(79 days)
The Arrow ® Seldinger Arterial Catheterization Devices permit access to the peripheral arterial circulation or to other small vessels.
The Arrow Seldinger arterial catheterization devices are comprised of an introducer needle, a spring wire guide, and an arterial catheter assembly. The catheter assembly consists of a polyurethane arterial catheter molded to a winged catheter juncture hub. An extension tubing segment is molded to the proximal end of the winged catheter hub. The proximal end of the extension tubing segment is molded to a luer-locking hub. A slide clamp is provided on the extension segment.
The provided document is a 510(k) summary for the Arrow® Seldinger Arterial Catheterization Device. It does not describe an AI/ML medical device, but rather a traditional medical device (catheterization device). Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test/training sets, ground truth establishment for training, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.
However, I can extract the available information regarding the device's acceptance criteria and the study that supports it within the context of a traditional medical device submission.
Acceptance Criteria and Study for the Arrow® Seldinger Arterial Catheterization Device
Study Overview:
The study performed for the Arrow® Seldinger Arterial Catheterization Device was a series of in-house verification and validation tests to demonstrate the safety and efficacy of the device. The conclusion of this testing was to demonstrate substantial equivalence to a legally marketed predicate device, the Arrow Radial Artery Catheterization Set (K810675).
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Needle penetration | Verification testing demonstrated the device met the required performance for needle penetration. (Specific quantitative pass/fail criteria are not detailed in this summary, but the general conclusion implies satisfactory performance.) |
| Component compatibility | Verification testing confirmed compatibility among the device's components. (No specific metrics provided, but successful compatibility is implied.) |
| Leak test | Verification testing demonstrated the device passed leak tests. (Quantitative leak rates or thresholds are not detailed, but the general conclusion implies satisfactory performance.) |
| Package integrity | Verification testing confirmed the integrity of the device's packaging. (No specific metrics provided, but successful integrity is implied.) |
| Tensile test | Verification testing demonstrated the device met required tensile strength. (Specific yield strengths or breakage points are not detailed, but the general conclusion implies satisfactory performance.) |
| Pull testing | Verification testing demonstrated the device met required pull strengths. (Specific pull-off forces or displacement limits are not detailed, but the general conclusion implies satisfactory performance.) |
| Overall Conclusion | The results of verification testing demonstrate substantial equivalence of the Arrow® Seldinger Arterial Catheterization device to the legally marketed predicate. The differences between the proposed and predicate devices do not raise new issues of safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes (number of units tested) for each of the performance tests.
- Data Provenance: The data is from in-house "Verification and validation testing." This suggests prospective testing conducted by the manufacturer, Arrow International, Inc., likely at their facilities in the USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This is not applicable to this type of device and study. The "ground truth" for a physical device like a catheterization kit is established through engineering and quality control specifications, not expert interpretation of outputs like images. Performance is measured against predefined technical specifications.
4. Adjudication Method for the Test Set:
- This is not applicable as the tests are objective physical performance measurements against specifications, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI/ML devices where human reader performance is being evaluated with and without AI assistance. This device is a physical medical instrument.
6. Standalone (Algorithm Only) Performance:
- No, a standalone (algorithm only) performance study was not done. This device is not an algorithm.
7. Type of Ground Truth Used:
- The "ground truth" for this device's performance tests is based on engineering specifications and industry standards for similar medical devices. These specifications would dictate acceptable ranges for parameters like "needle penetration force," "leak rate," "tensile strength," etc. The comparison to the predicate device also forms a "ground truth" for equivalence in fundamental technology and expected performance.
8. Sample Size for the Training Set:
- This is not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
- This is not applicable as there is no training set for this type of medical device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).