The Remunity® 2.0 Pump for Remodulin® (treprostinil) Injection (the Remunity 2.0 System) is intended for continuous subcutaneous delivery of Remodulin (treprostinil) Injection for use in patients, ages 17 and older.

Device Description

The Remunity 2.0 System is a wearable infusion pump designed to deliver Remodulin® (treprostinil) subcutaneously for the treatment of pulmonary arterial hypertension (PAH). Remodulin® was FDA-approved under NDA 021272. The system consists of several components: a wearable pump assembly, a remote interface, 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 system to the patient. The Remunity 2.0 System is prescription use only.

The pump assembly is composed of a durable pump and a disposable, single-use cassette with a user-filled drug reservoir. The pump 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 subject system utilizes a micro-dosing pump mechanism supplemented with acoustic volume sensor feedback to ensure delivery accuracy.

AI/ML Overview

The provided text describes the Remunity 2.0 Pump for Remodulin® (treprostinil) Injection, an infusion pump, and its substantial equivalence to a predicate device. However, it does not contain information about the acceptance criteria and study that proves a device meets those criteria in the context of an AI/ML medical device.

The document is a 510(k) summary for an infusion pump, which is a hardware device for drug delivery. The "Performance Data" section lists various functional areas evaluated for device performance (e.g., delivery accuracy, occlusion performance, durability) but does not provide specific acceptance criteria values or detailed results for these evaluations. It also mentions software, cybersecurity, human factors, electrical safety, EMC, and alarms as evaluated areas, but again, without specific acceptance criteria or study outcomes.

Therefore, I cannot populate the requested table and answer questions 2 through 9 based on the provided text. The information requested (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set size and ground truth establishment) is typically associated with studies for AI/ML-driven diagnostic or prognostic devices, which is not the type of device described here.

Summary

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January 16, 2025

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

Re: K241736

Trade/Device Name: Remunity® 2.0 Pump for Remodulin® (treprostinil) Injection Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN Dated: December 18, 2024 Received: December 18, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Rebecca Dorsey -S

For Jake Lindstrom, Ph.D. 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) K241736

Device Name

Remunity® 2.0 Pump for Remodulin® (treprostinil) Injection

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K241736 510(k) Summary

This 510(k) Summary is prepared in accordance with the requirements of 21 CFR Part 807.92.

Submitter Information

510(k) Sponsor	DEKA Research and Development Corp340 Commercial StreetManchester, NH 03101
Contact Person(s)	Paul Smolenski (primary)Lauren Blake (secondary)
	Regulatory AffairsPhone: (603) 669-5139Fax: (603) 624-0573psmolenski@dekaresearch.com lblake@dekaresearch.com

Date Prepared January 10, 2025

Proposed Device

Common/Usual Name:	Infusion Pump
Trade/Proprietary Name:	Remunity® 2.0 Pump for Remodulin® (treprostinil) Injection
Classification Name:	Infusion pump
Device Classification:	880.5725
Product Code:	FRN
Class:	II
Device Panel:	General Hospital

Predicate Device

Unity Subcutaneous Delivery System for Remodulin®, K190182

The predicate device has not been subject to a design-related recall.

Reference Devices

The cassette and pump hardware of the subject system are identical to those of the reference device, the DEKA ACE Pump System cleared on March 13, 2024 under K233952.

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The remote interface hardware of the subject system is identical to that of the reference device, the Remunity System which was previously cleared under premarket application K240256 on June 12, 2024.

Device Description

Indications for Use

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Substantial Equivalence Discussion

Intended Use Comparison

The tables below includes a matrix of the intended use between the subject device and the predicate device.

Characteristic	Predicate Device(K190182)	Subject Device	Equivalence
DeviceClassificationRegulation andProduct Code	Class II Infusion Pump21 CFR 880.5725Product Code: FRN	Class II Infusion Pump21 CFR 880.5725Product Code: FRN	No change
Indications forUse	The UnitySubcutaneous DeliverySystem forRemodulin® (the UnitySystem) is intended forcontinuoussubcutaneous deliveryof Remodulin(treprostinil) injectionfor use in adults(greater than 22 yearsof age).	The Remunity® 2.0Pump for Remodulin®(treprostinil) Injection(the Remunity 2.0System) is intended forcontinuoussubcutaneous deliveryof Remodulin(treprostinil) Injectionfor use in patients, ages17 and older.	EquivalentBoth devices are labeledspecifically for use withRemodulin. The subject systemhas a widened indicated patientpopulation age range in order toalign with the indications forRemodulin.
PrescriptionUse or Over theCounter (OTC)	Prescription	Prescription	No change
IntendedPatientPopulation	Greater than 22 yearsof age	Age 17 years and older	EquivalentThe subject system has awidened indicated patientpopulation age range, inalignment with the Remodulinindications.
PatientEnvironment	On-body wearableambulatory pump	On-body wearableambulatory pump	No change

The intended use remains unchanged in the subject device with respect to the predicate device (K190182). The indications for use have been updated expand the indicated patient population, in alignment with Remodulin drug labeling. This update has been verified through bench performance testing and validated through human factors testing.

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Technological Characteristic Comparison

The table below compares the updates made to the subject device as compared to the predicate device and includes an assessment of these updates in the context of safety and effectiveness.

Characteristic	Predicate Device(K190182)	Subject Device	Equivalence
Delivery Method	Microprocessor controlledmicro-dosing pumpmechanism supplementedwith acoustic volumesensor (AVS) feedbackfor monitoring deliveryaccuracy	Microprocessor controlledmicro-dosing pumpmechanism supplementedwith acoustic volumesensor (AVS) feedback formonitoring deliveryaccuracy	No change
Delivery type	Subcutaneous infusion	Subcutaneous infusion	No change
Dimensions	6 cm x 6 cm x 2 cm(2.4 in x 2.4 in x 0.4 in)	6 cm x 6 cm x 2 cm(2.4 in x 2.4 in x 0.4 in)	No change
Weight	50 g (1.76 oz.)	50 g (1.76 oz.)	No change
Basal DeliveryRate Range	16 µL/hr – 225 µL/hr,with increments of 1µL/hr	8 µL/hr – 225 µL/hr, withincrements of 1 µL/hr	EquivalentThe basal delivery raterange for the subjectsystem is wider thanthat of the predicate,but remains inalignment with theRemodulin prescribinginformation.Bench testing,including deliveryaccuracy and occlusiondetection, demonstratesequivalent performancefor the expanded flowrate range. Noadditional risks.
Basal Accuracy	+6%	+6%	No change
Characteristic	Predicate Device(K190182)	Subject Device	Equivalence
Bolus Volumeafter OcclusionRelease	< 40 µL at all rates	< 8 µL at all rates	EquivalentThe subject systemdemonstrates improvedpost-occlusion bolusvolume performancecompared to thepredicate device. Noadditional risks.
Time toOcclusion Alarm	Maximum time toocclusion alarm:• ≥ 100 µL/hr: 12minutes• < 100 µL/hr: 8 hours	Maximum time toocclusion alarm:• ≥ 100 µL/hr: 12minutes• < 100 µL/hr: 8 hours	No change
MaterialBiocompatibility	Fluid contacting:Polycarbonate (PC),Bromobutyl, SEBS,PolyurethanePatient contacting: PC,Acrylic, Polyurethane,ABS, Aluminum, PC-ABS	Fluid contacting:Polycarbonate (PC), COP,Bromobutyl, SEBS,PolyurethanePatient contacting: PC,Acrylic, Polyurethane,ABS, Aluminum	EquivalentThe materials of thesubject device meet thesame biocompatibilitystandards as thepredicate device. Noadditional risks.
Cassette ShelfLife	2 years	2 years	No change
Service Life	3 years	3 years	No change
Applicable SafetyStandards	• IEC 60601-1• IEC 60601-1-2• IEC 60601-1-8• IEC 60601-1-11• IEC 60601-2-24• ISO 11137-1(Sterilized viaGamma Radiation)• ISO 10993-1• ISO 14971	• IEC 60601-1• IEC 60601-1-2• IEC 60601-1-8• IEC 60601-1-11• IEC 60601-2-24• ISO 11137-1(Sterilized via GammaRadiation)• ISO 10993-1• ISO 14971• IEC 60601-4-2• ANSI C63.27• AIM 7351731	EquivalentThe subject devicecomplies withadditional safetystandards. Noadditional risks.
Power Source	Rechargeable Lithium IonBattery	Rechargeable Lithium IonBattery	No change
Characteristic	Predicate Device(K190182)	Subject Device	Equivalence
Pump StorageConditions	Temperature: -25 °C to 70 °C (-13 °F to 158 °F) Non-condensing humidity: up to 90% Pressure: 50 kPa to 106 kPa	Temperature: -25 °C to 70 °C (-13 °F to 158 °F) Non-condensing humidity: up to 90% Pressure: 50 kPa to 106 kPa	No change
OperatingConditions	Temperature: 5 °C to 40 °C (41 °F to 104 °F) Non-condensing humidity: up to 90% Pressure: 70 kPa to 106 kPa	Temperature: 5 °C to 40 °C (41 °F to 104 °F) Non-condensing humidity: up to 90% Pressure: 70 kPa to 106 kPa	No change
Remote Interface	Push-Button Device	Touchscreen Device	EquivalentThe subject RemoteInterface has identicalhardware andfunctionality to thereference device(K240256). Noadditional risks.
System UserFeedback	Visual, audible, vibratory	Visual, audible, vibratory	No change
Battery OperatingTime	72 hours	72 hours	No change
Infusion Set	Medtronic Quick-set Infusion Set: 23 in (58 cm), MMT-392, MMT-393 [K991759] Medtronic Silhouette Infusion Set: 23 in (58 cm), MMT-373 [K162812] Smiths Medical Cleo 90 Infusion Set: 24 in (61 cm), 21-7230-24, 21-7220-24 [K042172]	Medtronic Quick-set Infusion Set: 23 in (58 cm), MMT-392, MMT-393 [K991759] Medtronic Silhouette Infusion Set: 23 in (58 cm), MMT-373 [K162812] Smiths Medical Cleo 90 Infusion Set: 24 in (61 cm), 21-7230-24, 21-7220-24 [K042172]	No change
Characteristic	Predicate Device(K190182)	Subject Device	Equivalence
Cassette	Remodulin UnityCassettes, 3 mL, user-filled	Unity 2.0 Cassettes, 3 mL, user-filled	EquivalentThe subject Cassette isidentical to thereference deviceCassette (K233952).The updated designremoves the filling aidpresent in the predicateCassette. Workflowsassociated withremoval of the fillingaid were validatedthrough human factorstesting. No additionalrisks.
Priming Method	Manually primed by userbefore Cassetteattachment to the Pump	Primed by Pump afterCassette attachment to thePump	EquivalentHuman factors andbench testingdemonstrates that theupdated prime methodis safe and effective.No additional risks.

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Performance Data

Performance testing was conducted in order to verify and validate the subject device remote interface for its intended use, and to establish substantial equivalence to the respective predicate device remote interface in terms of safety and effectiveness. The FDA guidance document, Infusion Pumps Total Product Life Cycle, issued December 2, 2014 was followed.

DevicePerformance	The following functional areas were evaluated:Delivery accuracy Occlusion performance Fault Insertion Drug stability and particulate Incidental delivery performance Remodulin exposure Battery performance Durability Shipping and Storage
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Software andCybersecurity	The subject device is considered to require an “Enhanced Documentation Level” perthe 2023 FDA guidance document.Software and Cybersecurity testing was conducted per ANSI AAMI IEC62304:2006/A1:2016 and the following FDA guidance documents:Content of Premarket Submissions for Device Software Functions, issued June 14, 2023 Off-The-Shelf Software Use in Medical Devices, issued September 27, 2019 Content of Premarket Submissions for Management of Cybersecurity in MedicalDevices, issued September 27, 2023 Cybersecurity in Medical Devices: Quality System Considerations and Contentof Premarket Submissions, issued April 8, 2020 Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devicesand Related Systems Under Section 524B of the FD&C Act, issued March 30, 2023
HumanFactors	The human factors validation followed the FDA guidance document, ApplyingHuman Factors and Usability Engineering to Medical Devices, issued February 3,2016, and the following standards:IEC 60601-1-6:2020 ANSI AAMI IEC 62366-1:2015+A1:2020
ElectricalSafety	Per IEC 60601-1:2020
EMC	Per IEC 60601-1-2:2020, AIM 7351731
Alarms	Per IEC 60601-1-8:2020

Animal and Clinical Studies

No animal study or clinical trial data was obtained in support of this premarket submission.

Design Control

The subject system was specified and developed by DEKA. DEKA complies with the FDA Quality System Regulation as specified in 21 CFR Part 820, as well as to ISO 13485.

Conclusion

The differences between the predicate and the subject device do not raise different questions of safety or effectiveness. The Remunity 2.0 System is substantially equivalent to the Unity Subcutaneous Delivery System for Remodulin® cleared under 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).