physical measurement of fluid delivery, adjudication methods (like 2+1, 3+1, etc.) are not applicable in the same way they would be for subjective clinical assessments or image interpretations in AI studies. The performance is assessed against instrumental measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically used to evaluate the diagnostic performance of a medical imaging AI system, often comparing AI-assisted vs. unassisted human reader performance on a set of medical images.
This device is an infusion pump, and its primary function is accurate drug delivery, not diagnostic imaging. The clinical study focused on the physical performance of the pump (infusion accuracy, reliability, safety) in humans.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence, standalone performance was a primary focus. The non-clinical/performance testing sections describe extensive bench testing and engineering verification of the device's core functions (infusion accuracy, alarm reliability, electrical safety, biocompatibility, etc.).
- "Device performance: The essential performance requirements of the device were verified through performance testing in accordance with the intended use of the device..."
The clinical study then confirms key aspects of this performance in vivo (in healthy volunteers) and validates the Acoustic Volume Sensor (AVS) design. While used by humans, the AVS measurement process itself is an "algorithm only" aspect of the device's function being validated. The clinical study's objective was to assess the pump's performance, not a human-AI interaction.

7. The Type of Ground Truth Used

For the non-clinical (bench) testing: The ground truth was established by calibrated metrology/testing equipment for parameters like infusion accuracy, pressure, flow rates, and alarm thresholds.
For the clinical study: The ground truth for infusion accuracy was the measured volumetric flow rate of 0.9% sodium chloride, presumably obtained using highly accurate and calibrated measuring equipment. Safety ground truth was based on reported adverse events (AEs), serious adverse events (SAEs), and unanticipated adverse device effects (UADEs), which are outcome data.

8. The Sample Size for the Training Set

This device is an electromechanical infusion pump with a microprocessor and software. It's not a machine learning/AI model in the typical sense that requires a "training set" of data for learning patterns.
Therefore, the concept of a "training set" as it applies to deep learning or AI models is not applicable to this device. Its software and control algorithms are developed and verified through engineering principles and software validation (e.g., IEC 62304), not data-driven machine learning training.

9. How the Ground Truth for the Training Set Was Established

As explained in #8, there is no "training set" in the context of machine learning for this device. The "ground truth" for verifying its software and algorithms comes from engineering specifications, recognized standards (e.g., IEC 62304 for software), and internal quality assurance processes during development. These specifications define the desired behavior and performance, and the software is tested against them.

Summary

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May 6, 2019 DEKA Research & Development Brian Carney Project Regulatory Affairs Manager 340 Commercial Street Manchester, New Hampshire 03101

Re: K190182

Trade/Device Name: Unity Subcutaneous Delivery System for Remodulin Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: FRN Dated: January 31, 2019 Received: February 1, 2019

Dear Brian Carney:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190182

Device Name

Unity Subcutaneous Delivery System for Remodulin®

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY - K190182

Submitter Information

510(k) Sponsor:	DEKA Research & Development340 Commercial StreetManchester, NH 03101
Contact Person	Brian CarneyProject Regulatory Affairs ManagerDEKA Research & Development CorporationPhone: (603) 669-5139Fax: (603) 624-0573bcarney@dekaresearch.com
Date Prepared:	May 3, 2019

Proposed Device

Common/Usual Name:	Infusion Pump
Trade/Proprietary Name:	Unity Subcutaneous Delivery System for Remodulin®
Classification Name:	Infusion Pump
Device Classification:	880.5725
Product Code:	FRN
Class	II
Device Panel:	General Hospital Devices Branch

Predicate Device

CADD-MS3 Ambulatory Infusion Pump (Smiths Medical) K051568. No reference devices are used in this submission.

Device Description

The device is prescription use only.

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Indications for Use

The Unity Subcutaneous Infusion System (the Unity System) is intended for continuous subcutaneous delivery of Remodulin® (treprostinil) Injection for use in adults (greater than 22 years of age).

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	PredicateCADD-MS 3 AmbulatoryInfusion PumpK051568	ProposedUnity Subcutaneous Deliver Systemfor Remodulin®K190182
Indications for Use	The CADD-MS 3 AmbulatoryInfusion Pump is designed forsubcutaneous, intravenous, epiduraland intrathecal infusion ofmedication. The Smiths MedicalMD, Inc, 3-ml Cartridge Reservoiris designed for use with the CADD-MS 3 for delivering medication	The Unity Subcutaneous Delivery Systemfor Remodulin® (the Unity System) isintended for continuous subcutaneousdelivery of Remodulin (treprostinil)injection for use in adults (greater than 22years of age).
Prescription Only orOver the Counter	Prescription Only	Prescription Only
Intended Population	Not Specified	Adults (>22 years of age)
Environment of Use	In hospital or out-patient settings	In professional healthcare facilityand home healthcare environments
Characteristic	Predicate DeviceK051568	Subject DeviceK190182	Discussion of Differences
Mechanism ofaction	Microprocessor basedelectronic syringe pump	Microprocessor controlledMicro- dosing pumpmechanism supplementedwith acoustic volume sensor(AVS) feedback formonitoring delivery accuracy.	AVS technology providesaccuracy confirmation of thevolume of fluid delivered. Thiswas supported with clinical andnon-clinical testing.
InfusionAccuracy	±3% (nominal).	±6%	Compliant with RemodulinUSPI an infusion accuracy of±6% satisfies the Remodulindelivery accuracy requirementfor administration bysubcutaneous injection
MaximumInfusion pressure	23 psi (159 kPa)	<16.4 psi (<113 kPa)	The maximum infusion pressureis less that the predicate;however, the infusion accuracywas verified throughperformance testing andvalidated to be appropriate forthe intended use.
ProgrammableFlow rate ranges	0.000 mL/hr to 1.000 mL/hrwith increments of .002mL/hr	16 µl/hr to 225 µl/hr withincrements of 1 µl/hr	Infusion accuracy wasmaintained within specificationacross flow rates that span theprogrammable flow rates of thedevice through bench testingand is appropriate based on theintended use.
Time to occlusionalarm	Maximum time to occlusionalarm:12 min. to 15 min. at 124µl/hr (intermediate rate)9.5 hr. to 19 hr. at 2 µl/hr(minimum rate)	Maximum time to occlusionalarm:<12 min. at rates ≥ 100 µl/hrwithin 8 hr, at rates < 100µl/hr	Time to occlusion is similar tothe predicate. Differences wereevaluated through a risk basedapproach to be appropriate forthe intended use.
Post-occlusionbolus	At minimum rate:approximately 40 µl	<40 µl at all rates.	The range for the Unity Systemis tailored for the delivery ofRemodulin. These differencesdo not raise different questions
Characteristic	Predicate DeviceK051568	Subject DeviceK190182	Discussion of Differences
	at intermediate rate:approximately 210 µl		of safety and effectiveness andhave been verified throughperformance testing.
Alarms & Alerts	• Battery depleted• Battery low• Blockage detected• Cartridge empty• Cartridge removed• Cartridge very low• Depletes soon• Edit not saved• Key stuck• Program defaulted• Pump stopped• Site change reminder• System fault	• Battery depleted• Battery Low (pump)• Battery Low (remote)• Cassette Depleted• Cassette Problem• Cassette Removed• Depletes Soon• Pump Error• Pump Failure• Occlusion• Delivery Stopped• Basal Not Started• Idle• Software Version Error• Tech• Excessive Noise• No Communication• Message Timeout• Pairing Failed• Walkaway	Alarms were validated based onthe intended use of the deviceand the unique technologicalcharacteristics.
Device ServiceLife	Not stated	3 years	The device was evaluatedthrough performance testing tomeet the essential performancethroughout the service life.
Dimensions &Weight	3.2 in x 1.8 in x 0.95 inApproximately 3.2 ozincluding battery andcartridge	6 cm x 6 cm x 2 cm(2.4 in x 2.4 in x 0.4 in)50 g (1.76 oz)	The devices are similar in sizeand intended to be ambulatory.
Materials	Cartridge: Polypropylene(plunger and other materialsunknown)	Cassette fluid path:Polycarbonate, Bromobutyl,SEBS, polyurethanePump: ABS, Polycarbonate,AluminumCartridge: Polycarbonate,Acrylic, polyurethane	The appropriatebiocompatibility and toxicologytesting has been conducted onall materials found in the fluidpath. Non-clinical testingsupported the differences inmaterials. The differences in thematerials do not raise differentquestions of safety andeffectiveness.
Characteristic	Predicate DeviceK051568	Subject DeviceK190182	Discussion of Differences
Environment of Use	In hospital or out-patient settings	In professional healthcare facility and home healthcare environments	Same
Ingress protection	IPX8 when pump's labels and outer shell are intact	IP58 when connected to the reservoir	The Unity System provides protection against particle ingress in addition to moisture protection. This is appropriate based on the intended use of the device.
Power source	1 AAA alkaline battery	Rechargeable Lithium-Ion Battery	The differences were evaluated through performance testing; Lithium-Ion Battery complies with IEC 62133.
Storage Conditions	Temperature:-4°F to 140°F (-20°C to 60°C)Non-condensing humidity:up to 90%Pressure: 700 hPa to 1060 hPa	Temperature:-13°F to 158°F (-25°C to 70°C)Non-condensing humidity:up to 90%.Pressure: 500 hPa to 1060 hPa	The differences in storage conditions were evaluated through performance testing.
Operating Conditions	Temperature:35.6°F to 104°F (2°C to 40°C)Non-condensing humidity:up to 90%Pressure: 700 hPa to 1060 hPa	Temperature:41°F to 104°F (5°C to 40°C)Non-condensing humidity:up to 90%Pressure: 700 hPa to 1060 hPa	The operating conditions are similar. The differences in operating conditions were evaluated through performance testing.
Accessories
Remote user feedback	Audible, vibratory	Audible, vibratory	Same
Administration Set	Unomedical Comfort Infusion Set	Medtronic Quick-set Infusion Set Medtronic Silhouette and Infusion Set Smiths Medical Cleo 90 Infusion Set	Similar; compatibility testing was completed to verify use with the designated infusion sets
Cartridge	Smiths Medical, Inc. 3 ml Medication Cartridge,	Remodulin Unity cassettes, 3 ml, User filled	Both cartridges can be user filled and are appropriate for the design of the infusion pump.

Discussions of differences in Indications for Use statement

The indications for use statement for the Unity System is not identical to the predicate is indicated for four different delivery types, including subcutaneous delivery, whereas the Unity System limits delivery to subcutaneous infusion. Additionally, the predicate device does not specify a particular drug or set of drugs. The Unity System is labeled only for use with Remodulin. The Unity System's is a specific subset of the predicate device's indications for use and is therefore not a new intended use. Additionally, compatibility with Remodulin specifically has been verified through performance testing.

Discussions of differences in intended population

The Unity system is indicated for adults (greater than 22 years of age) whereas the predicate does not specify an indicated age group. The age group for the subject device was validated in the Human Factors testing.

Discussions of differences in environment of use

The environment of use for the subject device is identical to the predicate device.

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Comparison of Technological Characteristics with the Predicate Device

Table 1 compares the characteristics of the predicate device and includes an assessment of differences between them and why the difference between the subject device and predicate device do not introduce new or different questions of safety and effectiveness.

Table 1. Comparison of Predicate and Proposed Devices

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Non-Clinical/ Performance Testing:

The following performance data/non-clinical testing was provided in support of the substantial equivalence determination for the Unity System.

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

The stated goal of the safety assurance case is: "The Unity Remodulin Subcutaneous Infusion System is adequately safe for its intended use"

The assurance case defined the device system, including the indications for use, system definition, operational description, patient populations, and use environments. 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 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 according to FDA's Guidance for theContent of Premarket Submissions for Software Contained in Medical Devicesfor Major level of concern for the software embedded in the Unity System. Software validation was conducted according to IEC 62304 and the FDAguidance document General Principles of Software Validation – Final Guidancefor Industry and FDA Staff. Cybersecurity risks were assessed and documentation is included based on theFDA's Guidance of Premarket Submissions for Management of Cybersecurity inMedical Device. AAMI ANSI IEC 62304:2006 Medical Device Software – Software Life CycleProcess
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 requirementsfor basic safety and essential performance
EMC	IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1: GeneralRequirements for Safety-2-Collateral Standard: Electromagnetic Compatibility-Requirements & Tests
Wireless Coexistence& RF Wireless testing	FDA Guidance Document "Radio Frequency Wireless Technology in MedicalDevices - Guidance for Industry and Food and Drug Administration Staff" ANSI C63.27-2017 American National Standard for Evaluation of WirelessCoexistence
Accessorycompatibility	Verification of the pump essential performance was completed with labeledadministration sets

Device performance	● The essential performance requirements of the device were verified throughperformance testing in accordance with the intended use of the device and inaccordance with the FDA Guidance “Infusion Pumps Total Product Life Cycle”
Battery testing	● Li-ion battery safety successfully tested per IEC 62133
Human Factors	● Human factors studies per the FDA Guidance Applying Human Factors andUsability Engineering to Medical Devices (February 3, 2016). The humanfactors studies were conducted with the intended user population, useenvironment and use scenarios to simulate clinical conditions. Results of thehuman 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 asterilization 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 HealthCare Settings: Validation Methods and Labeling (March 17, 2015) confirmedcleaning and disinfection instruction provided in instructions for use
Biocompatibility	● The materials used for the Unity System comply with biocompatibilityrequirements outlined in ISO 10993-1:2009 and the Guidance for Industry andFood and Drug Administration Staff, Use of International Standard ISO 10993Biological Evaluation of Medical Devices Part 1: Evaluation and Testing withina Risk Management Process and are considered to be biocompatible.● Testing was conducted for cytotoxicity, sensitization, irritation, pyrogenicity,and hemolysis. The acute systemic toxicity, subchronic systemic toxicity, andgenotoxicity endpoints were addressed through the extractables/leachables studywith a toxicological risk assessment.● AAMI ST72: 2011 Bacterial Endotoxins – Test methods, routine monitoring, andalternatives to batch testing● USP 39 <788>:2016 Particulate Matter in Injections

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Clinical Testing

A clinical study was conducted to support the substantial equivalence of the device and to clinically validate the Acoustic Volume Sensor (AVS) design. The Performance Assessment of The Unity Infusion System with 0.9% Sodium Chloride Injection in Healthy Volunteers study was conducted to establish evidence that the AVS measurement process consistently produces results within an acceptable, predetermined measurement uncertainty. All participants were healthy subjects between 18 and 55 years of age, inclusive, at the time of informed consent.

Objective

The objective of this study was to assess the performance of the Unity System to deliver 0.9% sodium chloride (normal saline [NS]) by subcutaneous (SC) infusion to healthy volunteers by assessing the following:

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In vivo infusion delivery accuracy assessed by measured volumetric flow rate compared to programmed flow rate of the Unity System to demonstrate environmental noise of other elements of daily use interfered with the ability of the Unity System to deliver accurately when participants were challenged to loud sound exposures.
. In vivo the Unity System reliability assessed by device history logs (flow rate, malfunctions, etc.) and subject diaries (environmental exposures)

Criteria for Evaluation

Pump Performance: In vivo infusion delivery accuracy was assessed by measured volumetric flow rate compared to programmed flow rate of the Unity System. In vivo Unity System reliability was assessed by device history logs (flow rate, malfunction, complications, etc.) and subject diaries (environmental exposures).

Safety: Per protocol, all adverse events (AEs), serious adverse events (SAEs), and unanticipated adverse device effects (UADEs) were to be documented from Baseline until the subject was either discontinued from the study or all End of Infusion study assessments were complete. All AEs associated with a device complication were to be investigated.

Conclusions

Pump Performance: The study successfully demonstrated that the majority of measured data fell within the accuracy specification. There were brief intervals (less than six how rate measured was outside the performance specification limit for under delivery (-6%). Each of these intervals were within the measurement uncertainty of the measure equipment used in the study or associated with the delivery of air bubbles, and all were within 25%. The study found no evidence of environmental noise or other elements of daily use interfered with the ability of the Unity System to deliver accurately.

Safety: No safety concerns related to use of the Unity System were identified during this study.

Conclusion

Differences between the intended use and technological characteristics of the subject device compared to the predicate do not raise different questions of safety and effectiveness. The device is supported by non-clinical testing, clinical testing, and risk management activities. The Unity Subcutaneous Delivery System for Remodulin is Substantially Equivalent (SE) to the CADD-MS 3 Ambulatory Infusion Pump, cleared under K051568.

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).