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).

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® (treprostinil) (hereinafter referred to as 'Remodulin' or 'Remodulin (treprostinil)'). 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 subcutaneous 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 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.

Cassettes are identical to those cleared under K190182, with the specialty pharmacy will take the cassettes out of their sterile packaging, cap the cassette and aseptically fill the cassette reservoir through the cassette filling septum following USP 797 Compounding Sterile Preparations. The specialty pharmacy will then package these filled cassettes and ship to the intended end user under controlled conditions outlined in the labeling. The pharmacy-filled cassette is intended to be stored (inclusive of shipping item) up to 14-days and is intended to be in use for up to 72-hours.

The device is prescription use only.

AI/ML Overview

Here's a summary of the acceptance criteria and the study information based on the provided text, formatted to address your specific questions.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a previously cleared device (predicate device K190182). Therefore, much of the performance evaluation for this submission (K191313) builds upon the predicate device's data and specifically addresses changes related to the pre-filled cassettes. A full, comprehensive study proving all acceptance criteria might have been conducted for the original K190182 clearance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the "Same" performance characteristics compared to the predicate device, which would have had its own established performance targets. The "Discussion of Differences" column indicates how the current submission evaluated the impact of the specific changes.

Acceptance Criteria (Implied from Predicate/Evaluated)	Reported Device Performance (K191313)
Mechanism of Action	Microprocessor controlled, micro-dosing pump mechanism supplemented with acoustic volume sensor (AVS) feedback for monitoring delivery accuracy. (Same as predicate)
Infusion Accuracy	±6% (Same as predicate)
Maximum Infusion Pressure	<16.4 psi (<113 kPa) (Same as predicate)
Programmable Flow Rate Ranges	16 µl/hr to 225 µl/hr with increments of 1 µl/hr (Same as predicate)
Time to Occlusion Alarm	Maximum time to occlusion alarm: <12 min. at rates ≥ 100 µl/hr; within 8 hr, at rates < 100 µl/hr (Same as predicate)
Post-Occlusion Bolus	<40 µl at all rates. (Same as predicate)
Alarms & Alerts	Identical list of alarms and alerts as the predicate device. (Same as predicate)
Device Service Life	3 years (Same as predicate)
Dimensions & Weight	6 cm x 6 cm x 2 cm; 50 g (1.76 oz) (Same as predicate)
Materials	Additional materials for the cap (Polycarbonate). Evaluated and deemed to not introduce new biocompatibility issues.
Environment of Use	In professional healthcare facility and home healthcare environments. (Same as predicate)
Ingress Protection	IP58 when connected to the reservoir. (Same as predicate)
Power Source	Rechargeable Lithium-Ion Battery. (Same as predicate)
Storage Conditions	Temperature: -13°F to 158°F (-25°C to 70°C); Non-condensing humidity: up to 90%; Pressure: 500 hPa to 1060 hPa. (Same as predicate)
Operating Conditions	Temperature: 41°F to 104°F (5°C to 40°C); Non-condensing humidity: up to 90%; Pressure: 700 hPa to 1060 hPa. (Same as predicate)
Remote User Feedback	Audible, vibratory. (Same as predicate)
Administration Set Compatibility	Medtronic Quick-set Infusion Set, Medtronic Silhouette and Infusion Set, Smiths Medical Cleo 90 Infusion Set. (Same as predicate; verification confirmed compatibility)
Cassette Type	Remodulin Unity cassettes, 3 ml, Specialty Pharmacy filled. (Difference from predicate, which was user-filled)
Expiration – Cassette (Filled)	Pharmacy-Fill, 14 Days. (Difference from predicate, which was 6 months from manufacture for user-filled)
End User Packaging	Aseptically filled cassette with female luer lock fluid path closure, placed in plastic clamshell tray and sealed in foil pouch. (Difference from predicate, which was unfilled, terminally sterilized)
Drug Stability (with new cassette)	Maintained adequate assurance of drug stability for 14 days + 72 hours in-use. (Evaluated through drug stability studies)
Microbial Ingress Protection (with new cassette)	Maintained adequate assurance of protection from microbial ingress. (Evaluated through container closure integrity and antimicrobial effectiveness testing)
Biocompatibility (new materials)	Materials for new components comply with ISO 10993-1:2009 and FDA guidance.
Sterility/Packaging Integrity	Packaging for terminally sterilized medical devices (ISO 11607-1:2006 + A1:2014); Validation per FDA Guidance for Reprocessing Medical Devices in Health Care Settings.

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

The document does not explicitly state specific sample sizes for each test in the "Non-Clinical/ Performance Testing" section. It broadly mentions "drug stability studies," "container closure integrity and antimicrobial effectiveness testing," and "verification of the pump essential performance."

Sample Size: Not explicitly quantified in this summary.
Data Provenance: The studies were conducted by the device manufacturer (DEKA Research & Development) as part of their regulatory submission to the FDA. The location/country of data origin is not specified, but it's internal testing for a U.S. market submission. The studies detailed were conducted to support the changes in the device and are considered prospective in relation to this specific 510(k) submission (K191313).

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

This information is not provided in the document. The studies listed are performance, engineering, and laboratory-based tests (e.g., infusion accuracy, material testing, stability) rather than clinical studies requiring expert ground truth for a test set in the same way a diagnostic AI might.

4. Adjudication Method for the Test Set

This information is not applicable to the type of non-clinical, performance-based testing described. Adjudication methods are typically used in clinical trials or studies where expert review is needed to resolve discrepancies in diagnoses or assessments.

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

No, an MRMC comparative effectiveness study was not done.
The device is an infusion pump, not a diagnostic AI system intended to assist human readers. Therefore, this type of study is not relevant to this device.

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

The device is a physical infusion pump with integrated software, not a standalone AI algorithm. It operates to deliver medication based on programmed rates. The "essential performance requirements of the device were verified through performance testing" which can be considered its standalone performance.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on:

Engineering Specifications/Standards: (e.g., ±6% infusion accuracy, acceptable occlusion alarm times, material biocompatibility standards like ISO 10993-1).
Regulatory Guidance: (e.g., FDA guidance for Infusion Pumps Total Product Life Cycle, FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices", FDA Guidance for "Reprocessing Medical Devices").
Established Test Methods: (e.g., drug stability studies, container closure integrity, antimicrobial effectiveness testing as per pharmaceutical and medical device standards).

8. The Sample Size for the Training Set

This information is not applicable. This document describes an infusion pump (a hardware device with software), not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "safety assurance case" and performance testing are based on engineering principles and regulatory compliance rather than machine learning models.

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

This information is not applicable as there is no "training set" for an AI algorithm described for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

DEKA Research & Development Jason Demers Project Manager 340 Commercial Street Manchester, New Hampshire 03101

Re: K191313

Trade/Device Name: Unity Subcutaneous Infusion System for Remodulin Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: QJY Dated: May 14, 2019 Received: May 15, 2019

Dear Jason Demers:

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 mediation-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 Nikhil Thakur Assistant 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) K191313

Device Name

Unity Subcutaneous Delivery System for Remodulin®

Indications for Use (Describe)

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).

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 - K191313

Submitter Information

510(k) Sponsor:	DEKA Research & Development340 Commercial StreetManchester, NH 03101
Contact Person	Jason DemersProgram ManagerDEKA Research & Development CorporationPhone: (603) 669-5139Fax: (603) 624-0573jdemers@dekaresearch.com
Date Prepared:	February 21, 2020

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:	QJY, infusion pump, drug specific, pharmacy-filled
Class:	II
Device Panel:	General Hospital

Predicate Device

Unity Subcutaneous Delivery System for Remodulin® K190182. No reference devices are used in this submission.

Device Description

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these filled cassettes and ship to the intended end user under controlled conditions outlined in the labeling. The pharmacyfilled cassette is intended to be stored (inclusive of shipping item) up to 14-days and is intended to be in use for up to 72hours.

The device is prescription use only.

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	PredicateUnity Subcutaneous DeliverySystem for Remodulin®K190182	ProposedUnity Subcutaneous Delivery Systemfor Remodulin®K191313
Indications for Use	The Unity Subcutaneous DeliverySystem for Remodulin® (the UnitySystem) is intended for continuoussubcutaneous delivery ofRemodulin (treprostinil) injectionfor use in adults (greater than 22years of age).	No Change
Prescription Only orOver the Counter	Prescription Only	No Change
Intended Population	Adults (>22 years of age)	No Change
Environment of Use	In professional healthcare facilityand home healthcare environments	No Change

Discussions of differences in Indications for Use statement

The indications for use statement for the subject device is identical to the predicate device cleared under K190182.

Discussions of differences in intended population

The intended population is for the subject device is identical to the predicate device cleared under K190182.

The Unity system is indicated for adults (greater than 22 years of age)

Discussions of differences in environment of use

The environment of use for the subject device is identical to the predicate device cleared under K190182.

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Comparison of Technological Characteristics with the Predicate Device

Table 1 compares the characteristics of the predicate device to the proposed 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.

Characteristic	PredicateUnity SubcutaneousDelivery System forRemodulin®K190182	ProposedUnity SubcutaneousDelivery System forRemodulin®	Discussion of Differences
Mechanism ofaction	Microprocessor controlledMicro- dosing pumpmechanism supplementedwith acoustic volume sensor(AVS) feedback formonitoring delivery accuracy.	Same	N/A
Infusion Accuracy	±6%	Same	N/A
Maximum Infusionpressure	<16.4 psi (<113 kPa)	Same	N/A
ProgrammableFlow rate ranges	16 µl/hr to 225 µl/hr withincrements of 1 µl/hr	Same	N/A
Time to occlusionalarm	Maximum time to occlusionalarm:<12 min. at rates ≥ 100 µl/hrwithin 8 hr, at rates < 100µl/hr	Same	N/A
Post-occlusionbolus	<40 µl at all rates.	Same	N/A
Characteristic	PredicateUnity SubcutaneousDelivery System forRemodulin®K190182	ProposedUnity SubcutaneousDelivery System forRemodulin®	Discussion of Differences
Alarms & Alerts	• 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 FailedWalkaway	Same	N/A
Device ServiceLife	3 years	Same	N/A
Dimensions &Weight	6 cm x 6 cm x 2 cm(2.4 in x 2.4 in x 0.4 in)50 g (1.76 oz)	Same	N/A
Materials	Cassette fluid path:Polycarbonate, Bromobutyl,SEBS, polyurethanePump: ABS, Polycarbonate,AluminumCartridge: Polycarbonate,Acrylic, polyurethaneFilling Aid: PC-ABS	Additional Materials include:Cap: Polycarbonate	The new component utilizedthe same materials used in thepredicate and did not introducenew biocompatibility issues.Performance was evaluated tobe substantially equivalent.
Characteristic	PredicateUnity SubcutaneousDelivery System forRemodulin®K190182	ProposedUnity SubcutaneousDelivery System forRemodulin®	Discussion of Differences
Environment ofUse	In professional healthcarefacility and homehealthcare environments	Same	N/A
Ingress protection	IP58 when connected to thereservoir	Same	N/A
Power source	Rechargeable Lithium-IonBattery	Same	N/A
Storage Conditions	Temperature:-13°F to 158°F (-25°C to70°C)Non-condensing humidity:up to 90%.Pressure: 500 hPa to 1060 hPa	Same	N/A
OperatingConditions	Temperature:41°F to 104°F (5°C to 40°C)Non-condensing humidity:up to 90%Pressure: 700 hPa to 1060 hPa	Same	N/A
Remote userfeedback	Audible, vibratory	Same	N/A
Administration Set	Medtronic Quick-set InfusionSet Medtronic Silhouette andInfusion Set Smiths MedicalCleo 90 Infusion Set	Same	N/A
Cassette	Remodulin Unity cassettes, 3ml, User filled	Remodulin Unity cassettes, 3ml, Specialty Pharmacy filled	Cassettes are filled bySpecialty Pharmacist and areappropriate for the design ofthe infusion pump.
Expiration –Cassette	User Fill, 6 Months from dateof manufacture	Pharmacy-Fill, 14 Days	The differences in cassetteexpiration were evaluatedthrough container closureintegrity, antimicrobialeffectiveness and stabilitytesting.
Characteristic	PredicateUnity SubcutaneousDelivery System forRemodulin®K190182	ProposedUnity SubcutaneousDelivery System forRemodulin®	Discussion of Differences
End UserPackaging -	Unfilled cassette without luerlock fluid path closure, placedin vacuum formed tray withTyvek lid and then Gammasterilized	Aseptically filled cassette withfemale luer lock fluid pathclosure, placed in plasticclamshell tray and sealed infoil pouch	The predicate device providesa terminally sterilized unfilledcassette inside the sterilebarrier provided by thevacuum formed tray andTyvek lid. The pharmacy-filled cassette provides aclosed fluid pathway that wasterminally sterilized prior tobeing aseptically filled andrepackaged. The differencesin packaging were evaluatedthrough performance, sterility,container closure integrity and

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.

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 context for the assurance case was updated to reflect the new use scenario of pharmacy filled cassettes. 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 arguments were updated from the original assurance case presented in predicate, K190182, to reflect new hazards and requirements associated with the changes.

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.

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Since the assurance case builds on the original case, only evidence used to provide assurance related to the changes is listed here:

Accessorycompatibility	Verification of the pump essential performance was completed with labeled 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" Performance of the device to maintain adequate assurance of drug stability, and protection from microbial ingress was evaluated through drug stability studies, container closure integrity and antimicrobial effectiveness testing. The testing was done to represent 14 days + 72 hours of in-use at a minimum.
Human Factors	Human factors evaluation per the FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016).
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
Biocompatibility	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, Use of International Standard ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process are considered to be biocompatible.

Clinical Study

No clinical data was obtained in support of this premarket submission.

Conclusion

The modifications to the Unity System Operator's User Manual and the end user packaging to include the option for the cassettes to be filled with Remodulin by the Specialty Pharmacy as a user convenience does not change the intended use of the subject device compared to the Unity System cleared under premarket notification K190182. The changes summarized in this submission do not raise different questions of safety and effectiveness.

The performance of the device is supported by the assurance case, non-clinical testing and risk management activities. The Unity Subcutaneous Delivery System for Remodulin is Substantially Equivalent (SE) to the Unity Subcutaneous Delivery System for Remodulin cleared under premarket notification K190182.

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).