(140 days)
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Not Found
No
The summary describes a standard IV tubing set and contains no mention of AI, ML, or related concepts.
No
The device is used to administer IV fluids/medication, which is a supportive function rather than a direct therapeutic intervention that treats or cures a disease or condition.
No
Explanation: The device is described as an IV tubing set for administering fluids/medication, which is a therapeutic rather than diagnostic function. It does not collect or analyze data to determine the presence or nature of a disease or condition.
No
The intended use describes a physical device (IV tubing sets) used to administer fluids, which is a hardware component. There is no mention of software as the primary or sole component.
Based on the provided information, the NIVTS (Nexus IV Tubing Sets) is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to administer fluids/medication to the patient's vascular system. This is a direct interaction with the patient's body for therapeutic purposes.
- IVDs: In vitro diagnostics are devices used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health.
The NIVTS is a medical device used for administering treatment, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The NIVTS (Nexus IV Tubing Sets) are intended for use to administer IV fluids/medication to the patients's vascular system through a needle-free system that aids in the elimination of needle-stick injury
Product codes
FPA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 26 2004
Mr. AL Boedeker Director, Regulatory Affairs/Quality Assurance Nexus Medical, LLC 11315 Strang Line Road Lenexa, Kansas 66215
Re: K041861
Trade/Device Name: Nexus Intravenous Tubing Sets Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: November 2, 2004 Received: November 3, 2004
Dear Mr. Boedeker:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Eederal Register.
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Page 2 - Mr. Boedeker
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. 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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Image /page/2/Picture/1 description: The image shows the logo for Nexus Medical. The logo features the word "NEXUS" in bold, stylized letters, with the word "MEDICAL" underneath in a smaller font. To the left of the word "NEXUS" are curved lines that resemble a circular shape. The letters are in black, and there is a trademark symbol in the upper right corner of the logo.
11315 Strang Line Road, Lenexa, KS
Responses to Reviewers Fax of 8/5/04 11/2/04 Response
Indications for Use Statement
| Applicant: | Nexus Medical LLC |
|---|---|
| 510(k) Number (if known): | K041861 |
| Device Name: | Nexus Intravenous Tubing Sets |
| Indications For Use: |
The NIVTS (Nexus IV Tubing Sets) are intended for use to administer IV fluids/medication to the patients's vascular system through a needle-free system that aids in the elimination of needle-stick injury
| Prescription Use | X | AND/OR | Over-The -Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
| 510(k) Number: | K041861 |
|---|---|
| ---------------- | --------- |
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