(89 days)
The intended use is 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 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.
This document is a 510(k) summary for a medical device (an intravascular catheter) and does not contain information about acceptance criteria or a study proving device performance in the way typically found for AI/ML-driven medical devices.
The information provided describes the device's intended use, its comparison to a predicate device, and manufacturing details. It does not include any of the requested elements pertaining to AI/ML device performance studies, such as:
- Acceptance criteria tables
- Sample sizes for test or training sets
- Data provenance
- Expert involvement (ground truth, adjudication)
- MRMC studies
- Standalone performance
- Ground truth types
Therefore, I cannot fulfill your request based on the provided input.
{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
-
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.
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
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.
$\mu$
§ 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).