(32 days)
No
The document describes a standard infusion pump with a micro-dosing mechanism and acoustic volume sensor feedback. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
Yes
The device is designed to deliver a specific drug (Remodulin) to a patient for the treatment of pulmonary arterial hypertension (PAH), which is an intervention aimed at improving a health condition.
No
This device is described as a wearable infusion pump designed to deliver medication (Remodulin®) for the treatment of pulmonary arterial hypertension (PAH). Its function is drug delivery, not diagnosis.
No
The device description explicitly lists multiple hardware components including a wearable pump assembly, remote interface, rechargeable batteries, battery charger, charging cable, power adapter, and a disposable cassette with a drug reservoir.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of a drug (Remodulin) to a patient. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as an infusion pump that delivers medication subcutaneously. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The device is a drug delivery system, which falls under a different regulatory category than IVDs.
N/A
Intended Use / 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.
Product codes
FRN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
ages 17 and older.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K991759, K162812, K042172, K192647
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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
3
Indications for Use
510(k) Number (if known) K250357
Device Name
RemunityPRO™ Pump for Remodulin® (treprostinil) Injection
Indications for Use (Describe)
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.
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 Street
Manchester, NH 03101 |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person(s) | Paul Smolenski (primary), Lauren Blake (secondary)
Regulatory Affairs
Phone: (603) 669-5139
Fax: (603) 624-0573
psmolenski@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
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.
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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 |
|---|---|---|---|
| Device | |||
| Classification | |||
| Regulation and | |||
| Product Code | Class II Infusion Pump | ||
| 21 CFR 880.5725 | |||
| Product Code: FRN | Class II Infusion Pump | ||
| 21 CFR 880.5725 | |||
| Product Code: FRN | No change | ||
| Indications for | |||
| Use | The Remunity® 2.0 Pump for | ||
| Remodulin® (treprostinil) | |||
| Injection (the Remunity 2.0 | |||
| System) is intended for | |||
| continuous subcutaneous | |||
| delivery of Remodulin | |||
| (treprostinil) Injection for use in | |||
| patients, ages 17 and older. | 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. | No change | ||
| Prescription Use | |||
| or Over the | |||
| Counter (OTC) | Prescription | Prescription | No change |
| Intended Patient | |||
| Population | Age 17 years and older | Age 17 years and older | No change |
| Patient | |||
| Environment | On-body wearable ambulatory | ||
| pump | On-body wearable ambulatory | ||
| pump | No change | ||
| Characteristic | Predicate Device (K241736) | Subject Device | Equivalence |
| Delivery Method | Microprocessor controlled | ||
| micro-dosing pump mechanism | |||
| supplemented with acoustic | |||
| volume sensor (AVS) feedback | |||
| for monitoring delivery accuracy | Microprocessor controlled | ||
| micro-dosing pump mechanism | |||
| supplemented with acoustic | |||
| volume sensor (AVS) feedback | |||
| for 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 Delivery | |||
| Rate Range | 8 µL/hr – 225 µL/hr, with | ||
| increments of 1 µL/hr | 8 µL/hr – 225 µL/hr, with | ||
| increments of 1 µL/hr | No change | ||
| Basal Accuracy | ±6% | ±6% | No change |
| Bolus Volume | |||
| after Occlusion | |||
| Release |