(29 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 can be used with an additional infusion set.
The provided text describes a 510(k) premarket notification for a medical device called the "Remunity System," which is an infusion pump. The submission is for a modified version of an already cleared device, and the primary modification discussed is the addition of a compatible infusion set.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner for specific performance characteristics of the new infusion set. Instead, it states that "Performance testing with the Neria Guard demonstrates that subject device performance is equivalent to the predicate device. The methods and acceptance criteria used in this testing are well established in previous clearances."
However, the table comparing the predicate device and the subject device does list several performance characteristics and their values, which implicitly serve as the performance requirements that the modified device must meet to be considered equivalent. Since the subject device is stated to have "No change" in all these characteristics except the infusion set, it implies that the modified device performs identically to the predicate device for these parameters.
Acceptance Criteria (Implicit from Predicate Device Performance)
| Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Subject Device) |
|---|---|---|
| Basal Delivery Rate Range | 16 µL/hr – 225 µL/hr, increments of 1 µL/hr | No change (implies 16 µL/hr – 225 µL/hr, increments of 1 µL/hr) |
| Basal Accuracy | ±6% | No change (implies ±6%) |
| Bolus Volume after Occlusion Release | < 40 µL at all rates | No change (implies < 40 µL at all rates) |
| Time to Occlusion Alarm (≥ 100 µL/hr) | Maximum 12 minutes | No change (implies Maximum 12 minutes) |
| Time to Occlusion Alarm (< 100 µL/hr) | Maximum 8 hours | No change (implies Maximum 8 hours) |
| Pump Service Life | 3 years | No change (implies 3 years) |
| Ingress Protection | IP58 when connected to the Cassette | No change (implies IP58) |
| Battery Operating Time | 72 hours | No change (implies 72 hours) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses "bench performance testing." It does not specify the sample size for this testing. It also does not mention the country of origin of the data or whether the data was retrospective or prospective. Given that it is bench testing, it would inherently be prospective data collected in a laboratory setting.
3. 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)
This information is not provided in the document. The testing described is "bench performance testing" which typically does not involve human experts establishing "ground truth" in the same way clinical or diagnostic studies do. The "ground truth" in this context would be physical measurements of pump performance against engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable for bench performance testing of an infusion pump. Adjudication methods are typically used in clinical studies, especially those involving human interpretation of medical images or outcomes.
5. 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 study was done. The device in question is an infusion pump, which is a hardware device for delivering medication, not an AI-powered diagnostic tool requiring human reader interpretation. Therefore, questions about human readers and AI assistance are not relevant to this device and its clearance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is an infusion pump; therefore, the concept of "standalone algorithm performance" as typically applied to AI/ML devices is not directly applicable. The device's performance, as measured in bench testing, is inherently its "standalone" performance without "human-in-the-loop" assistance in terms of its core function (drug delivery accuracy, occlusion detection, etc.).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench performance testing of the infusion pump, the "ground truth" would be engineering specifications and metrology measurements. This isn't based on expert consensus, pathology, or outcomes data. It's about measuring physical phenomena (e.g., fluid volume delivered, time to alarm) against predefined design requirements.
8. The sample size for the training set
This information is not provided and is not applicable. This device is an infusion pump, which is a physical medical device, not a machine learning or AI algorithm that requires a "training set" of data in the conventional sense. Its function is based on mechanical and electronic engineering principles.
9. How the ground truth for the training set was established
This information is not provided and is not applicable as explained in point 8.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
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 (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) 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 & 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 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 – RemunitySystem (K191313) | Subject Device – ModifiedRemunity System | Equivalence |
|---|---|---|---|
| DeviceClassificationRegulation andProduct Code | 21 CFR 880.5725Product Code: QJY | 21 CFR 880.5725Product Code: QJY | No change |
| Class | II | II | No change |
| Indications forUse | 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 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). | No change |
| Prescription Useor Over theCounter (OTC) | Prescription | Prescription | No change |
| Characteristic | Predicate Device – RemunitySystem (K191313) | Subject Device – ModifiedRemunity System | Equivalence |
| Intended PatientPopulation | Age >22 years | Age >22 years | No change |
| PatientEnvironment | On-body wearable ambulatorypump | On-body wearable ambulatorypump | No change |
| Environment ofUse | In professional healthcarefacilities and home environments | In professional healthcarefacilities and home environments | No change |
| DeliveryMethod | Microprocessor controlled micro-dosing pump mechanismsupplemented with acousticvolume sensor (AVS) feedbackfor monitoring delivery accuracy | Microprocessor controlled micro-dosing pump mechanismsupplemented with acousticvolume sensor (AVS) feedbackfor monitoring delivery accuracy | 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, withincrements of 1 µL/hr | 16 µL/hr – 225 µL/hr, withincrements of 1 µL/hr | No change |
| Basal Accuracy | ±6% | ±6% | No change |
| Bolus Volumeafter OcclusionRelease | < 40 µL at all rates | < 40 µL at all rates | No change |
| Time toOcclusionAlarm | 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 |
| Pump ServiceLife | 3 years | 3 years | No change |
| IngressProtection | IP58 when connected to theCassette | IP58 when connected to theCassette | No change |
| 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 | • 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 | No change |
| Power Source | Rechargeable Lithium IonBattery | Rechargeable Lithium IonBattery | No change |
| Characteristic | Predicate Device - RemunitySystem (K191313) | Subject Device – ModifiedRemunity System | Equivalence |
| Pump StorageConditions | Temperature: -25 °C to 70 °C(-13 °F to 158 °F) | Temperature: -25 °C to 70 °C(-13 °F to 158 °F) | No change |
| Non-condensing Humidity: up to90% | Non-condensing Humidity: up to90% | ||
| Pressure: 50 kPa to 106 kPa | Pressure: 50 kPa to 106 kPa | ||
| OperatingConditions | Temperature: 5 °C to 40 °C(41 °F to 104 °F) | ||
| Non-condensing Humidity: up to90% | |||
| Pressure: 70 kPa to 106 kPa | |||
| RemoteInterface | |||
| System UserFeedback | Visual, audible, vibratory | Visual, audible, vibratory | |
| CommonAlarms | 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 | ||
| BatteryOperating Time | 72 hours | 72 hours | |
| Characteristic | Predicate Device - RemunitySystem (K191313) | Subject Device – ModifiedRemunity System | Equivalence |
| Infusion Set | Medtronic Quick-setInfusion Set [K991759] 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) | Medtronic Quick-setInfusion Set [K991759] 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) Neria Guard Infusion Set[K192647] 23" (704060-5226, 704060-5229) | 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 previousclearances. |
| CompatibleCassette | Remodulin Unity Cassettes, 3mL | Remodulin Unity Cassettes, 3mL | No change |
| Cassette FillingMethod | Specialty pharmacy User-filled | Specialty pharmacy User-filled | No change |
| Cassette ShelfLife (empty) | 2 years | 2 years | No change |
| Pharmacy-filledShelf-Life | 14 days (per <USP 797>) | 14 days (per <USP 797>) | No change |
| MaterialBiocompatibility | Cassette fluid path:Polycarbonate (PC), Bromobutyl,SEBS, polyurethanePump: ABS, PC, AluminumCartridge: PC, Acrylic, polyurethaneFilling Aid: PC-ABSCap (Pharmacy-fill): ABS | Cassette fluid path:Polycarbonate (PC),Bromobutyl, SEBS,polyurethanePump: ABS, PC, AluminumCartridge: PC, Acrylic,polyurethaneFilling Aid: PC-ABSCap (Pharmacy-fill): ABS | No change |
| Characteristic | Predicate Device – RemunitySystem (K191313) | Subject Device – ModifiedRemunity System | Equivalence |
| Pharmacy-fillEnd-userPackaging | 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 tray and sealed in foil pouch | No change |
| Priming Method | Manually primed by user before Cassette attachment to the Pump | Manually primed by user before Cassette attachment to the Pump | No change |
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Image /page/6/Picture/0 description: The image shows the word "DEKA" in a bold, stylized font. The letters are all capitalized and appear to be connected or very close together. The overall design is modern and geometric, with a strong emphasis on the shapes of the letters.
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Image /page/8/Picture/0 description: The image shows the word "DEKA" in a bold, stylized font. The letters are all capitalized and appear to be interconnected or very close together. The color of the letters is black, and the background is white, creating a high contrast. The font has a modern, almost futuristic look due to its rounded edges and geometric shapes.
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Image /page/9/Picture/0 description: The image shows the word "DEKA" in a bold, stylized font. The letters are all capitalized and appear to be connected or very close together. The color of the letters is black, and the background is white, creating a high contrast. The font style is modern and geometric, with rounded corners and straight lines.
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.
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 subject Remunity System is substantially equivalent to the predicate Remunity System, cleared under premarket application K191313, cleared on February 21, 2020. The differences 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 nonclinical testing and risk management activities.
§ 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).