(50 days)
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Not Found
No
The summary describes a mechanical, needle-less injection site accessory and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is described as an accessory for the delivery of drugs and fluids and aids in the prevention of needle stick injuries; it does not directly provide therapy.
No
Explanation: The device description states its purpose is for the "delivery of drugs and fluids" and to "aid in the prevention of needle stick injuries." There is no mention of it being used for diagnosis, disease detection, or medical assessment.
No
The device description explicitly states it is a "needle-less device intended as an intravascular administration set accessory," which describes a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of drugs and fluids intravascularly, acting as an accessory to an administration set. This is a therapeutic or delivery function, not a diagnostic one.
- Device Description: The description reinforces its role as a needle-less accessory for drug and fluid delivery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status or condition. IVDs are designed to perform tests on biological samples to diagnose, monitor, or screen for diseases or conditions.
Therefore, the Nexus Injection Site is a medical device, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Nexus Injection Site ("NIS") is a needle-less device intended as an intravascular administration set accessory for the delivery of drugs and fluids. The NIS device may aid in the prevention of needle stick injuries.
Product codes
FPA
Device Description
The Nexus Injection Site ("NIS") is a needle-less device intended as an intravascular administration set accessory for the delivery of drugs and fluids.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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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.
0
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol consisting of three abstract human profiles facing to the right, with three curved lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 2003
Nexus Medical, LLC C/O Dr. Jamie Abourched JASA Consulting, LLC 11428 Lostwood Lane, Suite B Raleigh, North Carolina 27614
Re: K024363
Trade/Device Name: Nexus Injection Site Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: December 19, 2002 Received: December 31, 2002
Dear Dr. Abourched:
11 -
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 Federal Register.
1
Page 2 - Dr. Abourched
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 (301) 594-4618. 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,
Susan Russer
Susan Runner, DDS, MA Interim 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 word "nexus" in white font on a black oval background. The word is written in lowercase letters. A white line underlines the word, starting from the left side of the "n" and ending on the right side of the "s". The font appears to be sans-serif.
Nexus Medical LLc
Nexus Injection Site K024363 Response to Reviewers Questions dated 02/06/03 510(k) Notification
Indications for Use Statement
| Ver/ 3 - 4/24/96 | |
|---|---|
| Applicant: | Nexus Medical LLC |
| 510(k) Number (if known): | K024363 |
| Device Name: | Nexus Injection Site |
| Indications For Use: |
The Nexus Injection Site ("NIS") is a needle-less device intended as an intravascular
administration set accessory for the delivery of drugs and fluids. The NIS device may aid in
the prevention of needle stick injuries.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Patricia Cucente
(Division Sign Off)
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
5 510(k) Number ________________________________________________________________________________________________________________________________________________________________
RESPONSE DATED 02/08/03
PAGE R-06
11315 Strang Line Road • Lenexa, Kansas 66215 • tel 913-451-2234 • fax 913-451-2363