(113 days)
This device is to be used under medical supervision in hospitals, nursing homes, extended care facilities and outpatient clinics. The HOPE nebulizer is a high output nebulizer to be used by patients who require aerosolized medications. It provides additional hydration to help loosen secretions for patients whose condition is such that superior sympathomines, parasympathetic amines, or other appropriate medications would be nebulized. It is intended for use with bronchodilators, corticosteroids, antibiotics, mucolytics, and diagnostic formulations.
HOPE Nebulizer
The provided document is a 510(k) premarket notification letter from the FDA for the "Hope Nebulizer II". It indicates that the device has been found substantially equivalent to a predicate device marketed before May 28, 1976. However, this document does not contain any information regarding acceptance criteria, device performance studies, or details about such studies. It is a regulatory approval letter, not a study report or technical specification document.
Therefore, I cannot provide the requested information based solely on the text provided.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 7 1998
Mr. Stephen W. Briggs B & B Medical Technologies, Inc. P.O. Box 1503 Orangevale, CA 95662
Re: K980407 Hope Nebulizer II (two) Regulatory Class: Product Code: 73 CAF May 15, 1998 Dated: May 18, 1998 Received:
Dear Mr. Briggs:
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 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 - Mr. Stephen W. Briggs
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. Callahon
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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S10(k) Number (if known): K980407
Device Name: HOPE Nebulizer
Indications For Usc. This device is to be used under medical supervision in hospitals nusring homes, extended care facilities and outpatient clinics. The HOPE nusring homes, extended care facilities and outport accorpolized medications
nebulizer is a high output nebulizer to be used by loosen nebullzer is a high output heads. It provides additional hudretion to help isoned and diagnostic formulacions. Tre provises and is required. Patient population: secretions for patients whole condition in in issuperior sympathomines, parasympathetic amines, or other appropriate medications would be nebulized. parasympathected annules, or other uppropriate modely via Multigas inlet.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. Pui
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
Prescription Usc ਮ (Pcr 21 CFR 801.109)
OR .
Over-The-Counter Use
(Optional Formal 1-2-96)
§ 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).