GASTRIC AND RECTAL CATHETERS

K973844 · G & J Electronics, Inc. · FFX · Jun 4, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K973844
• Device Name: GASTRIC AND RECTAL CATHETERS
• Applicant: G & J Electronics, Inc.
• Product Code: FFX · Gastroenterology, Urology
• Decision Date: Jun 4, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1725
• Device Class: Class 2

Intended Use

The Mui Scientific Y-type Barostat Gastric Catheter is used as part of a barostat system to measure sensory pressures and volumes in the stomach. The Mul Sclentific Y-type Barostat Rectal Catheter is used as part of a barostat system to measure sensory pressures and volumes in the anorectal region.

Device Story

Y-type Gastric and Rectal Barostat Catheters function as components of a barostat system; used to measure sensory pressures and volumes within the stomach or anorectal region. Catheters are inserted into the patient to facilitate pressure/volume monitoring during motility studies. Operated by clinical professionals in a medical setting. Output provides data for assessment of gastrointestinal or anorectal sensory function, aiding clinicians in diagnosing motility disorders.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Y-type catheter design for barostat systems; intended for pressure and volume sensing in the stomach or anorectal region. Mechanical device; no software or electronic components.

Indications for Use

Indicated for use as part of a barostat system to measure sensory pressures and volumes in the stomach or anorectal region in patients requiring gastrointestinal or anorectal motility assessment.

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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1 1999 II IN

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K973844

Mui Scientific Y-Type Gastric and Rectal Barostat Catheters Dated: March 8, 1999 Received: March 9, 1999 Requiatory 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 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 Cosmelic 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 requlations.

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), piease 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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## 06/01/09 - 17:15 FAX [phone]

FDA/CDRH/ODE/DRAERD

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Page 1 of 2

(Optional Formal 1-2-96)

| 510(k) Number (if known); | K973844 |
|---------------------------|--------------------------|
| Device Name: | Y-type Gastric Catheter: |

Indications For Use:

The Mui Scientific Y-type Barostat Gastric Catheter is used as part of a barostat system to measure sensory pressures and volumes in the stomach.

(PLEASE DO NOT WRITE DELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NHEIDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973844/5

scription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

{2}------------------------------------------------

08/01/90 17:15 FAX [phone]

FDA/CDRH/ODE/DRAERD

\$\underset{002}{q}\$

Page 2 of 2

| 510(k) Number (if known): | K973844 |
|---------------------------|-------------------------|
| Device Name: | Y-type Rectal Catheter: |

Indications For Use:

The Mul Sclentific Y-type Barostat Rectal Catheter is used as part of a barostat system to measure sensory pressures and volumes in the anorectal region.

(PLEASE DO NOT WRITE BEFLOW TIMS LINE - CONTINUE GIN ANOTHER I'ACE IF NEEDED)

Conourrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973844/5003

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

(Optional Formal 1-2-96)