MOTILITY VISUALIZATION SYSTEM

K031169 · Sierra Scientific Instruments, Inc. · FFX · Dec 12, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K031169
• Device Name: MOTILITY VISUALIZATION SYSTEM
• Applicant: Sierra Scientific Instruments, Inc.
• Product Code: FFX · Gastroenterology, Urology
• Decision Date: Dec 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1725
• Device Class: Class 2

Indications for Use

The MVS obtains a high resolution mapping of pressures within tubular organs of the human gastrointestinal tract. These organs include the esophagus from the pharyngeal region through the stomach, the duodenum, and the anus/rectum. It is used in a medical clinical setting to sense the pressures and store the corresponding data. The system also provides analysis information. The real time data as well as the analysis information can be viewed by a physician for diagnostic and analysis purposes. The system includes a catheter probe with 36 pressure sensing elements. During the clinical procedure, the catheter is inserted transnasally and pressure inside the pharynx, esophagus, or proximal gut (stomach/duodenum) is measured as the patient typically swallows small amounts of water. Alternatively, pressures within the anus/rectum are measured via rectal intubation. Real-time data is sampled from each sensing element via the MVS interface electronics and made available to the MVS software during each sample period. The software displays the data in real-time to support the clinical procedure.

Device Story

Motility Visualization System (MVS) provides high-resolution pressure mapping of GI tract. Input: pressure data from 36-element catheter probe inserted transnasally or rectally. Operation: MVS interface electronics sample real-time pressure signals; software processes data for display, storage, and analysis. Output: real-time visualization, stored session playback, and automated motility metrics (e.g., LES location/pressure, wave amplitude/velocity). Used in clinical settings by physicians to support diagnostic decision-making. Benefits: provides more complete pressure data set compared to lower-density catheters, aiding in motility disorder diagnosis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System includes 36-element manometric catheter, interface electronics, control computer, touchscreen, keyboard, mouse, printer, and calibration chamber. Proprietary signal processing scheme minimizes electrical conductors for high-density sensor array. Software-based data acquisition, storage, and analysis. Connectivity via standard peripherals. Sterilization method not specified.

Indications for Use

Indicated for patients requiring gastrointestinal motility assessment via high-resolution pressure mapping of the pharynx, esophagus, stomach, duodenum, or anus/rectum. Used in clinical settings by physicians for diagnostic and analysis purposes.

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

• Medtronic, Polygraf ID and Polygram 98 software (K011472)

Submission Summary (Full Text)

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K031169

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# DEC 1 2 2003

### 510(k) Summary

| Date prepared: | April 10, 2003 |
|-------------------|---------------------------------------------------------------------------------------------------|
| Date revised: | September 12, 2003 |
| Submitter/Owner: | Sierra Scientific Instruments, Inc.<br>5757 Century Boulevard, Suite 600<br>Los Angeles, CA 90045 |
| Contact person: | Sean M. Curry<br>16787 Bernardo Center Drive, Suite A-1<br>San Diego, CA |
| Phone number: | [phone] |
| Fax number: | [phone] |
| Proprietary name: | Motility Visualization System |
| Common name: | Gastrointestinal Motility (Electrical) System |
| Classification: | Class II |
| Product Code: | FFX |

#### Substantial equivalence claimed to:

1. K011472 - Medtronic, Polygraf ID and Polygram 98 software

#### Description:

The Motility Visualization System (MVS) obtains a high resolution mapping of pressures within tubular organs of the gastrointestinal tract. It is used in a medical clinical setting to sense the pressures along the gastrointestinal tract and stores the corresponding data. The system also provides analysis information. The real time data as well as the analysis information can be viewed by a physician for diagnostic and analysis purposes.

The system includes a catheter probe with 36 pressure sensing elements. During the clinical procedure, the catheter is inserted transnasally and pressures inside the upper esophageal sphincter (UES), esophagus, lower esophageal sphincter (LES), and proximal gut are measured as the patient typically swallows small amounts of water. Alternatively, the catheter may be inserted in the anus/rectum for measurement of contractile pressures in that region. Real-time data is sampled from each sensing element via the MVS interface electronics and made available to the MVS software during each sample period. The software displays the data in real-time to support the clinical procedure.

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K031169
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Image /page/1/Figure/1 description: This image shows an overview of the MVS system. The system includes a touchscreen, keyboard, mouse, printer, flash memory card or CD reader/writer, pump, manometric catheter in patient esophagus with a disposable sheath, MVS control computer, and calibration pressure chamber. The MVS control computer is connected to all of the other components.

MVS System Overview

The software also supports operational utility functions such as providing the user an interface for operating the pressure calibration system. It obtains the catheter sensor and calibration chamber data during the calibration process and determines the correction factors to be used in subsequent data collection.

The MVS supports physician diagnosis and analysis by mcans of a playback function, which replays a stored session using previously recorded data instead of real-time data. The MVS also indicates estimated parameters such as LES location, LES resting pressure, LES relaxation, LES residual pressure inversion point (PIP) location, UES pressure, and motility metrics such as peristaltic wave amplitude, duration and velocity.

## Product Functions

The primary MVS functions are:

- Calibrate the pressure sensors ●
- . Provide user interface displays, prompts, and controls
- Collect pressure data .
- Display and store collected data .
- Replay stored data .

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K031169
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### Intended use:

The MVS obtains a high resolution mapping of pressures within tubular organs of the human gastrointestinal tract. These organs include the esophagus from the pharyngeal region through the stomach, the duodenum, and the anus/rectum. It is used in a medical clinical setting to sense the pressures and store the corresponding data. The system also provides analysis information. The real time data as well as the analysis information can be viewed by a physician for diagnostic and analysis purposes.

The system includes a catheter probe with 36 pressure sensing elements. During the clinical procedure, the catheter is inserted transnasally and pressure inside the pharynx, esophagus, or proximal gut (stomach/duodenum) is measured as the patient typically swallows small amounts of water. Alternatively, pressures within the anus/rectum are measured via rectal intubation. Real-time data is sampled from each sensing element via the MVS interface electronics and made available to the MVS software during each sample period. The software displays the data in real-time to support the clinical procedure.

#### Summary of technological characteristics:

The MVS catheter is equivalent to the Medtronic catheter which is manufactured by the same company. Konigsberg Instruments. The primary difference being the larger number of pressure sensors (typically 4-16 for the predicate device and 36 for the applicant device). The MVS system uses a proprietary signal processing scheme to minimize the number of electrical conductors.

The user interface is via touch screen display, keyboard and mouse and the use of a hard drive that allows recording and play back of the data. By providing more data, the system gives a more complete pressure data set of the esophagus. The system can also be used if there are inactive sensors.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 2003

Sierra Scientific Instruments, Inc. c/o Mr. Sean M. Curry Certified Software Solutions, Inc. 16787 Bernardo Center Drive, Suite A-1 San Diego, CA 92128

Re: K031169

Trade/Device Name: Sierra Scientific Motility Visualization System (MVS) Regulation Number: 21 CFR §876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: 78 FFX Dated: September 12, 2003 Received: September 15, 2003

Dear Mr. Curry:

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 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 of 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 1000-1050.

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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/dsma/dsmamain.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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510(k) Number (if known): K031169

Device Name: Motility Visualization System

Indications for Use:

The Motility Visualization System obtains a high resolution mapping of pressures within tubular organs of the gastrointestinal tract. These organs include the esophagus from the pharyngeal region to the stomach, the proximal gut (stomach/duodenum), and the anus/recturn. It is used in a medical clinical setting to sense the pressures and store the corresponding data. The system also provides analysis information. The real time data as well as the analysis information can then be viewed by a physician for diagnostic and analysis purposes.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-the-Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|

| (Division Sign-Off) | |
|--------------------------------------|--|
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |

| 510(k) Number | K031169 |
|---------------|---------|
|---------------|---------|