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

Device Description

The RemunityPRO™ Pump for Remodulin® (treprostinil) Injection 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 RemunityPRO™ Pump for Remodulin® (treprostinil) Injection is prescription use only. The pump assembly is composed of a durable pump and a disposable, single-use cassette with a userfilled 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. The subject device has updated branding and also modifies the predicate device to be used with an additional infusion set.

AI/ML Overview

The provided text describes a 510(k) summary for the RemunityPRO™ Pump for Remodulin® (treprostinil) Injection. This is a submission to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study designed to establish acceptance criteria for an entirely new device or an AI algorithm. Therefore, many of the requested categories related to medical AI studies (like expert involvement, MRMC studies, or training sets) are not applicable.

The core of this submission is to show that the minor changes to an existing device (the RemunityPRO™ Pump compared to the Remunity® 2.0 Pump) do not raise new questions of safety or effectiveness. The primary change highlighted is the addition of compatibility with an additional infusion set.

Here's an attempt to fill in the requested information based on the provided text, noting where information is not applicable to this type of regulatory submission:

Acceptance Criteria and Device Performance

The provided document details a comparison between the subject device (RemunityPRO™ Pump) and its predicate (Remunity® 2.0 Pump). The "acceptance criteria" can be inferred from the performance characteristics of the predicate device, which the subject device is shown to match or be equivalent to.

Acceptance Criteria (Based on Predicate Performance)	Reported Device Performance (Subject Device)
Device Classification: Class II Infusion Pump, 21 CFR 880.5725, Product Code: FRN	No change (Equivalent)
Indications for Use: Continuous subcutaneous delivery of Remodulin (treprostinil) Injection for patients, ages 17 and older.	No change (Equivalent)
Prescription Use or OTC: Prescription	No change (Equivalent)
Intended Patient Population: Age 17 years and older	No change (Equivalent)
Patient Environment: On-body wearable ambulatory pump	No change (Equivalent)
Delivery Method: Microprocessor controlled micro-dosing pump mechanism supplemented with acoustic volume sensor (AVS) feedback for monitoring delivery accuracy	No change (Equivalent)
Delivery type: Subcutaneous infusion	No change (Equivalent)
Dimensions: 6 cm x 6 cm x 2 cm (2.4 in x 2.4 in x 0.4 in)	No change (Equivalent)
Weight: 50 g (1.76 oz.)	No change (Equivalent)
Basal Delivery Rate Range: 8 µL/hr – 225 µL/hr, with increments of 1 µL/hr	No change (Equivalent)
Basal Accuracy: ±6%	±6% (No change/Equivalent)
Bolus Volume after Occlusion Release: < 8 µL at all rates	< 8 µL at all rates (No change/Equivalent)
Time to Occlusion Alarm: Maximum time to occlusion alarm: • ≥ 100 µL/hr: 12 minutes • < 100 µL/hr: 8 hours	Maximum time to occlusion alarm: • ≥ 100 µL/hr: 12 minutes • < 100 µL/hr: 8 hours (No change/Equivalent)
Material Biocompatibility: Fluid contacting: Polycarbonate (PC), COP, Bromobutyl, SEBS, Polyurethane. Patient contacting: PC, Acrylic, Polyurethane, ABS, Aluminum.	No change (Equivalent)
Cassette Shelf Life: 2 years	2 years (No change/Equivalent)
Service Life: 3 years	3 years (No change/Equivalent)
Applicable Safety Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-11, IEC 60601-2-24, ISO 11137-1, ISO 10993-1, ISO 14971, IEC 60601-4-2, ANSI C63.27, AIM 7351731	No change (Equivalent)
Power Source: Rechargeable Lithium Ion Battery	No change (Equivalent)
Pump Storage Conditions: 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 (Equivalent)
Operating Conditions: 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 (Equivalent)
Remote Interface System User Feedback: Touchscreen Device, Visual, audible, vibratory	No change (Equivalent)
Battery Operating Time: 72 hours	72 hours (No change/Equivalent)
Infusion Set Compatibility: Medtronic Quick-set, Medtronic Silhouette, Smiths Medical Cleo 90 Infusion Sets	Equivalent - The subject device adds compatibility with the Neria Guard Infusion Set. Performance testing with Neria Guard demonstrated equivalent performance to the predicate device with established methods and acceptance criteria.
Cassette: Unity 2.0 Cassettes, 3 mL, user-filled	No change (Equivalent)
Priming Method: Primed by Pump after Cassette attachment to the Pump	No change (Equivalent)

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document states: "Bench performance testing was conducted in order to qualify the additional infusion set for use with the subject device, and to establish substantial equivalence to the predicate device in terms of safety and effectiveness."
- Specific sample sizes for these bench tests are not provided in the summary.
- Data provenance is not specified, but it would typically be internal laboratory testing by DEKA Research & Development Corp.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. This is a bench performance study for a physical medical device (infusion pump), not a study involving interpretation of medical data by experts to establish ground truth for an AI algorithm. The performance metrics are objective and measurable (e.g., flow rate accuracy, occlusion alarm time).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As this is a bench performance study of a physical device, there is no "adjudication" in the sense of resolving discrepancies between human readers or AI outputs. The tests involve direct measurement against established physical standards.
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. This is not an AI-assisted diagnostic or interpretative device; it's an infusion pump. Therefore, an MRMC study is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. While the pump contains a microprocessor and control algorithms, the "standalone" context typically refers to the performance of an AI algorithm in isolation for diagnostic tasks. This device is a complete system with mechanical, electronic, and software components, and its performance is evaluated as a whole in bench testing.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this type of device performance would be established physical and electrical measurement standards, regulatory standards (e.g., IEC 60601-2-24 for infusion pumps), and the known performance characteristics of the predicate device. These are objective engineering and regulatory requirements, not medical "ground truth" derived from patient data or expert consensus.
The sample size for the training set:
- Not Applicable. This device, while containing software, is not an AI/ML-driven device that undergoes a "training" phase in the context of machine learning. Its operation is based on programmed control logic and physical components.
How the ground truth for the training set was established:
- Not Applicable. As there is no AI/ML training set, this question is not relevant.

Summary

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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 11, 2025

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

Re: K250357

Trade/Device Name: RemunityPRO™ Pump for Remodulin® (treprostinil) Injection Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN Dated: February 7, 2025 Received: February 7, 2025

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) K250357

Device Name

RemunityPRO™ Pump for Remodulin® (treprostinil) Injection

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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K250357 510(k) Summary

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

Submitter Information

510(k) Sponsor	DEKA Research & Development Corp.340 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 March 4, 2025

Proposed Device(s)

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

Predicate Device

The predicate device is the Remunity® 2.0 Pump for Remodulin® (treprostinil) Injection. K241736. cleared on January 16, 2025.

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

Device Description

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The pump assembly is composed of a durable pump and a disposable, single-use cassette with a userfilled 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.

The subject device has updated branding and also modifies the predicate device to be used with an additional infusion set.

Indications for Use

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

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 (K241736)	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 Remunity® 2.0 Pump forRemodulin® (treprostinil)Injection (the Remunity 2.0System) is intended forcontinuous subcutaneousdelivery of Remodulin(treprostinil) Injection for use inpatients, ages 17 and older.	The RemunityPRO™ Pump forRemodulin® (treprostinil)Injection (the RemunityPROsystem) is intended forcontinuous subcutaneousdelivery of Remodulin(treprostinil) Injection for use inpatients, ages 17 and older.	No change
Prescription Useor Over theCounter (OTC)	Prescription	Prescription	No change
Intended PatientPopulation	Age 17 years and older	Age 17 years and older	No change
PatientEnvironment	On-body wearable ambulatorypump	On-body wearable ambulatorypump	No change
Characteristic	Predicate Device (K241736)	Subject Device	Equivalence
Delivery Method	Microprocessor controlledmicro-dosing pump mechanismsupplemented with acousticvolume sensor (AVS) feedbackfor monitoring delivery accuracy	Microprocessor controlledmicro-dosing pump mechanismsupplemented with acousticvolume sensor (AVS) feedbackfor monitoring 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	8 µL/hr – 225 µL/hr, withincrements of 1 µL/hr	8 µL/hr – 225 µL/hr, withincrements of 1 µL/hr	No change
Basal Accuracy	±6%	±6%	No change
Bolus Volumeafter OcclusionRelease	< 8 µL at all rates	< 8 µL at all rates	No change
Time to OcclusionAlarm	Maximum time to occlusionalarm:• ≥ 100 µL/hr: 12 minutes• < 100 µL/hr: 8 hours	Maximum time to occlusionalarm:• ≥ 100 µL/hr: 12 minutes• < 100 µL/hr: 8 hours	No change
MaterialBiocompatibility	Fluid contacting: Polycarbonate(PC), COP, Bromobutyl, SEBS,PolyurethanePatient contacting: PC, Acrylic,Polyurethane, ABS, Aluminum	Fluid contacting: Polycarbonate(PC), COP, Bromobutyl, SEBS,PolyurethanePatient contacting: PC, Acrylic,Polyurethane, ABS, Aluminum	No change
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 60601-4-2• ANSI C63.27• AIM 7351731	• 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 60601-4-2• ANSI C63.27• AIM 7351731	No change
Power Source	Rechargeable Lithium IonBattery	Rechargeable Lithium IonBattery	No change
Characteristic	Predicate Device (K241736)	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 InterfaceSystem UserFeedback	Touchscreen DeviceVisual, audible, vibratory	Touchscreen DeviceVisual, audible, vibratory	No change
Battery OperatingTime	72 hours	72 hours	No change
Infusion Set	Medtronic Quick-setInfusion Set: 23 in (58 cm),MMT-392, MMT-393[K991759]Medtronic SilhouetteInfusion Set: 23 in (58 cm),MMT-373 [K162812]Smiths Medical Cleo 90Infusion Set: 24 in (61 cm),21-7230-24, 21-7220-24[K042172]	Medtronic Quick-setInfusion Set: 23 in (58 cm),MMT-392, MMT-393[K991759]Medtronic SilhouetteInfusion Set: 23 in (58 cm),MMT-373 [K162812]Smiths Medical Cleo 90Infusion Set: 24 in (61 cm),21-7230-24, 21-7220-24[K042172]Neria Guard Infusion Set,23in (58 cm), 704060-5226, 704060-5229[K192647]	EquivalentThe subject devicehas an additionalcompatible infusionset. The Neria Guardinfusion set hassimilar physicalcharacteristics toother currently listedinfusion sets.Performance testingwith the Neria Guarddemonstrates thatsubject deviceperformance isequivalent to thepredicate device. Themethods andacceptance criteriaused in this testingare well establishedin the previousclearance(K241736).
Cassette	Unity 2.0 Cassettes, 3 mL, user-filled	Unity 2.0 Cassettes, 3 mL, user-filled	No change
Priming Method	Primed by Pump after Cassetteattachment to the Pump	Primed by Pump after Cassetteattachment to the Pump	No change

The intended use and indications for use remain unchanged in the subject device with respect to the predicate device (K241736).

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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.

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Animal, Clinical, and Bench Data

Bench performance testing was conducted in order to qualify the additional infusion set for use with the subject device, and to establish substantial equivalence to the predicate device in terms of safety and effectiveness.

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

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Design Control

The RemunityPRO™ Pump for Remodulin® (treprostinil) Injection was specified and developed by DEKA. DEKA complies with the FDA Quality System Regulation as specified in 21 CFR 820, as well as to ISO 13485:2016.

Conclusion

The differences between the predicate and the subject device do not raise different questions of safety or effectiveness. The RemunityPRO™ Pump for Remodulin® (treprostinil) Injection is substantially equivalent to the predicate Remunity® 2.0 Pump for Remodulin® cleared under K241736.

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).