(73 days)
NIMA™ Needleless Injectionsite Master Adapter and IV Sets
None
No
The provided text describes a mechanical valve for IV therapy and does not mention any AI or ML components or functionalities.
No.
The device is described as an adapter and valve for IV therapy, designed to prevent needle stick injuries and facilitate fluid access, not to provide therapeutic treatment itself.
No
The device is described as a two-way valve for IV therapy access, designed to prevent needle stick injuries, and there is no mention of it being used for diagnosis or detection of any 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/Indications for Use: The intended uses described are all related to the physical delivery or withdrawal of fluids in IV therapy. This involves connecting to IV lines, catheters, and syringes. None of the listed uses involve testing samples from the human body to provide diagnostic information.
- Device Description: The device is described as a "two-way valve" for "needleless intermittent and continuous access in IV therapy." This description aligns with a medical device used for fluid management, not for diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing any kind of diagnostic result.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health status, diagnose diseases, or monitor treatment. This device's function is purely mechanical and related to fluid handling in a clinical setting.
N/A
Intended Use / Indications for 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.
Product codes
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Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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: New materials meet 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)
NIMA™ Needleless Injectionsite Master Adapter 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 for Critical Device Corporation. The logo is black and white and features the company name in a bold, sans-serif font. Below the logo is the company's address, which is 499 Nibus Street, Brea, CA 92821. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and other communications.
FEB 1 0 1997
K964812
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 |
-
- Contact: Dan Hyun. President Critical Device Corporation
- November 22, 1996 3. Date prepared:
- Device trade name: NIMA™ Needleless Injectionsite Master Adapter and IV Sets 4.
- Common name: Intravenous (IV) Medication Connector and IV Sets
- Predicate device: 5. NIMA™ Needleless Injectionsite Master Adapter and IV Sets
-
- 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.
ನ್ನ
1
- 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: 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.
- Conclusion: 10. The NIMA™ modification(s) have demonstrated safety and effectiveness, and is substantially equivalent to the legally marketed predicate device.