IMPACT BALLOON DILATION CATHETER

K983373 · B. Braun/Mcgaw · KNQ · Jun 22, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K983373
• Device Name: IMPACT BALLOON DILATION CATHETER
• Applicant: B. Braun/Mcgaw
• Product Code: KNQ · Gastroenterology, Urology
• Decision Date: Jun 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5365
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Impact balloon dilation catheter is indicated for use in adult and adolescent patients to dilate esophageal strictures due to: esophageal surgery, primary gastroespoh reflux, radiation theropy.

Device Story

Impact Balloon Dilation Catheter is a medical device used by clinicians to dilate esophageal strictures. The device consists of a catheter with an inflatable balloon at the distal end. The clinician inserts the catheter into the esophagus and inflates the balloon to mechanically dilate the stricture. This procedure is performed in a clinical setting to improve patient swallowing and alleviate symptoms associated with esophageal narrowing. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Balloon dilation catheter designed for esophageal use. Consists of a catheter shaft and an inflatable balloon component. Operates via mechanical dilation through balloon inflation. Sterilization and material specifications are managed under the manufacturer's Quality System Regulation (21 CFR Part 820).

Indications for Use

Indicated for adult and adolescent patients requiring dilation of esophageal strictures resulting from esophageal surgery, primary gastroesophageal reflux, or radiation therapy.

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

JUN 2 2 1999

Mr. Mark S. Alsberge Requlatory Affairs Director B. Braun McGaw, Inc. 901 Marcon Boulevard Allentown, PA 18103-9341 Re: K983373 B. Braun Impact Balloon Dilatation Catheter Dated: May 3, 1999 Received: May 7, 1999 Regulatory Class: II 21 CFR §876.5365/Procode: 78 KNQ

Dear Mr. Alsberge:

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 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 oblication 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 Compiiance 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

Image /page/0/Picture/14 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the bird.

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| 510(k) Number (if known): | K983373 |
|---------------------------|----------------------------------|
| Device Name: | IMPACT BALLOON DILATION CATHETER |
| Indications For Use: | |

The Impact balloon dilation catheter is indicated for use in adult and adolescent patients to dilate esophageal strictures due to: esophageal surgery, primary gastroespoh reflux, radiation theropy.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Elinid G. Seymm

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

Prescription Use (Pcr 21 CFR 801.109)

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OR

Over-The-Counter Use

(Optional Formal 1-2-96)