(126 days)
NIMATM Needleless Injectionsite Master Adapter with PosiFlowTM Positive Displacement Feature, IV Sets
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No
The device description and intended use clearly describe a mechanical valve for IV access, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a needleless connection for IV therapy, designed to prevent needle stick injuries, rather than to treat a specific medical condition.
No.
The device is described as an adapter for IV lines, facilitating needleless injection, gravity flow, and fluid withdrawal, without any mention of diagnosing medical conditions.
No
The device description clearly describes a physical, two-way valve made of materials that require biocompatibility testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a needleless connector for IV therapy, facilitating the administration and withdrawal of fluids. This is a therapeutic and access function, not a diagnostic one.
- Device Description: The description focuses on the mechanical function of the valve for fluid access in IV therapy. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There are no mentions of analyzing blood, urine, tissue, or any other biological sample for the purpose of diagnosis, monitoring, or screening.
- Performance Studies: The performance studies mentioned are nonclinical tests related to the device's function and biocompatibility, not diagnostic accuracy or performance metrics like sensitivity or specificity.
In summary, the device's purpose is to provide a safe and convenient way to access IV lines for fluid management, which falls under the category of medical devices used for treatment and access, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
Device Description
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 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.
Mentions image processing
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NIMATM Needleless Injectionsite Master Adapter with PosiFlowTM Positive Displacement Feature, and IV Sets
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/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 Corporation
499 Nibus Street
Brea, CA 92821
Tel: 714-257-2197 or 800-321-6462
Fax: 800-299-4849 |
|----|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact: | Dan Hyun, President
Critical Device Corporation |
| 3. | Date prepared: | December 5, 1996 |
| 4. | Device trade name: | NIMATM Needleless Injectionsite Master Adapter with
PosiFlowTM Positive Displacement Feature, and IV Sets |
| | Common name: | Intravenous (IV) Medication Connector, and IV Sets |
| 5. | Predicate device: | NIMATM Needleless Injectionsite Master Adapter with
PosiFlowTM Positive Displacement Feature, and IV Sets |
| 6. | Description: | 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 |
| 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 a
primary IV line as a continuous or intermittent connection. |
| | b. | 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. |
1
| c. 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 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.
-
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.