(84 days)
No
The document describes a standard intravascular catheter and makes no mention of AI or ML technology.
No
The device is an intravascular catheter used for sampling blood, monitoring blood pressure, or administering fluids intravenously, which are diagnostic and supportive functions, not explicitly therapeutic.
No
The device is intended for sampling blood, monitoring blood pressure, or administering fluids. While blood sampling and blood pressure monitoring can be part of a diagnostic process, the device itself is a tool for obtaining data or delivering treatment, not for interpreting data to provide a diagnosis.
No
The device description clearly states it is an intravascular catheter, which is a physical medical device, not software.
Based on the provided information, the Nipro Safelet Cath is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to be inserted into a patient's vascular system for direct interaction with the body (sampling blood, monitoring blood pressure, administering fluids). This is an in-vivo (within the living organism) application.
- Device Description: The device is described as an intravascular catheter, which is a device used within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body's systems in the way a catheter does.
N/A
Intended Use / Indications for Use
The Nipro Safelet Cath is intended to be inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously.
Product codes
Not Found
Device Description
The devices that we intend to market are intravascular catheters as described in 21 CFR 880.5200. These devices are identical to those already marketed by Exel International, Inc. under K895768.
Two types of catheters will be available: the container case types L (long) and S (short). Type L catheters have needles 11/2 to 21/2 inches long and Type S have needles 3/4 to 11/4 inches long. Six gauges of catheters are described here (14, 16, 18, 20, 22, and 24 gauge). The tip of the cannula is beveled. The proximal end of the catheter has a filter cap.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for NISSHO CORPORATION. The logo consists of the word "Nipro" in a stylized font, with a circular shape around it. To the right of "Nipro" is the text "NISSHO CORPORATION" in a bold, sans-serif font. The logo is black and white.
7205 Corporate Center Drive Suite 305 Miami. Florida 33126 177-865 (505) 19 Fax: (305) 599-8454
- 2 6
SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO SAFELET CATH
§807.92 (a)(1)
Contact Person:
Luis Candelario General Manager
Nipro Safelet Cath
Intravascular catheter
Date of Summary Preparation: January 3, 1996
$807.92 (a)(2)
Trade Name:
Common Name:
Classification Name:
Intravascular catheter (for short-term use) (§880.5200)
§807.92 (a)(3)
Legally Marketed Substantially Equivalent Device: Exel Safelet Catheter, Exel International, Inc. (K895768)
$807.92 (a)(4)
Description of Device:
The devices that we intend to market are intravascular catheters as described in 21 CFR 880.5200. These devices are identical to those already marketed by Exel International, Inc. under K895768.
Two types of catheters will be available: the container case types L (long) and S (short). Type L catheters have needles 11/2 to 21/2 inches long and Type S have needles 3/4 to 11/4 inches long. Six gauges of catheters are described here (14, 16, 18, 20, 22, and 24 gauge). The tip of the cannula is beveled. The proximal end of the catheter has a filter cap.
1
$807.92 (a)(5)
- Intended Use: The Nipro Safelet Cath is intended to be inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously.
8807.92 (a)(6)
Comparison of Technical Characteristics:
The Nissho and Exel devices are exactly the same devices, therefore, all technical characteristics are identical.