(162 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML algorithms or data processing.
No.
The device is an intravenous administration extension set, which is used for the delivery or aspiration of fluids during IV therapy but does not in itself provide a therapeutic action.
No
This device is an extension set for IV therapy, designed for fluid administration and power injector procedures, not for diagnostic purposes.
No
The device description clearly outlines physical components such as tubing, connectors, a valve, and a stabilizing base, indicating it is a hardware medical 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 "direction, intermittent infusion, continuous infusion or aspiration for all patients for which IV therapy is prescribed." This describes a device used for administering fluids or aspirating substances from the body, not for testing samples outside the body.
- Device Description: The description details components like tubing, luer connectors, a valve, and a stabilizing base, all consistent with an intravenous administration set. There is no mention of components or functions related to analyzing biological samples.
- Performance Studies: The performance studies focus on the physical and functional aspects of the device for fluid administration (flow rate, pressure resistance, bond integrity, biocompatibility, sterilization, shelf life). There are no studies related to the accuracy or performance of diagnostic tests.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
In summary, the NP Medical Extension Set with stabilizing base is a medical device used for administering or aspirating fluids intravenously, which falls under the category of general medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The NP Medical Extension Set with stabilizing base is a sterile single patient use device.
The NP Medical Extension Set is intended for direction, intermittent infusion, continuous infusion or aspiration for all patients for which IV therapy is prescribed.
The NP Medical Extension Set incorporates a normally closed bidirectional pressure-activated valve that prevents low pressure retrograde flow and is intended for power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The NP Medical Extension Set with Stabilizing Base is a sterile, single use, non-pyrogenic intravenous administration extension set comprised of a side repositionable tube bonded to a connector hub on one end and a female luer on the other end with a clamp in between. The connector hub has a locking male luer and a rotating tube connection joint. The hub houses a bidirectional Pressure-Activated Valve (PAV) and an integral stabilizer under the connector hub. The stabilizing base component (along with IV tape / adhesive) is intended to help anchor the extension set to the patient. This device is not made with plasticizers Diethylhexylphthalate (DEHP). The NP Medical Extension Set with Stabilizing Base may be used with compatible Vascular Access Devices (VAD), Needle Free Connectors, and other commercially available devices.
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
all patients
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:
- Device flowrate (gravity and pressurized)
- Retrograde pressure resistance
- Dynamic hemolysis
- Positive pressure
- 325psi burst resistance (for rotating tube connection and other joints)
- Extension tube bond integrity
- Stabilization pad bond integrity
- Extension tubing port (rotating connection) interfaces, sub-atm. pressure air leakage
- Resistance to overriding
- ESC resistance to lipids
- PAV robustness
- Particulate contamination, sub-visible particles.
The results of the functional performance testing demonstrated that the proposed device met all requirements and the differences in design, such as rotating tube connection joint and integrated bidirectional Pressure-Activated Valve (PAV) feature do not affect the final product performance and the safety or effectiveness of the proposed device.
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 intact skin surface device (Stabilizing Base) and 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.
Stabilizing Base
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
Extension Set Fluid Pathway - Chemical Characterization
- Establishment of Allowable Limits
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- Hemocompatibility
All the Biocompatibility study results satisfy the acceptance criteria specified by the above applicable standards and proposed device has been found biocompatible for its intended use/indications for use.
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 10-9 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.
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.
Velano Vascular Velano ExT™ Extension Set (K200439)
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.
Nexus Medical, Nexus TKO®-6P, Luer Activated Device (K130416)
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.
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November 3, 2022
NP Medical Krishna Govindarajan Global Quality Regulatory Affairs Manager 101 Union Street Clinton, Massachusetts 01510
Re: K221518
Trade/Device Name: NP Medical nCompass Extension Set with Stabilizing Base Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: October 4, 2022 Received: October 5, 2022
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 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
1
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.
David Wolloscheck, Ph.D. For Paval Patel 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) K221518
Device Name
NP Medical nCompass Extension Set with Stabilizing Base
Indications for Use (Describe)
The NP Medical Extension Set with stabilizing base is a sterile single patient use device.
The NP Medical Extension Set is intended for direction, intermittent infusion, continuous infusion or aspiration for all patients for which IV therapy is prescribed.
The NP Medical Extension Set incorporates a normally closed bidirectional pressure-activated valve that prevents low pressure retrograde flow and is intended for power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second.
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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510(k)Summary
The following summary is provided in accordance with 21 CFR 807.92:
I. SUBMITTER
NP Medical, Inc., 101 Union Street Clinton, MA 01510 Phone: 978-368-6854
Contact Person: Krishna Govindaraian Date Prepared: November 3, 2022
II. DEVICE
| Trade/Device Name: | NP Medical nCompass™ Extension Set with Stabilizing Base |
|---|---|
| Common or Usual Name: | Extension Set |
| Regulation Number: | 21 CFR 880.5440 |
| Regulation Name: | Intravascular administration set |
| Regulatory Class: | Class II |
| Product Code: | FPA |
III. PREDICATE DEVICE
Primary Predicate Device:
Velano Vascular Velano ExT™ Extension Set (K200439).
Reference Device:
Nexus Medical, Nexus TKO®-6P, Luer Activated Device (K130416).
IV. DEVICE DESCRIPTION
The NP Medical Extension Set with Stabilizing Base is a sterile, single use, nonpyrogenic intravenous administration extension set comprised of a side repositionable tube bonded to a connector hub on one end and a female luer on the other end with a clamp in between. The connector hub has a locking male luer and a rotating tube connection joint. The hub houses a bidirectional Pressure-Activated Valve (PAV) and an integral stabilizer under the connector hub. The stabilizing base component (along with IV tape / adhesive) is intended to help anchor the extension set to the patient. This device is not made with plasticizers Diethylhexylphthalate (DEHP). The NP Medical Extension Set with Stabilizing Base may be used with compatible Vascular Access Devices (VAD), Needle Free Connectors, and other commercially available devices.
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510(k)Summary
The following summary is provided in accordance with 21 CFR 807.92:
V. INDICATIONS FOR USE
The NP Medical Extension Set with stabilizing base is a sterile single patient use device.
The NP Medical Extension Set is intended for direct injection, intermittent infusion, continuous infusion or aspiration for all patients for which IV therapy is prescribed.
The NP Medical Extension Set incorporates a normally closed bidirectional pressure-activated valve that prevents low pressure retrograde flow and is intended for power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Primary Predicate Device:
The proposed device and primary predicate device are identical with regards 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 extension set for direct injection, intermittent infusion, continuous infusion, or aspiration for which IV therapy is prescribed.
At a high level, the proposed and primary predicate devices are based on the following same technological elements:
-
Intravascular administration set/extension set
The following technological differences exist between the subject and predicate devices: -
Use of rotating tube connection joint for repositionable extension tube ●
-
Use of integrated Pressure Activated Valve (PAV) for retrograde flow control ●
Reference Device:
The proposed device integrated Pressure Activated Valve (PAV) for retrograde flow control functionality and reference device bidirectional pressure activated valve functionality are identical with regards to operating principle, technological characteristics, performance, safety, and effectiveness. Both the proposed device and reference device include a normally closed bidirectional pressure activated valve that opens in the forward direction enabling infusion, and in the reverse direction enabling blood aspiration.
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510(k)Summary
The following summary is provided in accordance with 21 CFR 807.92:
The following table provides a comparison of technological characteristics between the subject and predicate device:
| Comparison
Element | Subject Device -
NP Medical Extension
Set with stabilizing
base | Predicate Device -
Velano ExT™
Extension Set
(K200439) | Analysis of Differences |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | FPA | FPA | Same |
| Regulation Number | 880.5440 | 880.5440 | Same |
| Class | ll | ll | Same |
| Intended Use | Intravascular Extension
Set | Intravascular
Extension Set | Same |
| Indications for Use | The NP Medical
Extension Set with
stabilizing base is a
sterile single patient use
device.
The NP Medical
Extension Set is intended
for direct injection,
intermittent infusion,
continuous infusion or
aspiration for all patients
for which IV therapy is
prescribed.
The NP Medical
Extension Set
incorporates a normally
closed bidirectional
pressure-activated valve
that prevents low
pressure retrograde flow
and is intended for power
injector procedures to a
maximum pressure of
325 psi at a flow rate of
10ml per second. | The Velano ExT™
Extension Set with
needle free connector
is for single use only.
Each port of the
Velano ExT™
Extension Set may be
used for direct
injection, intermittent
infusion, continuous
infusion or aspiration.
The pressure rated
port of the Velano
ExT™ Extension Set
may be used with
power injector
procedures to a
maximum pressure of
325 psi at a flow rate
of 10ml per second. | Different. The subject
device does not
reference elements
associated with the
needle free connector of
the predicate device.
These excluded features
are intended for Velano's
PIVO™ compatibility for
which the subject device
does not seek to claim.
Added the incorporation
of a normally closed
bidirectional pressure-
activated valve similar to
reference device
K130416. (Performance
tests leveraged from the
reference device:
Retrograde pressure
resistance and PAV
robustness)
Device Flow Rate (gravity
and pressurized) and
Dynamic Hemolysis (per
USP ) testing
performed to demonstrate
substantial equivalence. |
| | The following summary is provided in accordance with 21 CFR 807.92: | | |
| Comparison
Element | Subject Device –
NP Medical Extension
Set with stabilizing
base | Predicate Device –
Velano ExT™
Extension Set
(K200439) | Analysis of Differences |
| Extension Set
Components
/Materials | Male Luer cap/HDPE
Male Luer/PC
Male Luer spin lock
connector/PC
Tubing/PVC
Pinch clamp/POM
Female Luer/PC
Female Luer Cap/HDPE
Fluid Path Body/Si, PC
Stabilizer/ Polystyrene,
Acrylic PSA, Polycoated
LDPE
Pressure activated
valve/Si | Male Luer
cap/HDPE Male
Luer/PC
Male Luer spin lock
connector/PC
Tubing/PVC
Pinch clamp/POM
Female Luer/PC
Female Luer
Cap/HDPE
Fluid Path Body/Si, PC
Stabilizer/ Polystyrene,
Acrylic PSA,
Polycoated LDPE
Pressure activated
valve/Si | Different. The subject
stabilizer uses a
polystyrene fabric with
acrylic PSA and
Polycoated LDPE liner
instead of TPE on the
predicate.
There is no T-Port
connector on subject
device since PIVO™
compatibility is not
required. The subject
device adds a PAV. ISO
10993 biocompatibility
testing was conducted to
demonstrate these
changes did not affect the
product performance and
did not raise any questions
of safety or effectiveness. |
| Overall Length | Overall Length:
3.7 inches (9.3cm) | Overall Length:
5.0 inches (12.7cm) | Different. The subject
device has a shorter
overall length.
Priming Volume, Device
Flow Rate (gravity and
pressurized) and Dynamic
Hemolysis (per USP
) testing conducted
did not raise any questions
of safety or effectiveness. |
| Priming Volume |