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.

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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Ivenix LVP Epidural Administration Set with NRFit Connector. It is not an AI/ML medical device, and therefore, many of the requested categories in your prompt are not applicable.

However, I can extract information related to the acceptance criteria and the studies performed to demonstrate substantial equivalence for this specific device, which is a hardware medical device (an administration set).

Here's a breakdown of the applicable information:

1. A table of acceptance criteria and the reported device performance

The document presents performance testing results to demonstrate that the new subject device (with NRFit connector) is substantially equivalent to the predicate device (with luer connector). The "acceptance criteria" can be inferred from the standards and requirements the device was tested against.

Acceptance Criteria (Inferred)	Reported Device Performance
Conformance to ISO 80369-6:2016 for NRFit connector	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 (meets ISO 8536-4:2019 requirements)	The epidural administration set with NRFit met the pull strength requirements of ISO 8536-4:2019.
Flow accuracy and shelf life meets functional requirements	The epidural administration set with NRFit connector met all functional requirements of the Ivenix epidural set with luer connector (the predicate device).
Microbial Ingress (maintains sterile fluid path)	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 (equivalent to predicate device material)	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. Therefore, no additional biocompatibility testing was conducted. (This implies an "acceptance" that no new testing was needed due to material equivalence).

2. Sample size used for the test set and the data provenance

Sample Size: The document does not explicitly state the sample sizes used for each of the bench tests (e.g., how many connectors were tested for bond strength or how many sets for flow accuracy). For microbial ingress, it mentions "any test article" implying multiple articles were tested for each of the four bacteria strains.
Data Provenance: This was "bench testing" performed by the manufacturer, or by an "accredited test laboratory" on behalf of the manufacturer. This is typical for a hardware device submission. The data is prospective for the purpose of this submission. The country of origin is not specified but implicitly within the regulatory framework of the U.S. FDA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a hardware administration set, not an AI/ML algorithm that requires expert "ground truth" for diagnostic or predictive purposes. The "ground truth" here is objective physical and biological performance as measured against established standards.

4. Adjudication method for the test set

Not applicable. This is not an AI/ML algorithm with subjective interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a hardware device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware device.

7. The type of ground truth used

The "ground truth" for this device is based on:

International standards (ISO 80369-6:2016, ISO 80369-20:2015, ISO 8536-4:2019).
Functional requirements for existing predicate devices.
Objective measurements of physical properties (e.g., pull strength, flow accuracy, sterility maintenance).

8. The sample size for the training set

Not applicable. This is a hardware device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K213089

Device Name

Ivenix LVP Epidural Administration Set with NRFit Connector

Indications for Use (Describe)

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)

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510(K) SUMMARY K213089

Manufacturer's Name:	Ivenix, Inc.50 High Street, North Andover, MA 01845
Corresponding Official:	John J. SokolowskiVice 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 luerconnector (SET-0016-1)

Device Description

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.

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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 DeviceIvenix Infusion System,Microbore single inlet, singleoutlet, for administration ofepidural fluids with NRFit®Connector (SET-0030-1)	Predicate DeviceIvenix Infusion SystemK183311, Microboresingle inlet, single outlet,for administration ofepidural fluids with luerconnector (SET-0016-1)	Discussion
Indications for Use	The Ivenix InfusionSystem is indicated for usein a hospital and inoutpatient careenvironments for thecontrolled administrationof fluids through clinicallyaccepted routes ofadministration:intravenous, intra-arterial,epidural, and subcutaneousto adults, pediatric andneonate patients.Administered fluids maybe pharmaceutical drugs,red blood cells, platelets,plasma, and other mixturesrequired for patienttherapy.	The Ivenix InfusionSystem is indicated foruse in a hospital and inoutpatient careenvironments for thecontrolled administrationof fluids throughclinically accepted routesof administration:intravenous, intra-arterial, epidural, andsubcutaneous to adults,pediatric and neonatepatients. Administeredfluids may bepharmaceutical drugs,red blood cells, platelets,plasma, and othermixtures required forpatient therapy.	No differencesbetween the devices.
Prescription Only orOver the Counter	Prescription Only	Prescription Only	No differencesbetween the devices.
Intended Population	Adult, pediatric, neonate	Adult, pediatric, neonate	No differencesbetween the devices.
Environment of Use	Hospital or out-patient setting	Hospital or out-patientsetting	No differencesbetween the devices.
Item	Subject Device - EpiduralAdministration Set withNRFit connector (SET-0030-1)	Predicate Device - EpiduralAdministration Set withluer connector (SET-0016-1)	Discussion
Single inlet	Primary line with vented spikeand cap, no secondary inlet.	Primary line with ventedspike and cap, no secondaryinlet.	No differences between thedevices.
Flowdial/regulator	The Flow Dial integrates withthe LVP to maintain flowaccuracy.	The Flow Dial integrateswith the LVP to maintainflow accuracy.	No differences between thedevices.
Connector	The connector that attachesthe downstream outlet tubingto the patient access devicehas an NRFit connector,complaint to ISO 80369-6:2016 with cap.	The connector that attachesthe distal line to the patientaccess device has a luer lockwith cap.	The subject device has aconnector that meets therequirements of a small boreconnector, per ISO 80369-6:2016
Outlet Tubing /Distal Line(Patient Line)	Runs from the cassette to thepatient.	Runs from the cassette to thepatient.	No differences between thedevices.
Upstream tubing	PE lined PVC with yellowstripe, length 29 +/- 1 in.	PE lined PVC with yellowstripe, length 29 +/- 1 in.	No differences between thedevices

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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:

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Item	Subject Device - EpiduralAdministration Set withNRFit connector (SET-0030-1)	Predicate Device - EpiduralAdministration Set withluer connector (SET-0016-1)	Discussion
Downstreamtubing	PE lined PVC with yellowstripe, length 73 +/- 2 in.	PE lined PVC with yellowstripe, length 73 +/- 2 in.	No differences between thedevices
Priming volume	10 mL	10 mL	No differences between thedevices
Patient accessconnectormaterials ofconstruction	Terlux 2802 ABS	Terlux 2802 ABS	No differences between thedevices

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 ISO80369-6:2013	The NRFit connector was tested against the requirements of ISO-80369-6:2016, using themethods described in ISO-80369-20:2015, by an accredited test laboratory. All requirementswere met.
Connector bond strength	The epidural administration set with NRFit met the pull strength requirements of ISO 8536-4:2019.
Flow accuracy and shelflife testing	The epidural administration set with NRFit connector met all functional requirements of theIvenix epidural set with luer connector.
Microbial Ingress	The sterile fluid path of the administration set was challenged, under simulated worst caseconditions, at the patient access device, with four strains of bacteria (2 gram positive, 2 gramnegative). Test results showed no growth of microorganism in any test article, demonstratingthe integrity of the NRFit connector to maintain the sterile fluid path under simulatedconditions of use.
Biocompatibility	The polymer material of the NRFit connector is identical to the standard luer connector of thepredicate device in its final finished form in formulation, processing, sterilization, andgeometry (with the exception of the geometry necessary to meet the requirements of ISO80369-6:2016), and no other chemicals have been added (e.g., plasticizers, fillers, additives,cleaning agents, mold release agents). Therefore, no additional biocompatibility testing wasconducted

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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.

Regulation Number and Section

§ 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.