(37 days)
No
The device description and intended use focus on mechanical components and their function in preventing needlestick injuries. There is no mention of AI, ML, or any computational analysis of data.
No
This device is intended to prevent "needlestick" injuries during the administration of fluids and medications, and re-seals upon removal of a cannula, but does not itself administer any therapy.
No
This device is designed for administering fluids and medications, providing a needleless entry point to an intravascular administration set. It does not perform any diagnostic function.
No
The device description clearly outlines physical components such as a tubular body, luer lock attachments, a retaining ring, and a septum, 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 clearly states the device is for providing protection against needlestick injuries during the administration of fluids and medications. This is a direct interaction with the patient's circulatory system for therapeutic purposes, not for examining specimens from the body to diagnose disease or other conditions.
- Device Description: The description details a mechanical device for connecting to intravascular administration sets and catheters. It does not involve reagents, assays, or any components used for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device's function is purely related to the delivery of substances into the body.
Therefore, this device falls under the category of a medical device used for patient care and administration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Needleless Injection Site is intended to provide additional protection against inadvertent "needlestick" injuries to health care providers during the administration of fluids and medications. The Needleless Injection Site provides for the entry to an intravascular administration set or catheter without the need of a sharp needle by allowing for the use of a blunt cannula.
Product codes
FPA
Device Description
The BEC Needleless Injection Site consists of a tubular body with a male luer lock attachment at one end. This attachment is designed to connect to a female luer lock or luer slip connector of a catheter or other intravascular administration device. The other end of the tubular body is provided with an enlarged section adapted to receive a cylindrical retaining ring which surrounds and compresses a pre-slit, natural rubber septum. The septum retaining ring and enlarged section of the tubular body are adapted to receive and latch with the BEC, MED-NET, or IMED shrouded plastic cannula. The pre-slit septum re-seals upon removal of the cannula.
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
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)
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 BEC laboratories, inc. The logo features the letters 'bec' in a bold, sans-serif font, with 'laboratories, inc.' written in a smaller font underneath. The letters are inside of a black circle with a white outline. There are three horizontal lines on the top and bottom of the circle.
510(k) Summary
Headquarters/ Laboratory
/05 front street 'oledo, ohio 43605 oncre, (419) 693-5307 **** (419) 691-0418
Environmental Laboratory
1732 enterprise parkway twinsburg, ohio 44087 phone: (216) 425-8200 1. 1x: (216) 425-1349
Sales Office
1 29 dixie way south south bend, indiana 46637 ohone: (219) 272-2200
Sales Office
o west elmwood drive suite 123 aayton, ohio 45459 phone (513)438-1711
Medical Products Division 615 front street toledo ohio 43605 phone (419) 693-5309
Re: Trade Name: BEC Needleless Injection Site Common Name: Needleless Injection Site Classification Name: Set, Administration, Intravascular 80 FPA
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 Needleless Injection Site consists of a tubular body with a male luer lock attachment at one end. This attachment is designed to connect to a female luer lock or luer slip connector of a catheter or other intravascular administration device. The other end of the tubular body is provided with an enlarged section adapted to receive a cylindrical retaining ring which surrounds and compresses a pre-slit, natural rubber septum. The septum retaining ring and enlarged section of the tubular body are adapted to receive and latch with the BEC, MED-NET, or IMED shrouded plastic cannula. The pre-slit septum re-seals upon removal of the cannula.
The Needleless Injection Site is intended to provide additional protection against inadvertent "needlestick" injuries to health care providers during the administration of fluids and medications. The Needleless Injection Site provides for the entry to an intravascular administration set or catheter without the need of a sharp needle by allowing for the use of a blunt cannula.
This needleless injection site is iclentical to Medical Network Associates, Incorporated's Needleless Injection Site reviewed by FDA in 510(k) # K953343 which was identical to and found to be substantially equivalent to IMED Corporations Needleless Injection Site submitted under 510(k) #K944320. These injection sites are made of the same material by the same foreign manufacturer. Technological data and performance data were submitted for the IMED predicate device.
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
4/3/96
Date Prepared