(231 days)
The RTC 21 Series MDI adapters are intended for use in intermittent aerosol therapy to I ho re o osol medications (in compressed cannister MDIs) via the proximal end of an endotracheal tube.
RTC 21-A is reusable. RTC 21-D is single patient use.
I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Metered Dose Inhaler Adapter). It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the request. The document primarily discusses regulatory approval based on substantial equivalence to a predicate device. Therefore, I cannot extract the requested information from this text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 1998
Ms. Lori Zuravleff Instrumentation Industries, Inc. 2990 Industrial Boulevard Bethel Park, PA 15102
Re: K981249 Metered Dose Inhaler Adapter Models: RTC 21-A reusable and RTC 21-D disposable Requlatory Class: II (two) Product Code: 73 CAF Dated: August 24, 1998 August 26, 1998 Received:
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 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 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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Page 2 - Ms. Lori Zuravleff
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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
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
RTC 21 Series Metered Dose Inhaler Adapter Device:
Summary:
- RTC 21-A is reusable .
- RTC 21-D is single patient use .
The RTC 21 Series MDI adapters are intended for use in intermittent aerosol therapy to I ho re o osol medications (in compressed cannister MDIs) via the proximal end of an endotracheal tube.
Link Mario 11-20-98
Lori Zurawsky
Signature
Lori Zurayleff Typed Name
April 3, 1998 Date
K981249 Premarket notification (510(k)) number
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).