(15 days)
The Lysus® 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 catheter with removable ultrasound core and an instrument that generates and controls the delivery of energy to the catheter. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 30 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor transducer temperature.
The provided text describes a 510(k) submission for the Lysus® Infusion System, a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for establishing novel performance acceptance criteria or conducting extensive clinical efficacy studies typically found in PMA submissions.
Therefore, many of the requested data points (like sample sizes for test/training sets, expert qualifications, MRMC studies, specific ground truth types) are not applicable to the information provided because a 510(k) summary focuses on demonstrating equivalence through design and limited testing, rather than proving new clinical performance.
Here's a breakdown of the available information based on your request:
Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (Lysus® Infusion System K041629 and K042456) | The proposed Lysus® Infusion System is considered substantially equivalent to the currently marketed Lysus® Infusion System based on a comparison of intended uses, designs, and results of testing and evaluations. |
| Similar in Construction | The modified system includes a lubricious coating on the inside of the Drug Delivery Catheter, yet it is still considered similar in construction. |
| Maintained Intended Use | The intended use remains the same: "The Lysus® Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature." |
2. Sample size used for the test set and the data provenance:
- Not explicitly stated. The 510(k) summary mentions "results of the testing and evaluations performed," but does not provide specific sample sizes for any test sets. The focus is on demonstrating equivalence through design and functionality, rather than detailed clinical trial data.
- Data Provenance: Not specified, but likely internal engineering and bench testing data given the nature of a 510(k) for a minor modification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not stated. In a 510(k) for a device like this, "ground truth" as it relates to expert review of output for clinical performance is not typically established or reported. The evaluation is focused on engineering and design equivalence.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not stated. This concept is generally relevant for clinical performance studies involving interpretation of data (e.g., medical images), which is not the primary focus of this 510(k) submission.
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:
- No. This is a medical device, not an AI/imaging diagnostic device. MRMC studies are not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is an infusion system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not explicitly stated. For this type of device, "ground truth" would likely refer to engineering specifications and performance benchmarks (e.g., flow rates, material compatibility, structural integrity) rather than clinical diagnostic outcomes. The summary merely states "results of the testing and evaluations performed."
8. The sample size for the training set:
- Not applicable/Not stated. This submission is for a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not stated. As above, no training set for an algorithm is involved.
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).