← Product Code [QJY](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QJY) · K191313
# Unity Subcutaneous Infusion System for Remodulin (K191313)
_DEKA Research & Development · QJY · Feb 21, 2020 · General Hospital · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QJY/K191313
## Device Facts
- **Applicant:** DEKA Research & Development
- **Product Code:** [QJY](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QJY.md)
- **Decision Date:** Feb 21, 2020
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5725
- **Device Class:** Class 2
- **Review Panel:** General Hospital
- **Attributes:** Therapeutic
## 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).
## Device Story
Wearable infusion pump for continuous subcutaneous delivery of Remodulin (treprostinil) to treat pulmonary arterial hypertension (PAH). System comprises reusable pump, disposable cassette reservoir, remote interface, and accessories. Specialty pharmacy aseptically fills cassettes; patient uses pump to deliver drug at programmed rates. Pump utilizes micro-dosing mechanism with acoustic volume sensor (AVS) feedback for delivery accuracy. Used in home and professional healthcare environments. Healthcare provider programs pump; patient wears device. Output includes drug delivery and various system alerts (e.g., occlusion, battery, cassette status). Benefits include automated, accurate, continuous drug administration, reducing manual intervention and improving patient convenience via pharmacy-filled cassettes.
## Clinical Evidence
No clinical data. Evidence consists of non-clinical performance testing, including safety assurance case, drug stability studies, container closure integrity, antimicrobial effectiveness, human factors evaluation, and biocompatibility testing per ISO 10993-1.
## Technological Characteristics
Microprocessor-controlled micro-dosing pump; acoustic volume sensor (AVS) feedback. Materials: Polycarbonate, Bromobutyl, SEBS, polyurethane, ABS, Aluminum, Acrylic. Dimensions: 6cm x 6cm x 2cm; Weight: 50g. Power: Rechargeable Li-Ion battery. Connectivity: Remote interface. Ingress protection: IP58. Sterilization: Radiation (ISO 11137-1).
## Regulatory 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.
## Predicate Devices
- Unity Subcutaneous Delivery System for Remodulin ([K190182](/device/K190182.md))
## Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
DEKA Research & Development Jason Demers Project Manager 340 Commercial Street Manchester, New Hampshire 03101
Re: K191313
Trade/Device Name: Unity Subcutaneous Infusion System for Remodulin Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: QJY Dated: May 14, 2019 Received: May 15, 2019
### Dear Jason Demers:
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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 Nikhil Thakur 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) K191313
Device Name
Unity Subcutaneous Delivery System for Remodulin®
Indications for Use (Describe)
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).
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 - K191313
#### Submitter Information
| 510(k) Sponsor: | DEKA Research & Development
340 Commercial Street
Manchester, NH 03101 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jason Demers
Program Manager
DEKA Research & Development Corporation
Phone: (603) 669-5139
Fax: (603) 624-0573
jdemers@dekaresearch.com |
| Date Prepared: | February 21, 2020 |
#### 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: | QJY, infusion pump, drug specific, pharmacy-filled |
| Class: | II |
| Device Panel: | General Hospital |
### Predicate Device
Unity Subcutaneous Delivery System for Remodulin® K190182. 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® (treprostinil) (hereinafter referred to as 'Remodulin' or 'Remodulin (treprostinil)'). 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 subcutaneous 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 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.
Cassettes are identical to those cleared under K190182, with the specialty pharmacy will take the cassettes out of their sterile packaging, cap the cassette and aseptically fill the cassette reservoir through the cassette filling septum following USP 797 Compounding Sterile Preparations. The specialty pharmacy will then package
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these filled cassettes and ship to the intended end user under controlled conditions outlined in the labeling. The pharmacyfilled cassette is intended to be stored (inclusive of shipping item) up to 14-days and is intended to be in use for up to 72hours.
The device is prescription use only.
## 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
Unity Subcutaneous Delivery
System for Remodulin®
K190182 | Proposed
Unity Subcutaneous Delivery System
for Remodulin®
K191313 |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| 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). | No Change |
| 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
The indications for use statement for the subject device is identical to the predicate device cleared under K190182.
### Discussions of differences in intended population
The intended population is for the subject device is identical to the predicate device cleared under K190182.
The Unity 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 K190182.
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## Comparison of Technological Characteristics with the Predicate Device
Table 1 compares the characteristics of the predicate device to the proposed device and includes an assessment of differences between them and why the difference between the subject device and predicate device do not introduce new or different questions of safety and effectiveness.
| Characteristic | Predicate
Unity Subcutaneous
Delivery System for
Remodulin®
K190182 | Proposed
Unity Subcutaneous
Delivery 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 | ±6% | Same | N/A |
| Maximum Infusion
pressure | <16.4 psi (<113 kPa) | Same | N/A |
| Programmable
Flow rate ranges | 16 µl/hr to 225 µl/hr with
increments of 1 µl/hr | Same | N/A |
| Time to occlusion
alarm | Maximum time to occlusion
alarm:
<12 min. at rates ≥ 100 µl/hr
within 8 hr, at rates < 100
µl/hr | Same | N/A |
| Post-occlusion
bolus | <40 µl at all rates. | Same | N/A |
| Characteristic | Predicate
Unity Subcutaneous
Delivery System for
Remodulin®
K190182 | Proposed
Unity Subcutaneous
Delivery System for
Remodulin® | Discussion of Differences |
| Alarms & Alerts | • Battery depleted
• Battery Low (pump)
• Battery Low (remote)
• Cassette Depleted
• Cassette Problem
• Cassette Removed
• Depletes Soon
• Pump Error
• Pump Failure
• Occlusion
• Delivery Stopped
• Basal Not Started
• Idle
• Software Version Error
• Tech
• Excessive Noise
• No Communication
• Message Timeout
• Pairing Failed
Walkaway | Same | N/A |
| Device Service
Life | 3 years | Same | N/A |
| Dimensions &
Weight | 6 cm x 6 cm x 2 cm
(2.4 in x 2.4 in x 0.4 in)
50 g (1.76 oz) | Same | N/A |
| Materials | Cassette fluid path:
Polycarbonate, Bromobutyl,
SEBS, polyurethane
Pump: ABS, Polycarbonate,
Aluminum
Cartridge: Polycarbonate,
Acrylic, polyurethane
Filling Aid: PC-ABS | Additional Materials include:
Cap: Polycarbonate | The new component utilized
the same materials used in the
predicate and did not introduce
new biocompatibility issues.
Performance was evaluated to
be substantially equivalent. |
| Characteristic | Predicate
Unity Subcutaneous
Delivery System for
Remodulin®
K190182 | Proposed
Unity Subcutaneous
Delivery System for
Remodulin® | Discussion of Differences |
| Environment of
Use | In professional healthcare
facility and home
healthcare environments | Same | N/A |
| Ingress protection | IP58 when connected to the
reservoir | Same | N/A |
| Power source | Rechargeable Lithium-Ion
Battery | Same | N/A |
| Storage Conditions | Temperature:
-13°F to 158°F (-25°C to
70°C)
Non-condensing humidity:
up to 90%.
Pressure: 500 hPa to 1060 hPa | Same | N/A |
| Operating
Conditions | Temperature:
41°F to 104°F (5°C to 40°C)
Non-condensing humidity:
up to 90%
Pressure: 700 hPa to 1060 hPa | Same | N/A |
| Remote user
feedback | Audible, vibratory | Same | N/A |
| Administration Set | Medtronic Quick-set Infusion
Set Medtronic Silhouette and
Infusion Set Smiths Medical
Cleo 90 Infusion Set | Same | N/A |
| Cassette | Remodulin Unity cassettes, 3
ml, User filled | Remodulin Unity cassettes, 3
ml, Specialty Pharmacy filled | Cassettes are filled by
Specialty Pharmacist and are
appropriate for the design of
the infusion pump. |
| Expiration –
Cassette | User Fill, 6 Months from date
of manufacture | Pharmacy-Fill, 14 Days | The differences in cassette
expiration were evaluated
through container closure
integrity, antimicrobial
effectiveness and stability
testing. |
| Characteristic | Predicate
Unity Subcutaneous
Delivery System for
Remodulin®
K190182 | Proposed
Unity Subcutaneous
Delivery System for
Remodulin® | Discussion of Differences |
| End User
Packaging - | Unfilled cassette without luer
lock fluid path closure, placed
in vacuum formed tray with
Tyvek lid and then Gamma
sterilized | Aseptically filled cassette with
female luer lock fluid path
closure, placed in plastic
clamshell tray and sealed in
foil pouch | The predicate device provides
a terminally sterilized unfilled
cassette inside the sterile
barrier provided by the
vacuum formed tray and
Tyvek lid. The pharmacy-
filled cassette provides a
closed fluid pathway that was
terminally sterilized prior to
being aseptically filled and
repackaged. The differences
in packaging were evaluated
through performance, sterility,
container closure integrity and |
### Table 1. Comparison of Predicate and Proposed Devices
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# Non-Clinical/ Performance Testing:
The following performance data/non-clinical testing was provided in support of the substantial equivalence determination for the Unity System.
A safety assurance case was provided for the Unity Subcutaneous Delivery System for Remodulin, as recommended in the FDA guidance document, Infusion Pumps Total Product Life Cycle.
The stated goal of the safety assurance case is: "The Unity Remodulin Subcutaneous Infusion System 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 context for the assurance case was updated to reflect the new use scenario of pharmacy filled cassettes. The supporting assurance arguments covered the following attributes:
- . 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 were updated from the original assurance case presented in predicate, K190182, to reflect new hazards and requirements associated with the changes.
The following specific evidence was included within the assurance case to demonstrate that the subject device is verified and validated for its intended use and to demonstrate substantial equivalence to the predicate devices.
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Since the assurance case builds on the original case, only evidence used to provide assurance related to the changes is listed here:
| Accessory
compatibility | Verification of the pump essential performance was completed with labeled administration sets |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device performance | The essential performance requirements of the device were verified through performance testing in accordance with the intended use of the device and in accordance with the FDA Guidance "Infusion Pumps Total Product Life Cycle" Performance of the device to maintain adequate assurance of drug stability, and protection from microbial ingress was evaluated through drug stability studies, container closure integrity and antimicrobial effectiveness testing. The testing was done to represent 14 days + 72 hours of in-use at a minimum. |
| Human Factors | Human factors evaluation per the FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016). |
| Reprocessing,
Cleaning, Sterility | ISO 11137-1:2006 + A1:2013 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11607-1:2006 + A1:2014 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems Validation per the FDA Guidance for Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (March 17, 2015) confirmed cleaning and disinfection instruction provided in instructions for use |
| Biocompatibility | The materials used for the Unity 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 are considered to be biocompatible. |
## Clinical Study
No clinical data was obtained in support of this premarket submission.
# Conclusion
The modifications to the Unity System Operator's User Manual and the end user packaging to include the option for the cassettes to be filled with Remodulin by the Specialty Pharmacy as a user convenience does not change the intended use of the subject device compared to the Unity System cleared under premarket notification K190182. The changes summarized in this submission do not raise different questions of safety and effectiveness.
The performance of the device is supported by the assurance case, non-clinical testing and risk management activities. The Unity Subcutaneous Delivery System for Remodulin is Substantially Equivalent (SE) to the Unity Subcutaneous Delivery System for Remodulin cleared under premarket notification K190182.
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