NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET

K964812 · Critical Device Corp. · FPA · Feb 10, 1997 · General Hospital

Device Facts

• Record ID: K964812
• Device Name: NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET
• Applicant: Critical Device Corp.
• Product Code: FPA · General Hospital
• Decision Date: Feb 10, 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; two-way valve; enables needleless intermittent/continuous IV access; connects to peripheral/central venous catheters or Y-sites; activated by standard male luer taper insertion; prevents needle stick injuries; reduces blood-borne pathogen transmission risk (HIV/HBV); used in clinical settings; operated by healthcare providers; replaces conventional injection ports/heparin caps; supports gravity flow and fluid withdrawal.

Clinical Evidence

Bench testing only. Tripartite biocompatibility testing performed on new materials; performance specifications verified against original device requirements.

Technological Characteristics

Two-way valve mechanism; standard luer taper interface; single patient use; materials meet performance specifications; biocompatibility verified per tripartite standards.

Indications for Use

Indicated for patients requiring IV therapy; provides needleless access for infusion of IV solutions, gravity flow, and fluid withdrawal; replaces conventional Y-sites or heparin caps on peripheral/central venous catheters.

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 and IV Sets (K964812)

Submission Summary (Full Text)

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Critical Device Corporation
499 Nibus Street • Brea • CA • 92821
FEB 10 1997
K964812

# 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: November 22, 1996

4. Device trade name: NIMA™ Needleless Injectionsite Master Adapter and IV Sets
Common name: Intravenous (IV) Medication Connector and IV Sets

5. Predicate device: NIMA™ Needleless Injectionsite Master Adapter 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.
c. For use as a replacement to the injection cap (heparin cap) on an I. V. catheter for intermittent injections.

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

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# Critical Device Corporation
## 510(k) Summary

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 technological characteristics are equivalent to the currently approved NIMA™ Needleless Injectionsite Master Adapter and IV Sets. Alternate materials and use duration extended from 24 to 96 hours are approved in this application.

9. Nonclinical test summary:
New materials meet 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™ modification(s) have demonstrated safety and effectiveness, and is substantially equivalent to the legally marketed predicate device.

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