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.

Device Description

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.

AI/ML Overview

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.

Summary

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Ki22294
NOV 1 2012 PAGE 1 OF 2

Mivision of Mui Scientific Enterprises Inc 145 Traders Blvd. E., Unit #34, Mississauga, ON, Canada, L4Z 3L3 Tel: (905) 890-5525 Toll Free: 1-800-303-6611 Fax: (905) 890-3523 Website: www.muiscientific.com Email: mail@muiscientific.com

October 31, 2012

510(k) Summary

RE: Electrical and Portable Pressurized Infusion Pump

Summary prepared by:

Contact Person: Tammy Mui Title: Operations Manager Manufaxturer: Mui Scientific, a Division of H&A Mui Enterprises Address: 145 Traders Blvd. East, Unit #33-34, Mississauga, Ontario, Canada L4Z 3L3 Phone: (905) 890-5525 Fax: (905) 890-3523 Email: tammy.mui@muiscientific.com

Trade name: Pressurized Infusion Pump Common name: Water-perfused motility pump Classification name: Gastrointestinal motility system

This 510(k) Summary is for the Pressurized Infusion Pump.

Indications for Use: 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.

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122294 AGE 2 OF 2

Division of Mui Scientific Enterprises Inc.

145 Traders Blvd. E., Unit #34, Mississauga, ON, Canada, L4Z 3L3 Tel: (905) 890-5525 Toll Free: 1-800-303-6611 Fax: (905) 890-3523 Website: www.muiscientific.com Email: mail@muiscientific.com

(to display the pressure of the regulated air), to a water reservoir filled with sterilized irrigation water. The requlated 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 The water will flow through the entire lenath of the motility catheter to the distal end pump. 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 requlated pressurized water flowing through the catheter at a constant rate, when the qut 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.

We are claiming this system to be substantially equivalent to the following predicates:

Mui Scientific's Nitrogen gas model of the pressurized infusion pump -
The Electrical and Portable pump versions are similar to this predicate in that they use pressure to push water from a water reservoir through resistors that further reduce the flow rate before passing through a motility catheter. The difference is the source of the pressure: compressed nitrogen gas in the predicate, and an air compressor motor in the Electrical and Portable pump models.

Bench tests were conducted with the Electrical and Portable Pressurized Infusion Pumps, comparing performance data with that of its predicates. With the systems on and perfusing, a pinch test was performed over each of the 8 pressure ports along the motility catheter, to mimic a muscle contraction. The pressure exerted was shown to equal the pressure measured and transmitted on the predicate pump.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter date: November 1, 2012

Mui Scientific Division of H&A Mui Enterprises Inc. % Ms. Tammy Mui Operations Manager 145 Traders Blvd. East, Unit #34 MISSISSAUGA ON CANADA L4Z 3L3

Re: K122294

Trade/Device Name: Pressurized Infusion Pump Regulation Number: 21 CFR§ 876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: FFX Dated: October 15, 2012 Received: October 19, 2012

Dear Ms. Mui:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Tammy Mui

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K122294

Device Name: Pressurized Infusion Pum

Indications For Use:

The Pressurized Infusion Pump (Electrically Powered Models #PIP-4-4SS, 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 Pressunzed Infusion Pump is intended to be used with a separate legally marketed compatible motility catheter and separate computerized gastrointestinal monitoring system.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

oncurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fisher 1 16:46:29 -04'00

(Division Sign-Off) wision of Reproductive, Gastro-Renal, and Proiogical Devices SIU(K) NUr

Page 1 of

Regulation Number and Section

§ 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).