Remunity System

K243354 · Deka Research & Development Corp. · QJY · Nov 27, 2024 · General Hospital

Device Facts

• Record ID: K243354
• Device Name: Remunity System
• Applicant: Deka Research & Development Corp.
• Product Code: QJY · General Hospital
• Decision Date: Nov 27, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

Wearable infusion pump for continuous subcutaneous delivery of Remodulin (treprostinil) to treat pulmonary arterial hypertension. System comprises reusable pump, disposable single-use cassette (pharmacy or user-filled), remote interface, and accessories. Pump uses microprocessor-controlled micro-dosing mechanism with acoustic volume sensor (AVS) feedback for delivery accuracy. Patient wears device; operates via remote interface. Healthcare provider programs individualized delivery rate. Output is continuous drug infusion. Benefits include ambulatory delivery of medication. Modified device adds compatibility with Neria Guard infusion set.

Clinical Evidence

Bench testing only. No clinical or animal data provided. Performance testing verified compatibility and safety of the Neria Guard infusion set with the Remunity System.

Technological Characteristics

Wearable ambulatory pump; micro-dosing mechanism with AVS feedback. Materials: PC, Bromobutyl, SEBS, polyurethane, ABS, Aluminum. Power: Rechargeable Li-ion battery. Connectivity: Remote interface. IP58 rating. Sterilization: Gamma radiation (cassette). 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.

Indications for Use

Indicated for continuous subcutaneous delivery of Remodulin (treprostinil) in adults >22 years old with pulmonary arterial hypertension (PAH).

Regulatory Classification

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.

Predicate Devices

• Remunity Subcutaneous Delivery System for Remodulin (K191313)

Reference Devices

• Medtronic Quick-set Infusion Set (K991759)
• Medtronic Silhouette Infusion Set (K162812)
• Smiths Medical Cleo 90 Infusion Set (K042172)
• Neria Guard Infusion Set (K192647)

Submission Summary (Full Text)

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November 27, 2024

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

Re: K243354

Trade/Device Name: Remunity System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: OJY Dated: October 28, 2024 Received: October 29, 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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

# Jake K. Lindstrom -S

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) K243354

Device Name Remunity system

Indications for Use (Describe)

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

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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# K243354 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<br>340 Commercial Street<br>Manchester, NH 03101 |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person(s) | Paul Smolenski (primary), Lauren Blake (secondary)<br>Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail], [e-mail] |

Date Prepared October 28, 2024

#### Proposed Device(s)

| Common/Usual Name: | Infusion Pump |
|-------------------------|------------------------------------------------------|
| Trade/Proprietary Name: | Remunity Subcutaneous Delivery System for Remodulin® |
| Classification Name: | Infusion pump, drug specific, pharmacy-filled |
| Device Classification: | 880.5725 |
| Product Code: | QJY |
| Class: | II |
| Device Panel: | General Hospital |

### Predicate Device(s)

The predicate device is the Remunity Subcutaneous Delivery System for Remodulin®, which was previously cleared under premarket application K191313 on February 12, 2020.

#### 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

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

The device is prescription use only.

The modified device can be used with an additional infusion set.

#### Indications for Use

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

#### Substantial Equivalence Discussion

The following table is a matrix of the intended use and technological characteristics between the subject device and the predicate device. The table also discusses why these differences do not introduce new or different questions of safety and effectiveness.

| Characteristic | Predicate Device – Remunity<br>System (K191313) | Subject Device – Modified<br>Remunity System | Equivalence |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Classification<br>Regulation and<br>Product Code | 21 CFR 880.5725<br>Product Code: QJY | 21 CFR 880.5725<br>Product Code: QJY | No change |
| Class | II | II | No change |
| Indications for<br>Use | The Remunity® Pump for<br>Remodulin® (treprostinil)<br>Injection (the Remunity System)<br>is intended for continuous<br>subcutaneous delivery of<br>Remodulin (treprostinil)<br>Injection for use in adults<br>(greater than 22 years old). | The Remunity® Pump for<br>Remodulin® (treprostinil)<br>Injection (the Remunity System)<br>is intended for continuous<br>subcutaneous delivery of<br>Remodulin (treprostinil)<br>Injection for use in adults<br>(greater than 22 years old). | No change |
| Prescription Use<br>or Over the<br>Counter (OTC) | Prescription | Prescription | No change |
| Characteristic | Predicate Device – Remunity<br>System (K191313) | Subject Device – Modified<br>Remunity System | Equivalence |
| Intended Patient<br>Population | Age >22 years | Age >22 years | No change |
| Patient<br>Environment | On-body wearable ambulatory<br>pump | On-body wearable ambulatory<br>pump | No change |
| Environment of<br>Use | In professional healthcare<br>facilities and home environments | In professional healthcare<br>facilities and home environments | No change |
| Delivery<br>Method | Microprocessor controlled micro-<br>dosing pump mechanism<br>supplemented with acoustic<br>volume sensor (AVS) feedback<br>for monitoring delivery accuracy | Microprocessor controlled micro-<br>dosing pump mechanism<br>supplemented with acoustic<br>volume sensor (AVS) feedback<br>for monitoring delivery accuracy | No change |
| Delivery type | Subcutaneous infusion | Subcutaneous infusion | No change |
| Dimensions | 6 cm x 6 cm x 2 cm<br>(2.4 in x 2.4 in x 0.4 in) | 6 cm x 6 cm x 2 cm<br>(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 Delivery<br>Rate Range | 16 µL/hr – 225 µL/hr, with<br>increments of 1 µL/hr | 16 µL/hr – 225 µL/hr, with<br>increments of 1 µL/hr | No change |
| Basal Accuracy | ±6% | ±6% | No change |
| Bolus Volume<br>after Occlusion<br>Release | < 40 µL at all rates | < 40 µL at all rates | No change |
| Time to<br>Occlusion<br>Alarm | Maximum time to occlusion<br>alarm:<br>• ≥ 100 µL/hr: 12 minutes<br>• < 100 µL/hr: 8 hours | Maximum time to occlusion<br>alarm:<br>• ≥ 100 µL/hr: 12 minutes<br>• < 100 µL/hr: 8 hours | No change |
| Pump Service<br>Life | 3 years | 3 years | No change |
| Ingress<br>Protection | IP58 when connected to the<br>Cassette | IP58 when connected to the<br>Cassette | No change |
| Applicable<br>Safety Standards | • IEC 60601-1<br>• IEC 60601-1-2<br>• IEC 60601-1-8<br>• IEC 60601-1-11<br>• IEC 60601-2-24<br>• ISO 11137-1 (Sterilized via<br>Gamma Radiation)<br>• ISO 10993-1<br>• ISO 14971 | • IEC 60601-1<br>• IEC 60601-1-2<br>• IEC 60601-1-8<br>• IEC 60601-1-11<br>• IEC 60601-2-24<br>• ISO 11137-1 (Sterilized via<br>Gamma Radiation)<br>• ISO 10993-1<br>• ISO 14971 | No change |
| Power Source | Rechargeable Lithium Ion<br>Battery | Rechargeable Lithium Ion<br>Battery | No change |
| Characteristic | Predicate Device - Remunity<br>System (K191313) | Subject Device – Modified<br>Remunity System | Equivalence |
| Pump Storage<br>Conditions | Temperature: -25 °C to 70 °C<br>(-13 °F to 158 °F) | Temperature: -25 °C to 70 °C<br>(-13 °F to 158 °F) | No change |
| | Non-condensing Humidity: up to<br>90% | Non-condensing Humidity: up to<br>90% | |
| | Pressure: 50 kPa to 106 kPa | Pressure: 50 kPa to 106 kPa | |
| | Operating<br>Conditions | Temperature: 5 °C to 40 °C<br>(41 °F to 104 °F) | |
| | | Non-condensing Humidity: up to<br>90% | |
| | | Pressure: 70 kPa to 106 kPa | |
| | | Remote<br>Interface | |
| System User<br>Feedback | Visual, audible, vibratory | | Visual, audible, vibratory |
| | Common<br>Alarms | Battery Depleted | Battery Depleted |
| Cassette Depleted | | Cassette Depleted | |
| Cassette Removed | | Cassette Removed | |
| Cassette Problem | | Cassette Problem | |
| Occlusion | | Occlusion | |
| Pump Error | | Pump Error | |
| Pump Failure | | Pump Failure | |
| Basal Not Started | | Basal Not Started | |
| Adjust Pump | | Adjust Pump | |
| Delivery Stopped | | Delivery Stopped | |
| Depletes Soon | | Depletes Soon | |
| Excessive Noise | | Excessive Noise | |
| Message Timeout | | Message Timeout | |
| No Communication | | No Communication | |
| Pairing Failed | | Pairing Failed | |
| Pairing Lost | | Pairing Lost | |
| Pump Idle | | Pump Idle | |
| Pump Battery Low | | Pump Battery Low | |
| Remote Battery Low | | Remote Battery Low | |
| Request Refused | | Request Refused | |
| Software Version Error | | Software Version Error | |
| Tech | | Tech | |
| Walkaway | | Walkaway | |
| Battery<br>Operating Time | | 72 hours | 72 hours |
| Characteristic | Predicate Device - Remunity<br>System (K191313) | Subject Device – Modified<br>Remunity System | Equivalence |
| Infusion Set | Medtronic Quick-set<br>Infusion Set [K991759] 23" (MMT-392, MMT-393) Medtronic Silhouette<br>Infusion Set [K162812] 23" (MMT-373) Smiths Medical Cleo 90<br>Infusion Set [K042172] 24" (21-7220-24, 21-7230-24) | Medtronic Quick-set<br>Infusion Set [K991759] 23" (MMT-392, MMT-393) Medtronic Silhouette<br>Infusion Set [K162812] 23" (MMT-373) Smiths Medical Cleo 90<br>Infusion Set [K042172] 24" (21-7220-24, 21-7230-24) Neria Guard Infusion Set<br>[K192647] 23" (704060-5226, 704060-5229) | Equivalent<br>The subject device<br>has an additional<br>compatible infusion<br>set. The Neria Guard<br>infusion set has<br>similar physical<br>characteristics to<br>other currently listed<br>infusion sets.<br>Performance testing<br>with the Neria Guard<br>demonstrates that<br>subject device<br>performance is<br>equivalent to the<br>predicate device. The<br>methods and<br>acceptance criteriaused in this testing<br>are well established<br>in previous<br>clearances. |
| Compatible<br>Cassette | Remodulin Unity Cassettes, 3<br>mL | Remodulin Unity Cassettes, 3<br>mL | No change |
| Cassette Filling<br>Method | Specialty pharmacy User-filled | Specialty pharmacy User-filled | No change |
| Cassette Shelf<br>Life (empty) | 2 years | 2 years | No change |
| Pharmacy-filled<br>Shelf-Life | 14 days (per <USP 797>) | 14 days (per <USP 797>) | No change |
| Material<br>Biocompatibility | Cassette fluid path:<br>Polycarbonate (PC), Bromobutyl,<br>SEBS, polyurethane<br><br>Pump: ABS, PC, Aluminum<br><br>Cartridge: PC, Acrylic, polyurethane<br><br>Filling Aid: PC-ABS<br><br>Cap (Pharmacy-fill): ABS | Cassette fluid path:<br>Polycarbonate (PC),<br>Bromobutyl, SEBS,<br>polyurethane<br><br>Pump: ABS, PC, Aluminum<br><br>Cartridge: PC, Acrylic,<br>polyurethane<br><br>Filling Aid: PC-ABS<br><br>Cap (Pharmacy-fill): ABS | No change |
| Characteristic | Predicate Device – Remunity<br>System (K191313) | Subject Device – Modified<br>Remunity System | Equivalence |
| Pharmacy-fill<br>End-user<br>Packaging | Aseptically filled cassette with female luer lock fluid path closure, placed in plastic clamshell tray and sealed in foil pouch | Aseptically filled cassette with female luer lock fluid path closure, placed in plastic clamshell…