(134 days)
The PowerGlide ST™ Midline Catheter is inserted into a patient's vascular system for short term use to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide ST™ Midline Catheter is suitable for use with power injectors.
Bard Access Systems, Inc.'s PowerGlide ST™ 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 (
This document describes the premarket notification for a medical device, the PowerGlide ST™ Midline Catheter. It focuses on demonstrating substantial equivalence to a predicate device, not on proving clinical effectiveness through novel AI or diagnostic algorithms. Therefore, many of the requested criteria related to AI performance, ground truth establishment, expert readers, and MRMC studies are not applicable to this type of regulatory submission.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests and states that the "subject device met all predetermined acceptance criteria". However, the specific quantitative acceptance criteria values and the exact reported performance results for each test are not disclosed in this summary. It only indicates that the device passed.
| Performance Test | Acceptance Criteria (Not Explicitly Stated) | Reported Performance |
|---|---|---|
| Dilator Outer Diameter | Within design specifications (Bard internal stds) | Met criteria |
| Dilator Effective Length | Within design specifications (BS EN ISO 11070:2014) | Met criteria |
| Dilator Luer Connector | Comply with ISO 594-1 and 594-2 (6% luer taper) | Met criteria |
| Catheter/Dilator Tip Adhesion Break Force | Force required to remove dilator (Bard internal stds) | Met criteria |
| Dilator Assembly Tensile | Does not fail in tension (BS EN ISO 11070:2014) | Met criteria |
| Catheter/Dilator Assembly Burst Pressure | Greater than maximum use pressure (ISO 10555-1:2013) | Met criteria |
Biocompatibility Tests:
| Biological Test | Acceptance Criteria (Not Explicitly Stated) | Reported Performance |
|---|---|---|
| Cytotoxicity | Per ISO 10993-5 (2009) | Met criteria |
| Sensitization | Per ISO 10993-10 (2010) | Met criteria |
| Intracutaneous Reactivity | Per ISO 10993-10 (2010) | Met criteria |
| Acute Systemic Toxicity | Per ISO 10993-11 (2006) | Met criteria |
| Pyrogenicity | Per ISO 10993-11 (2006) | Met criteria |
| Hemocompatibility | Per ISO 10993-4 (2002, amended 2006) | Met criteria |
| Genotoxicity | Per ISO 10993-3 (2014), ISO/TR 10993-33 (2015) | Met criteria |
| Sterilization Residuals | Per ISO 10993-7 | Met criteria |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for the described physical and biological performance tests. It also does not discuss data provenance (e.g., country of origin, retrospective/prospective) as these are non-clinical, in-vitro/bench tests on device components, not clinical data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The "ground truth" for this medical device submission is based on engineering specifications, physical/chemical properties, and biological safety standards (ISO standards). It does not involve expert interpretations of medical images or diagnoses that would require human expert consensus.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic accuracy, where there's a need to resolve discrepancies between human readers or between AI and human reads. This document describes bench testing and biocompatibility assessments which do not involve this type of adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. This submission is for a physical medical device (catheter) and does not involve AI or human readers for diagnostic purposes. Therefore, an MRMC study and effects on human reader performance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical medical catheter, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's acceptance is based on:
- Engineering design specifications: The physical dimensions and properties of the dilator and catheter.
- Industry Standards (ISO/BS EN ISO): Established international and national standards for medical devices, specifically for intravascular catheters, luer connectors, and biocompatibility.
- Bard internal standards and procedures: Proprietary testing methods and acceptance criteria used by the manufacturer.
8. The sample size for the training set
This question is not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 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).