(30 days)
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No
The provided text describes a simple mechanical device (needle-less intravascular administration set accessory) and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
Explanation: The device is described as an "intravascular administration set accessory for the delivery of drugs and fluids," which is a support function for therapeutic procedures, rather than a therapeutic device itself. Its purpose is to aid in drug and fluid delivery and prevent needle stick injuries, not to directly treat a medical condition.
No
The device is described as an "intravascular administration set accessory for the delivery of drugs and fluids," and its purpose is to "aid in the prevention of needle stick injuries." There is no mention of it being used for diagnosis or collecting information for diagnostic purposes.
No
The device is described as a "needle-less device intended as an intravascular administration set accessory," which strongly suggests a physical hardware component, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "intravascular administration set accessory for the delivery of drugs and fluids." This describes a device used in vivo (within the body) for administering substances, not a device used in vitro (outside the body) for examining specimens from the body to diagnose conditions.
- Anatomical Site: The anatomical site is "Intravascular," which further confirms its use within the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening
Therefore, the NIS-5 device, as described, falls under the category of a medical device used for drug and fluid delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NIS-5 Is a needle-less device intended as an intravascular administration set accessory for the delivery of drugs and fluids. The NIS-5 device may aid in the prevention of needle stick injuries.
Product codes
FPA
Device Description
The NIS-5 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)
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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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2005 DEC 8
2005
Mr. AL Boedeker Director of Quality Nexus Medical, LLC 11315 Strang Line Road Lenexa, Kansas 66215
Re: K053129
Trade/Device Name: NexusTKO Needleless Access Device, Model NIS-5 Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 25, 2005 Received: November 8, 2005
Dear Mr. Boedeker:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have revealy one and have determined the device is substantially cquivalent (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 mendments, or to devices that have been reclassified in accordance with the provisions of / Innendments, or to do rooms act (Act) that do not require approval of a premarket the Fought F 600; Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents of a 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 (1 MA), it may of subject to back of federal Regulations, Title 21, Parts 800 to 898. In your device ear. 80 rear over announcements concerning your device in the Ecderal Register.
1
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 modi that 1 Dr may Federal statutes and regulations administered by other Federal agencies. or the Fet of any - with all the Act's requirements, including, but not limited to: registration 1 ou Intilet compry was a 807); labeling (21 CFR Part 801); good manufacturing practice and fiscing (21 certer as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as be forth in are quartion 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 premarket notification. The PDF 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), rr you desire spbeint at 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 maj South 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/industry/support/index.html.
Sincerely yours,
Souite y. Michie Omd
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
2
Indications for Use
510(k) Number (if known): HO53129
Device Name: NIS-5
Indications for Use:
The NIS-5 Is a needle-less device intended as an intravascular administration set accessory for the delivery of drugs and fluids. The NIS-5 device may aid in the prevention of needle stick injuries.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PILEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) for MD2
October 2005 Nexus Medical LLC: NIS-5 Childsion Sign-Off)
City sion of Anesthesiology, General Hos in coron Control, Danial Devices
3 - રે
1 10(k) Number __