(217 days)
The PowerMidline™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerMidline™ Catheters are suitable for use with power injectors.
Bard Access Systems, Inc.'s (BAS) PowerMidline™ catheters are a family of peripherally placed catheters made from radiopaque body-softening polyurethane materials. Each PowerMidline™ catheter is designed with kink-resistant, reverse taper design. The PowerMidline™ catheters are offered in a 3 F Single Lumen (SL) and 4 F Single Lumen (SL) configuration for reliable short term (less than 30 days) vascular access. These catheters are offered in 20 cm trimmable lengths. The PowerMidline™ catheters are suitable for use with power injectors.
I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the study that proves the device meets them.
Specifically, the text does not directly state:
- A table of acceptance criteria and the reported device performance: While it lists performance tests, it does not provide the specific quantitative acceptance criteria or the results achieved.
- Sample sized used for the test set and the data provenance: The document mentions performance tests were completed but does not specify the sample sizes used for these tests or the origin of any data (e.g., country, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present as the studies described are primarily engineering performance tests of the catheter itself, not clinical studies involving expert evaluation of outcomes or data.
- Adjudication method: Not applicable to the type of performance tests described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: The document does not describe any MRMC studies.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used: For the performance tests, the "ground truth" would be established by the test specifications and standards themselves (e.g., ISO, ASTM standards, BAS internal protocols), but not in the sense of clinical ground truth like pathology or expert consensus.
- The sample size for the training set: Not applicable, as this is a physical medical device.
- How the ground truth for the training set was established: Not applicable, as this is a physical medical device.
What the document does provide regarding performance:
The document states that "The subject device met all predetermined acceptance criteria derived from the above listed tests and demonstrated substantially equivalent performance as compared to the cited predicate and reference devices."
It lists the following Performance Tests that were completed on the subject device, along with the standards utilized:
- Device Dimensional Characterization
- Catheter Assembly Tensile (ISO 10555-1: 2013)
- Catheter Assembly Leak
- Burst Pressure Without Power Injection
- Burst Pressure Post Power Injection Gravity Flow (ISO 10555-1: 2013)
- Tensile, Modulus and Elongation Requirements (FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995)
- Priming Volume (FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995)
- Catheter Radiopacity (BAS Internal Protocols/Procedures, ASTM F640-79 (reapproved 2000))
- Power Injection Testing (ISO 10555-1: 2013)
- Tip Displacement During Power Injection (BAS Internal Protocols/Procedures)
- Catheter Cyclic Kink (BAS Internal Protocols/Procedures)
Additionally, the following sterilization and biological tests were performed:
- Sterilant Residual Testing (ISO 10993-7: 2008)
- Cytotoxicity (ISO 10993-5: 2009)
- Sensitization/Irritation (ISO 10993-10: 2010)
The document concludes that the device met these criteria and demonstrated substantially equivalent performance to predicate and reference devices. However, the specific quantitative values for the acceptance criteria and the device's performance are not detailed in this summary.
§ 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).