(47 days)
Not Found
No
The description focuses on the mechanical components and fluid delivery mechanism of an administration set, with no mention of AI or ML capabilities.
No
The device is described as an "Epidural Administration Set," which is used for the "controlled administration of pharmaceutical drugs or other therapies." It facilitates the delivery of therapeutic substances, but it is not a therapeutic device itself.
No
The device is an administration set intended for the controlled delivery of pharmaceutical drugs and other therapies, not for diagnosing a medical condition.
No
The device description clearly outlines physical components like tubing, a vented cap spike, a cassette, and an NRFit connector, indicating it is a hardware device, not software-only.
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 "controlled administration of pharmaceutical drugs or other therapies via the epidural pathway." This describes a device used for delivering substances into the body for therapeutic purposes, not for examining specimens from the body to diagnose conditions.
- Device Description: The description focuses on the components and function related to fluid delivery (tubing, cassette, connector, sterile fluid path, interface with the LVP). There is no mention of analyzing biological samples or providing diagnostic information.
- Anatomical Site: The device is used with the "epidural pathway," which is a location within the body for drug administration. IVDs typically interact with biological specimens like blood, urine, tissue, etc.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing diagnostic information about a patient's health status.
- Reagents or assays.
In summary, the Ivenix LVP Epidural Administration Set with NRFit Connector is a medical device used for drug delivery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Ivenix LVP Epidural Administration Set with NRFit Connector (SET-0030-1) is intended for the controlled administration of pharmaceutical drugs or other therapies via the epidural pathway. The Ivenix LVP Epidural Administration Set is intended only for use with the Ivenix Infusion System in a hospital or outpatient.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The Ivenix LVP Epidural Administration Set with NRFit connector is comprised of a primary channel inlet tubing with a vented cap spike, a cassette which contains the fluid pumping mechanism and serves as the interface to the Ivenix LVP, and outlet tubing for connection to patient access. The end of the outlet tubing is fitted with a NRFit connector that is compliant to ISO 80369-6:2013.
The Ivenix LVP Epidural Administration Set with NRFit Connector provides a sterile fluid path for the delivery of pharmaceutical drugs and other therapies via the epidural pathway, provides a means for a clinician to aseptically connect to the fluid source and to the patient access site, and interfaces with the LVP to enable measurement and control of the fluid delivery.
The Ivenix LVP Epidural Administration Set with NRFit Connector is intended for use within the Ivenix Infusion System for controlled fluid delivery; it is not recommended for gravity infusion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural pathway
Indicated Patient Age Range
adults, pediatric and neonate patients.
Intended User / Care Setting
hospital or outpatient care environment.
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:
- Conformance to ISO 80369-6:2013: The NRFit connector was tested against the requirements of ISO-80369-6:2016, using the methods described in ISO-80369-20:2015, by an accredited test laboratory. All requirements were met.
- Connector bond strength: The epidural administration set with NRFit met the pull strength requirements of ISO 8536-4:2019.
- Flow accuracy and shelf life testing: The epidural administration set with NRFit connector met all functional requirements of the Ivenix epidural set with luer connector.
- Microbial Ingress: The sterile fluid path of the administration set was challenged, under simulated worst case conditions, at 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 NRFit connector to maintain the sterile fluid path under simulated conditions of use.
- Biocompatibility: The polymer material of the NRFit connector is identical to the standard luer connector of the predicate device in its final finished form in formulation, processing, sterilization, and geometry (with the exception of the geometry necessary to meet the requirements of ISO 80369-6:2016), and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents). Therefore, no additional biocompatibility testing was conducted.
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
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
Ivenix, Inc. John Sokolowski VP, Regulatory Affairs 50 High St North Andover, Massachusetts 01845
Re: K213089
Trade/Device Name: Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: October 7, 2021 Received: October 8, 2021
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
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/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,
Carolyn Dorgan 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
2
Indications for Use
510(k) Number (if known) K213089
Device Name
Ivenix LVP Epidural Administration Set with NRFit Connector
Indications for Use (Describe)
The Ivenix LVP Epidural Administration Set with NRFit Connector (SET-0030-1) is intended for the controlled administration of pharmaceutical drugs or other therapies via the epidural pathway. The Ivenix LVP Epidural Administration Set is intended only for use with the Ivenix Infusion System in a hospital or outpatient.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) SUMMARY K213089
| 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: | john.sokolowski@ivenix.com |
| Trade Name: | Ivenix LVP Epidural Administration Set with NRFit Connector, SET-
0030-1 |
| Common or Usual Name: | Epidural infusion administration set |
| Regulation Name: | Set, administration, intravascular |
| Regulation Number: | 21 CFR 880.5440 |
| Product Codes: | FPA |
| Device Class: | Class II |
| Predicate Device: | K183311 Ivenix Infusion System, Epidural Administration set with luer
connector (SET-0016-1) |
Device Description
The Ivenix LVP Epidural Administration Set with NRFit connector is comprised of a primary channel inlet tubing with a vented cap spike, a cassette which contains the fluid pumping mechanism and serves as the interface to the Ivenix LVP, and outlet tubing for connection to patient access. The end of the outlet tubing is fitted with a NRFit connector that is compliant to ISO 80369-6:2013.
The Ivenix LVP Epidural Administration Set with NRFit Connector provides a sterile fluid path for the delivery of pharmaceutical drugs and other therapies via the epidural pathway, provides a means for a clinician to aseptically connect to the fluid source and to the patient access site, and interfaces with the LVP to enable measurement and control of the fluid delivery.
The Ivenix LVP Epidural Administration Set with NRFit Connector is intended for use within the Ivenix Infusion System for controlled fluid delivery; it is not recommended for gravity infusion.
Indications for Use
The Ivenix LVP Epidural Administration Set with NRFit Connector (SET-0030-1) is intended for the controlled administration of pharmaceutical drugs or other patient therapies via the epidural pathway. The Ivenix LVP Epidural Administration Set is intended only for use with the Ivenix Infusion System in a hospital or outpatient care environment.
4
Substantial Equivalence Discussion
Intended Use Comparison
The table below includes a comparison of the intended use between the subject device and those of the predicate device:
| Characteristic | Subject Device
Ivenix Infusion System,
Microbore single inlet, single
outlet, for administration of
epidural fluids with NRFit®
Connector (SET-0030-1) | Predicate Device
Ivenix Infusion System
K183311, Microbore
single inlet, single outlet,
for administration of
epidural fluids with luer
connector (SET-0016-1) | 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
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 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 to adults,
pediatric and neonate
patients. Administered
fluids may be
pharmaceutical drugs,
red blood cells, platelets,
plasma, and other
mixtures required for
patient therapy. | No differences
between the devices. |
| 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 | Hospital or out-patient
setting | No differences
between the devices. |
| Item | Subject Device - Epidural
Administration Set with
NRFit connector (SET-0030-
-
| Predicate Device - Epidural
Administration Set with
luer connector (SET-0016-
-
| Discussion |
| Single inlet | Primary line with vented spike
and cap, no secondary inlet. | Primary line with vented
spike and cap, no secondary
inlet. | No differences between the
devices. |
| Flow
dial/regulator | The Flow Dial integrates with
the LVP to maintain flow
accuracy. | The Flow Dial integrates
with the LVP to maintain
flow accuracy. | No differences between the
devices. |
| Connector | The connector that attaches
the downstream outlet tubing
to the patient access device
has an NRFit connector,
complaint to ISO 80369-
6:2016 with cap. | The connector that attaches
the distal line to the patient
access device has a luer lock
with cap. | The subject device has a
connector that meets the
requirements of a small bore
connector, per ISO 80369-
6:2016 |
| Outlet Tubing /
Distal Line
(Patient Line) | Runs from the cassette to the
patient. | Runs from the cassette to the
patient. | No differences between the
devices. |
| Upstream tubing | PE lined PVC with yellow
stripe, length 29 +/- 1 in. | PE lined PVC with yellow
stripe, length 29 +/- 1 in. | No differences between the
devices |
5
Discussions of differences in Indications for Use statement
The indications for use statements are identical for both subject and predicate devices.
Discussions of differences in intended population
The intended population for the subject device is identical to the predicate device.
Discussions of differences in environment of use There are no differences in the environment of use.
Technological Characteristics
The Ivenix LVP Epidural Administration Set with NRFit Connector is a modification of the Ivenix LVP Epidural Administration Set with Luer Connector (SET-0016-1). These sets have equivalent technological characteristics, as described below, and support substantial equivalence.
The table below includes a comparison of the technological characteristics between the new device and those of the predicate device:
6
| Item | Subject Device - Epidural
Administration Set with
NRFit connector (SET-0030-
- | Predicate Device - Epidural
Administration Set with
luer connector (SET-0016- - | Discussion |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------|
| Downstream
tubing | PE lined PVC with yellow
stripe, length 73 +/- 2 in. | PE lined PVC with yellow
stripe, length 73 +/- 2 in. | No differences between the
devices |
| Priming volume | 10 mL | 10 mL | No differences between the
devices |
| Patient access
connector
materials of
construction | Terlux 2802 ABS | Terlux 2802 ABS | No differences between the
devices |
Discussions of differences in technological characteristics
The technological characteristics of the subject and predicate devices are identical except for the dimensional characteristics of the patient access connector. The subject device meets the dimensional specifications of ISO 80369-6:2016.
Performance Testing
The following bench testing was performed and reviewed to support the substantial equivalence of the subject device:
| Conformance to ISO
80369-6:2013 | The NRFit connector was tested against the requirements of ISO-80369-6:2016, using the
methods described in ISO-80369-20:2015, by an accredited test laboratory. All requirements
were met. |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Connector bond strength | The epidural administration set with NRFit met the pull strength requirements of ISO 8536-
4:2019. |
| Flow accuracy and shelf
life testing | The epidural administration set with NRFit connector met all functional requirements of the
Ivenix epidural set with luer connector. |
| Microbial Ingress | The sterile fluid path of the administration set was challenged, under simulated worst case
conditions, at 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 NRFit connector to maintain the sterile fluid path under simulated
conditions of use. |
| Biocompatibility | The polymer material of the NRFit connector is identical to the standard luer connector of the
predicate device in its final finished form in formulation, processing, sterilization, and
geometry (with the exception of the geometry necessary to meet the requirements of ISO
80369-6:2016), and no other chemicals have been added (e.g., plasticizers, fillers, additives,
cleaning agents, mold release agents). Therefore, no additional biocompatibility testing was
conducted |
7
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.