(87 days)
This catherer is intended for:
- Temporarily occlude blood vessel.
- Irrigating facility for heparin or contrast media.
- USed for the non-surgical removal of emboli and thrombi,
This balloon catheter is furnished in three, four, five, six, seven, eight and nine French sizes. The device has an balloon mounted at the distal tip. The shaft has bands every ten centimeters. The proximal end has a manifold and one extension with a hub and a second extension with a stopcock.
The provided text is a 510(k) summary for the Embolectomy Irrigation - Occlusion Balloon Catheter (EIOBC). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI or medical imaging device. Therefore, much of the requested information regarding acceptance criteria, study details, and AI performance is not applicable to this submission.
Here's an analysis based on the provided text, addressing the points where information is available or noting when it's not applicable:
1. A table of acceptance criteria and the reported device performance
The submission does not present a table of specific acceptance criteria or reported device performance in the typical sense of a clinical or technical effectiveness study with quantifiable metrics. Instead, the "acceptance criteria" for a 510(k) submission like this are met by demonstrating "substantial equivalence" to a legally marketed predicate device. The performance is assessed by comparison to the predicate device.
| Acceptance Criteria (Implied by 510(k) Process) | Reported Device Performance (vs. Predicate) |
|---|---|
| Intended Use Equivalence | The new device shares the same intended uses as the predicate device: temporary vessel occlusion, injection of contrast media and other fluids, and removal of thrombi and emboli. |
| Technological Characteristics Equivalence | The new device is "basically the same" as the predicate, using the "same materials, the same basic design and the same methods of assembly." The only difference is the addition of a lumen, which increases function. |
| Performance Data Equivalence | "The performance data such as mechanical strengths and balloon tests remain the same as with the Predicate Device." (This implies the new device meets the same or similar established internal specifications as the predicate for these aspects). Note: Specific numerical values for these tests are not provided in this summary. |
| Biological, Chemical, and Sterilization Equivalence | "The Biological, Chemical, and Sterilization specifications remain the same as the Predicate Device." |
| Safety Equivalence | The device presents an "acceptable level of safety" when properly used by a trained physician, based on engineering testing and the long-standing use of the basic design of the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not describe a "test set" in the context of an AI or diagnostic device study. The comparison is based on the design, materials, and intended use to a predicate device already on the market. The "engineering testing" mentioned for safety and performance (mechanical strengths, balloon tests) would have been conducted internally by the manufacturer, likely on a sample of devices, but the size of this sample is not specified, nor is the data provenance in terms of country or retrospective/prospective nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no "ground truth" establishment in the context of expert consensus, as this is not a diagnostic device or an AI performance study. The assessment is based on comparison to an existing device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication method described for performance evaluation in this 510(k) summary.
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 is not an AI-assisted device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (catheter), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The validation for this device is based on demonstrating substantial equivalence to a predicate device, which includes equivalence in design, materials, manufacturing, intended use, and performance claims derived from engineering testing (rather than clinical ground truth via expert consensus, pathology, or outcomes data).
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned in this 510(k) summary.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).