NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector

K220288 · Np Medical, Inc. · FPA · Apr 19, 2023 · General Hospital

Device Facts

• Record ID: K220288
• Device Name: NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector
• Applicant: Np Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Apr 19, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Indications for Use

The nPulse™ neutral displacement connector is a single patient use, sterile, nonpyrogenic device for needleless access to the IV line and/or IV catheter during IV therapy. The nPulse™ connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.

Device Story

The nPulse K150 is a sterile, single-patient-use, luer-activated, neutral displacement needle-free connector. It functions as a valve between an IV line/catheter and external medical equipment. The device features an internal mechanism that maintains a neutral fluid displacement during connection and disconnection, preventing blood reflux into the catheter tip. It is operated by clinicians in clinical settings to facilitate direct injection, intermittent or continuous infusion, and aspiration. The device is designed to be compatible with lipids, alcohol, and chlorhexidine gluconate (CHG). It provides a closed system when not in use and an open path during activation. By maintaining neutral displacement and allowing for 7-day indwell, it reduces the risk of catheter-related complications and minimizes the frequency of connector changes for the patient.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including air bolus/bubble-free priming, repeat insertion, blood flushing, bolus back pressure, activated pressure resistance, docking stability, flow rate, fluid displacement, gland height, hydraulic burst leak, torque, chemical stress resistance, and particulate contamination. Microbial ingress testing confirmed performance for a 7-day indwell period. Biocompatibility was evaluated per ISO 10993-1.

Technological Characteristics

Materials: Polycarbonate, LIM silicone, silicone oil. Design: Cylindrical, 26mm L x 12mm D, 1.55g mass. Principle: Luer-activated, normally closed valve with neutral displacement. Connectivity: ISO Luer. Sterilization: Ethylene Oxide (ISO 11135:2014). Packaging: ISO 11607-1:2019 compliant. Pressure rating: 325 psi. Priming volume: 0.12 mL.

Indications for Use

Indicated for single patient use for needleless access to IV lines or IV catheters during IV therapy, including direct injection, intermittent infusion, continuous infusion, or aspiration.

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

• NP Medical K100 Neutral Displacement Needle Free Connector (K130023)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 19, 2023

NP Medical, Inc. Krishna Govindarajan Global Quality Regulatory Affairs Manager 101 Union Street Clinton, Massachusetts 01510

Re: K220288

Trade/Device Name: NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: March 17, 2023 Received: March 20, 2023

Dear Krishna Govindarajan:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (OS) 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,

David Walloschek

David Wolloscheck, Ph.D. Acting 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) K220288

Device Name NP Medical nPulse™ K150 Neutral Displacement Needle Free Connector

#### Indications for Use (Describe)

The nPulse™ neutral displacement connector is a single patient use, sterile, nonpyrogenic device for needleless access to the IV line and/or IV catheter during IV therapy. The nPulse™ connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the logo for NP Medical. The logo consists of a blue abstract shape on the left, followed by the text "NPMedical" in a dark blue sans-serif font. Below the logo, there is a tagline that reads "We Make Quality Patient Care Possible" in a smaller, lighter blue font.

The following summary is provided in accordance with 21 CFR 807.92

#### -SUBMITTER

| Owner's Name: | NP Medical, Inc., |
|---------------|-------------------|
| Address: | 101 Union Street |
| | Clinton, MA 01510 |
| Phone: | 978-368-6854 |

Contact Person: Krishna Govindarajan Krishna [e-mail] email:

Date Prepared: April 19, 2023

# II. DEVICE

| Trade/Device Name: | NP Medical nPulse ^TM K150 Neutral Displacement Needle Free Connector |
|-----------------------|---------------------------------------------------------------------------------|
| Common or Usual Name: | Needle Free Connector |
| Regulation Number: | 21 CFR 880.5440 |
| Regulation Name: | Intravascular administration set |
| Regulatory Class: | Class II |
| Product Code: | FPA |

# III. PREDICATE DEVICE (Previously Cleared Device)

NP Medical K100 Neutral Displacement Needle Free Connector (K130023)

# IV. DEVICE DESCRIPTION

The nPulse K150 Neutral Displacement Needle Free Connector is a single patient use, sterile, non-pyrogenic device for needleless access to the IV line and/or IV catheter during IV therapy. The nPulse K150 Neutral Displacement Needle Free Connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration. The nPulse K150 valve is a normally closed, luer-activated, valved connector which has an open mode that permits bi-directional fluid flow and a closed mode that prevents fluid flow.

# V. INDICATIONS FOR USE

The nPulse™ neutral displacement connector is a single patient use, sterile, nonpyrogenic device for needleless access to the IV line and/or IV catheter during IV therapy. The nPulse™ connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.

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Image /page/4/Picture/0 description: The image shows the logo for NP Medical. The logo consists of a blue icon on the left and the text "NP Medical" on the right. The icon is a stylized letter "N" and "P" in blue. Below the logo is the text "We Make Quality Patient Care Possible" in a smaller font.

The following summary is provided in accordance with 21 CFR 807.92

# VI.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The proposed device and predicate device are identical with reqards to intended use and are substantially equivalent with regards to design, technological characteristics, performance, safety, and effectiveness. Both devices also have the same indications for use as needle free connector for direct injection, intermittent infusion, continuous infusion or aspiration without the need for sharps devices.

At a high level, the proposed and predicate devices are based on the following same technological element:

- Neutral Displacement Needle Free Connector .
The following table provides a comparison of technological characteristics between the subject and predicate device:

| Comparison<br>Element | Subject Device –<br>NP Medical nPulse K150 | Predicate Device - NP<br>Medical K100 (K130023) | Analysis of Differences |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | FPA | FPA | Same |
| Regulation Number | 880.5440 | 880.5440 | Same |
| Class | II | II | Same |
| Intended Use | Intravascular Extension<br>Set | Intravascular Extension<br>Set | Same |
| Indications for Use | The nPulse™ neutral<br>displacement connector<br>is a single patient use,<br>sterile, nonpyrogenic<br>device for needleless<br>access to the IV line<br>and/or IV catheter<br>during IV therapy. The<br>nPulse™ connector can<br>be used for direct<br>injection, intermittent<br>infusion, continuous<br>infusion, or aspiration. | The K100 Neutral<br>Displacement Connector<br>is a single patient use,<br>sterile, non-pyrogenic<br>device for needleless<br>access to the IV line<br>and/or IV catheter during<br>IV therapy. The K100<br>connector can be used<br>for direct injection,<br>intermittent infusion,<br>continuous<br>infusion, or aspiration. | Same |
| Size, shape | 26mm L x 12mm D,<br>Cylindrical | 26mm L x 12mm D,<br>Cylindrical | Same |
| Mass | 1.55 grams | 1.55 grams | Same |
| Comparison<br>Element | Subject Device –<br>NP Medical nPulse K150 | Predicate Device – NP<br>Medical K100 (K130023) | Analysis of Differences |
| Components | Inlet, Outlet,<br>Upper Seal, Lower<br>Gland, Post, Slit<br>Lube, G/P Lube | Inlet, Outlet, Upper<br>Seal, Lower Gland,<br>Post, Slit Lube, G/P<br>Lube | Same |
| Materials | Polycarbonate, LIM<br>Silicone, Silicone Oil | Polycarbonate, LIM<br>Silicone, Silicone Oil | Same. The LIM silicone<br>durometer is adjusted in<br>the subject device. |
| Displacement Type | Neutral | Neutral | Same |
| Luer Connector | ISO Luer | ISO Luer | Same |
| Multiple Activations | 200 intermittent | 96 intermittent | Different. The subject<br>device has demonstrated<br>applicable performance<br>following 200 activations<br>through Gland Height and<br>Integrity, Back Pressure,<br>and Activated Pressure<br>Resistance. |
| Indwell | 96 hours | 96 hours | Same |
| Use Days | 7 days | 4 days | Different. The proposed<br>device aligns with current<br>best practices for use<br>days, specifically through<br>an evaluation of the<br>microbial ingress<br>performance over a period<br>of seven days resulting in<br>0 CFU recovered for all<br>test device replicates,<br>which supports this<br>difference. |
| Chemical<br>Compatibility | Lipids, Alcohol,<br>Chlorhexidine gluconate<br>(CHG) | Lipids, Alcohol, CHG | Same |
| Pressure Rating | 325 psi | 325 psi | Same |
| Priming Volume | 0.12 mL | 0.12 mL | Same |
| Package | Blister | Blister | Same |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same |
| Comparison<br>Element | Subject Device -<br>NP Medical nPulse K150 | Predicate Device - NP<br>Medical K100 (K130023) | Analysis of Differences |
| Shelf Life | 5 years | 1 year launch, 3 years<br>planned | Different. The subject<br>device has demonstrated<br>performance after 5 years<br>of aging including microbial<br>ingress testing resulting in<br>0 CFU recovered for all<br>test device replicates. |
| Disposable or<br>Reusable | Disposable | Disposable | Same |

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Image /page/5/Picture/0 description: The image contains the logo for NPMedical. The logo consists of a stylized blue shape resembling a medical symbol, followed by the text "NPMedical" in a combination of dark blue and light blue. Below the logo, there is a tagline that reads "We Make Quality Patient Care Possible™".

# The following summary is provided in accordance with 21 CFR 807.92

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Image /page/6/Picture/0 description: The image shows the logo for NPMedical. The logo consists of a blue icon to the left of the text "NPMedical". Below the text is the tagline "We Make Quality Patient Care Possible™".

#### K220288 - 510(k) Summary The following summary is provided in accordance with 21 CFR 807.92

# VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

# 1. Performance Testing - Bench

The functional performance of the proposed device has been evaluated using the appropriate methodology as specified in the FDA recognized consensus standards and in conjunction with NP Medical established test protocols in accordance with the recommendations provided in the FDA guidance document titled "Intravascular Administration Sets Premarket Notification Submissions [510(k)]".

The following functional performance tests were conducted as part of the Design Verification and Validation activities:

- Air Bolus and Bubble Free Priming ●
- Repeat Insertion o
- Blood Flushing Evaluation ●
- Bolus Back Pressure ●
- Activated Pressure Resistance ●
- Docking Stability ●
- Flow Rate ●
- Fluid Displacement ●
- Gland Height Determination ●
- Hydraulic Burst Leak
- Torque Testing ●
- Stress Resistance to Swabbing Chemicals ●
- Particulate Contamination, Sub-visible Particles o

In addition, NP Medical has successfully conducted Microbial Ingress testing to support a 7- day change protocol.

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Image /page/7/Picture/0 description: The image contains the logo for NP Medical. The logo consists of a blue icon on the left and the text "NP Medical" on the right. Below the logo is the text "We Make Quality Patient Care Possible™".

The following summary is provided in accordance with 21 CFR 807.92

#### 2. Biocompatibility

The biocompatibility evaluation was conducted in accordance with the FDA Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", as recognized by FDA. Biocompatibility of indirect blood path external communicating device (Fluid Pathway) with prolonged contact duration were confirmed by evaluating the following ISO 10993-1 recommended biocompatibility evaluation endpoints.

Fluid Pathway

- Chemical Characterization ●
- Establishment of Allowable Limits ●
- Cytotoxicity ●
- Sensitization ●
- Irritation or Intracutaneous Reactivity ●
- Acute Systemic Toxicity ●
- Material Mediated Pyrogenicity ●
- o Hemocompatibility

The proposed device has been found biocompatible for its intended use/indications for use.

#### 3. Sterilization and Shelf Life

The sterilization validation activities have been performed using Ethylene Oxide sterilization method in accordance with ISO 11135:2014 Sterilization of health care products - Ethylene oxide — Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices to state the Sterility Assurance Level (SAL) of 10 for the proposed device labeled as sterile.

The stability of the package in maintaining sterility has been assessed through the transit and storage life cycles in accordance with the ISO 11607-1:2019 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems by way of visual assessment, package peel strength and sterile package integrity (bubble test) following applicable conditioning.

#### VIII. CLINICAL DATA

Not applicable.

#### IX. CONCLUSIONS

NP Medical believes that the NP Medical nPulse™ K150 Neutral Displacement Needle Free Connector as indicated in this traditional 510(k) premarket notification submission is substantially equivalent to the predicate device NP Medical K100 Neutral Displacement Needle Free Connector (K130023).