PATTISON ESOPHAGEAL DILATOR

K971615 · Tri-Med Specialties, Inc. · KNQ · Jul 24, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971615
• Device Name: PATTISON ESOPHAGEAL DILATOR
• Applicant: Tri-Med Specialties, Inc.
• Product Code: KNQ · Gastroenterology, Urology
• Decision Date: Jul 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5365
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TRI-MED SPECIALTIES, INC. Pattison Esophageal Dilator is for dilation of, but not limited to, peptic esophageal strictures, caustic strictures, upper esophageal webs, lower esophageal (Schatzki) rings, and palliation of esophageal cancer or lymphoma.

Device Story

Pattison Esophageal Dilator is a mechanical device used by physicians to dilate esophageal strictures or rings and provide palliation for esophageal malignancies. Device functions via mechanical dilation of the esophagus. Used in clinical settings by medical professionals. Benefits include restoration of esophageal patency and symptom relief for patients with obstructive esophageal conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical esophageal dilator. Specific materials and dimensions not detailed in provided text.

Indications for Use

Indicated for patients requiring esophageal dilation due to peptic strictures, caustic strictures, upper esophageal webs, Schatzki rings, or for palliation of esophageal cancer or lymphoma.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUI 24 1997

Mr. Mike Knoth Director of Regulatory Affairs Tri-Med Specialties, Inc. 16309 West 108th Circle Lenexa. Kansas 66219

Re: K971615 Pattison Esophageal Dilator Dated: May 1, 1997 Received: May 2, 1997 Regulatory class: II 21 CFR §876.5365/Product code: 78 KNQ

Dear Mr. Knoth:

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 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). 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 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 OS 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 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 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 intp://www.fda.gov/odth/dsmamain.html".

Sincerely your

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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Image /page/1/Picture/0 description: The image shows the logo for TRI-MED Specialties Inc. The logo is in black and white and features the company name in a bold, sans-serif font. The letters "TRI" and "MED" are connected by a triangle shape. The words "Specialties Inc." are written in a smaller, cursive font below the company name. The logo is framed by a triangle.

16309 WEST 108th CIRCLE LENEXA, KS 66219

## INDICATIONS FOR USE

The TRI-MED SPECIALTIES, INC. Pattison Esophageal Dilator is for dilation of, but not limited to, peptic esophageal strictures, caustic strictures, upper esophageal webs, lower esophageal (Schatzki) rings, and palliation of esophageal cancer or lymphoma.

Mike Knoth

Mike Knoth Director of Regulatory Affairs

5/1/97
*_*_Date

Date

Robert R. Ratliff
(Division Sign-Off)

Division of Reproductive, Abdominal. ENT, and Radiological Devices

510(k) Number K971615

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use _

[phone]