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The Disposable Suction And Irrigation System is used to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to remove fluid waste, tissue debris and smoke from the surgical site.

The Disposable Suction And Irrigation System is composed of a stainless steel Suction / Irrigation Probe which is connected to a handle having two trumpet type valves. Using the fingers, the action of depressing one valve will control the irrigation fluid from the Poly Venyl Chloride (PVC) tubing through the irrigation probe and be delivered onto the site of surgery. By depressing the other valve would enable the action of suction to remove blood and tissue debris from the site of surgery through the suction probe and these will be transported through the PVC tubing and be deposited into a waste container. The handle is joined to two PVC tubes. One divides itself into two branches to conduct irrigation fluids from a saline bag. The clamp is used to hold the two tubes in a vertical position. This irrigation fluid passes down the tubes, then through the Suction / Irrigation Probe and is deposited onto the surgical site. The other tube will conduct waste tissue debris or blood or smoke. A vacuum pump will be connected to the Suction end to draw the tissue debris or blood or smoke from the site of surgery, through the stainless steel Suction / Irrigation Probe and these are transported through this PVC tubing until they are deposited into a waste container. This device is for single use only.

The provided document describes a 510(k) Premarket Notification for a medical device called the "Disposable Suction And Irrigation System." This type of submission to the FDA focuses on demonstrating substantial equivalence to a currently marketed predicate device, rather than proving novel effectiveness or meeting specific performance acceptance criteria through a standalone study.

Therefore, the information typically requested in your prompt (e.g., acceptance criteria table, sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance) is not present and not applicable to this type of regulatory submission.

Here's why and what information can be extracted:

• Substantial Equivalence: The primary goal of a 510(k) is to show that a new device is "as safe, as effective, and performs very much the same way as" a legally marketed predicate device. This is done by comparing technological characteristics, intended use, and indications for use.
• No "Acceptance Criteria Study" in the sense of a clinical trial: The document does not describe a study designed to prove the device meets specific performance metrics against pre-defined acceptance criteria. Instead, it relies on a comparison to the predicate device.
• No AI Component: The device described is a physical medical instrument for suction and irrigation, not an AI/ML powered device. Therefore, questions regarding AI performance metrics, training sets, and ground truth for AI algorithms are not relevant.

Information Extracted from the Document:

1. A table of acceptance criteria and the reported device performance:

   • Not applicable. This document demonstrates substantial equivalence, not performance against specific acceptance criteria. The "performance" assessment is comparative to 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):

   • Not applicable. No test set or clinical study data is described. The comparison is based on device characteristics.

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. No ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. No test set or adjudication method is described.

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 device, and no MRMC study is described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable. No ground truth is established for device performance in the context of a clinical study. Substantial equivalence relies on comparing the device's design, materials, and intended use to those of a predicate device.

8. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established:

   • Not applicable. No training set is described.

Information Related to Substantial Equivalence (as found in the document):

• Predicate Device: Applied SI Suction Irrigator
• Basis for Equivalence: "The technological characteristics of The Disposable Suction System as compared to the predicate device - Applied SI Suction Irrigator, are found to be very similar. This device has the same technological characteristics in terms of design, structure, material composition, indication for use, intended use are similar as the predicate device."
• Conclusion: "It is demonstrated that the device Disposable Suction And Irrigation System is as safe, as effective, and performs very much the same way as the predicate device, Applied SI Suction Irrigator. It also has the same design, performance and structure as predicate device. Hence it is substantially equivalent to the predicate device."

In summary, this document is a regulatory submission for substantial equivalence for a physical medical device, not a performance study for an AI algorithm or a clinical trial against specified acceptance criteria.

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