(53 days)
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 (
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 (
Here's a breakdown of the acceptance criteria and study information for the PowerGlide™ Midline Catheter, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the safety and performance testing for the PowerGlide™ Midline Catheter. It states that the device "met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate devices." However, it does not provide a specific table with numerical acceptance criteria and corresponding device performance values. Instead, it refers to compliance with various industry standards and guidance documents.
Here's a summary of the areas of performance verification mentioned:
| Acceptance Criteria Area (Implied from References) | Reported Device Performance |
|---|---|
| General Catheter Requirements: (from ISO 10555-1, ISO 10555-5) | - The device met predetermined acceptance criteria for general requirements of sterile, single-use intravascular catheters. |
| Intravascular Catheter Introducer Requirements: (from ISO 11070) | - The device met predetermined acceptance criteria for sterile, single-use intravascular catheter introducers. |
| Guidewire Requirements: (from Coronary and Cerebrovascular Guidewire Guidance) | - The device met predetermined acceptance criteria for guidewire performance. |
| Luer Taper Fittings Requirements: (from ISO 594-1, ISO 594-2) | - The device met predetermined acceptance criteria for conical luer taper fittings. |
| Hypodermic Needles Requirements: (from ISO 9626, ISO 7864) | - The device met predetermined acceptance criteria for stainless steel needle tubing and sterile hypodermic needles for single use. |
| Sharps Injury Protection Features: (from ISO 23908, FDA Guidance: Medical Devices with Sharps Injury Prevention Features, BS 7320) | - The device met predetermined acceptance criteria for sharps injury protection features. The device description mentions a "passive safety mechanism" for the introducer needle. |
| Biocompatibility: (from AAMI/ANSI/ISO 10993-1, AAMI/ANSI/ISO 10993-7, #G95-1) | - The device met predetermined acceptance criteria for biological evaluation and ethylene oxide sterilization residuals. |
| Sterilization: (from AAMI/ANSI/ISO 11135) | - The device met predetermined acceptance criteria for ethylene oxide sterilization validation and routine control. |
| Radiopacity: (from ASTM F640-79) | - The device met predetermined acceptance criteria for radiopacity. |
| Risk Management: (from ISO 14971) | - A Failure Modes and Effects Analysis (FMEA) was conducted, and the device met predetermined acceptance criteria for risk management. |
| Overall Safety & Effectiveness / Substantial Equivalence: | - The device met the requirements considered sufficient for its intended use and is as safe and as effective as the cited predicate devices. |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set for performance validation studies. It only mentions that "Verification and validation tests have been performed in accordance with Design Controls as per 21 CFR §820.30."
The data provenance (country of origin, retrospective/prospective) is also not mentioned. The testing appears to be primarily bench testing and in-house validation based on compliance with international standards, rather than clinical data from human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. Given that the testing appears to be primarily bench and laboratory-based, the concept of "experts establishing ground truth for a test set" in a clinical sense (e.g., radiologist consensus) does not directly apply here. Performance was likely evaluated against engineering specifications derived from the referenced standards.
4. Adjudication Method for the Test Set
This information is not applicable and not specified. Adjudication methods are typically used in clinical studies where multiple reviewers interpret data, which is not described here.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document describes engineering and biocompatibility testing for substantial equivalence, not a clinical trial comparing human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This question is not applicable as the device is a physical medical catheter, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance of the PowerGlide™ Midline Catheter was established through compliance with recognized international and national standards and guidance documents. These standards define measurable requirements (e.g., material properties, dimensional tolerances, flow rates, tensile strength, biocompatibility limits, sterilization efficacy, luer connection integrity, sharps protection effectiveness). The device's performance was measured against these predefined specifications.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical medical catheter, not an AI algorithm. There is no "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a physical medical catheter, not an AI algorithm. There is no "training set" or corresponding ground truth establishment for it.
§ 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).