(106 days)
No reference devices are used in this submission.
No
The document does not mention AI, ML, or related terms, and the device description focuses on mechanical and sensor-based delivery mechanisms.
Yes
This device is a wearable infusion pump designed to deliver Remodulin (treprostinil) for the treatment of pulmonary arterial hypertension (PAH), directly addressing a medical condition.
No
Explanation: The device is an infusion pump designed for continuous subcutaneous delivery of medication (Remodulin®), not for diagnosing a medical condition. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly lists multiple hardware components including a wearable pump assembly, remote interface, filling and priming aid, accessories (rechargeable batteries, battery charger, charging cable, power adapter), and a disposable single-use cassette.
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 function, not a diagnostic one.
- Device Description: The device is described as a wearable infusion pump designed to deliver medication. This aligns with a therapeutic device, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information.
Therefore, the Remunity Subcutaneous Infusion System is a therapeutic medical device, specifically an infusion pump, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Remunity Subcutaneous Infusion System (the Remunity System) is intended for continuous subcutaneous delivery of Remodulin® (treprostinil) Injection for use in adults (greater than 22 years of age).
Product codes (comma separated list FDA assigned to the subject device)
QJY
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 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 pharmacy-filled cassette is intended to be stored (inclusive of shipping time) up to 14-days and is intended to be in use for up to 72-hours. The cassettes are identical to those cleared under K191313, with the exception that the luer lock cap material was changed from Polycarbonate to ABS.
The device is prescription use only.
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 of age)
Intended User / Care Setting
In professional healthcare facility and home healthcare 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)
Non-Clinical/ Performance Testing:
The safety assurance case provided for the Remunity Subcutaneous Delivery System for Remodulin® as recommended in the FDA guidance document, "Infusion Pumps Total Product Life Cycle" and cleared under premarket notification K191313 applies to the subject device in all aspects.
The stated goal of the safety assurance case ("safety case") is: "The Remunity Subcutaneous Infusion System for Remodulin® is adequately safe for its intended use."
The assurance case defined the device system, including the indications for use, system definition, operational description, patient populations, and use environments. The assurance case was updated to reflect the new luer lock cap material and continues to cover all system attributes that were stated for the predicate:
- All hazards associated with the system have been identified and adequately addressed
- . Device reliability is adequate
- The device design requirements are adequately verified and validated ●
The arguments specific to the luer lock cap material change were updated from that of the predicate K191313. Since the assurance case builds on the original case, only evidence used to provide assurance related to the changes are listed here:
Container Closure performance: Performance of the device to maintain adequate assurance of protection from microbial ingress was evaluated through container closure testing.
Biocompatibility: The materials used for the Remunity System comply with biocompatibility requirements outlined in ISO 10993-1:2009 and the "Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process" and are considered to be biocompatible.
Clinical Study:
No clinical data was obtained in support of this premarket submission.
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.
Unity Subcutaneous Delivery System for Remodulin K191313.
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.
No reference devices are used in this submission.
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
December 30, 2020
DEKA Research and Development Paul Smolenski Regulatory Affairs 340 Commercial Street Manchester, New Hampshire 03101
Re: K202690
Trade/Device Name: Remunity Subcutaneous Delivery System for Remodulin Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: QJY Dated: December 4, 2020 Received: December 4, 2020
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 (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 located 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.
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely.
For CAPT. Alan Stevens Acting 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
2
Indications for Use
510(k) Number (if known) K202690
Device Name
Remunity Subcutaneous Delivery System for Remodulin®
Indications for Use (Describe)
The Remunity Subcutaneous Infusion System (the Remunity System) is intended for continuous subcutaneous delivery of Remodulin® (treprostinil) Injection for use in adults (greater than 22 years of age).
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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510(k) Summary - K202690
Submitter Information
| 510(k) Sponsor: | DEKA Research & Development
340 Commercial Street
Manchester, NH 03101 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Paul Smolenski
Regulatory Affairs
DEKA Research & Development Corporation
Phone: (603) 669-5139
Fax: (603) 624-0573
psmolenski@dekaresearch.com |
| Date Prepared: | December 18, 2020 |
Proposed Device
| Common/Usual Name: | Infusion Pump |
|---|---|
| Trade/Proprietary Name: | Remunity Subcutaneous Delivery System for |
| Remodulin® | |
| Classification Name: | Infusion Pump |
| Device Classification: | 880.5725 |
| Product Code: | QJY, Infusion pump, drug specific, pharmacy-filled |
| Class | II |
| Device Panel: | General Hospital |
Predicate Device
Unity Subcutaneous Delivery System for Remodulin K191313.
No reference devices are used in this submission.
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.
4
The pump assembly is composed of a reusable pump and a disposable single-use cassette with a pharmacy-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 pharmacy-filled cassette is intended to be stored (inclusive of shipping time) up to 14-days and is intended to be in use for up to 72-hours. The cassettes are identical to those cleared under K191313, with the exception that the luer lock cap material was changed from Polycarbonate to ABS.
The device is prescription use only.
Indications for Use
The Remunity Subcutaneous Infusion System (the Remunity System) is intended for continuous subcutaneous delivery of Remodulin® (treprostinil) Injection for use in adults (greater than 22 years of age).
Substantial Equivalence Discussion
Intended Use Comparison
The table below includes a summation matrix of the intended use between the new device and those of the current device:
| Characteristic | Unity Subcutaneous Deliver
System for Remodulin®
K191313 | Proposed
Remunity Subcutaneous Deliver
System for Remodulin® |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| 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). | Same Indications for Use. Branding
has been updated from "Unity" to
"Remunity". |
| Prescription Only
or Over the Counter | Prescription Only | No Change |
| Intended Population | Adults (>22 years of age) | No Change |
| Environment of Use | In professional healthcare
facility and home healthcare
environments | No Change |
Discussions of differences in Indications for Use statement
5
The indications for use for the subject device is the same as the device cleared under K191313. The branding of the device has been updated from "Unity" to "Remunity".
Discussions of differences in intended population
The intended population for the subject device is identical to the predicate device cleared under K191313.
The Remunity system is indicated for adults (greater than 22 years of age)
Discussions of differences in environment of use
The environment of use for the subject device is identical to the predicate device cleared under K191313.
Comparison of Technological Characteristics with the Predicate Device
The below table compares the characteristics of the subject device to the Unity System cleared under K191313 and includes an assessment of differences between them and why the differences between the subject device and predicate device do not introduce new or different questions of safety and effectiveness.
| Characteristic | Predicate Device
Unity Subcutaneous
Deliver System for
Remodulin®
K191313 | Subject Device
Remunity
Subcutaneous Deliver
System for
Remodulin® | Discussion of
Differences |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mechanism of
action | Microprocessor controlled
Micro- dosing pump
mechanism supplemented
with acoustic volume sensor
(AVS) feedback for
monitoring delivery
accuracy. | Same | N/A |
| Infusion
Accuracy | $\pm$ 6% | Same | N/A |
| Maximum
Infusion pressure |