(164 days)
ScoutPro Inner Catheters are indicated for the delivery of contrast media or Biotronik devices into the left ventricular coronary venous system. ScoutPro Inner Catheters are not intended to introduce left ventricular leads through their lumen.
The Thomas Medical Products, Inc. (TMP) ScoutPro Inner Catheters are intended to access the coronary venous system, either alone or in a telescopic assembly with other introducers. The guide catheters serve as a conduit to guide devices, including guidewires, or to deliver contrast medium into specific branches of the coronary venous system. ScoutPro Inner Catheters are not intended to introduce left ventricular leads through their lumen. They have direct contact to the inner heart. ScoutPro Inner Catheters come with a 50° to 90° tip angle. They are designed as single use devices and for short term application (
The provided document describes a medical device, the "ScoutPro Inner Catheters," and its 510(k) summary for FDA clearance. This summary focuses on demonstrating "substantial equivalence" to predicate devices, rather than an independent clinical study proving specific acceptance criteria in the manner of a multi-reader multi-case (MRMC) or standalone algorithm study for AI.
Therefore, many of the requested sections regarding AI study design (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC study effect size, standalone algorithm performance, and training set details) are not applicable and cannot be extracted from this document. This document details engineering and bench testing to demonstrate that the device performs similarly to existing, cleared devices.
Here's an analysis based on the provided text, aligning with the sections where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly "Pass" for each test, indicating that the device met pre-defined internal specifications for safe and effective operation comparable to predicate devices. The document does not provide numerical thresholds for these "Pass" criteria but affirms that the device successfully met them.
| Test Description | Acceptance Criteria (Implicit) | Reported Device Performance | Comments |
|---|---|---|---|
| Simulated Use Testing: | |||
| ScoutPro Inner Catheter insertion and removal forces of .014" and .035" guidewires | Pass | Pass | Demonstrated ability to safely introduce and withdraw specified guidewires. |
| insertion and removal forces through outer sheath and valve | Pass | Pass | Confirmed compatibility and ease of use with associated components. |
| shaft kink and buckling resistance | Pass | Pass | Indicated structural integrity under simulated use. |
| tip section kink, corrugation, and peel back resistance | Pass | Pass | Confirmed structural integrity of the critical distal tip region. |
| curve configuration after straightening | Pass | Pass | Ensured the catheter returns to its intended shape after manipulation. |
| shaft joint integrity when bend around mandrel | Pass | Pass | Verified the robustness of shaft connections under stress. |
| Physical/Dimensional Testing: | |||
| Stopcock leak resistance of stopcock/catheter assembly | Pass | Pass | Ensured secure connections to prevent fluid leakage. |
| ScoutPro Inner Catheter pull forces of shaft joints | Pass | Pass | Tested the strength of shaft segment connections. |
| pull force of hub/tube joint | Pass | Pass | Tested the strength of the connection between the hub and the main catheter shaft. |
| tube shaft O.D. | Pass | Pass | Verified the outer diameter conforms to specifications. |
| tip section O.D. | Pass | Pass | Verified the outer diameter of the tip conforms to specifications. |
| tip I.D. | Pass | Pass | Verified the inner diameter of the tip conforms to specifications. |
| length | Pass | Pass | Verified the overall length conforms to specifications. |
| curve configuration | Pass | Pass | Verified the shape and angle of the distal curve conform to specifications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size (number of devices) used for each test. It only lists the tests performed and their outcomes ("Pass").
- Data Provenance: The tests are described as "Testing" and appear to be bench testing conducted by the manufacturer, Thomas Medical Products - A GE Healthcare Company. This implies an internal, prospective testing methodology rather than a retrospective analysis of clinical data from specific countries.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable: For this type of 510(k) submission based on bench testing for substantial equivalence, clinical expert ground truth establishment for a "test set" in the context of diagnostic performance is not relevant or described. The "ground truth" here is adherence to engineering specifications and performance in simulated scenarios, which would be assessed by engineers and quality assurance personnel.
4. Adjudication Method for the Test Set
- Not Applicable: As this is bench testing against engineering specifications, there is no mention of an adjudication method in the sense of clinical reviewers or consensus. Each test would have pre-defined pass/fail criteria, and results would be recorded.
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
- Not Applicable: This document describes a medical device (catheter) and its physical and mechanical performance, not an AI-powered diagnostic system. Therefore, an MRMC study or effect size related to AI assistance for human readers is not relevant and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This document is about a physical medical device (catheter), not an algorithm or AI system.
7. The Type of Ground Truth Used
- For the bench and simulated use testing, the "ground truth" is based on engineering specifications and performance standards. These standards would define acceptable ranges for forces, dimensions, structural integrity, and functional performance (e.g., kink resistance, leak resistance). The predicate devices' performance would also serve as a benchmark for what constitutes an acceptable level of performance.
8. The Sample Size for the Training Set
- Not Applicable: This document does not describe the development of an AI algorithm with a training set.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: This document does not describe the development of an AI algorithm with a training set and its ground truth establishment.
§ 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).