(41 days)
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.
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.
This document, K962801, describes an I.V. extension set, but it does not contain the information requested about acceptance criteria and a study proving the device meets those criteria. The provided text is a 510(k) summary, which focuses on describing the device, its intended use, and its substantial equivalence to predicate devices based on materials and components.
Therefore, I cannot extract the following information:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
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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
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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
§ 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.