(89 days)
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Not Found
No
The summary describes a standard midline catheter kit and does not mention any AI or ML components or functionalities.
No.
The device is a catheter kit used to sample blood or administer substances intravenously, which are diagnostic or supportive functions rather than direct therapeutic treatments.
No
The device is described as a catheter kit for sampling blood or administering fluids, not for diagnosing medical conditions.
No
The device description clearly states it is a kit containing a physical catheter and other components for insertion, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to sample blood or administer substances intravenously. This is a direct interaction with the patient's circulatory system for therapeutic or diagnostic purposes in vivo (within the living body).
- Device Description: The device is an intravascular catheter designed for accessing veins. This is a medical device used for direct patient intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the living body) to provide information about a physiological state, health, or disease. IVDs typically involve reagents, calibrators, controls, and instruments used to analyze biological samples like blood, urine, or tissue.
Therefore, this device falls under the category of a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The kit contains a midline catheter suitable to sample blood or administer drug solutions, blood products, or other fluids intravenously. Other components are used in the course of placing the catheter as indicated above.
Product codes (comma separated list FDA assigned to the subject device)
80 LJS
Device Description
The subject kit contains a long term, single use, single or 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 also contains drugs and devices for preparing the insertion site, placing the catheter, securing the catheter and dressing the site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
large veins such as the baslic or cephalic veins
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The Becton Dickinson Vascular Access FIRST PICC™ brand kit.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K964048
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 Kit Brand: FIRST MIDLINE™ Common Name: Midline Catheter Kit Classification Name: None. The catheter component is classified as a 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 kit. -
D. A description of the device that is the subject of the Premarket Notification submission.
The subject kit contains a long term, single use, single or 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 also contains drugs and devices for preparing the insertion site, placing the catheter, securing the catheter and dressing the site. -
E. Statement of intended use of the device.
The kit contains a midline catheter suitable to sample blood or administer drug solutions, blood products, or other fluids intravenously. Other components are used in the course of placing the catheter as indicated above. -
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 kit differs from the FIRST PICC™ brand kit in that the FIRST MIDLINE™catheter is shorter than the FIRST PICC™ catheter; 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. Other componentry varies to meet customer needs.