(29 days)
No
The summary describes a standard infusion pump with a micro-dosing mechanism and acoustic sensor feedback. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" and "Description of the training set, sample size, data source, and annotation protocol" sections are explicitly marked as "Not Found".
Yes.
The device is a wearable infusion pump designed to deliver Remodulin® for the treatment of pulmonary arterial hypertension (PAH), directly addressing a medical condition.
No
Explanation: The device is described as a wearable infusion pump designed to deliver medication (Remodulin) continuously for the treatment of pulmonary arterial hypertension (PAH). Its function is to administer therapy, not to diagnose a condition.
No
The device description explicitly lists multiple hardware components including a wearable pump assembly, remote interface, filling and priming aid, accessories (batteries, charger, cables, 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, not for the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description clearly outlines a wearable infusion pump designed to deliver medication subcutaneously. It describes the mechanical components and how it functions to administer the drug.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the Remunity® Pump for Remodulin® (treprosimil) Injection is a drug delivery device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Remunity® Pump for Remodulin® (treprosinil) Injection (the Remunity System) is intended for continuous subcutaneous delivery of Remodulin (treprostinil) Injection for use in adults (greater than 22 years old).
Product codes (comma separated list FDA assigned to the subject device)
OJY
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 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.
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
adults (greater than 22 years old)
Intended User / Care Setting
In professional healthcare facilities and home environments
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K991759, K162812, K042172, K192647
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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 & Development
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 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 – Remunity
System (K191313) | Subject Device – Modified
Remunity System | Equivalence |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Classification
Regulation and
Product Code | 21 CFR 880.5725
Product Code: QJY | 21 CFR 880.5725
Product Code: QJY | No change |
| Class | II | II | No change |
| 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). | 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). | No change |
| Prescription Use
or Over the
Counter (OTC) | Prescription | Prescription | No change |
| Characteristic | Predicate Device – Remunity
System (K191313) | Subject Device – Modified
Remunity System | Equivalence |
| Intended Patient
Population | Age >22 years | Age >22 years | No change |
| Patient
Environment | On-body wearable ambulatory
pump | On-body wearable ambulatory
pump | No change |
| Environment of
Use | In professional healthcare
facilities and home environments | In professional healthcare
facilities and home environments | No change |
| 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 | 16 µL/hr – 225 µL/hr, with
increments of 1 µL/hr | No change |
| Basal Accuracy | ±6% | ±6% | No change |
| Bolus Volume
after Occlusion
Release | ) | 14 days (per ) | No change |
| Material
Biocompatibility | Cassette fluid path:
Polycarbonate (PC), Bromobutyl,
SEBS, polyurethane
Pump: ABS, PC, Aluminum
Cartridge: PC, Acrylic, polyurethane
Filling Aid: PC-ABS
Cap (Pharmacy-fill): ABS | Cassette fluid path:
Polycarbonate (PC),
Bromobutyl, SEBS,
polyurethane
Pump: ABS, PC, Aluminum
Cartridge: PC, Acrylic,
polyurethane
Filling Aid: PC-ABS
Cap (Pharmacy-fill): ABS | No change |
| Characteristic | Predicate Device – Remunity
System (K191313) | Subject Device – Modified
Remunity System | Equivalence |
| Pharmacy-fill
End-user
Packaging | 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/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.