(174 days)
The PowerGlide Pro™ Midline Catheter is inserted into a patient's vascular system for short-term use (
Bard Access Systems, Inc.'s PowerGlide Pro™ 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 (
The provided FDA 510(k) clearance letter for the PowerGlide Pro™ Midline Catheter specifies that no new performance tests, including verification and validation activities, were conducted because the modifications were limited to labeling updates (specifically, changes to the Indications for Use and associated Instructions for Use/labeling), with no changes to the device's design, materials, performance, or risk profile.
Therefore, based on the provided document, the typical information requested for acceptance criteria and study details (such as sample size, provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details) is not available as no new studies were deemed necessary due to the nature of the submission. The acceptance criteria essentially rely on the previously established performance of the legally marketed predicate device (K162377), which the subject device is substantially equivalent to.
However, I can extract the comparison table that highlights the differences between the subject device and the predicate device, which implicitly states that the performance criteria for the subject device are considered to be the same as the predicate device due to the lack of design or performance changes.
Here's a summary based on the provided document, addressing the points where information is available or where the document indicates why it's not applicable:
1. A Table of Acceptance Criteria and the Reported Device Performance
Since no new performance studies were conducted for this 510(k) submission, there are no new specific acceptance criteria or reported device performance metrics beyond those previously established for the predicate device. The document explicitly states:
"The results of the risk analysis determined that no verification or validation activities were required because the subject device modifications to the Indications for use and resulting modifications to the instructions for use and labeling do not include any changes to the design, materials, performance, or risk profile of the cited predicate device. Therefore, it is not necessary to conduct additional performance tests including verification and validation."
The "reported device performance" would therefore implicitly be identical to the predicate device, K162377, for all functional aspects. The acceptance criteria for this submission were that the labeling changes do not introduce new questions of safety or effectiveness and do not introduce any new or significantly modified risks. The document claims this was met for each change.
Summary of Device Comparison (Implicit Acceptance of Predicate Performance)
| Attribute | Predicate Device (K162377) | Subject Device | Comparison / "Acceptance Met" |
|---|---|---|---|
| Indications for Use | "The PowerGlide Pro™ 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).