SOLAR GI SYSTEM

K031084 · Medical Measurement Systems B.V. · FFX · Mar 19, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K031084
• Device Name: SOLAR GI SYSTEM
• Applicant: Medical Measurement Systems B.V.
• Product Code: FFX · Gastroenterology, Urology
• Decision Date: Mar 19, 2004
• Decision: SESE
• Submission Type: Traditional
• 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, sphirycter of oddi, small bowel, colon and anorectal area including rectum and pelvic flor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area.

Device Story

Solar GI system; records, stores, views, and analyzes physiological data including pressure, EMG, swallow, and respiration; utilizes designated catheters and accessories for specific GI tract locations (pharynx, esophagus, stomach, duodenum, sphincter of Oddi, small bowel, colon, anorectal area); used by clinicians to assist in diagnosis and evaluation of GI and swallowing disorders; provides on-line data visualization and analysis to support clinical decision-making.

Technological Characteristics

Gastrointestinal motility monitoring system; utilizes specialized catheters and accessories for signal acquisition; supports multi-modal inputs including pressure, EMG, swallow, and respiration; software-based analysis and storage.

Indications for Use

Indicated for patients requiring diagnostic evaluation of gastrointestinal and swallowing disorders via recording and analysis of pressure, EMG, swallow, and respiration data throughout the GI tract.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 1 9 2004

Ms. Karin Ogink-Somhorst Quality Assurance and Regulatory Affairs Manager Medical Measurement Systems, B.V. Colosseum 25, 7521 PV Enschede P.O. Box 580, 7500 AN Enschede THE NETHERLANDS

Re: K031084

Trade/Device Name: Solar GI Regulation Number: 21 CFR §876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: 78 FFX Dated: December 19, 2003 Received: December 22, 2003

Dear Ms. 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, Or ve 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.

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 af the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 100-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsmaldsmamain.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): K031084

Device Name: Solar Gl

Indications For 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, sphirycter of oddi, small bowel, colon and anorectal area including rectum and pelvic flor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders.

Designated catheters and accessories are required for measurement in each specific area.

Yes Prescription Use (Parl 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 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 Sign-Off)

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

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No