(76 days)
Restores the integrity of damaged endotracheal and tracheostomy pilot tubes
When the endotracheal or tracheostomy pilot tube no longer maintains cuff inflation pressure, the needle of the BE 409 Pilot Tube Repair Kit is inserted into the cut pilot tube. The cuff can then be re-inflated in the usual manner. Such a repair can deter the need to replace the entire endotracheal or tracheostomy tube because of a damaged pilot tube.
BE 409 Pilot Tube Repair Kit
The provided text is a 510(k) clearance letter for a medical device: "BE 409 Pilot Tube Repair Kit." This document is related to regulatory approval based on substantial equivalence to a predicate device, not an AI or algorithm-based device. Therefore, it does not contain the information required to answer the questions about acceptance criteria for an AI study, such as sample sizes for training/test sets, ground truth establishment, expert qualifications, or MRMC studies.
The document describes the intended use of the device and its function:
- Device: BE 409 Pilot Tube Repair Kit
- Summary: Restores the integrity of damaged endotracheal and tracheostomy pilot tubes. When the pilot tube no longer maintains cuff inflation pressure, the kit's needle is inserted into the cut pilot tube, allowing the cuff to be re-inflated in the usual manner. This avoids replacing the entire endotracheal/tracheostomy tube due to a damaged pilot tube.
Since this is a physical repair kit and not an AI device, the requested information (acceptance criteria, study details for AI, sample sizes for AI training/test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI) is not applicable or available in this document.
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DEC 17 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lori Zuravleff OA/RA Manager Instrumentation Industries, Inc. 2990 Industrial Boulevard Bethel Park, Pennsylvania 15102
Re : K973755 Pilot Tube Repair Kit Regulatory Class: II (two) Product Code: BSK September 30, 1997 Dated: Received: October 2, 1997
Dear Ms. Zuravleff:
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 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 Requlations, 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 regulations.
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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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE STATEMENT
Device: BE 409 Pilot Tube Repair Kit
Summary: Restores the integrity of damaged endotracheal and tracheostomy pilot tubes
When the endotracheal or tracheostomy pilot tube no longer maintains cuff inflation pressure, the needle of the BE 409 Pilot Tube Repair Kit is inserted into the cut pilot tube. The cuff can then be re-inflated in the usual manner. Such a repair can deter the need to replace the entire endotracheal or tracheostomy tube because of a damaged pilot tube.
Keri Zunwalt
Signature
Lori Zuravleff Typed Name
September 30, 1997 Date
K973755 Premarket notification (510(k)) number
to Hlletershans
510(k) Number .
(Division Sign-Off) (Division Sign-Oir)
Division of Cardiovascular, Respiratory, Division of Neurological Devices
Prescription Use
Page 4-1
§ 868.5750 Inflatable tracheal tube cuff.
(a)
Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.(b)
Classification. Class II (performance standards).