(271 days)
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.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device (B. Braun Impact Balloon Dilatation Catheter). It determines substantial equivalence to a predicate device but does not contain any information about acceptance criteria or a study proving device performance against such criteria.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document.
The document focuses on the regulatory clearance process, specifically the FDA's determination of substantial equivalence, which is a different aspect of device approval than a specific performance study against acceptance criteria.
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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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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)
イ..
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
§ 876.5365 Esophageal dilator.
(a)
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).(b)
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.