(102 days)
Not Found
Not Found
No
The summary describes a mechanical device (tubing sets with a check valve) and makes no mention of AI or ML.
No
The device is described as administering IV fluids/medication, which is a therapeutic action, but the device itself is a tubing set with a check valve, facilitating the administration rather than having a direct therapeutic effect on the patient's condition or disease state. It's an accessory for therapy delivery.
No
The device is described as administering IV fluids/medication, which is a treatment function, not a diagnostic one. It facilitates fluid flow in a specific direction.
No
The device description explicitly states "Nexus IV Tubing Sets with Luer-Accessible One-Way Check Valve," indicating a physical hardware component (tubing sets and a valve) is the core of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to administer IV fluids/medication to a patient's vascular system. This is a direct interaction with the patient's body for therapeutic purposes.
- Device Description: The device is an IV tubing set with a check valve, designed for fluid administration.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVDs are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body for treatment.
N/A
Intended Use / Indications for Use
The NIVTS-LACV (Nexus IV Tubing Sets with Luer-Accessible One-Way Check Valve) are intended to administer IV fluids/medication to the patient's vascular system through a needle-free device system that aids in the elimination of needle-stick injury.
The Nexus Luer-Accessible One-Way Check Valve (LACV) is designed to allow fluid flow in one direction and stop or check fluid flow in the opposite direction.
Product codes
FPA
Device Description
Nexus IV Tubing Sets with Luer-Accessible One-Way Check Valve (NIVTS-LACV) are designed to administer IV fluids/medication. The Nexus Luer-Accessible One-Way Check Valve (LACV) component allows fluid flow in one direction and stops or checks fluid flow in the opposite direction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
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)
Not Found
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.
Not Found
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
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 for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and a circle of text around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6 Silver Spring, MD 20993-0002
July 9, 2013
Nexus Medical, LLC Ms. Heather Turner Director of Quality & Regulatory 11315 Strang Line Road LENEXA KS 66215
Re: K130879
Trade/Device Name: Nexus IV Tubing Sets with Luer-Accessible One-Way Check Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 3, 2013 Received: June 4, 2013
Dear Ms. Tuner:
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 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.
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/Resourcesfor You/Industry/default.htm.
https://www.fda.gov/medical-devices/resources-learn-about-medical-devices/condensation
Sincerely yours.
Mary S. Runner -S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Premarket Notification 510(k) Traditional
. . . . . . . .
004.0 Indications for Use Statement
中国际网址 - bet365体育在线
Indications for Use
510(k) Number (if known): K (30879
Device Name: Nexus IV Tubing Sets with Luer-Accessible One-Way Check Valve
Indications for Use:
The NIVTS-LACV (Nexus IV Tubing Sets with Luer-Accessible One-Way Check Valve) are intended to administer IV fluids/medication to the patient's vascular system through a needle-free device system that aids in the elimination of needle-stick injury.
The Nexus Luer-Accessible One-Way Check Valve (LACV) is designed to allow fluid flow in one direction and stop or check fluid flow in the opposite direction.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Richard C. Chapman
2013.07.01 14:51:14
-04'00' | (Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K130879 |
Nexus Medical LLC: NIVTS-LACV 004-1