SOLAR GI by MEDICAL MEASUREMENT SYSTEMS,B.V.

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.

Device Description

Not Found

AI/ML Overview

The provided FDA 510(k) document is a clearance letter for the MPP Plus device, which is an accessory for gastrointestinal motility monitoring. This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device.

It does NOT contain the detailed information required to describe acceptance criteria or a specific study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance studies. The 510(k) clearance process focuses on substantial equivalence to existing devices, not necessarily on novel performance claims requiring extensive new clinical proof.

Therefore, for almost all of the requested information, the answer will be that it is not available in this document.

Here's an attempt to answer based on the provided text, and explicitly stating where information is missing:

1. A table of acceptance criteria and the reported device performance

Not available in this document. The 510(k) clearance letter does not include a table of acceptance criteria or detailed performance data from a study. It confirms substantial equivalence based on information submitted by the manufacturer, which would have included performance data, but that data is not part of this public letter.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not available in this document. The document does not describe a particular test set, its sample size, or its provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not available in this document. No information on ground truth establishment or expert involvement for a test set is provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not available in this document. No information on an adjudication method is provided.

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 / Not available in this document. The MPP Plus is a physical accessory (perfusion pump) for a gastrointestinal motility monitoring system. It is not an AI-driven diagnostic device that would typically involve human "readers" or an MRMC study comparing AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable / Not available in this document. As noted above, the device is a physical accessory, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not available in this document. Information on ground truth, if any was collected for performance verification, is not included. However, given it's a measurement device, the "ground truth" would likely relate to the accuracy and precision of the pressure measurements and pump functionality compared to calibrated standards, rather than clinical endpoints like pathology or outcomes data.

8. The sample size for the training set

Not applicable / Not available in this document. This device is hardware for physiological measurement, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable / Not available in this document. As above, no training set is relevant for this type of device.

Summary

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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

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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,

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

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Indications for Use

510(k) Number (if known):

MPP Plus Device Name:

Indications For Use:

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

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).