(89 days)
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No
The summary describes a standard intravascular catheter and does not mention any AI or ML capabilities, image processing, or performance studies related to algorithmic analysis.
No
The device is described as providing access to the vascular system for sampling blood or administering fluids and blood products, which are diagnostic or supportive functions, not directly therapeutic in itself.
No
The device is described as a catheter used for accessing the vascular system to administer fluids or sample blood, not for diagnosing medical conditions.
No
The device description clearly describes a physical catheter, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide access to the vascular system to sample blood or administer drug solutions, blood products, or other fluids intravenously." This describes a device used in vivo (within the body) for direct patient care, not for testing samples in vitro (outside the body).
- Device Description: The description details an "intravascular catheter" inserted into veins. This is a medical device used for accessing the circulatory system, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, diagnostic assays, or any other components typically associated with IVD devices.
Therefore, this device falls under the category of a general medical device used for vascular access, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use is to provide access to the vascular system to sample blood or administer drug solutions, blood products, or other fluids intravenously.
Product codes
80 LJS
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
The Becton Dickinson Vascular Access FIRST PICC™ brand catheters.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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.