(133 days)
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).
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 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 utilizes a touchscreen remote controller.
The provided text describes the Remunity System, an infusion pump. However, the document is a 510(k) summary for a substantial equivalence determination, not a study report proving a device meets specific acceptance criteria.
The 510(k) process primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety or effectiveness. It does not typically involve the presentation of detailed clinical study results or performance data in the format of acceptance criteria and proven performance as might be found in a clinical trial report or a comprehensive validation study.
Specifically, the document states:
- "No animal study or clinical trial data was obtained in support of this premarket submission."
- "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." This indicates that performance testing was done, but the details of acceptance criteria and reported numerical performance values are not provided within this summary.
- The only "performance data" mentioned are the types of tests conducted (e.g., Touchscreen Remote Reliability, Functionality, Wireless Communication, Software and Cybersecurity, Human Factors, Electrical Safety, EMC, Alarms), not the quantitative results of those tests.
Therefore, Based solely on the provided FDA 510(k) summary (K240256), I cannot extract the specific information requested regarding acceptance criteria and a study proving the device meets those criteria, as detailed as your prompt requires. The document attests that appropriate testing was performed and that the modified device (with a touchscreen remote controller) is substantially equivalent to its predicate, but it does not present the raw or summarized performance data against explicit acceptance criteria.
The information you are asking for, such as sample size for test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details, are typically found in more detailed study reports (e.g., clinical study reports, validation reports) that might be referenced in a 510(k) submission but are not fully elaborated in the summary itself.
In summary, the provided text does not contain the detailed information required to fill out the table and answer the specific questions about acceptance criteria and performance study methods.
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June 12, 2024
Deka Research and Development Paul Smolenski Regulatory Affairs 340 Commercial Street Manchester, New Hampshire 03101
Re: K240256
Trade/Device Name: Remunity System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: QJY Dated: Mav 9, 2024 Received: May 10, 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.
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,
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) K240256
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 & Development340 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 30, 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 K202690 on December 30, 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
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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 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 utilizes a touchscreen remote controller.
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
Intended Use Comparison
| Characteristic | Predicate Device - RemunitySystem (K202690) | Subject Device – RemunitySystem |
|---|---|---|
| Indications for Use | The Remunity SubcutaneousInfusion System (the RemunitySystem) is intended forcontinuous subcutaneousdelivery of Remodulin®(treprostinil) Injection for use inadults (greater than 22 years ofage). | The Remunity® Pump forRemodulin® (treprostinil)Injection (the Remunity System)is intended for continuoussubcutaneous delivery ofRemodulin (treprostinil)Injection for use in adults(greater than 22 years old). |
The tables below includes a matrix of the intended use between the subject device and the predicate device.
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| Characteristic | Predicate Device – RemunitySystem (K202690) | Subject Device – RemunitySystem |
|---|---|---|
| Prescription Use orOver the Counter(OTC) | Prescription | No change |
| Intended PatientPopulation | Greater than 22 years of age | No change |
| Patient Environment | On-body wearable ambulatorypump | No change |
| Environment of Use | In professional healthcarefacilities and homeenvironments | No change |
The intended use remains unchanged in the subject device with respect to the predicate device (K202690). The Indications for Use have been updated to reflect the current branding for the device. This update does not affect the intended patient population or environment of use.
Technological Characteristic Comparison
The table below compares the characteristics of the predicate and subject devices, and includes an assessment of the differences and why these differences do not introduce new or different questions of safety and effectiveness.
| Characteristic | Predicate Device –Remunity System(K202690) | Subject Device –Remunity System | Equivalence |
|---|---|---|---|
| DeliveryMethod | Microprocessorcontrolled micro-dosing pumpmechanismsupplemented withacoustic volume sensor(AVS) feedback formonitoring deliveryaccuracy | Same | N/A |
| Delivery type | Subcutaneous infusion | Same | N/A |
| Dimensions | 6 cm x 6 cm x 2 cm(2.4 in x 2.4 in x 0.4 in) | Same | N/A |
| Weight | 50 g (1.76 oz.) | Same | N/A |
| Basal DeliveryRate Range | 16 μL/hr – 225 μL/hr,with increments of 1μL/hr | Same | N/A |
| Basal Accuracy | +6% | Same | N/A |
| Characteristic | Predicate Device –Remunity System(K202690) | Subject Device -Remunity System | Equivalence |
| Bolus Volumeafter OcclusionRelease | < 40 µL at all rates | Same | N/A |
| Time toOcclusionAlarm | Maximum time toocclusion alarm:• ≥ 100 µL/hr: 12 minutes• ≤ 100 µL/hr: 8 hours | Maximum time toocclusion alarm:• ≥ 100 µL/hr: 12 minutes• ≤ 100 µL/hr: 8 hours | N/A |
| Pump ServiceLife | 3 years | Same | N/A |
| IngressProtection | IP58 when connected tothe Cassette | Same | N/A |
| ApplicableSafety Standards | • 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 | Same | N/A |
| Power Source | Rechargeable LithiumIon Battery | Same | N/A |
| Pump StorageConditions | Temperature: -25 °C to70 °C (-13 °F to 158 °F)Humidity: up to 90%Pressure: 50 kPa to 106 kPa | Same | N/A |
| OperatingConditions | Temperature: 5 °C to 40 °C (41 °F to 104 °F)Humidity: up to 90%Pressure: 70 kPa to 106 kPa | Same | N/A |
| Characteristic | Predicate Device –Remunity System(K202690) | Subject Device –Remunity System | Equivalence |
| RemoteInterface | • Push-button device | • Touchscreen device | EquivalentThe subject device provides a touchscreen device for use with the pump. The text and format of information displayed to the user, as well as workflows and required user input remains unchanged. No additional risks have been introduced. |
| System UserFeedback | Visual, audible, vibratory | Same | N/A |
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| Characteristic | Predicate Device –Remunity System(K202690) | Subject Device –Remunity System | Equivalence |
|---|---|---|---|
| CommonAlarms | Battery DepletedCassette DepletedCassette RemovedCassette ProblemOcclusionPump ErrorPump FailureBasal Not StartedAdjust PumpDelivery StoppedDepletes SoonExcessive NoiseMessage TimeoutNo CommunicationPairing FailedPairing LostPump IdlePump Battery LowRemote Battery LowRequest RefusedSoftware Version ErrorTechWalkaway | Same | N/A |
| BatteryOperating Time | 72 hours | Same | N/A |
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| Characteristic | Predicate Device –Remunity System(K202690) | Subject Device –Remunity System | Equivalence |
|---|---|---|---|
| Infusion Set | Medtronic Quick-setInfusion Set [K991759]42" (MMT-390, MMT-391)23" (MMT-392, MMT-393)Medtronic SilhouetteInfusion Set [K162812]23" (MMT-373)Smiths Medical Cleo 90Infusion Set [K042172]24" (21-7220-24, 21-7230-24)31" (21-7221-24, 21-7231-24)42" (21-7222-24, 21-7232-24) | Same | N/A |
| CompatibleCassette | Remodulin UnityCassettes, 3 mL | Same | N/A |
| Cassette FillingMethod | Specialty pharmacyUser-filled | Same | N/A |
| Cassette ShelfLife (empty) | 2 years | Same | N/A |
| Pharmacy-filledShelf-Life | 14 days (per <USP797>) | Same | N/A |
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| Characteristic | Predicate Device –Remunity System(K202690) | Subject Device –Remunity System | Equivalence |
|---|---|---|---|
| MaterialBiocompatibility | Cassette fluid path:Polycarbonate (PC),Bromobutyl, SEBS,polyurethane | Same | N/A |
| Pump: ABS, PC,Aluminum | |||
| Cartridge: PC, Acrylic,polyurethane | |||
| Filling Aid: PC-ABS | |||
| Cap (Pharmacy-fill):ABS | |||
| Pharmacy-fillEnd-userPackaging | Aseptically filledcassette with femaleluer lock fluid pathclosure, placed inplastic clamshell trayand sealed in foil pouch | Same | N/A |
| Priming Method | Manually primed byuser before Cassetteattachment to the Pump | Same | N/A |
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, specific to the remote interface, were evaluated:Touchscreen Remote Reliability Touchscreen Remote Functionality Wireless Communication |
|---|---|
| Software andCybersecurity | The subject device is considered to require an “Enhanced Documentation Level” per the 2023 FDA guidance document. |
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| 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 Cybersecurityin Medical Devices, issued September 27, 2023 | |
| • Cybersecurity in Medical Devices: Quality System Considerations andContent of Premarket Submissions, issued April 8, 2020 | |
| • Cybersecurity in Medical Devices: Refuse to Accept Policy for CyberDevices and Related Systems Under Section 524B of the FD&C Act,issued March 30, 2023 | |
| Human Factors | The human factors evaluation followed the FDA Guidance Document,Applying Human 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 | |
| Electrical Safety | Per IEC 60601-1:2020 |
| EMC | Per IEC 60601-1-2:2020 |
| 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 Remunity System 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 any new or different questions of safety or effectiveness. The Remunity Subcutaneous Delivery System for Remodulin® is substantially equivalent to the Remunity Subcutaneous Delivery System for Remodulin® cleared under K202690 with respect to the indications for use, target populations, treatment method, and technological characteristics.
§ 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).