(190 days)
Not Found
No
The description focuses on the pneumatic fluid delivery mechanism, pressure calculations using the ideal gas law, and the Infusion Management System for data sharing and reporting. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes.
The device is used for the "controlled administration of fluids" which may include "pharmaceutical drugs, red blood cells, platelets, plasma, and other mixtures required for patient therapy", directly indicating a therapeutic purpose to administer substances for medical treatment.
No
The given text describes the Ivenix Infusion System as a device for "controlled administration of fluids" and "patient therapy". It focuses on delivering substances rather than diagnosing conditions.
No
The device description clearly states that the system consists of three primary components, including a "Single channel large volume pump (LVP)" and "Single use, sterile, disposable fluid administration sets," which are hardware components. While the Infusion Management System (IMS) is software-based, it is only one part of the overall system.
Based on the provided information, the Ivenix Infusion System is not an In Vitro Diagnostic (IVD) device.
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 for diagnosis, monitoring, or screening.
- Ivenix Infusion System Function: The Ivenix Infusion System is designed to administer fluids directly into the patient's body through various routes (intra-arterial, epidural, subcutaneous). It is a delivery system for therapeutic substances, not a device that analyzes biological samples.
The device description and intended use clearly indicate its function is to control the flow of fluids into a patient, which is a therapeutic delivery function, not an in vitro diagnostic function.
N/A
Intended Use / Indications for Use
The Ivenix Infusion System is indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration: intra-arterial, epidural, and subcutaneous, to adults, pediatric and neonate patients. Administered fluids may be pharmaceutical drugs, red blood cells, platelets, plasma, and other mixtures required for patient therapy.
The Ivenix Large Volume Pump (LVP) is indicated for use only with the Ivenix sterile, single use, disposable administration sets, including:
Primary dual inlet, single outlet, 1 Y-site
Primary single inlet, single outlet
Blood Set, dual inlet, single outlet, 1 Y-site, for administration of red blood cells, platelets and plasma
Microbore single inlet, single outlet, for administration of epidural fluids
Microbore dual inlet, single outlet, 1 Y-site
Infusion Management System (IMS):
The IMS provides information to the clinician regarding the use of the Ivenix Large Volume Pump (LVP) by way of a drug library, LVP configurations, and by providing remote information regarding LVP status. It also provides information on pump usage data reports to various functions within an institution.
Product codes (comma separated list FDA assigned to the subject device)
FRN, PHC, FPA
Device Description
The Ivenix Infusion System (IIS) consists of three primary components:
-
- Single channel large volume pump (LVP),
-
- Single use, sterile, disposable fluid administration sets, and
-
- Infusion Management System (IMS) server applications.
The Large Volume Infusion Pump (LVP) is built around a closed-loop, pneumatically driven fluid delivery mechanism. Negative pressure is used to draw liquid from the source container into an intermediate pumping chamber (IPC). Positive pressure is then used to push the liquid out of the IPC and to the patient. The pneumatic drive allows for direct measurement of volume changes in the IPC.
The pump used the ideal gas equation, P1V1 = P2V2, to accurately calculate volume of fluid delivered. Using a known reference volume, pressure measurements are taken at various intervals during the fill and empty cycles to allow the system to determine flow rate to the patient. The LVP then adjusts drive pressure and/or fluidic resistance through a variable fluidic resistor to bring the actual flow rate to match the target flow rate.
The LVP System is a dual-inlet, single-outlet delivery system that can selectively draw from up to two fluid sources and deliver either of those fluids to the patient through a single outlet. Active delivery from two inlets provides for managed intermittent and "piggy-back" infusions. The system does not support concurrent delivery of the same time. The LVP can use 5 ml to 60 ml syringes, manufactured by Becton Dickinson, B. Braun, or Covidien, directly connected to the secondary inlet of the primary and microbore administration sets as a fluid source.
The system delivers fluid through a single-use, dual-inlet, single-outlet, disposable administration set. There are five varieties of administration sets:
-
- Primary dual inlet, single outlet, 1 Y-site
-
- Primary single inlet, single outlet
- Blood Set, dual inlet, single outlet. 1 Y-site, for administration of red blood cells, platelets and plasma 3.
- Microbore single inlet, single outlet, for administration of epidural fluids 4.
-
- Microbore dual inlet, single outlet, 1 Y-site
The Infusion Management System (IMS) allows the pump to share information with other pumps and applications provided by Ivenix, such as an infusate library, or other systems that reside within the hospital. In addition, the IMS provides other features, such as remote viewing dashboards, clinical analytics, and advisories that provide information about the infusion delivery both at, and away from, the point of care.
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, pediatric and neonate patients.
Intended User / Care Setting
Hospital and in outpatient care environments. The device is prescription only. The device is intended to be used by licensed health care providers.
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)
The following bench testing was performed and reviewed to support the substantial equivalence of the subject device:
A safety assurance case was provided for the Ivenix Infusion System, as recommended in the FDA guidance document, Infusion Pumps Total Product Life Cycle.
The stated goal of the safety assurance case is: "The Ivenix Infusion System is reasonably safe for its intended use"
The safety assurance case addressed the system in its intended use environment. 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 system adequately secures data
- . The pump system functions under all anticipated conditions of use
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:
Software & Cybersecurity
- Software documentation is included per FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for Major level of concern for the software embedded in the Ivenix Infusion System.
- Software validation was conducted per IEC 62304 and the FDA guidance document General Principles of Software Validation – Final Guidance for Industry and FDA Staff.
- Cybersecurity risks were assessed and documentation is included based on the FDA's Guidance of Premarket Submissions for Management of Cybersecurity in Medical Device.
- AAMI ANSI IEC 62304:2006 Medical Device Software - Software Life Cycle Process
Electrical Safety
- AAMI/ANSI ES 60601-1:2005/(R)2012 + A1:2012, C1:2009/(R)2012 + A2:2010/(R) 2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
EMC
- IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1: General Requirements for Safety-2-Collateral Standard: Electromagnetic Compatibility-Requirements & Tests
Wireless Coexistence & RF Wireless testing
- FDA Guidance Document "Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff"
- ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence
- AIM 7351731 Rev. 2.00 RFID Immunity
Administration Set Compatibility
- Verification of the pump essential performance was completed with the indicated 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"
Syringe compatibility
- Performance testing was conducted on 5 ml to 60 ml syringes manufactured by B. Braun, Becton Dickinson, and Covidien at flow rates from 0.5 ml/hr to 20 ml/hr. The pump maintained flow accuracy with all syringe sizes and manufacturers tested, with no occlusions observed.
Battery testing
- Li-ion battery safety successfully tested per IEC 62133
Human Factors
- Human factors studies per the FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016). The human factors studies were conducted with the intended user population, use environment and use scenarios to simulate clinical conditions. Results of the human factors testing demonstrate validation of the device per the intended use.
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
Microbial Ingress
- The sterile fluid path of the administration set was challenged, under simulated worst case conditions, at the needless access ports, the spike connection to the fluid source, and the luer connection to the patient access device, with four strains of bacteria (2 gram positive, 2 gram negative). Test results showed no growth of microorganism in any test article, demonstrating the integrity of the sterile fluid path under simulated conditions of use.
Biocompatibility
- The materials used for in the Ivenix Administration Sets 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.
- Testing was conducted for cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, and hemocompatibility.
- USP Physicochemical properties
- AAMI ST72: 2011 Bacterial Endotoxins - Test methods, routine monitoring, and alternatives to batch testing
- USP 39 :2016 Particulate Matter in Injections and ISO 8536-4.
Blood products compatibility
- Packed red blood cells, platelets, and plasma were pumped through the Ivenix device at 14 ml/hr, 350 ml/hr, and 500 ml/hr flow rates. No appreciable degradation of any of the blood products was observed.
No testing was performed regarding use with magnetic resonance imaging (MRI) equipment. The pump is MR Unsafe.
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.
Not Found
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 contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 7, 2019
Ivenix, Inc. John Sokolowski Vice President, Regulatory Affairs 50 High St., Suite 50 North Andover, Massachusetts 01845
Re: K183311
Trade/Device Name: Invenix Infusion System (IIS) Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: FRN, FPA, PHC Dated: November 28, 2018 Received: November 29, 2018
Dear John Sokolowski:
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 medical devices and radiation-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 Tina Kiang, Ph.D. Director
DHT3C: Division of Drug Delivery and General Hospital Devices and Human Factors | OHT3: Office of Gastrorenal, OB/GYN, General Hospital, and Urology Devices | Office of Product Evaluation and Quality CDRH | Food and Drug Administration
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Ivenix Infusion System (IIS)
Indications for Use (Describe)
The Ivenix Infusion System is indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration: intra-arterial, epidural, and subcutaneous, to adults, pediatric and neonate patients. Administered fluids may be pharmaceutical drugs, red blood cells, platelets, plasma, and other mixtures required for patient therapy.
The Ivenix Large Volume Pump (LVP) is indicated for use only with the Ivenix sterile, single use, disposable administration sets, including:
Primary dual inlet, single outlet, 1 Y-site Primary single inlet, single outlet Blood Set, dual inlet, single outlet, 1 Y-site, for administration of red blood cells, platelets and plasma Microbore single inlet, single outlet, for administration of epidural fluids Microbore dual inlet, single outlet, 1 Y-site
Infusion Management System (IMS):
The IMS provides information to the clinician regarding the use of the Ivenix Large Volume Pump (LVP) by way of a drug library, LVP configurations, and by providing remote information regarding LVP status. It also provides information on pump usage data reports to various functions within an institution.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K183311 510(K) SUMMARY
| Preparation Date: | June 7, 2019 |
|---|---|
| Manufacturer's Name: | Ivenix, Inc. |
| 50 High Street, North Andover, MA 01845 | |
| Corresponding Official: | John J. Sokolowski |
| Vice President, Regulatory Affairs | |
| Telephone Number: | (978) 775-8050 |
| Fax Number: | (978) 775-8052 |
| E-mail Address: | jsokolowski@ivenix.com |
| Trade Name: | Ivenix Infusion System (IIS) |
| Common or Usual Name: | Large Volume Infusion Pump, Infusion Safety |
| Management Software | |
| Regulation Name: | Infusion Pump |
| Regulation Number: | 21 CFR 880.5725 |
| Product Codes: | FRN, PHC, FPA |
| Device Class: | Class II |
| Predicate Device: | K173084, Baxter SIGMA Spectra Infusion Pump |
| K161469, Hospira Inc. Plum 360 Infusion System |
Device Description
The Ivenix Infusion System (IIS) consists of three primary components:
-
- Single channel large volume pump (LVP),
-
- Single use, sterile, disposable fluid administration sets, and
-
- Infusion Management System (IMS) server applications.
The Large Volume Infusion Pump (LVP) is built around a closed-loop, pneumatically driven fluid delivery mechanism. Negative pressure is used to draw liquid from the source container into an intermediate pumping chamber (IPC). Positive pressure is then used to push the liquid out of the IPC and to the patient. The pneumatic drive allows for direct measurement of volume changes in the IPC.
The pump used the ideal gas equation, P1V1 = P2V2, to accurately calculate volume of fluid delivered. Using a known reference volume, pressure measurements are taken at various intervals during the fill and empty cycles to allow the system to determine flow rate to the patient. The LVP then adjusts drive pressure and/or fluidic resistance through a variable fluidic resistor to bring the actual flow rate to match the target flow rate.
The LVP System is a dual-inlet, single-outlet delivery system that can selectively draw from up to two fluid sources and deliver either of those fluids to the patient through a single outlet. Active delivery from two inlets provides for managed intermittent and "piggy-back" infusions. The system does not support concurrent delivery of the same time. The LVP can use 5 ml to 60 ml syringes, manufactured by Becton Dickinson, B. Braun, or Covidien, directly connected to the secondary inlet of the primary and microbore administration sets as a fluid source.
4
The system delivers fluid through a single-use, dual-inlet, single-outlet, disposable administration set. There are five varieties of administration sets:
-
- Primary dual inlet, single outlet, 1 Y-site
-
- Primary single inlet, single outlet
- Blood Set, dual inlet, single outlet. 1 Y-site, for administration of red blood cells, platelets and plasma 3.
- Microbore single inlet, single outlet, for administration of epidural fluids 4.
-
- Microbore dual inlet, single outlet, 1 Y-site
The Infusion Management System (IMS) allows the pump to share information with other pumps and applications provided by Ivenix, such as an infusate library, or other systems that reside within the hospital. In addition, the IMS provides other features, such as remote viewing dashboards, clinical analytics, and advisories that provide information about the infusion delivery both at, and away from, the point of care.
Indications for Use
The Ivenix Infusion System is indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration: intra- arterial, epidural, and subcutaneous to adults, pediatric and neonate patients. Administered fluids may be pharmaceutical drugs, red blood cells, platelets, plasma, and other mixtures required for patient therapy.
The Ivenix Large Volume Pump (LVP) is indicated for use only with the Ivenix sterile, single use, disposable administration sets, including:
-
- Primary dual inlet, single outlet, 1 Y-site
-
- Primary single inlet, single outlet
-
- Blood Set, dual inlet, single outlet, 1 Y-site, for administration of red blood cells, platelets and plasma
-
- Microbore single inlet, single outlet, for administration of epidural fluids
-
- Microbore dual inlet, single outlet, 1 Y-site
Infusion Management System (IMS):
The IMS is intended to provide information to the clinician regarding the use of the Ivenix Large Volume Pump (LVP) by way of a drug library, LVP configurations, and by providing remote information regarding LVP status. It is also intended to provide information on pump usage data reports to various functions within an institution.
The device is prescription only.
5
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 Device
Baxter SIGMA Spectrum
K173084 | Subject Device
Ivenix Infusion System
K183311 | Discussion |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Ivenix Infusion System is
indicated for use in a hospital and
in outpatient care environments for
the controlled administration of
fluids through clinically accepted
routes of administration:
intravenous, intra-arterial, epidural,
and subcutaneous. Administered
fluids may be pharmaceutical
drugs, red blood cells, platelets,
plasma, and other mixtures required
for patient therapy. | The Baxter SIGMA
Spectrum Infusion Pump
with Master Drug Library is
intended to be used for the
controlled administration of
fluids. These may be
pharmaceutical drugs,
blood, blood products and
mixtures of required patient
therapy. The intended routes
of administration consist of
the following clinically
accepted routes:
intravenous, arterial,
subcutaneous, epidural or
irrigation of fluid space. | The subject device and
predicate device deliver
medications and other
fluids to a patient by
clinically accepted routes
of administration.
The difference is that the
Ivenix Infusion System is
not indicated for whole
blood, since whole blood
is rarely used for
transfusion. |
| Prescription Only or
Over the Counter | Prescription Only | Prescription Only | No differences between
the devices. |
| Intended Population | Adult, pediatric, neonate | Adult, pediatric, neonate | No differences between
the devices. |
| Environment of Use | Hospital or out-patient setting | Not specified | Both devices are intended
to be used by licensed
health care providers. |
| Item | Ivenix Infusion System –
LVP (K183311) | SIGMA Spectrum Pump
K173084 | Discussion |
| Mechanism of action | Pneumatically driven
diaphragm pump | Peristaltic pump action on
the administration set
tubing. | Both the subject and predicate
device deliver infusion fluid to
the patient in a controlled
manner at a programmed flow
rate.
Although different pumping
technologies are employed by
the subject device and the
predicate device, verification of
the subject device demonstrates
that it meets its intended use of
delivering fluids to a patient in a
controlled manner |
| Infusion accuracy | +/- 5% @ 0.5 - 1000 ml/hr. | +/- 5% @ 2 – 999 ml/hr,
+/- 0.1 ml/hr for rates $ Physicochemical properties
• AAMI ST72: 2011 Bacterial Endotoxins - Test methods, routine monitoring, and alternatives to batch testing
• $USP 39 :2016$ Particulate Matter in Injections and ISO 8536-4. |
| Blood products
compatibility | • Packed red blood cells, platelets, and plasma were pumped through the Ivenix device at 14 ml/hr, 350 ml/hr, and 500 ml/hr flow rates. No appreciable degradation of any of the blood products was observed. |
12
No testing was performed regarding use with magnetic resonance imaging (MRI) equipment. The pump is MR Unsafe.
13
Clinical Tests
Clinical evaluation is not required for this submission to support substantial equivalence. Similarly, the predicate devices did not undergo clinical evaluation to support substantial equivalence.
Conclusions
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Ivenix Infusion System is substantially equivalent to the Baxter SIGMA Spectrum Infusion Pump cleared under K173084 with respect to the indications for use, target populations, treatment method, and technological characteristics.