(113 days)
Not Found
Not Found
No
The summary describes a mechanical anti-reflux device with no mention of AI, ML, or related concepts.
No
The device is an anti-reflux accessory to an IV catheter for administration of fluids and blood. It does not treat or cure a disease or condition itself.
No
This device is an anti-reflux device intended for IV administration and does not mention any diagnostic capabilities.
No
The device description clearly indicates a physical, pressure-rated, luer-activated anti-reflux device, which is hardware.
Based on the provided information, the Nexus TKO®-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 blood, drugs, and fluids to the patient. This is a direct interaction with the patient's circulatory system for therapeutic or diagnostic purposes in vivo, not for examining samples in vitro.
- Device Description (Not Found): While the description isn't available, the intended use is the primary indicator of whether a device is an IVD.
- No Mention of In Vitro Testing: There is no mention of analyzing samples (blood, urine, tissue, etc.) outside of the body.
- Focus on Patient Administration: The entire description revolves around facilitating the safe and efficient delivery of substances into the patient's veins or arteries.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The Nexus TKO®-6P's function is entirely focused on the delivery of substances into the body.
N/A
Intended Use / Indications for Use
The Nexus TKO®-6P is a pressure-rated, luer-activated, normally closed, bidirectional, neutral pressure anti-reflux 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 TKO®6P may also be safely used with power injectors at 10mL/sec and pressures up to 325 psi.
The Nexus TKO®-6P incorporates anti-reflux technology which prevents blood reflux resulting from the following conditions: bag run-dry, connection and disconnection of luer lock devices, syringe plunger compression and patient vascular changes, such as coughing or sneezing.
The Nexus TKO®-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 TKO®-6P is a pressure-rated, luer-activated, normally closed, bidirectional, neutral pressure anti-reflux device. It is designed to be used as an accessory to an IV catheter. It incorporates anti-reflux technology and has a pre-slit septum.
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): 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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes extending from its back, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2013
Nexus Medical, LLC Ms. Heather Turner Director of Quality and Regulatory 11315 Strang Lane Road LENEXA KS 66215
Re: K130416
Trade/Device Name: Nexus TKO® -6P, Luer Activated Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 13, 2013 Received: May 14, 2013
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 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/Resourcesfor You/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.
Sincerely vours.
Susan Runner DDS, MA 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
Indications for Use
510(k) Number (if known): K1304 Lo
Device Name: Nexus TKO®-6P, Luer Activated Device
Indications for Use:
The Nexus TKO®-6P is a pressure-rated, luer-activated, normally closed, bidirectional, neutral pressure anti-reflux 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 TKO®6P may also be safely used with power injectors at 10mL/sec and pressures up to 325 psi.
The Nexus TKO®-6P incorporates anti-reflux technology which prevents blood reflux resulting from the following conditions: bag run-dry, connection and disconnection of luer lock devices, syringe plunger compression and patient vascular changes, such as coughing or sneezing.
The Nexus TKO®-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.
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 2013.06.11
12:03:38 -04'00' Nexus Medical LLC: TKO-6P
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
004-1
510(k) Number: K130