(120 days)
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Not Found
No
The summary describes a perfusion pump for measuring pressures and filling balloons, with no mention of AI or ML capabilities.
No
The device is described as an accessory device used to perfuse water for pressure measurements and balloon filling, which are diagnostic procedures, not therapeutic ones.
Yes
Explanation: The device is used to measure pressures in the gastrointestinal tract for intraluminal studies, which aids in diagnosing conditions related to pressure abnormalities in these areas.
No
The device description explicitly states it is an "accessory device to be used with the MMS Solar GI system" and describes functions like "perfuse demineralized or distilled water through the lumen of a multi-lumen catheter" and "automated balloon filling." These are hardware-based functions, indicating the device is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description states the device is a perfusion pump used to perfuse water through a catheter within the gastro-intestinal tract to measure pressures. This is an in vivo (within the living body) procedure, not an in vitro (outside the living body) test on a sample.
- Lack of mention of samples: The description does not mention the analysis of any biological samples.
Therefore, the MPP Plus, as described, is a device used for physiological measurements within the body, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The MPP Plus is an accessory device to be used with the MMS Solar GI system for intraluminal studies of the gastro-intestinal tract (Pharynx, esophagus, stomach, duodenum, Sphincter of Oddi, small bowel, colon, and anorectal area including rectum) to perfuse demineralized or distilled water through the lumen of a multi-lumen catheter to measure pressures.
The perfusion pump can also be used for automated balloon filling (for anorectal manometry studies). The filling lumen of the catheter can be connected to the perfusion pump.
Designated catheters and accessories are required for measurement in each specific area.
Product codes
FFX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Pharynx, esophagus, stomach, duodenum, Sphincter of Oddi, small bowel, colon, and anorectal area including rectum
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mrs. Karin Ogink-Somhorst Manager Quality Assurance and Regulatory Affairs Medical Measurement Systems B.V. Colosseum 25 ENSCHEDE 7521 PV NETHERLANDS
AUG 1 2012
Re: K121014 Trade/Device Name: MPP Plus Regulation Number: 21 CFR§ 876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: FFX Dated: July 26, 2012 Received: July 27, 2012
Dear Mrs. Ogink-Somhorst:
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 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 your de 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 that I Dr Has intact a and regulations administered by other Federal agencies. You must or uny I outral statutes the requirements, including, but not limited to: registration and listing confirs will and the 100 bag (21 CFR Part 801); medical device reporting (reporting of medical
1
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/CDRHQffices/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,
Sincerely yours,
Benjamin K. Zirkin
Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
MPP Plus Device Name:
Indications For Use:
The MPP Plus is an accessory device to be used with the MMS Solar GI system for intraluminal studies of the gastro-intestinal tract (Pharynx, esophagus, stomach, duodenum, Sphincter of Oddi, small bowel, colon, and anorectal area including rectum) to perfuse demineralized or distilled water through the lumen of a multi-lumen catheter to measure pressures.
The perfusion pump can also be used for automated balloon filling (for anorectal manometry studies). The filling lumen of the catheter can be connected to the perfusion pump.
Designated catheters and accessories are required for measurement in each specific area.
YES __ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use NO (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)
Herlud Stum
Division Sign-Off) Division of Reproductive, Gastro-Renal, and Irological Devices 510(k) Number
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