DISTENDER SERIES II BAROSTAT

K991288 · G & J Electronics, Inc. · FFX · Jun 8, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K991288
• Device Name: DISTENDER SERIES II BAROSTAT
• Applicant: G & J Electronics, Inc.
• Product Code: FFX · Gastroenterology, Urology
• Decision Date: Jun 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1725
• Device Class: Class 2

Intended Use

The G&J Electronics Distender Series II Dual Drive Barostat device with the Protocol Plus software is an electro-pnuematic device used for volume/pressure measurement in tho alimentrary tract. This device is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of pationts with symptoms consistent with gastrointestinal motility disorders.

Device Story

Distender Series II Dual Drive Barostat is an electro-pneumatic device for measuring volume and pressure within the alimentary tract. Used in clinical settings by healthcare professionals as an adjunct to diagnostic procedures for gastrointestinal motility disorders. Device utilizes Protocol Plus software to manage pressure/volume parameters. Output provides quantitative data on gastrointestinal tract response to distension, assisting clinicians in evaluating motility function. Benefits include objective assessment of visceral sensitivity and compliance, aiding diagnosis of functional GI disorders.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electro-pneumatic system; includes Protocol Plus software; designed for alimentary tract pressure/volume measurement; standalone device configuration.

Indications for Use

Indicated for patients with symptoms consistent with gastrointestinal motility disorders requiring volume/pressure measurement in the alimentary tract as an adjunct to other diagnostic methods.

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

JUN 8 1999

Mr. Sam Jundler President G & J Electronics Inc. 6 Dornfell Street Willowdale, Ontario CANADA M2R 2Y6

Re: K991288 Distender Series II Barostat Dated: April 8, 1999 Received: April 14, 1999 Regulatory Class: II 21 CFR §876.1725/Procode: 78 FFX

Dear Mr. Jundler:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally asternment and is cabstantean, oquitantean, oquitante commerce prior to May 28, 1976, the enactment date of the manical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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00/01/00 - 17:15 FAX [phone]

TDA/CDRH/ODE/DRAERD

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| 510(k) Number (if known): | k9912188 |
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| Device Name: | Distender Series II Dual Drive Barostat: |

Indications For Use:

The G&J Electronics Distender Series II Dual Drive Barostat device with the Protocol Plus software is an electro-pnuematic device used for volume/pressure measurement in tho alimentrary tract. This device is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of pationts with symptoms consistent with gastrointestinal motility disorders.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number

scription Use (Pcr 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Funnul 1-2-96)