(28 days)
Not Found
No
The 510(k) summary describes a standard medical catheter and does not mention any AI or ML components or functionalities.
No
The device is described as a catheter for accessing the vascular system to sample blood or administer fluids, which are diagnostic or supportive functions, not directly therapeutic.
No
This device is a catheter intended for administering fluids or sampling blood, not for diagnosing conditions. Its function is to provide access to the vascular system, which is a therapeutic or procedural function, not a diagnostic one.
No
The device description clearly states it is a physical catheter with an introducer needle and guidewire, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Function: The PowerGlide® Midline Catheter is a device that is inserted into the patient's vascular system to directly administer fluids or sample blood from within the body. It is a tool for accessing the vascular system, not for analyzing samples outside the body.
- Intended Use: The intended use clearly states it's for "sampling blood or administer fluids intravenously," which are procedures performed on the patient, not on a sample in a lab.
Therefore, based on the provided information, the PowerGlide® Midline Catheter is a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PowerGlide® Midline Catheter is intended to be inserted in the patient's vascular system for short term use (less than 30 days) to sample blood or administer fluids intravenously.
The PowerGlide® Midline Catheter is inserted into a patient's vascular system for short-term use (
§ 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
. JAN 16 2014
Image /page/0/Picture/2 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font. Below the word "BARD" is the text "ACCESS SYSTEMS" in a smaller, sans-serif font. The logo is black and white.
510(k) Summary
21 CFR 807.92
| Submitter Name: | Bard Access Systems, Inc. | |
|---|---|---|
| Submitter Address: | 605 North 5600 West | |
| Salt Lake City, UT 84116 | ||
| General | ||
| Provisions | Contact Person: | Casey Coombs |
| Regulatory Affairs Specialist | ||
| Telephone Number: | (801) 522-5869 | |
| Fax Number: | (801) 522-5425 | |
| Date of Preparation: | December 17, 2013 | |
| Subject | ||
| Device | Trade Name: | PowerGlide® Midline Catheter |
| Common Name: | Intravascular Catheter | |
| Classification Name: | Intravascular Catheter | |
| Product Code/ | ||
| Regulation: | FOZ/21 CFR §880.5200 | |
| Predicate | ||
| Device | Predicate Trade Name: | PowerGlide® Midline Catheter |
| Classification Name: | Intravascular Catheter | |
| Premarket Notification: | K121073 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| Device | ||
| Description | Bard Access Systems, Inc.'s PowerGlide® Midline Catheter is a sterile, | |
| single use device designed to provide access to the patient's vascular | ||
| system. The device is intended for short term use ( Prescription Use _ (Part 21 CFR §801 Subpart D) AND/OR |
Over-The-Counter Use (21 CFR §801 Subpart C)
(Please Do Not WRITE BELOW THIS LINE – Continue on ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Mary S. Runner -S
Susan Runner DDS, MA 2014.01.15
15:12:52 -05'00'