(89 days)
to provide access to the vascular system to sample blood or administer drug solutions, blood products, or other fluids intravenously.
The subject catheter is a long term, single use, dual lumen, intravascular catheter of various French sizes and lengths which is designed to provide access to large veins such as the baslic or cephalic veins. It is inserted into the vascular system through a spittable introducer catheter.
This submission describes a medical device, specifically a "Midline Catheter with Dual Lumens," and seeks to establish its substantial equivalence to a predicate device. However, the provided text does not contain the information necessary to describe acceptance criteria or a study proving the device meets those criteria in the context of device performance,
such as accuracy or efficacy. The document focuses on regulatory identification and comparison to a predicate device based on material and design, not on performance metrics.
Therefore, I cannot generate the requested table and details about a performance study. The provided text is insufficient for this purpose.
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K96 4049
JAN. 6, 1997
SUMMARY OF SAFETY AND EFFICACY
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A. The submitter's name, address, telephone number, contact person, and date of preparation.
Submitted by Becton Dickinson Vascular Access, 9450 South State Street, Sandy, UT 84070. Contact: C. J. Welle. Telephone: 801-565-2535. Prepared: October 8, 1996. -
B. The name of the device including trade or proprietary name if applicable, the common or usual name, and the classification name.
Name: Midline Catheter with Dual Lumens Brand: FIRST MIDCATH™ Common Name: Midline Catheter with Dual Lumens Classification Name: Long Term Intravascular Catheter (80 LJS) -
C. An identification of the predicate or legally marketed device to which substantial equivalence is claimed:
Predicate Device: The Becton Dickinson Vascular Access FIRST PICC™ brand catheters. -
D. A description of the device that is the subject of the Premarket Notification submission.
The subject catheter is a long term, single use, dual lumen, intravascular catheter of various French sizes and lengths which is designed to provide access to large veins such as the baslic or cephalic veins. It is inserted into the vascular system through a spittable introducer catheter. -
E. Statement of intended use of the device.
The intended use is to provide access to the vascular system to sample blood or administer drug solutions, blood products, or other fluids intravenously. -
F. A statement of how the technological characteristics compare to those of the predicate or legally marketed device identified in section C above.
The proposed catheter differs from the FIRST PICC™ brand catheter in that it is shorter however, the materials used, the design concept, the manner in which the catheter is placed, and designation as a long term catheter are the same.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).