SOLAR GI

K121014 · Medical Measurement Systems B.V. · FFX · Aug 1, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K121014
• Device Name: SOLAR GI
• Applicant: Medical Measurement Systems B.V.
• Product Code: FFX · Gastroenterology, Urology
• Decision Date: Aug 1, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1725
• Device Class: Class 2

Intended 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.

Device Story

MPP Plus is a perfusion pump accessory for the MMS Solar GI system; used for intraluminal gastrointestinal pressure measurement and automated balloon filling during anorectal manometry. Device perfuses demineralized or distilled water through multi-lumen catheters to enable pressure sensing. Operated by clinicians in clinical settings; integrates with existing manometry hardware. Output consists of controlled fluid delivery for pressure transduction; assists in diagnosing GI motility disorders. Benefits include standardized, automated perfusion and balloon inflation for accurate manometric data acquisition.

Clinical Evidence

Bench testing only.

Technological Characteristics

Perfusion pump system; utilizes multi-lumen catheters for fluid delivery; compatible with demineralized or distilled water; designed for integration with MMS Solar GI system; electrical operation; standard clinical manometry interface.

Indications for Use

Indicated for patients requiring intraluminal pressure measurement of the gastrointestinal tract (pharynx, esophagus, stomach, duodenum, Sphincter of Oddi, small bowel, colon, and anorectal area) and anorectal manometry studies.

Regulatory Classification

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.

Reference Devices

• MMS Solar GI system

Submission Summary (Full Text)

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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 [phone] or [phone] 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

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## 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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