(25 days)
The EKOS Peripheral Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The system consists of a disposable infusion/ultrasound catheter and an instrument that generates and controls the delivery of energy to the catheter. The catheter contains a single ultrasound transducer, located at the distal tip, a thermal sensor and a distal end hole for placement over a guide wire and fluid infusion.
I am sorry, but the provided text from the FDA 510(k) notification for the EKOS Peripheral Infusion System does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria, as outlined in your request.
Specifically, the document is a substantial equivalence (SE) determination letter and a 510(k) summary. These types of documents focus on demonstrating that a new device is as safe and effective as a legally marketed predicate device. They do not typically include:
- Explicit acceptance criteria: The document states the device is "substantially equivalent" which is the overall regulatory acceptance, but it doesn't detail performance metrics or thresholds.
- Detailed study methodology: While it mentions "testing and evaluations performed" in the Test Summary, it does not provide specifics about:
- Sample sizes for test sets (or training sets)
- Data provenance
- Number or qualifications of experts
- Adjudication methods
- Results of multi-reader multi-case (MRMC) studies
- Standalone algorithm performance
- Type of ground truth used or how it was established.
The 510(k) summary (page 4) lists general characteristics and intended use, and the "Test Summary" section simply states that the new device is "substantially equivalent" to the previously cleared device based on a comparison of uses, designs, and testing results. It does not elaborate on the specific tests, their criteria, or their results.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes and data provenance.
- Number and qualifications of experts.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth.
- Training set sample size.
- Ground truth establishment for the training set.
This information would typically be found in the full 510(k) submission, which is not provided in this excerpt.
§ 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).