NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS

K964918 · Critical Device Corp. · FPA · Apr 14, 1997 · General Hospital

Device Facts

• Record ID: K964918
• Device Name: NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS
• Applicant: Critical Device Corp.
• Product Code: FPA · General Hospital
• Decision Date: Apr 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

a. For use as a needleless alternative to IV set injection ports. The NIMA™ 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. c. For use as a replacement to the injection cap (heparin cap) on an I. V. catheter for intermittent injections. d. For use for injection, as a gravity flow connector, and as an access port for withdrawal of fluids. e. For use with standard luer taper connections. f. For single patient use.

Device Story

NIMA™ adapter is a two-way valve for needleless IV access; connects to peripheral/central venous catheters or Y-sites. Operates via standard male luer taper insertion to open normally closed valve. Features PosiFlow™ positive displacement to compensate for volume displacement during disconnection, preventing blood retrograde and potential catheter occlusion. Used in clinical settings by healthcare providers for IV therapy, fluid withdrawal, and gravity flow. Eliminates need for hypodermic needles, reducing needle stick injury risk and blood-borne pathogen transmission. Single-patient use.

Clinical Evidence

Bench testing only. Tripartite biocompatibility testing performed; performance specifications verified against original approved device design.

Technological Characteristics

Two-way valve; reseal septum; PosiFlow™ positive displacement mechanism; standard male luer taper interface; single-patient use; non-pyrogenic materials.

Indications for Use

Indicated for patients requiring IV therapy via peripheral or central venous catheters; facilitates needleless intermittent or continuous access for infusion, gravity flow, or fluid withdrawal.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• NIMA™ Needleless Injectionsite Master Adapter with PosiFlow™ Positive Displacement Feature, and IV Sets (K9C4918)

Submission Summary (Full Text)

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Critical Device Corporation
499 Nibus Street • Brea • CA • 92821
APR 14 1997
K9C4918

# 510(k) Summary

1. Submitter: Critical Device Corporation
499 Nibus Street
Brea, CA 92821
Tel: [phone] or 800-321-6462
Fax: [phone]

2. Contact: Dan Hyun, President
Critical Device Corporation

3. Date prepared: December 5, 1996

4. Device trade name: NIMA™ Needleless Injectionsite Master Adapter with PosiFlow™ Positive Displacement Feature, and IV Sets

Common name: Intravenous (IV) Medication Connector, and IV Sets

5. Predicate device: NIMA™ Needleless Injectionsite Master Adapter with PosiFlow™ Positive Displacement Feature, and IV Sets

6. Description: The NIMA™ 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 NIMA™ 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 NIMA™ adapter.

This device does not require the use of hypodermic needles for the infusion of IV solutions. Thus preventing needle stick injuries. The NIMA™ 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 NIMA™ 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.

Toll Free (800) 321-NIMA • Phone [phone] • Fax [phone]

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# Critical Device Corporation
## 510(k) Summary

c. For use as a replacement to the injection cap (heparin cap) on an I. V. catheter for intermittent injections.

d. For use for injection, as a gravity flow connector, and as an access port for withdrawal of fluids.

e. For use with standard luer taper connections.

f. For single patient use.

8. Technological comparison to predicate device:

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.

9. 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.

10. Conclusion:

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.