(89 days)
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Not Found
No
The summary describes a standard intravascular catheter and does not mention any AI or ML components or functionalities.
No.
The device description indicates it is a catheter for accessing the vascular system to sample blood or administer fluids and is not described as treating a disease or condition.
No
Explanation: The device description states its intended use is for vascular access to sample blood or administer fluids and drugs, which are therapeutic or procedural functions, not diagnostic. There is no mention of it being used to detect, diagnose, monitor, or treat a disease or condition.
No
The device description clearly describes a physical catheter, which is a hardware component. There is no mention of software being the primary or sole component of the device.
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 accessing the circulatory system.
- Device Description: The description confirms it's an "intravascular catheter" inserted into veins. This is a medical device used for direct patient intervention.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information about a patient's health. The provided information does not mention any analysis of specimens or diagnostic testing.
Therefore, this device is a 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 FOZ
Device Description
The subject catheter is a short term, single use, 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
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
vascular system; large veins such as the baslic or cephalic veins
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
KAC4050
Jan. 6, 1997
SUMMARY OF SAFETY AND EFFICACY
- 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: December 31, 1996.
- B. The name of the device including trade or proprietary name if applicable, the common or usual name, and the classification name.
Name: Intravascular Catheter Brand: FIRST MIDCATH™ Common Name: Midline Catheter Classification Name: Intravascular Catheter (80 FOZ)
E. C. ... Hosenmil
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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 short term, single use, 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.
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יוח משורי ב
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, and the manner in which the catheter is placed are the same.
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