Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector

K213089 · Ivenix, Inc. · FPA · Nov 10, 2021 · General Hospital

Device Facts

• Record ID: K213089
• Device Name: Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector
• Applicant: Ivenix, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Nov 10, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

The Ivenix LVP Epidural Administration Set is a sterile fluid delivery component for the Ivenix Infusion System. It consists of a primary inlet tubing with a vented spike, a pumping cassette, and outlet tubing terminating in an ISO 80369-6:2013 compliant NRFit connector. The device is operated by clinicians in hospital or outpatient environments. It interfaces with the Ivenix Large Volume Pump (LVP) to enable controlled fluid delivery; it is not intended for gravity infusion. The NRFit connector prevents misconnections with non-epidural access devices, enhancing patient safety by ensuring the sterile fluid path is maintained during epidural therapy.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including ISO 80369-6:2016 compliance, connector bond strength (ISO 8536-4:2019), flow accuracy, shelf life, and microbial ingress testing.

Technological Characteristics

Materials: PE-lined PVC tubing, Terlux 2802 ABS connector. Dimensions: 29 +/- 1 in upstream, 73 +/- 2 in downstream. Priming volume: 10 mL. Connector: NRFit (ISO 80369-6:2016). Energy source: Powered by Ivenix LVP. Sterilization: Sterile fluid path.

Indications for Use

Indicated for controlled administration of pharmaceutical drugs or other therapies via epidural pathway in hospital or outpatient settings for adult, pediatric, and neonate patients.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Ivenix Infusion System, Epidural Administration set with luer connector (SET-0016-1) (K183311)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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) | |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-family: Arial, sans-serif;"> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(K) SUMMARY K213089

| Manufacturer's Name: | Ivenix, Inc.<br>50 High Street, North Andover, MA 01845 |
|-------------------------|-------------------------------------------------------------------------------------------------|
| Corresponding Official: | John J. Sokolowski<br>Vice President, Regulatory Affairs |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| E-mail Address: | [e-mail] |
| Trade Name: | Ivenix LVP Epidural Administration Set with NRFit Connector, SET-<br>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<br>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.

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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 Device<br>Ivenix Infusion System,<br>Microbore single inlet, single<br>outlet, for administration of<br>epidural fluids with NRFit®<br>Connector (SET-0030-1) | Predicate Device<br>Ivenix Infusion System<br>K183311, Microbore<br>single inlet, single outlet,<br>for administration of<br>epidural fluids with luer<br>connector (SET-0016-1) | Discussion |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Ivenix Infusion<br>System is indicated for use<br>in a hospital and in<br>outpatient care<br>environments for the<br>controlled administration<br>of fluids through clinically<br>accepted routes of<br>administration:<br>intravenous, intra-arterial,<br>epidural, and subcutaneous<br>to adults, pediatric and<br>neonate patients.<br>Administered fluids may<br>be pharmaceutical drugs,<br>red blood cells, platelets,<br>plasma, and other mixtures<br>required for patient<br>therapy. | The Ivenix Infusion<br>System is indicated for<br>use in a hospital and in<br>outpatient care<br>environments for the<br>controlled administration<br>of fluids through<br>clinically accepted routes<br>of administration:<br>intravenous, intra-<br>arterial, epidural, and<br>subcutaneous to adults,<br>pediatric and neonate<br>patients. Administered<br>fluids may be<br>pharmaceutical drugs,<br>red blood cells, platelets,<br>plasma, and other<br>mixtures required for<br>patient therapy. | No differences<br>between the devices. |
| Prescription Only or<br>Over the Counter | Prescription Only | Prescription Only | No differences<br>between the devices. |
| Intended Population | Adult, pediatric, neonate | Adult, pediatric, neonate | No differences<br>between the devices. |
| Environment of Use | Hospital or out-patient setting | Hospital or out-patient<br>setting | No differences<br>between the devices. |
| Item | Subject Device - Epidural<br>Administration Set with<br>NRFit connector (SET-0030-<br>1) | Predicate Device - Epidural<br>Administration Set with<br>luer connector (SET-0016-<br>1) | Discussion |
| Single inlet | Primary line with vented spike<br>and cap, no secondary inlet. | Primary line with vented<br>spike and cap, no secondary<br>inlet. | No differences between the<br>devices. |
| Flow<br>dial/regulator | The Flow Dial integrates with<br>the LVP to maintain flow<br>accuracy. | The Flow Dial integrates<br>with the LVP to maintain<br>flow accuracy. | No differences between the<br>devices. |
| Connector | The connector that attaches<br>the downstream outlet tubing<br>to the patient access device<br>has an NRFit connector,<br>complaint to ISO 80369-<br>6:2016 with cap. | The connector that attaches<br>the distal line to the patient<br>access device has a luer lock<br>with cap. | The subject device has a<br>connector that meets the<br>requirements of a small bore<br>connector, per ISO 80369-<br>6:2016 |
| Outlet Tubing /<br>Distal Line<br>(Patient Line) | Runs from the cassette to the<br>patient. | Runs from the cassette to the<br>patient. | No differences between the<br>devices. |
| Upstream tubing | PE lined PVC with yellow<br>stripe, length 29 +/- 1 in. | PE lined PVC with yellow<br>stripe, length 29 +/- 1 in. | No differences between the<br>devices |

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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 - Epidural<br>Administration Set with<br>NRFit connector (SET-0030-<br>1) | Predicate Device - Epidural<br>Administration Set with<br>luer connector (SET-0016-<br>1) | Discussion |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------|
| Downstream<br>tubing | PE lined PVC with yellow<br>stripe, length 73 +/- 2 in. | PE lined PVC with yellow<br>stripe, length 73 +/- 2 in. | No differences between the<br>devices |
| Priming volume | 10 mL | 10 mL | No differences between the<br>devices |
| Patient access<br>connector<br>materials of<br>construction | Terlux 2802 ABS | Terlux 2802 ABS | No differences between the<br>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<br>80369-6:2013 | The NRFit connector was tested against the requirements of ISO-80369-6:2016, using the<br>methods described in ISO-80369-20:2015, by an accredited test laboratory. All requirements<br>were met. |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Connector bond strength | The epidural administration set with NRFit met the pull strength requirements of ISO 8536-<br>4:2019. |
| Flow accuracy and shelf<br>life testing | The epidural administration set with NRFit connector met all functional requirements of the<br>Ivenix epidural set with luer connector. |
| Microbial Ingress | The sterile fluid path of the administration set was challenged, under simulated worst case<br>conditions, at the patient access device, with four strains of bacteria (2 gram positive, 2 gram<br>negative). Test results showed no growth of microorganism in any test article, demonstrating<br>the integrity of the NRFit connector to maintain the sterile fluid path under simulated<br>conditions of use. |
| Biocompatibility | The polymer material of the NRFit connector is identical to the standard luer connector of the<br>predicate device in its final finished form in formulation, processing, sterilization, and<br>geometry (with the exception of the geometry necessary to meet the requirements of ISO<br>80369-6:2016), and no other chemicals have been added (e.g., plasticizers, fillers, additives,<br>cleaning agents, mold release agents). Therefore, no additional biocompatibility testing was<br>conducted |

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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.