(203 days)
Not Found
Not Found
No
The summary describes a mechanical device (luer-activated connector) and makes no mention of AI, ML, or any software-driven analytical capabilities.
No.
The device is described as an accessory to an IV catheter for administration of substances, and aids in reducing needlestick injuries, but it does not directly provide a therapeutic effect itself.
No
Explanation: The device is described as an accessory for intravenous administration of blood, IV drugs, and fluids, and capable of being used with power injectors. Its function is to facilitate the delivery of substances to the body, not to diagnose conditions or diseases.
No
The device description clearly indicates it is a physical, pressure-rated, luer-activated device with a pre-slit septum, which are all hardware components.
Based on the provided information, the Nexus NIS®-6P is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's an accessory to an IV catheter for administering substances to the patient. IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on its mechanical function as a luer-activated, normally closed, bidirectional, neutral pressure device. This aligns with a device used for fluid delivery, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or any other components typically associated with IVD devices.
Therefore, the Nexus NIS®-6P is a medical device used for intravenous administration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Nexus NIS®-6P is a pressure-rated, luer-activated, normally closed, bidirectional, neutral pressure device intended for use as an accessory to an IV catheter placed in the vein or artery for intravenous administration of blood, IV drugs and IV fluids to the patient including neonatal, pediatric and immunocompromised patients. The Nexus NIS®-6P may also be safely used with power injectors at 10mL/sec and pressures up to 325 psi. The Nexus NIS®-6P has a pre-slit septum which does not require the use of a stainless steel needle and passively aids in the reduction of needlestick injuries.
Product codes
FPA
Device Description
The Nexus NIS®-6P is a pressure-rated, luer-activated, normally closed, bidirectional, neutral pressure device intended for use as an accessory to an IV catheter placed in the vein or artery for intravenous administration of blood, IV drugs and IV fluids to the patient including neonatal, pediatric and immunocompromised patients. The Nexus NIS®-6P may also be safely used with power injectors at 10mL/sec and pressures up to 325 psi. The Nexus NIS®-6P has a pre-slit septum which does not require the use of a stainless steel needle and passively aids in the reduction of needlestick injuries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vein or artery
Indicated Patient Age Range
neonatal, pediatric
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 seal for the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
· Public Ilealth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2014
NEXUS Medical Limited Liability Company C/O Ms. Heather Turner Director of Quality and Regulatory 11315 Strang Line Road Lenexa, Kansas 66215
Re: K 133351
Trade/Device Name: Nexus NIS-6P Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Il Product Code: FPA Dated: April 14, 2014 Received: April 16, 2014
Dear Ms. Turner:
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. 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 cither 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.
1
Page 2 - Ms. Turner
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K133351
Device Name
Nexus NIS®-6P, Luer Activated Device
Indications for Use (Describe)
The Nexus NIS®-6P is a pressure-rated, luer-activated, normally closed, bidirectional, neutral pressure device intended for use as an accessory to an IV catheter placed in the vein or artery for intravenous administration of blood, IV drugs and IV fluids to the patient including neonatal, pediatric and immunocompromised patients. The Nexus NIS®-6P may also be safely used with power injectors at 10mL/sec
and pressures up to 325 psi. The Nexus NIS®-6P has a pre-slit septum which does not require the use of a stainless steel needle and passively aids in the reduction of needlestick injuries.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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