(153 days)
The Nexus TKO®-6 is a luer-activated, normally closed, bi-directional, 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®-6 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®6 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.
The Nexus TKO®-6 is a luer-activated, normally closed, bi-directional, 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®-6 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®6 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.
This document is a 510(k) premarket notification approval letter from the FDA for a medical device called the "Nexus Luer-Activated Device, Nexus TKO®-6." It confirms that the FDA has found the device to be substantially equivalent to a legally marketed predicate device.
However, this document does not contain information about acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study report proving a device meets acceptance criteria.
The letter explicitly states: "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... You may, therefore, market the device, subject to the general controls provisions of the Act." This means the device met the requirements for 510(k) clearance, which is primarily about demonstrating substantial equivalence, not necessarily meeting a predefined set of performance acceptance criteria through clinical studies detailed in the provided text.
Therefore,Based on the provided FDA 510(k) clearance letter, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them. This document is an approval letter, not a study report. It states that the device is "substantially equivalent" to a predicate device, which is the basis for its clearance, rather than detailing a specific study with acceptance criteria and performance metrics.
The document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication methods.
- Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Information about standalone (algorithm only) performance.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Therefore, I am unable to provide the requested information from the given text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Heather Turner Director of Quality and Regulatory Nexus Medical, LLC 11315 Strang Line Road Lenexa, Kansas 66215
APR 18 2012
Re: K113398
Trade/Device Name: Nexus Luer-Activated Device, Nexus TKO®-6 Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: March 22, 2012 Received: March 23, 2012
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.
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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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours,
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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Premarket Notification 510(k) Traditional
004.0 Indications for Use Statement
Indications for Use
510(k) Number (if known): _
Device Name: Nexus Luer-Activated Device, Nexus TKO®-6
Indications for Use:
The Nexus TKO®-6 is a luer-activated, normally closed, bi-directional, 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®-6 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®6 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.
X Prescription Use (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 (6) livision Sign-Off) Jivision of Anesthesiology, General Hospital 004-1 Nexus Medical LLC: TKO-6 intection Control, Dental Devices 510(k) Number.
§ 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.