(126 days)
For use as a needleless alternative to IV set injection ports. The NIMATM adapter will replace the conventional Y-site on a primary IV line as a continuous or intermittent connection.
For use as part of a program to reduce needle stick injuries and the associated transmission of blood borne pathogens such as HIV and HBV.
For use as a replacement to the injection cap (heparin cap) on an I. V. catheter for intermittent injections.
For use for injection, as a gravity flow connector, and as an access port for withdrawal of fluids.
For use with standard luer taper connections.
For single patient use.
The NIMATM adapter is a two-way valve that permits easy needleless intermittent and continuous access in IV therapy. It can be connected to peripheral or central venous catheters or Y-sites. The normally closed NIMATM adapter valve is opened by inserting a standard male luer taper, such as on an extension set, IV tubing or syringe to the female end of the NIMATM adapter. This device does not require the use of hypodermic needles for the infusion of IV solutions. Thus preventing needle stick injuries. The NIMATM adapter is packaged individually and as attached as part of extension sets
The provided text is a 510(k) summary for a medical device called the "NIMA™ Needleless Injection Site Master Adapter with PosiFlow™ Positive Displacement Feature." This document describes the device, its intended use, and its comparison to a predicate device.
However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets these criteria, or any details about sample sizes, ground truth establishment, expert involvement, or AI/human reader studies.
The summary states:
- "The new design meets all performance specifications established for the originally approved device."
- "Tripartite biocompatibility testing indicates that the new materials are safe and biocompatible."
- "The NIMA™ adapter with PosiFlow™ Positive Displacement Feature modification(s) have demonstrated safety and effectiveness, and is substantially equivalent to the legally marketed predicate device."
These are generalized statements of compliance and equivalence, but they do not provide the detailed information requested in the prompt about specific acceptance criteria and the methods used to demonstrate that the criteria were met.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, or any of the other study-specific details, as that information is not present in the provided text.
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Image /page/0/Picture/0 description: The image shows the logo and address of Critical Device Corporation. The address is 499 Nibus Street, Brea, CA 92821. The logo is a black square on the left and the company name on the right.
APR 1 4 1997
K9649/8
510(k) Summary
| 1. | Submitter: | Critical Device Corporation499 Nibus StreetBrea, CA 92821Tel: 714-257-2197 or 800-321-6462Fax: 800-299-4849 |
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| 2. | Contact: | Dan Hyun, PresidentCritical Device Corporation |
| 3. | Date prepared: | December 5, 1996 |
| 4. | Device trade name: | NIMATM Needleless Injectionsite Master Adapter withPosiFlowTM Positive Displacement Feature, and IV Sets |
| Common name: | Intravenous (IV) Medication Connector, and IV Sets | |
| 5. | Predicate device: | NIMATM Needleless Injectionsite Master Adapter withPosiFlowTM Positive Displacement Feature, and IV Sets |
| 6. | Description: | The NIMATM adapter is a two-way valve that permits easyneedleless intermittent and continuous access in IV therapy.It can be connected to peripheral or central venous cathetersor Y-sites. The normally closed NIMATM adapter valve isopened by inserting a standard male luer taper, such as on anextension set, IV tubing or syringe to the female end of theNIMATM adapter.This device does not require the use of hypodermic needlesfor the infusion of IV solutions. Thus preventing needle stickinjuries. The NIMATM adapter is packaged individually and asattached as part of extension sets |
| 7. | Intended Use:a. | For use as a needleless alternative to IV set injection ports.The NIMATM adapter will replace the conventional Y-site on aprimary IV line as a continuous or intermittent connection. |
| b. | For use as part of a program to reduce needle stick injuriesand the associated transmission of blood borne pathogenssuch as HIV and HBV. |
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| c. For use as a replacement to the injection cap (heparin cap) on |
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| an I. V. catheter for intermittent injections. |
- For use for injection, as a gravity flow connector, and as an d. access port for withdrawal of fluids.
- For use with standard luer taper connections. e.
- f. For single patient use.
- Technological comparison to predicate device: 8.
The NIMA™ adapter with PosiFlow™ feature compensates for the displaced volume due to the adapter seal closing when the proximal (up line, or away from the patient) standard luer connection is removed. This feature is expected to be most effective in very small bore peripheral vascular access devices which are filled with a heparin flush to keep the access patent. Blood retrograde is one of the factors associated with clot formation and potential occlusion of catheters and cannulas. The PosiFlow™ feature is designed to compensate for blood retrograde into the vascular access device as a result of disconnecting a fluid source from the NIMA ™ adapter.
The performance of the NIMA™ adapter in microbial challenge is centered on the design and configuration of the reseal septum. Neither the material nor the design of the reseal septum is changed from the predicate design.
The proposed change does not require any procedural changes by the user.
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റ്റ് Nonclinical test summary:
The new design meets all performance specifications established for the originally approved device. Tripartite biocompatibility testing indicates that the new materials are safe and biocompatible. -
The NIMA™ adapter with PosiFlow™Positive Displacement 10. Conclusion: Feature modification(s) have demonstrated safety and effectiveness, and is substantially equivalent to the legally marketed predicate device.
§ 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.