(120 days)
The sphincter of Oddi manometric pump and catheter are used in conjunction with a computerized motility system for motility studies, to measure the Contraction rates along the gastrointestinal system (specifically the sphincter of Oddi); for research or diagnostic purposes within a clinical setting.
This system consists of a water-perfused SOM pump, an air compressor unit, and a Toouli SOM Sleeve catheter. The air compressor unit consists of a compressor motor, a pressure switch, a pressure gauge, and a drying cylinder. When turned on, the motor will compress air into the drying cylinder, which will remove the water by-product from the compression. The pressure switch will turn the motor off at 30psi (as displayed on the pressure gauge), and will restart it when the pressure drops to 10psi. An air hose connects the air compressor unit to the SOM pump to deliver the pressurized air to the SOM pump. The pressurized air will flow through a high pressure gauge (to display the pressure of the supplied compressed air), to a regulator (which will regulate the pressurized air down to 5psi), then a low pressure gauge (to display the pressure of the regulated air), to a water reservoir filled with sterilized irrigation water. The regulated air will push the water reservoir at a constant rate through resistors that will further reduce the water flow rate to 0.18mL/min before it travels through a pressure transducer to the Toouli SOM Sleeve catheter. The proximal end of the Toouli SOM Sleeve catheter has a female luer that connects to the top of the pressure transducer on the SOM pump. The water will flow through the entire length of the Toouli SOM Sleeve catheter to the distal end where a silicone sleeve sensor is located. The Toouli SOM Sleeve catheter is then inserted through the biopsy channel of an endoscope, and then the sleeve sensor is positioned along the Sphincter of Oddi. With the regulated pressurized water flowing through the sleeve sensor at a constant rate, when the sphincter contracts, it will constrict the flow of water through the sleeve sensor, and the pressure change will be transmitted back through the water flow to the pressure transducer on the SOM pump, where the signal will be displayed onto the computer.
The provided text is a 510(k) Summary for the Mui Scientific Sphincter of Oddi Manometric (SOM) System. It describes the device, its intended use, and the basis for substantial equivalence to predicate devices. However, the document does not contain the detailed clinical study results (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, etc.) that would typically be found in a comprehensive study report proving a device meets specific acceptance criteria.
The document does mention "bench tests" as the primary form of testing conducted.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or provide specific numerical device performance metrics in a table format. It describes the bench testing qualitatively:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Pressure exerted by a mimicked sphincter contraction should equal the pressure measured and transmitted by the SOM catheters. | "With the systems on and perfusing, a specific external force was applied to the distal ends of the SOM catheters to mimic a sphincter contraction. The pressure exerted was shown to equal the pressure measured and transmitted by the SOM catheters." (This indicates qualitative agreement, but no specific numerical tolerance or statistical measure is provided). |
| Compatibility and interchangeability with predicate devices. | "Bench tests were also conducted combining and interchanging the Sphincter of Oddi Manometric System with its predicates, demonstrating that they are compatible and interchangeable." (Again, a qualitative statement of success without quantitative metrics or a defined standard for "compatible and interchangeable"). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified. The document refers to "systems" and "catheters" in the plural, but no specific number of devices tested is given.
- Data Provenance: The tests conducted were "bench tests," meaning they were laboratory-based simulations, not involving human subjects. Therefore, there is no country of origin for patient data, nor is it retrospective or prospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. The "ground truth" for the bench tests was the "specific external force" applied to the catheters, which was a physical measurement, not an expert-derived truth.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Since the ground truth was a direct physical measurement ("pressure exerted"), there was no need for expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- MRMC Study: No. This device is a measurement system (pump and catheter), not an AI-assisted diagnostic tool for image or signal interpretation by human readers. Therefore, an MRMC study is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable in the context of an "algorithm." This device is a mechanical/electronic system for physiological measurement. Its "performance" is its ability to accurately measure pressure changes, which was evaluated via the described bench tests. There is no AI algorithm component mentioned. The system transmits signals to a "computerized motility system," but the performance described is for the hardware (pump and catheter) itself.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the bench tests, the ground truth was an "external force" or "pressure exerted" that was known and applied, mimicking a sphincter contraction. This is a physical measurement standard or controlled experimental input, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- Sample Size (Training Set): Not applicable. This device is not an AI/ML product developed using a training set. The design of the system relies on established biophysical principles of pressure transmission in fluids.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
Summary of Study Information Provided:
The documentation focuses on demonstrating substantial equivalence through a technical description and bench tests. These bench tests confirmed:
- The system's ability to accurately transmit measured pressures ("pressure exerted was shown to equal the pressure measured and transmitted").
- Compatibility and interchangeability with predicate devices.
The information provided is typical for a 510(k) submission for a medical device of this nature, where engineering performance and substantial equivalence to existing devices are demonstrated through bench testing, rather than complex clinical trials or AI model validation studies.
§ 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).