(213 days)
No
The summary describes a standard infusion pump with feedback mechanisms and software for control, but there is no mention of AI or ML algorithms for decision-making, pattern recognition, or adaptive learning. The performance studies focus on traditional device metrics and regulatory compliance.
Yes
The device is an infusion pump designed to deliver medication (Remodulin®) to patients for the treatment of pulmonary arterial hypertension, which directly impacts a patient's health by providing continuous therapeutic delivery.
No
The device is an infusion pump designed to deliver medication (Remodulin) for the treatment of pulmonary arterial hypertension, not to diagnose a condition.
No
The device description clearly outlines multiple hardware components including a wearable pump assembly, remote interface, batteries, charger, and a disposable cassette with a drug reservoir. It is an infusion pump system, not solely software.
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 continuous subcutaneous delivery of a drug (Remodulin) to a patient. This is a therapeutic delivery system, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a wearable infusion pump designed to deliver medication. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition.
- Lack of IVD Characteristics: The description and performance studies focus on aspects relevant to drug delivery, such as delivery accuracy, occlusion performance, battery life, and software/cybersecurity for a medical device. There is no mention of analytes, reagents, or diagnostic measurements.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to administer a treatment, not to perform a diagnostic test.
N/A
Intended Use / 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.
Product codes
FRN
Device Description
The Remunity 2.0 System 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 Remunity 2.0 System is prescription use only.
The pump assembly is composed of a durable pump and a disposable, single-use cassette with a user-filled 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
Indicated Patient Age Range
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
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.
Device Performance: The following functional areas were evaluated: Delivery accuracy Occlusion performance Fault Insertion Drug stability and particulate Incidental delivery performance Remodulin exposure Battery performance Durability Shipping and Storage
Software and Cybersecurity: The subject device is considered to require an “Enhanced Documentation Level” per the 2023 FDA guidance document.
Software and Cybersecurity testing was conducted per ANSI AAMI IEC 62304:2006/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 Cybersecurity in Medical Devices, issued September 27, 2023
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, issued April 8, 2020
Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act, issued March 30, 2023
Human Factors: The human factors validation 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, AIM 7351731
Alarms: Per IEC 60601-1-8:2020
No animal study or clinical trial data was obtained in support of this premarket submission.
Key Metrics
Basal Accuracy: +6%
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).
0
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January 16, 2025
DEKA Research and Development Corp. Paul Smolenski Regulatory Affairs 340 Commercial Street Manchester, New Hampshire 03101
Re: K241736
Trade/Device Name: Remunity® 2.0 Pump for Remodulin® (treprostinil) Injection Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN Dated: December 18, 2024 Received: December 18, 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"
1
2
(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) K241736
Device Name
Remunity® 2.0 Pump for Remodulin® (treprostinil) Injection
Indications for Use (Describe)
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.
| 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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K241736 510(k) Summary
This 510(k) Summary is prepared in accordance with the requirements of 21 CFR Part 807.92.
Submitter Information
| 510(k) Sponsor | DEKA Research and 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 January 10, 2025
Proposed Device
| Common/Usual Name: | Infusion Pump |
|---|---|
| Trade/Proprietary Name: | Remunity® 2.0 Pump for Remodulin® (treprostinil) Injection |
| Classification Name: | Infusion pump |
| Device Classification: | 880.5725 |
| Product Code: | FRN |
| Class: | II |
| Device Panel: | General Hospital |
Predicate Device
Unity Subcutaneous Delivery System for Remodulin®, K190182
The predicate device has not been subject to a design-related recall.
Reference Devices
The cassette and pump hardware of the subject system are identical to those of the reference device, the DEKA ACE Pump System cleared on March 13, 2024 under K233952.
5
The remote interface hardware of the subject system is identical to that of the reference device, the Remunity System which was previously cleared under premarket application K240256 on June 12, 2024.
Device Description
The Remunity 2.0 System 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 Remunity 2.0 System is prescription use only.
The pump assembly is composed of a durable pump and a disposable, single-use cassette with a user-filled 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.
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.
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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
(K190182) | 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 Unity
Subcutaneous Delivery
System for
Remodulin® (the Unity
System) is intended for
continuous
subcutaneous delivery
of Remodulin
(treprostinil) injection
for use in adults
(greater than 22 years
of age). | 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. | Equivalent
Both devices are labeled
specifically for use with
Remodulin. The subject system
has a widened indicated patient
population age range in order to
align with the indications for
Remodulin. |
| Prescription
Use or Over the
Counter (OTC) | Prescription | Prescription | No change |
| Intended
Patient
Population | Greater than 22 years
of age | Age 17 years and older | Equivalent
The subject system has a
widened indicated patient
population age range, in
alignment with the Remodulin
indications. |
| Patient
Environment | On-body wearable
ambulatory pump | On-body wearable
ambulatory pump | No change |
The intended use remains unchanged in the subject device with respect to the predicate device (K190182). The indications for use have been updated expand the indicated patient population, in alignment with Remodulin drug labeling. This update has been verified through bench performance testing and validated through human factors testing.
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Technological Characteristic Comparison
The table below compares the updates made to the subject device as compared to the predicate device and includes an assessment of these updates in the context of safety and effectiveness.
| Characteristic | Predicate Device
(K190182) | 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 | 16 µL/hr – 225 µL/hr,
with increments of 1
µL/hr | 8 µL/hr – 225 µL/hr, with
increments of 1 µL/hr | Equivalent
The basal delivery rate
range for the subject
system is wider than
that of the predicate,
but remains in
alignment with the
Remodulin prescribing
information.
Bench testing,
including delivery
accuracy and occlusion
detection, demonstrates
equivalent performance
for the expanded flow
rate range. No
additional risks. |
| Basal Accuracy | +6% | +6% | No change |
| Characteristic | Predicate Device
(K190182) | Subject Device | Equivalence |
| Bolus Volume
after Occlusion
Release |