(94 days)
No reference devices are used in this submission.
No
The document describes a standard infusion pump with sensor feedback and programmable rates, but there is no mention of AI or ML algorithms for decision-making, data analysis, or adaptive control.
Yes
Explanation: The device is designed to deliver a drug (Remodulin) to treat a medical condition (pulmonary arterial hypertension), which directly contributes to therapy.
No
The device is described as an infusion pump, designed to deliver medication, not to diagnose a condition.
No
The device description explicitly states that the Unity System consists of several hardware components, including a wearable pump assembly, a remote interface, a filling and priming aid, and accessories. It also mentions a micro-dosing pump mechanism and an acoustic volume sensor. This indicates it is a hardware device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Unity System Function: The Unity Subcutaneous Delivery System is an infusion pump designed to deliver a drug (Remodulin) into the patient's body (subcutaneously). It is a therapeutic device, not a diagnostic one.
The provided information clearly describes a drug delivery system, not a device used for testing biological samples.
N/A
Intended Use / 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).
Product codes
FRN
Device Description
The Unity Subcutaneous Delivery System for Remodulin® (Unity 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® (treprostimil) (hereinafter referred to as 'Remodulin (treprostinily), NDA 021272. The Unity System consists of several components: a wearable pump assembly, a remote interface, a filling and priming aid, and accessories (e.g., rechargeable batteries, battery 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 Unity System to the patient.
The pump assembly is composed of a reusable pump and a disposable single-use cassette with a 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 Unity System utilizes a micro-dosing pump mechanism supplemented with acoustic volume sensor feedback to ensure delivery accuracy.
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
subcutaneous
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)
Clinical Testing
Study Type: Performance Assessment of The Unity Infusion System with 0.9% Sodium Chloride Injection in Healthy Volunteers
Sample Size: All participants were healthy subjects between 18 and 55 years of age, inclusive, at the time of informed consent.
Key Results:
- Pump Performance: The study successfully demonstrated that the majority of measured data fell within the accuracy specification. There were brief intervals (less than six how rate measured was outside the performance specification limit for under delivery (-6%). Each of these intervals were within the measurement uncertainty of the measure equipment used in the study or associated with the delivery of air bubbles, and all were within 25%. The study found no evidence of environmental noise or other elements of daily use interfered with the ability of the Unity System to deliver accurately.
- Safety: No safety concerns related to use of the Unity System were identified during this study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Infusion Accuracy: ±6%
- Maximum Infusion pressure:
§ 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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May 6, 2019 DEKA Research & Development Brian Carney Project Regulatory Affairs Manager 340 Commercial Street Manchester, New Hampshire 03101
Re: K190182
Trade/Device Name: Unity Subcutaneous Delivery System for Remodulin Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: FRN Dated: January 31, 2019 Received: February 1, 2019
Dear Brian Carney:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Tina Kiang, Ph.D 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) K190182
Device Name
Unity Subcutaneous Delivery System for Remodulin®
Indications for Use (Describe)
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).
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 - K190182
Submitter Information
| 510(k) Sponsor: | DEKA Research & Development
340 Commercial Street
Manchester, NH 03101 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Brian Carney
Project Regulatory Affairs Manager
DEKA Research & Development Corporation
Phone: (603) 669-5139
Fax: (603) 624-0573
bcarney@dekaresearch.com |
| Date Prepared: | May 3, 2019 |
Proposed Device
| Common/Usual Name: | Infusion Pump |
|---|---|
| Trade/Proprietary Name: | Unity Subcutaneous Delivery System for Remodulin® |
| Classification Name: | Infusion Pump |
| Device Classification: | 880.5725 |
| Product Code: | FRN |
| Class | II |
| Device Panel: | General Hospital Devices Branch |
Predicate Device
CADD-MS3 Ambulatory Infusion Pump (Smiths Medical) K051568. No reference devices are used in this submission.
Device Description
The Unity Subcutaneous Delivery System for Remodulin® (Unity 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® (treprostimil) (hereinafter referred to as 'Remodulin (treprostinily), NDA 021272. The Unity System consists of several components: a wearable pump assembly, a remote interface, a filling and priming aid, and accessories (e.g., rechargeable batteries, battery 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 Unity System to the patient.
The pump assembly is composed of a reusable pump and a disposable single-use cassette with a 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 Unity System utilizes a micro-dosing pump mechanism supplemented with acoustic volume sensor feedback to ensure delivery accuracy.
The device is prescription use only.
4
Indications for Use
The Unity Subcutaneous Infusion System (the Unity 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 comparison of the intended use between the new device and those of the predicate device:
| Characteristic | Predicate
CADD-MS 3 Ambulatory
Infusion Pump
K051568 | Proposed
Unity Subcutaneous Deliver System
for Remodulin®
K190182 | |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The CADD-MS 3 Ambulatory
Infusion Pump is designed for
subcutaneous, intravenous, epidural
and intrathecal infusion of
medication. The Smiths Medical
MD, Inc, 3-ml Cartridge Reservoir
is designed for use with the CADD-
MS 3 for delivering medication | 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). | |
| Prescription Only or
Over the Counter | Prescription Only | Prescription Only | |
| Intended Population | Not Specified | Adults (>22 years of age) | |
| Environment of Use | In hospital or out-patient settings | In professional healthcare facility
and home healthcare environments | |
| Characteristic | Predicate Device
K051568 | Subject Device
K190182 | Discussion of Differences |
| Mechanism of
action | Microprocessor based
electronic syringe pump | Microprocessor controlled
Micro- dosing pump
mechanism supplemented
with acoustic volume sensor
(AVS) feedback for
monitoring delivery accuracy. | AVS technology provides
accuracy confirmation of the
volume of fluid delivered. This
was supported with clinical and
non-clinical testing. |
| Infusion
Accuracy | ±3% (nominal). | ±6% | Compliant with Remodulin
USPI an infusion accuracy of
±6% satisfies the Remodulin
delivery accuracy requirement
for administration by
subcutaneous injection |
| Maximum
Infusion pressure | 23 psi (159 kPa) | :2016 Particulate Matter in Injections |
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Clinical Testing
A clinical study was conducted to support the substantial equivalence of the device and to clinically validate the Acoustic Volume Sensor (AVS) design. The Performance Assessment of The Unity Infusion System with 0.9% Sodium Chloride Injection in Healthy Volunteers study was conducted to establish evidence that the AVS measurement process consistently produces results within an acceptable, predetermined measurement uncertainty. All participants were healthy subjects between 18 and 55 years of age, inclusive, at the time of informed consent.
Objective
The objective of this study was to assess the performance of the Unity System to deliver 0.9% sodium chloride (normal saline [NS]) by subcutaneous (SC) infusion to healthy volunteers by assessing the following:
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- In vivo infusion delivery accuracy assessed by measured volumetric flow rate compared to programmed flow rate of the Unity System to demonstrate environmental noise of other elements of daily use interfered with the ability of the Unity System to deliver accurately when participants were challenged to loud sound exposures.
- . In vivo the Unity System reliability assessed by device history logs (flow rate, malfunctions, etc.) and subject diaries (environmental exposures)
Criteria for Evaluation
Pump Performance: In vivo infusion delivery accuracy was assessed by measured volumetric flow rate compared to programmed flow rate of the Unity System. In vivo Unity System reliability was assessed by device history logs (flow rate, malfunction, complications, etc.) and subject diaries (environmental exposures).
Safety: Per protocol, all adverse events (AEs), serious adverse events (SAEs), and unanticipated adverse device effects (UADEs) were to be documented from Baseline until the subject was either discontinued from the study or all End of Infusion study assessments were complete. All AEs associated with a device complication were to be investigated.
Conclusions
Pump Performance: The study successfully demonstrated that the majority of measured data fell within the accuracy specification. There were brief intervals (less than six how rate measured was outside the performance specification limit for under delivery (-6%). Each of these intervals were within the measurement uncertainty of the measure equipment used in the study or associated with the delivery of air bubbles, and all were within 25%. The study found no evidence of environmental noise or other elements of daily use interfered with the ability of the Unity System to deliver accurately.
Safety: No safety concerns related to use of the Unity System were identified during this study.
Conclusion
Differences between the intended use and technological characteristics of the subject device compared to the predicate do not raise different questions of safety and effectiveness. The device is supported by non-clinical testing, clinical testing, and risk management activities. The Unity Subcutaneous Delivery System for Remodulin is Substantially Equivalent (SE) to the CADD-MS 3 Ambulatory Infusion Pump, cleared under K051568.