(41 days)
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities that would suggest AI/ML.
No
The device is described as an I.V. extension set, designed to facilitate the administration of fluids and medications by providing a needle-free access point, and to protect healthcare providers from needlestick injuries. Its primary function is to serve as a conduit for drug delivery and enhance safety, rather than to treat or cure a disease itself.
No
The device is an I.V. extension set used for administering fluids and medications, not for diagnosing conditions.
No
The device description clearly outlines physical components such as PVC tubing, luer connectors, split septum injection sites, and clamps, indicating it is a hardware 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 the "intravascular administration of fluids and medications" and to "provide additional protection against inadvertent 'needlestick' injuries." This describes a device used in vivo (within the body) for delivering substances, not for testing samples in vitro (outside the body).
- Device Description: The description details components like tubing, luer connectors, injection sites, and clamps, all consistent with devices used for intravenous fluid delivery. There is no mention of reagents, assays, or any components typically associated with diagnostic testing of biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
Therefore, this device is a medical device used for administering fluids and medications intravenously, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The I.V. Extension Sets provide for the entry to an intravascular administration set 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. Extension Sets consist of a PVC tubing set which has a male luer (slip, fixed luer-lock, or rotating luer-lock) connector at one end intended to connect to an I.V. catheter or needle. At the distal end (or ends in the case of the bifurcated extension set or T-Connector extension set) is a female luer and/or split septum Needleless Injection Site for connection to an I.V. administration set. Extension set lengths may vary from 4" up to 36" or longer. The PVC tubing may be of standard bore (approximately 0.115" I.D.) or Minibore (approximately 0.040" I.D.) design and may be configured into a J-loop to facilitate tape fixation. Extension 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Technological data and performance data were submitted for the IMED predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
AUG 28 1996
Image /page/0/Picture/2 description: The image shows a logo for "bec laboratories, inc.". The logo consists of a circle with the letters "bec" inside, with the word "laboratories, inc." written below the circle. To the left of the circle are three horizontal lines of decreasing length.
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
Saies 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 tax: (419) 691-1227
Safe Mate I.V. Extension Sets Re: Trade Name: Common Name: I.V. Extension 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. Extension Sets consist of a PVC tubing set which has a male luer (slip, fixed luer-lock, or rotating luer-lock) connector at one end intended to connect to an I.V. catheter or needle. At the distal end (or ends in the case of the bifurcated extension set or T-Connector extension set) is a female luer and/or split septum Needleless Injection Site for connection to an I.V. administration set. Extension set lengths may vary from 4" up to 36" or longer. The PVC tubing may be of standard bore (approximately 0.115" I.D.) or Minibore (approximately 0.040" I.D.) design and may be configured into a J-loop to facilitate tape fixation. Extension 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 concem. These I.V. Extension 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. Extension Sets provide for the entry to an intravascular administration set 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. Extension Sets utilize materials and components identical to Medical Network Associates, Incorporated's I.V. Extension Sets reviewed by FDA in 510(k) #K955821. These sets use needleless split septum
1
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. 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