(325 days)
The I.C. Medical SI Controller Model SI 500 is intended to control the flow of irrigation fluids and vacuum to suction/irrigation and multifunction accessories having compatible suction/irrigation features during wound care and closed surgical procedures. When used with appropriate accessories the SI Controller may be used for hydro-dissection.
The SI Controller is not intended for use in delivering any blood or blood products
The SI Controller Model SI500 controls the flow of fluids and vacuum to suction/irrigation and multifunction accessories used during -wound-eare and-open and closed surgical procedures and may be used for hydrodissection. Also included in this 510(k) application are tubing sets, disposable fluid canisters and accessories used to connect other surgical accessories to the irrigation fluid and vacuum sources. An electrical cable is also provided to accommodate remote sensing from I.C. Medical Crystal Vision smoke evacuators (K932230) in order to automatically activate and deactivate the SI Controller. I.C. Medical recommends that this device be used with the PenEvac SI (K95166) which is a multifunction suction, irrigation, ESU monopolar electrode device.
The provided text is a 510(k) summary for a medical device (SI Controller, Model SI 500) from 1996. This type of document is a premarket submission to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.
Crucially, this document is a summary for regulatory approval, not a scientific study report demonstrating the device meets specific performance acceptance criteria in a research setting.
Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies cannot be found within this document. These types of detailed studies and the specific reporting of acceptance criteria are typical for a device's rigorous clinical validation, which is a different purpose than a 510(k) summary.
The 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, primarily by comparing technological characteristics and intended use.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not define specific, quantifiable acceptance criteria (e.g., "flow rate must be within X% of target") nor does it report the device's performance against such criteria. It states that the pump can deliver "continuously variable flows from 0-3.5 gpm" and that "Pressure may also be varied within a pressure range that is comparable to other devices used during laparoscopic procedures." These are descriptions of capabilities, not measurements against predefined acceptance criteria.
- The heat-retaining plate's maximum temperature is stated as "38 degrees centigrade" (a correction from "30 decrees centigrade" earlier in the document, suggesting a typo was corrected or the specification changed). This is a specification, but not tied to a specific acceptance criterion for a study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. No "test set" in the context of a performance study is mentioned. The document relies on comparisons to predicate devices and descriptions of functionality, not on a study with a defined test set.
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):
- Cannot be provided. No ground truth establishment by experts is mentioned, as no performance study is detailed with a "test set" requiring ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. No adjudication method is mentioned.
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 was not done and is not relevant. This device (SI Controller) is a physical medical device for irrigation and suction, not an AI or imaging device that would involve "human readers" or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this was not applicable/done. This is not an algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Cannot be provided. No ground truth is established in the context of a performance study. The "truth" for a 510(k) is about demonstrating equivalence to existing, legally marketed devices.
8. The sample size for the training set:
- Cannot be provided. No "training set" is mentioned, as this device does not involve machine learning algorithms.
9. How the ground truth for the training set was established:
- Cannot be provided. Not applicable.
Summary of available information from the document:
The provided document is a 510(k) summary for the I.C. Medical SI Controller, Model SI 500, from 1996. Its purpose is to demonstrate substantial equivalence to previously cleared predicate devices for regulatory approval, not to present the results of detailed performance studies against specific acceptance criteria.
The document describes the device's functionality, its various modes of operation (irrigation, suction, manual, AUTO 1, AUTO 2, AUTO 3EF), its accessories (tubing sets, ESU sensor), and its intended use. It largely relies on comparing its technological characteristics (e.g., flow range, pressure range, heat plate temperature) to those of the predicate devices rather than presenting specific quantitative performance data or results from clinical validation studies.
Key statements related to "performance" (though not against formal acceptance criteria):
- Flow Rate: "The pump can deliver continuously variable flows from 0-3.5 gpm."
- Pressure: "Pressure may also be varied within a pressure range that is comparable to other devices used during laparoscopic procedures."
- Heat Retaining Plate Temperature: "The heat retaining plate is not meant to heat cold bags of fluids and it has a maximum temperature of 38 degrees centigrade." (Initially stated as 30 degrees Celsius, then corrected to 38 degrees Celsius).
- Tubing Sets: "The materials used in the tubing sets are the same, with the exception of the peristaltic pump tubing, as those used in the predicate devices. The peristaltic pump tubing is suitable for use in these tubing sets."
In conclusion, this specific document does not contain the information required to populate the requested table and answer the study-related questions, as it is a regulatory submission for substantial equivalence rather than a clinical or performance study report.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.