(41 days)
Not Found
No
The device description and intended use focus on mechanical components for fluid delivery and needle-stick prevention. There is no mention of AI, ML, or any computational analysis of data.
No
The device is intended for fluid and medication delivery, focusing on safety for healthcare providers by preventing needlestick injuries, not for treating any specific disease or condition.
No
Explanation: The device description and intended use clearly state that this product is an I.V. Fluid Delivery Set, used for administering fluids and medications, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like PVC tubing, luer connectors, cannulas, Y-sites, and clamps, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "intravascular administration of fluids and medications" and provides protection against "needlestick" injuries. This is a direct interaction with the patient's circulatory system for therapeutic purposes.
- Device Description: The description details a "PVC tubing set" with connectors and potential Y-sites and clamps, designed to connect to an I.V. catheter or injection site. This is consistent with a device used for delivering substances into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. The device's function is purely for delivery of fluids and medications.
Therefore, this device falls under the category of a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The I.V. Fluid Delivery Sets provide for the entry into an intravascular administration system without the need of a sharp needle by allowing for the penetration of a split septum injection sites or split septum Y-sites using an 11 gauge blunt plastic cannula.
Product codes
LHI
Device Description
The B.E.C. Safe Mate I.V. Fluid Delivery Sets consist of a PVC tubing set which has a male luer (slip, fixed luer-lock, or rotating luer-lock) connector or an attached schrouded plastic cannula at one end intended to connect to an I.V. catheter, needle or a split septum injection site extension set affixed to an I.V. catheter. Fluid delivery set lengths may vary from 60" up to 120" or longer. Fluid Delivery Sets may also have one or more split septum Y-sites for the infusion of other liquid medications. Clamps (slide, clip, or roller) may also be included.
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
Technological data and performance data were submitted for the IMED predicate devices. Tubing and standard set components are of medical grade and meet USP Class VI and/or Tripartite guideline biocompatability requirements.
Key Metrics
Not Found
Predicate Device(s)
K955821, K945070, K944320, K931173
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/1 description: The image shows a sequence of handwritten characters. The characters are 'K962802'. The characters are written in black ink on a white background and appear to be part of a serial number or identification code.
Image /page/0/Picture/2 description: The image shows a logo for "bec laboratories, inc." The logo consists of a black circle with the letters "bec" in white inside the circle. Below the letters, the words "laboratories, inc." are written in a smaller font. There are three horizontal lines to the left of the circle, with a white circle on the left side of the lines.
510(k) Summary
Headquarters/ Laboratory 705 front street toledo, ohio 43605 phone: (419) 693-5307 fax: (419) 691-0418
Environmental Laboratory
1632 enterprise parkway twinsburg, ohio 44087 phone: (216) 425-8200 fax: (216) 425-1349
Sales Office
129 dixie way south south bend, indiana 46637 phone: (219) 272-2200
Sales Office
77 west elmwood drive suite 123 dayton, ohio 45459 phone: (513) 438-1711
Medical Products Division 615 front street toledo, ohio 43605 phone: (419) 693-5307 fax: (419) 691-1227
Safe Mate I.V. Fluid Delivery Sets Trade Name: Re: Common Name: I.V. Fluid Delivery Sets Classification Name: Set, I.V. Fluid Transfer 80 LHI
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 B.E.C. Safe Mate I.V. Fluid Delivery Sets consist of a PVC tubing set which has a male luer (slip, fixed luer-lock, or rotating luer-lock) connector or an attached schrouded plastic cannula at one end intended to connect to an I.V. catheter, needle or a split septum injection site extension set affixed to an I.V. catheter. Fluid delivery set lengths may vary from 60" up to 120" or longer. Fluid Delivery Sets may also have one or more split septum Y-sites for the infusion of other liquid medications. Clamps (slide, clip, or roller) may also be included.
The risk to health care providers of "needlestick" injuries has become a major public health and worker safety concern. These I.V. Fluid Delivery Sets are intended to provide additional protection against inadvertent "needlestick" injuries to health care providers during the intravascular administration of fluids and medications. The I.V. Fluid Delivery Sets provide for the entry into an intravascular administration system without the need of a sharp needle by allowing for the penetration of a split septum injection sites or split septum Y-sites using an 11 gauge blunt plastic cannula.
These I.V. Fluid Delivery Sets utilize materials and components identical to Medical Network Associates, Incorporated's I.V. Fluid Delivery Sets reviewed by FDA in 510(k) #K955821. These sets use needleless split septum components identical to and found to be substantially equivalent to IMED Corporations Needleless Devices submitted under 510(k) #'s K945070, K944320, and K931173. The needleless components are made of the same material by the same foreign manufacturer.
1
Technological data and performance data were submitted for the IMED predicate devices. Tubing and standard set components are of medical grade and meet USP Class VI and/or Tripartite guideline biocompatability requirements.
Packaging of these 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
7/17/96
Date Prepared