(203 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 document is a 510(k) premarket notification for the C. R. Bard, Inc. PowerGlide Pro™ Midline Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria in the manner typically seen for novel diagnostic or AI devices.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details, ground truth types) are not applicable or derivable from this type of regulatory submission. The document emphasizes mechanical and biological performance tests that are standard for this class of medical device.
Here's the information that can be extracted or deduced from the provided text:
1. Table of Acceptance Criteria and Reported Device 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 device." However, the exact numerical acceptance criteria for each test are not explicitly detailed. The tests performed are as follows:
| Performance Test Completed | ISO Standard Utilized | Reported Device Performance |
|---|---|---|
| Burst Pressure Post Power Injection | ISO 10555 - 1: 2013, Sterile, single use intravascular catheters, Part 1: General requirements | Met all predetermined acceptance criteria |
| Burst Pressure Without Power Injection | ISO 10555 - 1: 2013, Sterile, single use intravascular catheters, Part 1: General requirements | Met all predetermined acceptance criteria |
| Effective Needle Length | ISO 11070: 2014, Sterile, single use intravascular catheter introducer | Met all predetermined acceptance criteria |
| Effective Guidewire Length | Coronary and Cerebrovascular Guidewire Guidance, January 1995 | Met all predetermined acceptance criteria |
| Needle to Hub Tensile Strength | Not explicitly stated | Met all predetermined acceptance criteria |
| Guidewire Bond Tensile Strength | Not explicitly stated | Met all predetermined acceptance criteria |
| Cytotoxicity | ISO 10993-5: 2009 | Met all predetermined acceptance criteria |
| Sensitization/Irritation | ISO 10993-10: 2010 | Met all predetermined acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for this type of device and regulatory submission. The document describes engineering and biological performance tests, not a clinical study on a patient test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth as typically defined for diagnostic or AI algorithm studies is not relevant here. The "ground truth" for these performance tests would be the established engineering and biocompatibility standards.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is not relevant for the performance testing of an intravascular catheter to demonstrate substantial equivalence based on mechanical and biological properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an intravascular catheter, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's acceptable performance is based on International Organization for Standardization (ISO) standards for sterile, single-use intravascular catheters and biological evaluation of medical devices, along with internal predetermined acceptance criteria for mechanical and biocompatibility tests.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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).