(480 days)
The BESTNEB is designed to provide a compressed air source to aerosolize physician-prescribed liquid medication when used in combination with the packaged Salter Labs 8900 series nebulizer, except for Pentamidine.
The BESTNEB is designed to provide a compressed air source to aerosolize physician-prescribed liquid medication when used in combination with the packaged Salter Labs 8900 series nebulizer, except for Pentamidine.
This document is a 510(k) clearance letter from the FDA for a medical device called the "Bestneb Portable Aerosol Therapy Unit, AP-10010". As such, it does not contain the detailed information about acceptance criteria or a specific study that proves the device meets those criteria, as typically found in clinical trial reports or detailed scientific publications.
The letter explicitly states: "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...". This means the device was cleared based on its equivalence to a legally marketed predicate device, not necessarily on a novel study demonstrating performance against specific acceptance criteria.
Therefore, I cannot provide the requested information from this document. The document primarily confirms regulatory clearance based on substantial equivalence.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 5 20
Mr. Daniel Lee President Apex Medical Corporation 10th Fl., No. 31, Lane 169 Kang Ning St. His Chih Chen, Taipei Hsein ▼ Taiwan, ROC
Re: K990435 Bestneb Portable Aerosol Therapy Unit, AP-10010 Regulatory Class: II (two) Product Code: 73 CAF Dated: April 21, 2000 April 24, 2000 Received:
Dear Mr. Lee:
We have reviewed your Section 510(k) notification of intent to market wo nave referenced above and we have determined the device is che devros ly equivalent (for the indications for use stated in the bubbeancelly of 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 In accordance with . You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls enc golora 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 oditional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set were 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 abounce of the roll. 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 response of Jour ryst have under sections 531 through 542 of the Act our gavices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Daniel Lee
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 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/dsma/dsmamain.html".
Sincerely yours,
Mark N-Milken
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
The BESTNEB is designed to provide a compressed air source to aerosolize physician-prescribed liquid medication when used in combination with the packaged Salter Labs 8900 series nebulizer, except for Pentamidine.
Madi Al-Mukassar
(Division Sign-Off) -Division of Cardiovascular, Respiratory, and Neurological Devices K990435 510(k) Number _
Image /page/2/Picture/4 description: The image shows a checkmark above a line, next to the words "prescription use". The checkmark indicates that the prescription use option has been selected. The handwriting is legible and clear.
§ 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).