(93 days)
The Pressurized Infusion Pump (Electrically Powered Models #PIP-4-4SS, PIP-4-6SS, PIP-4-8SS, PIP-4-12SS, and Portable Models #PIP-6-4SS, PIP-6-6SS, PIP-6-8SS, PIP-6-12SS, PIP-6-16SS, PIP-6-22SS, PIP-6-24SS, PIP-6-36SS) is intended to provide a regulated and channeled perfusate of water to a motility catheter to perform manometric motility studies along the gastrointestinal tract. The Pressurized Infusion Pump is intended to be used with a separate legally marketed compatible motility catheter and separate computerized gastrointestinal monitoring system.
These pressurized infusion pumps consist of an electrical compartment, a water chamber, a regulator and a set of gauges, and flow restrictors. The electrical compartment 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 byproduct from the compression. The pressure switch will turn the motor off at 42psi (as displayed on the pressure gauge), and will restart it when the pressure drops to 18psi. For the Portable Pressurized Infusion Pump, an air hose connects the electrical unit to the main pump housing to deliver the pressurized air to the 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 17psi), 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 out of the water reservoir at a constant rate through resistors that will further reduce the water flow rate to 0.60mL/min before it travels through a pressure transducer to the motility catheter. At the proximal end of the motility catheter are female luers that connect to the top of the pressure transducers on the infusion pump. The water will flow through the entire length of the motility catheter to the distal end where the pressure ports are located. The motility catheter is then inserted into the patient and placed along the specific section of the gastrointestinal system being measured. With the regulated pressurized water flowing through the catheter at a constant rate, when the gut muscles contract, it will constrict the flow of water through the pressure ports, and the pressure change will be transmitted back through the water flow to the pressure transducer on the pressurized infusion pump, where the signal will be displayed onto the computer.
The provided text describes a 510(k) Summary for a Pressurized Infusion Pump. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and expert evaluation of AI. Therefore, much of the requested information regarding AI performance, human readers, and expert-established ground truth is not applicable.
Here's an analysis of the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanism of pressure delivery for water flow: The new devices (Electrical and Portable Pressurized Infusion Pumps) must effectively deliver regulated and channeled perfusate of water to a motility catheter. | The new devices use an air compressor motor to compress air into a drying cylinder. This pressurized air (regulated to 17psi) pushes water from a reservoir at a constant rate through resistors to reduce flow rate to 0.60mL/min. |
| Mimicry of muscle contraction: The device in conjunction with a motility catheter should be able to accurately transmit pressure changes caused by simulated muscle contractions. | During bench tests, a "pinch test" performed over each of the 8 pressure ports along the motility catheter (to mimic a muscle contraction) showed that "the pressure exerted was shown to equal the pressure measured and transmitted on the predicate pump." |
| Constant water flow rate: The device should maintain a constant water flow rate to the motility catheter. | The regulated air will push the water out of the water reservoir at a constant rate through resistors that will further reduce the water flow rate to 0.60mL/min. |
| Pressure regulation: The device should regulate pressure within specified ranges. | The pressure switch turns the motor off at 42psi and restarts it when pressure drops to 18psi (for the electrical compartment). The air is then regulated down to 17psi before reaching the water reservoir. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated beyond "Bench tests were conducted." The number of devices tested (Electrical and Portable Pressurized Infusion Pumps) isn't specified, nor is the number of "pinch tests" or motility catheters used.
- Data Provenance: The study was a bench test, comparing the new devices against a predicate. There is no information regarding country of origin of data as it's a lab-based test, not human or observational data. It is a prospective test in the sense that newly manufactured devices were tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. The study was a bench test verifying physical performance against a predicate device, not involving expert interpretation of medical images or data from human subjects. Ground truth was established by direct physical measurement and comparison to the predicate device's expected performance.
4. Adjudication Method for the Test Set
- Not Applicable. As this was a bench test with objective measurements (pressure, flow rate), there was no need for adjudication by experts as would be the case in subjective or diagnostic assessments. The performance was directly compared to the predicate's known output.
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 a physical medical device (a pump), not an AI-powered diagnostic or interpretive system. Therefore, no MRMC study or assessment of human reader improvement with AI was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a physical device, not an algorithm. Its performance is inherent in its mechanical and electrical design.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- The ground truth was established by the performance of the predicate device ("the pressure measured and transmitted on the predicate pump") and the design specifications of the new device (e.g., regulated air pressure, constant water flow rate). For mimicking muscle contraction, the "pinch test" served as a simulated physiological event, with the predicate's response serving as the expected "ground truth" for comparison.
8. The Sample Size for the Training Set
- Not Applicable. This device uses no AI and therefore has no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. Since there is no training set, there is no ground truth for it.
§ 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).