MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)

K972119 · Medovations, Inc. · FAT · Feb 2, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K972119
• Device Name: MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)
• Applicant: Medovations, Inc.
• Product Code: FAT · Gastroenterology, Urology
• Decision Date: Feb 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5365
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Maloney and Hurst Bougies indications for use are for the dilation of: 1 - Upper esophageal webs. 2 - Lower esophageal rings. 3 - Caustic strictures. 4 - Peptic esophageal strictures. 5 - Temporary ease of esophageal carcinoma.

Device Story

Tungsten-filled Maloney and Hurst Bougies are medical devices used for esophageal dilation. They are inserted into the esophagus by a clinician to mechanically dilate strictures or webs, or to provide temporary relief in cases of esophageal carcinoma. The device functions as a physical dilator; it does not involve electronic inputs, software, or automated processing. Used in clinical settings by physicians to improve esophageal patency and patient swallowing function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Tungsten-filled bougies; mechanical dilation device; non-electronic; no software; no specific material standards or connectivity features described.

Indications for Use

Indicated for dilation of upper esophageal webs, lower esophageal rings, caustic strictures, peptic esophageal strictures, and temporary ease of esophageal carcinoma.

Regulatory Classification

Identification

An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 2 1998

Charles G. Stanford Chairman · Medovations, Inc. W194 N11340 McCormick Drive Germantown, WI 53022-3034

Re: K972119 Tungsten Filled Maloney and Hurst Bougies Dated: December 15, 1997 Received: December 22, 1997 Regulatory Class: II 21 CFR 876.5365/Procode: 78 FAT

Dear Mr. Stanford:

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 interstate in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of 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 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 requirement, as set forth in the Quality System Regulation (OS) 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 Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your 510(k) prematet 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 question 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/dsmamain.html".

Sincerely yours,

h.D. liau lfu

Lillian Yin, Ph.D. 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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Page 1 of 1

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

ESOPHAGEAL BOUGIES Device Name:

Indications For Use:

The Maloney and Hurst Bougies indications for use are for the dilation of:

1 - Upper esophageal webs.

2 - Lower esophageal rings.

3 - Caustic strictures.

.. \

4 - Peptic esophageal strictures.

5 - Temporary ease of esophageal carcinoma.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 72119 ડી く 510(k) Number . Prescription Use V OR Over-The-Counter Use_____ (Per 21 CFR 801.109) (Optional Format 1-2-96)