(120 days)
Not Found
Not Found
No
The device description focuses on mechanical and hydraulic principles for pressure measurement, and there is no mention of AI or ML in the text.
No
The device is strictly for research or diagnostic purposes, measuring contraction rates for information gathering, not for treating any condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is for "research or diagnostic purposes within a clinical setting." The "Device Description" also details how it measures pressure changes from sphincter contractions, which are then displayed on a computer, indicating its use in diagnosing motility issues.
No
The device description clearly outlines multiple hardware components including a pump, air compressor unit, catheter, pressure gauges, regulator, and pressure transducer. While a computerized motility system is mentioned, the core functionality relies on physical components and water flow.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. The device description clearly states that the catheter is inserted into the body (specifically, the sphincter of Oddi) to measure physiological activity (contractions). It is not analyzing a sample like blood, urine, or tissue that has been removed from the body.
- The measurement is taken in vivo. The pressure changes are measured directly within the sphincter of Oddi while it is still inside the patient.
- The intended use is for motility studies and measuring contraction rates. This is a physiological measurement, not a diagnostic test performed on a biological sample.
Therefore, this device falls under the category of a medical device used for physiological measurement and diagnosis in vivo, rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
When used in conjunction with a computerized motility system for motility studies, this Sphincter of Oddi Manometric System is used to measure the contraction rates of the Sphincter of Oddi within the gastrointestinal system; for research or diagnostic purposes within a clinical setting. The purpose of conducting these diagnostic motility studies is to determine if a patient's pain is caused by Sphincter of Oddi Dysfunction, where the contractions of the Sphincter of Oddi are abnormally high and/or erratic. This dysfunction is most commonly found in patients who have already undergone the removal of their gall bladder. Once diagnosed, the main course of treatment is either medication or sphincterotomy.
Product codes
FFX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Sphincter of Oddi, gastrointestinal system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were conducted with the Sphincter of Oddi Manometric System, comparing performance data with that of its predicates. 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. Bench tests were also conducted combining and interchanging the Sphincter of Oddi Manometric System with its predicates, demonstrating that they are compatible and interchangeable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for Mui Scientific. The logo consists of a circle with a dot in the center and three smaller circles around the perimeter. To the right of the logo is the text "Mui Scientific" in a bold, serif font.
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
May 31, 2012
JUN 2 1 2012
510(k) Summary
nterprises Inc.
RE: Sphincter of Oddi Manometric System
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: Sphincter of Oddi Manometric (SOM) System Common name: SOM pump and catheter Classification name: Gastrointestinal motility system
This 510(k) Summary is for the Sphincter of Oddi Manometric (SOM) System. Indications for Use: When used in conjunction with a computerized motility system for motility studies, this Sphincter of Oddi Manometric System is used to measure the contraction rates of the Sphincter of Oddi within the gastrointestinal system; for research or diagnostic purposes within a clinical setting. The purpose of conducting these diagnostic motility studies is to determine if a patient's pain is caused by Sphincter of Oddi Dysfunction, where the contractions of the Sphincter of Oddi are abnormally high and/or erratic. This dysfunction is most commonly found in patients who have already undergone the removal of their gall bladder. Once diagnosed, the main course of treatment is either medication or sphincterotomy.
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
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Image /page/1/Picture/0 description: The image shows the text "K120524 PAGE 2 OF 2". The text appears to be handwritten. The top line shows a code, and the bottom line indicates that this is page 2 of 2.
Image /page/1/Picture/1 description: The image shows a circle with a dot in the center and four smaller circles evenly spaced around the circumference. The four smaller circles are connected to the outer circle by lines. The image is simple and appears to be a diagram or symbol.
Mui Scientific
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
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.
We are claiming this system to be substantially equivalent to the following predicates:
- -Mui Scientific's pressurized infusion pump
- Mui Scientific's (formerly Dentsleeve Pty) manometric perfusion pump and । manometric assemblies
- -Arndorfer Inc's pneumo-hydraulic capillary infusion system and ERCP manometric catheters
- -Cook Medical's Lehman Sphincter of Oddi Manometric catheter
The SOM pump and air compressor unit is similar to its predicates in that it is driven by a motor to compress the air that gets regulated before it pushes water from a water reservoir through resistors that further reduce the flow rate before passing through the SOM catheter. The Toouli SOM Sleeve catheter is similar to its predicates in that it is long in length and small in diameter, for passing through the biopsy channel of an endoscope, and into the Sohingter of Oddi. The proximal end consists of a female luer, a standard fitting that is compatible with all the predicate water-perfused motility pumps. The number of channels/resistors through which the water is pushed through may vary, and the regulated pressure and flow rates may differ due to the organ being measured, but the concept of pressure transmission along the water medium as a result of a muscle contraction is still the same.
Bench tests were conducted with the Sphincter of Oddi Manometric System, comparing performance data with that of its predicates. 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. Bench tests were also conducted combining and interchanging the Sphincter of Oddi Manometric System with its predicates, demonstrating that they are compatible and interchangeable.
We intend to market the SOM pump and the Toouli SOM Sleeve catheter as a system. However, other Sphincter of Oddi catheters have been proven to function equally well on the Mui Scientific SOM pump. Likewise, test results have shown that the Toouli SOM Sleeve catheter is able to perform satisfactorily on other water-perfused motility pumps. Therefore. we will also be intending to market the SOM pump and Toouli SOM Sleeve catheter separately, for those doctors wanting to acquire a new SOM pump but continue to use the predicate SOM catheters, and/or for those who already have an existing SOM pump but would like to start using the new Toouli SOM Sleeve catheter.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
JUN 2 1 2012
Ms. Tammy Mui Operations Manager Mui Scientific 145 Traders Blvd. East, Unit #33-34 MISSISSAUGA ON L4Z 3L3 CANADA
K120524 Re:
Trade/Device Name: Sphincter of Oddi Manometric System Regulation Number: 21 CFR§ 876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: FFX Dated: May 31, 2012 Received: June 6, 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 10 abo stars in 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.
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 or urf Feather State Act is requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin K. Tuke
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
4
Indications for Use
510(k) Number (if known): K120524
Device Name: Sphincter of Oddi Manometric system
Indications For Use:
The sphincter of Oddi manometric pump and catheter
are used in conjunction with a computerized motility
st 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.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helut Remm
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