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 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.

AI/ML Overview

The provided text describes a medical device, the NP Medical nPulse™ K150 Neutral Displacement Needle Free Connector, and its substantial equivalence to a predicate device (NP Medical K100 Neutral Displacement Needle Free Connector) for FDA 510(k) clearance.

The document highlights performance testing conducted to support this equivalence. Here's extraction of relevant information regarding acceptance criteria and study details:

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

The document does not explicitly present a table of acceptance criteria alongside performance data in a direct row-by-row comparison. Instead, it lists the performance tests conducted and generally states that the 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" and that differences from the predicate "demonstrated applicable performance" or "aligns with current best practices."

However, specific performance claims and how they relate to the predicate and established standards are mentioned for certain differences:

Performance Characteristic	Acceptance Criteria (Implied / Achieved)	Reported Device Performance (Subject Device - NP Medical nPulse K150)
Multiple Activations	Applicable performance following 200 activations based on Gland Height and Integrity, Back Pressure, and Activated Pressure Resistance.	Demonstrated applicable performance following 200 activations.
Use Days	Microbial ingress performance supporting a 7-day change protocol with 0 CFU recovered.	Aligning with current best practices for 7-day use; 0 CFU recovered for all test device replicates.
Shelf Life	Performance after 5 years of aging, including microbial ingress testing with 0 CFU recovered.	Demonstrated performance after 5 years of aging; 0 CFU recovered for all test device replicates.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for each of the performance tests (e.g., number of devices tested for Air Bolus, Repeat Insertion, etc.). It mentions "all test device replicates" for microbial ingress testing but doesn't quantify this.

The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in the provided text. It implies internal testing by NP Medical, Inc., located in Clinton, MA, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable to this type of device and study. The testing for the NP Medical nPulse™ K150 connector involves technical performance benchmarks (e.g., flow rates, pressure resistance, sterility) rather than clinical evaluations requiring expert interpretation of diagnostic images or patient outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are typically used in clinical studies, particularly when interpreting subjective data or reaching consensus on diagnoses, which is not the nature of the bench testing described here.

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

This information is not applicable. MRMC studies and AI assistance are relevant to diagnostic tools or image analysis, not to a needle-free connector's performance.

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

This information is not applicable. This device is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests conducted on the NP Medical nPulse™ K150 connector and its predicate device is established by specified functional requirements and consensus standards. For example:

Microbial ingress testing: The ground truth is the absence of microbial growth (0 CFU recovered), demonstrating sterility barrier integrity.
Pressure ratings, flow rates, etc.: The ground truth is compliance with pre-defined engineering specifications and relevant FDA recognized consensus standards (e.g., ISO standards) for intravascular administration sets.

8. The sample size for the training set

This information is not applicable. This is not a machine learning or AI device that requires a training set.

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

This information is not applicable. As in point 8, this device does not utilize machine learning or AI requiring a training set with established ground truth.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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)

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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 Govindarajan@NPMedical.com 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

V. INDICATIONS FOR USE

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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:

ComparisonElement	Subject Device –NP Medical nPulse K150	Predicate Device - NPMedical K100 (K130023)	Analysis of Differences
Product Code	FPA	FPA	Same
Regulation Number	880.5440	880.5440	Same
Class	II	II	Same
Intended Use	Intravascular ExtensionSet	Intravascular ExtensionSet	Same
Indications for Use	The nPulse™ neutraldisplacement connectoris a single patient use,sterile, nonpyrogenicdevice for needlelessaccess to the IV lineand/or IV catheterduring IV therapy. ThenPulse™ connector canbe used for directinjection, intermittentinfusion, continuousinfusion, or aspiration.	The K100 NeutralDisplacement Connectoris a single patient use,sterile, non-pyrogenicdevice for needlelessaccess to the IV lineand/or IV catheter duringIV therapy. The K100connector can be usedfor direct injection,intermittent infusion,continuousinfusion, or aspiration.	Same
Size, shape	26mm L x 12mm D,Cylindrical	26mm L x 12mm D,Cylindrical	Same
Mass	1.55 grams	1.55 grams	Same
ComparisonElement	Subject Device –NP Medical nPulse K150	Predicate Device – NPMedical K100 (K130023)	Analysis of Differences
Components	Inlet, Outlet,Upper Seal, LowerGland, Post, SlitLube, G/P Lube	Inlet, Outlet, UpperSeal, Lower Gland,Post, Slit Lube, G/PLube	Same
Materials	Polycarbonate, LIMSilicone, Silicone Oil	Polycarbonate, LIMSilicone, Silicone Oil	Same. The LIM siliconedurometer is adjusted inthe subject device.
Displacement Type	Neutral	Neutral	Same
Luer Connector	ISO Luer	ISO Luer	Same
Multiple Activations	200 intermittent	96 intermittent	Different. The subjectdevice has demonstratedapplicable performancefollowing 200 activationsthrough Gland Height andIntegrity, Back Pressure,and Activated PressureResistance.
Indwell	96 hours	96 hours	Same
Use Days	7 days	4 days	Different. The proposeddevice aligns with currentbest practices for usedays, specifically throughan evaluation of themicrobial ingressperformance over a periodof seven days resulting in0 CFU recovered for alltest device replicates,which supports thisdifference.
ChemicalCompatibility	Lipids, Alcohol,Chlorhexidine gluconate(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
ComparisonElement	Subject Device -NP Medical nPulse K150	Predicate Device - NPMedical K100 (K130023)	Analysis of Differences
Shelf Life	5 years	1 year launch, 3 yearsplanned	Different. The subjectdevice has demonstratedperformance after 5 yearsof aging including microbialingress testing resulting in0 CFU recovered for alltest device replicates.
Disposable orReusable	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).

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.