SOLAR GI

K052338 · Medical Measurement Systems B.V. · FFX · Dec 15, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K052338
• Device Name: SOLAR GI
• Applicant: Medical Measurement Systems B.V.
• Product Code: FFX · Gastroenterology, Urology
• Decision Date: Dec 15, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1725
• Device Class: Class 2

Intended Use

The Solar GI system is intended to record, store, view and analyse pressure, EMG, swallow and respiration and various auxiliary input device data on-line anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphincter of oddi, small bowel, colon and anorectal area including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders.

Device Story

Solar GI system records, stores, views, and analyzes physiological data including pressure, EMG, swallow, and respiration; utilizes specialized catheters and CIM-AUX module for data acquisition; intended for clinical use by healthcare professionals to assist in diagnosing gastrointestinal and swallowing disorders; system provides on-line monitoring and analysis of GI tract function; output allows clinicians to evaluate motility and functional integrity of various GI segments; benefits patients by facilitating accurate diagnosis of complex GI and swallowing pathologies.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Gastrointestinal motility monitoring system; includes CIM-AUX module; utilizes specialized catheters for pressure, EMG, swallow, and respiration sensing; software-based data acquisition and analysis; Class II device.

Indications for Use

Indicated for patients requiring diagnostic evaluation of gastrointestinal and swallowing disorders via pressure, EMG, swallow, and respiration monitoring across the GI tract (pharynx, esophagus, stomach, duodenum, sphincter of oddi, small bowel, colon, rectum, and pelvic floor).

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.

Predicate Devices

• K032336

Submission Summary (Full Text)

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DEC 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karin Ogink-Somhorst Ms. Karin Ognar e and Regulatory Affairs Manager Medical Measurement Systems, B.V. Colosseum 25 Enschede NETHERLANDS 7521 PV

Re: K052338

K032336
Trade/Device Name: Solar GI including CIM-AUX Module Regulation Number: 21 CFR §876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: FFX Dated: November 7, 2005 Received: November 15, 2005

Dear Ms. Ogink-Somhorst:

Dour and 100 -We have revewed your Section 510(x) promation institutions for use stated in
above and have determined the device is substantially equivalent (for the stated in above and have delemined the devices marketed in interstate commerce prior to devices that her the enclosure) to regally marketed predical Device Amendments, or to devices that have been a May 28, 1976, the enactified in the Frederal Food, Dugg, and Cosmetic Act (Act) that reclassified in accordance with the provisions of and instal. You may, therefore, market the A do not require approval of a prematics approvisions of the Act. The general controls provisions of the Act
device, subject to the general controls provisions of the Act. device, subject to the gelleral controls of the real and of the solor of the practice, labeling, morado roquires against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Prematket If your device is classified (sec above) into other existing major regulations affecting your Approval), if may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title 21, Parls 800 Port device can be found in the Sodo of the Code of the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that PDA 's issualled of a successions lies with other requirements of the Act of all FDA has made a delemination that your do receives was agencies. You must comply with all the rederal statues and regulations administered of ourse and listing (2 CFR Part 807); labeling areams (OS Act s requirements, including, but not mined to regulation the quality systems (QS)
(21 CFR Part 801); good manufacturing practice requirements as set for the positions (21 CFR Part 801), good manufacturing practice the electronic product radiation control provisions
regulation (21 CFR Part 820); and if applicable, the electronic product rad (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 5 I0(k) This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA indian if your device and this ocruits premarket notification. The FDA inding of substantial equive and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r in the may of the follow following sumbers, based on the regulation num If you desire specific advice for your device on our labeling regulations.
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misoration on your responsibilities under the Act from the 807.97). You may obtain other general information on your responsibility of the number (800)
Division of Small Manufacturers, International and Consumer Assistance at its to DIVIsion of Binan Man......................................................................................................................................................... 056-2041 or (2 gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

K052338

Device Name:

Solar GI including CIM-AUX module

Indications For Use:

The Solar GI system is intended to record, store, view and analyse pressure, EMG,
anywhere in the state in the successions william innut dovice data on-line anywhere in The Solar Gl system is intended to record, store, wew and data on-line anywhere in the
swallow and respiration and various antemant dudenmenting of oddi. swallow and respiration and valious auxinal y mpara ovloodenum, sphincter of oddi,
gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphincter of oddi, gastrointestinal tract (pharynx, esophagus, stomaon, adocuments |
small bowel, colon and anorectal area including rectum and pelvio floor) to assist in the small bower, color and anorestal drou installing wallowing disorders.
diagnosis and evaluation of gastrointestinal and swallowing disorders.

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 (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)

Nancy C. Brogdon

Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

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