(32 days)
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.
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.
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: |
§ 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).