(77 days)
Not Found
No
The device description and intended use are for standard intravenous fluid administration sets, and there is no mention of AI or ML technology in the provided text.
No
The device is described as an "Intravenous Fluid Solution Infusion Set" used for administration of fluids, not for treatment or diagnosis of a disease or condition. The stated intended use is for "administration of intravenous fluid solution into the body."
No
The device is an infusion set, which is used for the administration of fluids, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like tubing, clamps, luer locks, and connectors, 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 is "for the administration of intravenous fluid solution into the body." This describes a device used in vivo (within the living body) for therapeutic purposes (delivering fluids).
- Device Description: The description details components like tubing, clamps, and luer locks, which are typical for devices used to deliver substances directly into the bloodstream.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing blood, urine, tissue, or other biological samples.
Therefore, the description clearly points to a device used for direct patient treatment, not for laboratory testing of samples.
N/A
Intended Use / Indications for Use
The Solution Infusion Sets are intended to be used for the administration of intravenous fluid solution into the body.
Product codes
Not Found
Device Description
Intravascular administration sets are described in 21 CFR 5880.5440. The Disposable Solution Infusion Sets that we intend to market include 4 types of designs. The sets consist of a length of polyvinylchloride tubing with a clamp roller along it and a male luer lock at one end and a nonvented infusion subassembly without filter at the other end. Model number NNC-3L has a maie luer-lock conector (without injection site) and NNC-3CL has the male luer lock connector and Y-connector with injection site. Model NNC-3CS has the cone luer slip and Y-connector with injection site and NNC-3C has the cone slip connector (without injection site).
The materials used for the components include polyethylene (PE), polyvinylchloride (PVC) (contains DEHP), polypropylene (PP) and acrylonitrile butadiene styrene (ABS). Cyclohexanone and adhesive bond are used and are present in trace amounts.
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
As these sets have been marketed for several years, safety and effectiveness has been established through years of clinical use. There have not been problems reported during use of the sets.
Key Metrics
Not Found
Predicate Device(s)
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
MAR 2 7 1997
Image /page/0/Picture/2 description: The image shows the logo for Nipro. The logo consists of two overlapping circles on the left, followed by the word "NIPRO" in bold, sans-serif font. The entire logo is black against a white background.
NIPRO MEDICAL CORPORATION 10877 N.W. 33rd Street Miami, Florida 33172 Tel .: (305) 599-7174 Fax: (305) 599-8454
SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO® DISPOSABLE SOLUTION INFUSION SET
$807.92 (a)(1)
Contact Person:
Luis Candelario General Manager
Address:
Nipro Medical Corporation 10877 NW 33rd Street Miami, Florida 33172 (305) 599-7174 (telephone) (305) 599-8454 (fax)
Date of Summary Preparation:
March 19, 1997
$807,92 (a)(2)
| Trade Name: | Nipro ® Disposable Solution Infusion Set |
|---|---|
| ------------- | ------------------------------------------ |
Disposable Solution Infusion Set or I.V. Administration Set Common Name:
Classification Name: Intravascular administration set (21 CFR §880.5440)
$807.92 (a)(3)
Legally Marketed Substantially Equivalent Device: I.V. Administration Set , Gainor Medical U.S.A., Inc. (K926448)
$807.92 (a)(4)
Intravascular administration sets are described in 21 CFR Description of Device: 5880.5440. The Disposable Solution Infusion Sets that we intend to market include 4 types of designs. The sets consist of a length of polyvinylchloride tubing with a clamp roller along it and a male luer lock at one end and a nonvented infusion subassembly without filter at the other end. Model number NNC-3L has a maie luer-lock conector (without injection site) and NNC-3CL has the male luer
1
lock connector and Y-connector with injection site. Model NNC-3CS has the cone luer slip and Y-connector with injection site and NNC-3C has the cone slip connector (without injection site).
The materials used for the components include polyethylene (PE), polyvinylchloride (PVC) (contains DEHP), polypropylene (PP) and acrylonitrile butadiene styrene (ABS). Cyclohexanone and adhesive bond are used and are present in trace amounts.
$807.92 (a)(5)
Intended Use:
The Solution Infusion Sets are intended to be used for the administration of intravenous fluid solution into the body.
$807.92 (a)(6)
Comparison of Technical Characteristics:
The Nissho and Gainor Medical devices are exactly the same devices, therefore, all technical characteristics are identical.
As these sets have been marketed for several years, safety and effectiveness has been established through years of clinical use. There have not been problems reported during use of the sets.