(405 days)
The Rapid Barostat Bag Pump and Catheter are used together for the inflation of a barostat balloon to measure rectal capacity, as well as rectal volume at points of sensation, urge, and discomfort, to determine hypersensitivity, hyposensitivity, or normal rectal sensations. These determinations aid in the diagnosis of anorectal disorders, such as fecal incontinence and constipation.
The Rapid Barostat Bag system consists of a pump unit and a disposable catheter. The pump uses an air compressor pneumatic system and is operated through a touch screen. It is electrically powered by rechargeable batteries and is wirelessly connected to a peripheral remote control for the patient to input different levels of sensation during the study. The catheter is made up of single-lumen PVC tubing with a plastic non-compliant barostat balloon at the distal end, and a female luer at the proximal end. The balloon end of the catheter is inserted into a patient's rectum, and the luer end is connected to the pump.
The study, also known as RBB Protocol, consists of two or more rounds of inflation and deflation of the catheter. The first round will inflate the balloon to the set internal pressure of 40 mmHg to determine the maximum volume of the rectum. The second round of inflation will be used to determine the volumetric points of sensation, urge, and discomfort associated with the patient's rectum. During the study, the pump will push air through the catheter tubing into the barostat balloon at a constant rate of 2 mL/sec, while displaying the fluctuating pressure within the balloon onto the pump's touch screen display. When the patient begins to feel the sensation of the inflated balloon, they would push the "sensation" button on the remote control to transmit a signal to the pump. The inflation volume and pressure will be recorded at that point of reference. The pump will continue to inflate the balloon for the patient to report the point of the feeling of urge, and then discomfort, and the data points are collected and stored in the systems internal memory. Upon pressing the discomfort indicator button, the system will automatically stop the inflow of air into the balloon and begin to rapidly deflate the balloon at 3 mL/sec. By extrapolating the volume and pressure measurements recorded within the barostat balloon, the pump will be able to provide the healthcare professional with clearer data for a more accurate diagnosis of anorectal functions and rectum disorder.
The provided text describes the Mui Scientific Rapid Barostat Bag (RBB) Pump and Catheter System, detailing its intended use, design, and a comparison to predicate devices to demonstrate substantial equivalence. The document is primarily a 510(k) Summary for regulatory purposes.
Based on the provided information, here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail format typical of a rigorous study. Instead, it describes performance in relation to a predicate device to demonstrate "substantial equivalence." The key performance metrics and their comparison are:
| Feature/Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (RBB Pump and Catheter) |
|---|---|---|
| RBB Pump: | ||
| Indications for Use | Measure rectal capacity, as well as rectal volume at points of sensation, urge, and discomfort, to determine hypersensitivity, hyposensitivity, or normal rectal sensations. These determinations aid in the diagnosis of anorectal disorders, such as fecal incontinence and constipation. (Predicate's general indication is "indirectly measures the muscle tone of a hollow organ") | The Rapid Barostat Bag Pump and Catheter are used together for the inflation of a barostat balloon to measure rectal capacity, as well as rectal volume at points of sensation, urge, and discomfort, to determine hypersensitivity, hyposensitivity, or normal rectal sensations. These determinations aid in the diagnosis of anorectal disorders, such as fecal incontinence and constipation. |
| Pressure Range | 0 to 60 mmHg | 0 to 40 mmHg |
| Airflow Rate | 2 to 25 mL/sec | 1.5 to 3 mL/sec |
| Performance | Obtained the same measurement for rectal capacity and compliance as the Submission Device when running the same RBB Protocol. | Obtained the same measurement for rectal capacity and compliance as the Predicate Device when running the same RBB Protocol. |
| Software Validation | Information not readily available by manufacturer (for predicate) | Substantial equivalency demonstrated. |
| Measurement Accuracy | Information not readily available by manufacturer (for predicate) | Substantial equivalency demonstrated. |
| Measurement Consistency | Information not readily available by manufacturer (for predicate) | Substantial equivalency demonstrated. |
| RBB Catheter: | ||
| Indications for Use | Must be used in conjunction with a Barostat machine to indirectly measure the muscle tone of a hollow organ by inflating a barostat balloon and keeping the pressure constant while measuring the volume changes. Also measures rectal capacity. | The Rapid Barostat Bag Pump and Catheter are used together for the inflation of a barostat balloon to measure rectal capacity, as well as rectal volume at points of sensation, urge, and discomfort, to determine hypersensitivity, hyposensitivity, or normal rectal sensations. These determinations aid in the diagnosis of anorectal disorders, such as fecal incontinence and constipation. |
| Catheter OD | Various | 5.2 mm |
| Lumen ID | Various | 3.2 mm |
| Balloon Details | Various volumes (150 mL - 1000 mL), various lengths | 700 mL, 10 cm in length |
| Material | Polyvinylchloride tubing, polyolefin balloon | Polyvinylchloride tubing, polyolefin balloon |
| Length | Various (100 cm standard) | 100 cm |
| Connector End | Polyvinylchloride tubing (10 cm length, OD 7.9 mm, ID 4.8 mm) | Female luer |
| Number of uses | Single-use and reusable models | Single-use |
| Balloon Burst/Leak Tests | Substantial equivalency demonstrated | Substantial equivalency demonstrated. |
| Tensile Strength Test | Substantial equivalency demonstrated | Substantial equivalency demonstrated. |
| Biocompatibility | Passed Cytotoxicity, Irritation, and Sensitization tests | Passed Cytotoxicity, Irritation, and Sensitization tests. |
| Shelf Life | 2 years | 2 years. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- RBB Pump: A "comparison test was performed to demonstrate that the RBB Pump can measure the same results as the Barostat when both machines are running the same RBB Protocol." The sample size for this test set is not specified. The document does not provide information on the country of origin of the data or whether it was retrospective or prospective, implying it was likely an internal lab-based performance comparison.
- RBB Catheter: Various tests (Balloon Burst/Leak, Tensile Strength, Biocompatibility, Shelf Life) were performed. The sample sizes for these tests are not specified. The data provenance (country, retrospective/prospective) is not provided, suggesting these were internal lab tests for the device itself.
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. The tests performed are engineering/performance comparison tests against a predicate device, not diagnostic studies requiring clinical ground truth established by experts. The "ground truth" for the pump comparison was the measurements obtained by the predicate device under the same protocol. For the catheter, it was the results of standardized material and safety tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The studies described are performance comparisons of medical devices, not clinical studies involving expert adjudication of patient data.
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 document describes a medical device (pump and catheter) for physiological measurement, not an AI or imaging diagnostic tool. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The primary study mentioned for the RBB Pump is a "comparison test" between the new device and the predicate device, both performing the "same RBB Protocol." This implies a standalone performance test of the new device against the predicate, likely in a controlled environment. The document states: "A comparison test was performed to demonstrate that the RBB Pump can measure the same results as the Barostat when both machines are running the same RBB Protocol." This focuses on the device's inherent measurement capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- RBB Pump: The "ground truth" was a direct comparison of measurements obtained by the proposed RBB Pump against those obtained by the legally marketed predicate device (Distender Series II Barostat) when both were running the "same RBB Protocol." This is a performance equivalence ground truth, not a clinical diagnostic ground truth.
- RBB Catheter: The ground truth for catheter-related tests (burst, leak, tensile, biocompatibility, shelf life) was established by demonstrating equivalence to the predicate's performance or compliance with recognized standards (e.g., biocompatibility standards like those for Cytotoxicity, Irritation, and Sensitization).
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 876.1725 Gastrointestinal motility monitoring system.
(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).