(28 days)
The Squirt® Fluid Delivery System is intended for the controlled administration of thrombolytic agents into the peripheral vasculature.
The Squirt® Fluid Delivery System is a hand held instrument to provide consistent, forceful, pulsed injections for optimal thrombolysis procedures. It's designed to be attached to a syringe and a catheter, to infuse controlled administration of thrombolytic agents into the peripheral vasculature.
The provided text describes a 510(k) premarket notification for the "Squirt Fluid Delivery System." This notification asserts substantial equivalence to a predicate device, rather than proving performance against predefined acceptance criteria for a novel device or AI algorithm.
Therefore, the requested information about acceptance criteria, study details, and AI-specific metrics (like MRMC studies) is not applicable in the context of this 510(k) submission. The document explicitly states: "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices."
Instead, the submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The document does not present specific quantitative acceptance criteria for a novel device performance, nor does it report specific performance metrics for a clinical study comparing the device against such criteria. The "Performance Data" section lists various international standards and specific tests (e.g., Merit Rotational Torque Test, Merit Hydrostatic Pressure Test, Biocompatibility tests) that were performed. The conclusion is that "The results of the testing demonstrated that the subject Squirt® Fluid Delivery System met the predetermined acceptance criteria and thus is substantially equivalent to the predicate device." However, the specific numerical acceptance criteria or performance results for each of these tests are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document summarizes engineering and biocompatibility testing, not a clinical trial with a test set of patient data. Therefore, concepts like sample size for a test set, data provenance (country, retrospective/prospective), or ground truth are not relevant in the context of this 510(k) summary.
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. See point 2. The tests performed are engineering and laboratory-based, not reliant on expert clinical interpretation or ground truth establishment in a medical imaging or diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 2.
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 device is a fluid delivery system, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI-related effectiveness metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The ground truth in this context refers to the defined specifications and standards (e.g., ISO standards, ASTM standards, USP) against which the physical and chemical properties of the device are tested.
8. The sample size for the training set
- Not Applicable. This device uses standard engineering and manufacturing processes, not machine learning or AI that would require a "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Summary based on the provided document:
The provided document is a 510(k) summary for a "Squirt Fluid Delivery System." The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device, not to prove the performance of a novel device or AI algorithm against predefined clinical acceptance criteria.
The "Performance Data" section indicates that various engineering, chemical, and biological tests were conducted to ensure the device meets safety and performance characteristics in line with established international standards (e.g., ISO 8536-4, ISO 10993 series) and in-house "Merit" tests (e.g., Rotational Torque Test, Hydrostatic Pressure Test, Vacuum Leak Test). The comparison to the predicate device explicitly states that "The technological characteristics of the subject Squirt® Fluid Delivery System are identical to the predicate device... with the exception of the O-Ring... which has undergone a chemical formulation change."
The "acceptance criteria" for this type of submission would relate to meeting the specifications outlined in these standards and internal tests, demonstrating that the design change (O-ring material) does not negatively impact safety or performance, thereby maintaining substantial equivalence to the predicate. However, the specific numerical acceptance criteria and the detailed test results are not included in this high-level 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).