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

Device Description

The Remunity Subcutaneous Delivery System for Remodulin® (Remunity 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 Remunity System consists of several components: a wearable pump assembly, a remote interface, a filling and priming aid, and accessories (e.g., rechargeable batteries, battery charger, 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 Remunity System to the patient. The pump assembly is composed of a reusable pump and a disposable single-use cassette with a pharmacy-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 Remunity System utilizes a micro-dosing pump mechanism supplemented with acoustic volume sensor feedback to ensure delivery accuracy. The pharmacy-filled cassette is intended to be stored (inclusive of shipping time) up to 14-days and is intended to be in use for up to 72-hours. The cassettes are identical to those cleared under K191313, with the exception that the luer lock cap material was changed from Polycarbonate to ABS. The device is prescription use only.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Remunity Subcutaneous Delivery System for Remodulin, based on the provided document:

This document is a 510(k) Premarket Notification, which is generally used to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving independent safety and effectiveness through extensive clinical trials for a novel device. The primary change in this submission is a material change to a luer lock cap. Therefore, the "study" described is focused on validating this specific change against established standards and functions.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are largely derived from the predicate device (Unity Subcutaneous Delivery System for Remodulin K191313) and are confirmed to be the same for the subject device (Remunity Subcutaneous Delivery System for Remodulin). The primary focus of the reported performance is to confirm that the change in a material does not compromise these established criteria.

Acceptance Criterion	Reported Device Performance (Remunity System)
Mechanism of action	Same (Microprocessor controlled Micro- dosing pump mechanism supplemented with acoustic volume sensor (AVS) feedback for monitoring delivery accuracy)
Infusion Accuracy	Same (± 6%)
Maximum Infusion pressure	Same (<16.4 psi (<113 kPa))
Programmable Flow rate ranges	Same (16 µl/hr to 225 µl/hr with increments of 1 μl/hr)
Time to occlusion alarm	Same (Maximum time to occlusion alarm: <12 min. at rates ≥ 100 µl/hr; within 8 hr, at rates < 100 µl/hr)
Post-occlusion bolus	Same (<40 µl at all rates)
Alarms & Alerts	Same (Numerous, including Battery depleted, Low, Cassette problems, Occlusion, Error, Communication, etc.)
Device Service Life	Same (3 years)
Dimensions & Weight	Same (6 cm x 6 cm x 2 cm, 50 g)
Materials (Cassette fluid path)	Same (Polycarbonate, Bromobutyl, SEBS, polyurethane)
Materials (Pump)	Same (ABS, Polycarbonate, Aluminum)
Materials (Cartridge)	Same (Polycarbonate, Acrylic, polyurethane)
Materials (Filling Aid)	Same (PC-ABS)
Materials (Luer Lock Cap)	Changed from Polycarbonate to ABS
Environment of Use	Same (In professional healthcare facility and home healthcare environments)
Ingress protection	Same (IP58 when connected to the reservoir)
Power source	Same (Rechargeable Lithium-Ion Battery)
Storage Conditions	Same (Temperature: -13°F to 158°F; Non-condensing humidity: up to 90%; Pressure: 500 hPa to 1060 hPa)
Operating Conditions	Same (Temperature: 41°F to 104°F; Non-condensing humidity: up to 90%; Pressure: 700 hPa to 1060 hPa)
Remote user feedback	Same (Audible, vibratory)
Administration Set	Same (Medtronic Quick-set, Medtronic Silhouette, Smiths Medical Cleo 90)
Cassette	Same (Remodulin Unity cassettes, 3 ml, Specialty Pharmacy filled)
Expiration - Cassette	Same (Pharmacy-Fill, 14 Days (consistent with USP 797))
End User Packaging - Cassette	Same (Aseptically filled cassette with female luer lock fluid path closure, placed in plastic clamshell tray and sealed in foil pouch)
Biocompatibility	Complies with ISO 10993-1 and FDA guidance
Luer Lock Cap packaging	Same (Tyvek/LDPE pouch)
Luer Lock Cap sterility assurance level	Same (SAL 10-6)

Study Proving Device Meets Acceptance Criteria

The study described is non-clinical performance testing focused on the specific change introduced: the material of the Luer Lock Cap.

Sample size used for the test set and the data provenance:
- The document does not specify numerical sample sizes for the non-clinical tests (e.g., how many luer lock caps were tested for container closure or biocompatibility).
- The data provenance is internal to DEKA Research & Development ("DEKA's design control process"). No specific country of origin for test data is mentioned, but DEKA is a U.S.-based company. The retrospective/prospective nature of the tests is not explicitly stated. These are typically controlled laboratory tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to the non-clinical testing described. The "ground truth" for non-clinical performance evaluation comes from established engineering standards, regulatory guidance (like ISO 10993-1 and FDA Infusion Pumps guidance), and predefined specifications, rather than expert consensus on individual cases.
Adjudication method for the test set:
- Not applicable in the human-reader sense. The "adjudication" is against established engineering and regulatory standards for biocompatibility and container closure performance.
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 MRMC or human reader study was done, as this device is an infusion pump, not an imaging or diagnostic AI-driven device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not directly applicable in the terms of typical AI/software performance. However, standalone non-clinical testing of the device components (specifically the luer lock cap material change) was performed to ensure it met functional and safety standards without human interaction during the test itself. This included:
  - Container Closure performance testing: This evaluated the device's ability to maintain protection against microbial ingress.
  - Biocompatibility testing: This confirmed that the new material complies with ISO 10993-1 and relevant FDA guidance.
  - Functional (container closure) testing: This was performed to demonstrate equivalence to the predicate device.
The type of ground truth used:
- Regulatory Standards: ISO 10993-1:2009 for biocompatibility and FDA's "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."
- Engineering Specifications: Performance metrics listed in the table (e.g., infusion accuracy, maximum infusion pressure, alarm parameters) are based on established design specifications and validated against the predicate device's performance.
- Functional Equivalence: The primary ground truth for this 510(k) submission is demonstrating equivalence in safety and effectiveness to the predicate device (Unity Subcutaneous Delivery System for Remodulin K191313), despite the material change.
The sample size for the training set:
- No "training set" in the machine learning sense is relevant here, as this is a hardware medical device with a minor material change, not an AI/ML algorithm.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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December 30, 2020

DEKA Research and Development Paul Smolenski Regulatory Affairs 340 Commercial Street Manchester, New Hampshire 03101

Re: K202690

Trade/Device Name: Remunity Subcutaneous Delivery System for Remodulin Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: QJY Dated: December 4, 2020 Received: December 4, 2020

Dear Paul Smolenski:

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 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 CAPT. Alan Stevens Acting 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) K202690

Device Name

Remunity 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 - K202690

Submitter Information

510(k) Sponsor:	DEKA Research & Development340 Commercial StreetManchester, NH 03101
Contact Person	Paul SmolenskiRegulatory AffairsDEKA Research & Development CorporationPhone: (603) 669-5139Fax: (603) 624-0573psmolenski@dekaresearch.com
Date Prepared:	December 18, 2020

Proposed Device

Common/Usual Name:	Infusion Pump
Trade/Proprietary Name:	Remunity 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 K191313.

No reference devices are used in this submission.

Device Description

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The pump assembly is composed of a reusable pump and a disposable single-use cassette with a pharmacy-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 Remunity System utilizes a micro-dosing pump mechanism supplemented with acoustic volume sensor feedback to ensure delivery accuracy.

The pharmacy-filled cassette is intended to be stored (inclusive of shipping time) up to 14-days and is intended to be in use for up to 72-hours. The cassettes are identical to those cleared under K191313, with the exception that the luer lock cap material was changed from Polycarbonate to ABS.

The device is prescription use only.

Indications for Use

Substantial Equivalence Discussion

Intended Use Comparison

The table below includes a summation matrix of the intended use between the new device and those of the current device:

Characteristic	Unity Subcutaneous DeliverSystem for Remodulin®K191313	ProposedRemunity Subcutaneous DeliverSystem for Remodulin®
Indications for Use	The Unity SubcutaneousDelivery System forRemodulin® (the Unity System)is intended for continuoussubcutaneous delivery ofRemodulin® (treprostinil)injection for use in adults(greater than 22 years of age).	Same Indications for Use. Brandinghas been updated from "Unity" to"Remunity".
Prescription Onlyor Over the Counter	Prescription Only	No Change
Intended Population	Adults (>22 years of age)	No Change
Environment of Use	In professional healthcarefacility and home healthcareenvironments	No Change

Discussions of differences in Indications for Use statement

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The indications for use for the subject device is the same as the device cleared under K191313. The branding of the device has been updated from "Unity" to "Remunity".

Discussions of differences in intended population

The intended population for the subject device is identical to the predicate device cleared under K191313.

The Remunity 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 K191313.

Comparison of Technological Characteristics with the Predicate Device

The below table compares the characteristics of the subject device to the Unity System cleared under K191313 and includes an assessment of differences between them and why the differences between the subject device and predicate device do not introduce new or different questions of safety and effectiveness.

Characteristic	Predicate DeviceUnity SubcutaneousDeliver System forRemodulin®K191313	Subject DeviceRemunitySubcutaneous DeliverSystem forRemodulin®	Discussion ofDifferences
Mechanism ofaction	Microprocessor controlledMicro- dosing pumpmechanism supplementedwith acoustic volume sensor(AVS) feedback formonitoring deliveryaccuracy.	Same	N/A
InfusionAccuracy	$\pm$ 6%	Same	N/A
MaximumInfusion pressure	<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
Characteristic	Predicate DeviceUnity SubcutaneousDeliver System forRemodulin®K191313	Subject DeviceRemunitySubcutaneous DeliverSystem forRemodulin®	Discussion ofDifferences
Post-occlusionbolus	<40 µl at all rates.	Same	N/A
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 Failed• Walkaway	Same	N/A
Device ServiceLife	3 years	Same	N/A
Characteristic	Predicate DeviceUnity SubcutaneousDeliver System forRemodulin®K191313	Subject DeviceRemunitySubcutaneous DeliverSystem forRemodulin®	Discussion ofDifferences
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-ABSLuer Lock Cap:Polycarbonate	Cassette fluid path:Polycarbonate, Bromobutyl,SEBS, polyurethanePump: ABS, Polycarbonate,AluminumCartridge: Polycarbonate,Acrylic, polyurethaneFilling Aid: PC-ABSLuer Lock Cap: ABS	The change in luer lock capmaterial was evaluated to thesame standards forbiocompatibility under ISO-10993-1 as the predicate.The revised materialdemonstrates equivalentbiocompatibility.Functional (containerclosure) testing wasperformed. Subject devicewas found to be equivalentto the predicate.
Environment ofUse	In professional healthcarefacility and home healthcareenvironments	Same	N/A
Ingress protection	IP58 when connected to thereservoir	Same	N/A
Power source	Rechargeable Lithium-IonBattery	Same	N/A
StorageConditions	Temperature:-13°F to 158°F (-25°C to70°C)Non-condensing humidity:up to 90%.Pressure: 500 hPa to 1060hPa	Same	N/A
Characteristic	Predicate DeviceUnity SubcutaneousDeliver System forRemodulin®K191313	Subject DeviceRemunitySubcutaneous DeliverSystem forRemodulin®	Discussion ofDifferences
OperatingConditions	Temperature:41°F to 104°F (5°C to 40°C)Non-condensing humidity:up to 90%Pressure: 700 hPa to 1060hPa	Same	N/A
Remote userfeedback	Audible, vibratory	Same	N/A
AdministrationSet	Medtronic Quick-setInfusion Set MedtronicSilhouette and Infusion SetSmiths Medical Cleo 90Infusion Set	Same	N/A
Cassette	Remodulin Unity cassettes,3 ml, Specialty Pharmacyfilled	Same	N/A
Expiration -Cassette	Pharmacy-Fill, 14 Days(consistent with USP 797)	Same	N/A
End UserPackaging -	Aseptically filled cassettewith female luer lock fluidpath closure, placed inplastic clamshell tray andsealed in foil pouch	Same	N/A
Biocompatibility	Complies with ISO 10993-1and the Agency's "Use ofInternational Standard ISO10993-1, 'BiologicalEvaluation of MedicalDevices - Part 1: Evaluationand testing within a RiskManagement Process' -Guidance for Industry andFood and DrugAdministration Staff" datedJune 16, 2016	Same	N/A
Luer Lock Cappackaging	Tyvek/LDPE pouch	Same	N/A
Characteristic	Predicate DeviceUnity SubcutaneousDeliver System forRemodulin®K191313	Subject DeviceRemunitySubcutaneous DeliverSystem forRemodulin®	Discussion ofDifferences
Luer Lock Capsterility assurancelevel	SAL 10-6	Same	N/A

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Non-Clinical/ Performance Testing:

The safety assurance case provided for the Remunity Subcutaneous Delivery System for Remodulin® as recommended in the FDA guidance document, "Infusion Pumps Total Product Life Cycle" and cleared under premarket notification K191313 applies to the subject device in all aspects.

The stated goal of the safety assurance case ("safety case") is: "The Remunity Subcutaneous Infusion System for Remodulin® 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 assurance case was updated to reflect the new luer lock cap material and continues to cover all system attributes that were stated for the predicate:

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 specific to the luer lock cap material change were updated from that of the predicate K191313. Since the assurance case builds on the original case, only evidence used to provide assurance related to the changes are listed here:

Container Closureperformance	Performance of the device to maintain adequate assurance ofprotection from microbial ingress was evaluated through containerclosure testing.
Biocompatibility	The materials used for the Remunity System comply withbiocompatibility requirements outlined in ISO 10993-1:2009 and the"Guidance for Industry and Food and Drug Administration Staff, Useof International Standard ISO 10993 Biological Evaluation of MedicalDevices Part 1: Evaluation and Testing within a Risk ManagementProcess" and are considered to be biocompatible.

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Clinical Study

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

Design Control

The Remunity System was specified and developed by DEKA. DEKA is a registered medical device specification developer and complies with the FDA Quality System Regulation as specified in 21 CFR 820, as well as registered to ISO 13485.

Conclusion

The modifications in the luer lock cap material do not change the intended use or technological characteristics of the subject device compared to the Unity System cleared under premarket notification K191313. The changes summarized in this submission do not raise different questions of safety and effectiveness.

The performance of the device is supported by DEKA's design control process which included non-clinical testing and risk management activities. The Remunity Subcutaneous Delivery System for Remodulin® is Substantially Equivalent (SE) to the Remunity Subcutaneous Delivery System for Remodulin® cleared under premarket notification K191313.

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).