(442 days)
Not Found
No
The device description and performance studies focus on the mechanical and fluid dynamics of a needle-free connector, with no mention of AI or ML.
No
The device is a connector for IV lines, used for administering fluids or drawing blood, not for treating a disease or condition itself.
No
The device description indicates its use for "needleless access to the IV line and/or IV catheter during IV therapy" for purposes such as "direct injection, intermittent infusion, continuous infusion, or aspiration." These functions relate to administering or withdrawing substances, not to diagnosing conditions.
No
The device description and performance studies clearly indicate a physical medical device (a connector) with bench testing, biocompatibility, sterilization, and shelf life evaluations, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "needleless access to the IV line and/or IV catheter during IV therapy" for purposes like "direct injection, intermittent infusion, continuous infusion, or aspiration." These are all related to administering or withdrawing substances from a patient's bloodstream, not for testing or analyzing samples in vitro (outside the body).
- Device Description: The description reinforces its function as a "needleless access" device for fluid flow in an IV line.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) for diagnostic purposes. There is no mention of reagents, assays, or any other components typically associated with IVD devices.
- Performance Studies: The performance studies focus on the device's functional performance in an IV line context (flow rate, pressure resistance, leak testing, etc.) and biocompatibility, not on diagnostic accuracy or analytical performance.
Therefore, the nPulse™ neutral displacement connector is a medical device used in the administration of IV therapy, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FPA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 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
- 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
In addition, NP Medical has successfully conducted Microbial Ingress testing to support a 7-day change protocol.
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". 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: Chemical Characterization, Establishment of Allowable Limits, Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility. The proposed device has been found biocompatible for its intended use/indications for use.
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.
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.
NP Medical K100 (K130023)
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 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
1
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
2
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)
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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
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
Element | Subject Device –
NP Medical nPulse K150 | Predicate Device - NP
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
Set | Intravascular Extension
Set | Same |
| 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. | The K100 Neutral
Displacement 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 K100
connector can be used
for direct injection,
intermittent infusion,
continuous
infusion, 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 |
| Comparison
Element | Subject Device –
NP Medical nPulse K150 | Predicate Device – NP
Medical K100 (K130023) | Analysis of Differences |
| Components | Inlet, Outlet,
Upper Seal, Lower
Gland, Post, Slit
Lube, G/P Lube | Inlet, Outlet, Upper
Seal, Lower Gland,
Post, Slit Lube, G/P
Lube | Same |
| Materials | Polycarbonate, LIM
Silicone, Silicone Oil | Polycarbonate, LIM
Silicone, Silicone Oil | Same. The LIM silicone
durometer is adjusted in
the subject device. |
| Displacement Type | Neutral | Neutral | Same |
| Luer Connector | ISO Luer | ISO Luer | Same |
| Multiple Activations | 200 intermittent | 96 intermittent | Different. The subject
device has demonstrated
applicable performance
following 200 activations
through Gland Height and
Integrity, Back Pressure,
and Activated Pressure
Resistance. |
| Indwell | 96 hours | 96 hours | Same |
| Use Days | 7 days | 4 days | Different. The proposed
device aligns with current
best practices for use
days, specifically through
an evaluation of the
microbial ingress
performance over a period
of seven days resulting in
0 CFU recovered for all
test device replicates,
which supports this
difference. |
| Chemical
Compatibility | 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 |
| Comparison
Element | Subject Device -
NP Medical nPulse K150 | Predicate Device - NP
Medical K100 (K130023) | Analysis of Differences |
| Shelf Life | 5 years | 1 year launch, 3 years
planned | Different. The subject
device has demonstrated
performance after 5 years
of aging including microbial
ingress testing resulting in
0 CFU recovered for all
test device replicates. |
| Disposable or
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.
7
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).