(52 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or data-driven features. There is no mention of AI, ML, image processing, or performance metrics typically associated with AI/ML devices.
No.
The device is intended to prevent needlestick injuries and facilitate fluid/medication administration, not to treat a disease or condition itself.
No.
The device's intended use is to provide protection against needlestick injuries during the administration of fluids and medications, and it describes a cannula for drug delivery, not for diagnosis.
No
The device description clearly describes a physical, hardware-based medical device (a shrouded blunt tubular cannula with a luer attachment) and does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide protection against needlestick injuries during the administration of fluids and medications into the intravascular system. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description details a cannula for accessing the intravascular system, not for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
- Anatomical Site: The device interacts with the intravascular system (inside the body), which is typical for therapeutic or procedural devices, not IVDs which analyze samples taken from the body.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Shrouded Plastic Cannula is intended to provide additional protection against inadvertent "needlestick" injuries to health care providers during the administration of fluids and medications. The Shrouded Plastic Cannula provides the ability to penetrate a split septum injection site or Y-site for entry into a intravascular system without the need of a sharp needle.
Product codes
79 GAA
Device Description
The BEC Shrouded Plastic Cannula consists of a shrouded blunt tubular cannula at one end and a female luer attachment at the other. This luer attachment is designed to connect to a male luer lock or luer slip connector of a tubing set, syringe, or other intravascular administration device. The cannula end of the body is designed to penetrate a pre-slit, natural rubber septum and latch with the BEC, MED-NET or IMED Needleless Injection Site or Y-site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intravascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care providers
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)
Technological data and performance data were submitted for the IMED predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image is a logo for "bec laboratories, inc." The logo features the letters "bec" in a bold, sans-serif font, stacked on top of the words "laboratories, inc." The text is set against a black circle with a white outline. To the left of the circle are four horizontal black bars of varying lengths, creating a visual element that complements the circular design.
K96 1328
510(k) Summary
MAY 3 0 1996
Trade Name: Re: Common Name:
BEC Shrouded Plastic Cannula Shrouded Plastic Cannula Classification Name: Needle, Aspiration & Injection, Disposable 79 GAA
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 and DSMA 1995.
The BEC Shrouded Plastic Cannula consists of a shrouded blunt tubular cannula at one end and a female luer attachment at the other. This luer attachment is designed to connect to a male luer lock or luer slip connector of a tubing set, syringe, or other intravascular administration device. The cannula end of the body is designed to penetrate a pre-slit, natural rubber septum and latch with the BEC, MED-NET or IMED Needleless Injection Site or Y-site.
The Shrouded Plastic Cannula is intended to provide additional protection against inadvertent "needlestick" injuries to health care providers during the administration of fluids and medications. The Shrouded Plastic Cannula provides the ability to penetrate a split septum injection site or Y-site for entry into a intravascular system without the need of a sharp needle.
This Shrouded Plastic Cannula is identical to Medical Network Associates, Incorporated's Shrouded Plastic Cannula reviewed by FDA in 510(k) #K952834 which was identical to and found to be substantially equivalent to IMED Corporations Shrouded Plastic Cannula submitted under 510(k) #K945070. These cannulas are made of the same material by the same foreign manufacturer. Technological data and performance data were submitted for the IMED predicate device.
Headquarters/ Laboratory 705 front street toledo, ohio 43605 : none (419) 693-5307 tax: (419) 691-0418
Environmental Laboratory
- I enterprise parkway twinsburg, ohio 44087 phone (216) 425-8200 10x. (216) 425-1349
Sales Office
129 dixie way south sout* bend. indiana 46637 ; >hone: (219) 272-2200
Sales Office
' : west elmwood drive suite 123 dayton, ohio 45459 phone: (513) 438-1711
Medical Products Division 615 front street toledo, ohio 43605 ാhone: (419) 693-5307 fox: (419) 691-1227
1
510(k) Summary (Continued)
Packaging of the device is either performed in-house or under contract by a registered device establishment. Sterilization is performed in-house using a validated ethylene oxide process. Both packaging and sterilization procedures are consistent with those generally used by the medical device industry.
Contact Person:
James P. Kulla, President
4/22/96
Date Prepared