(22 days)
The MABIS NB-02 is an ultrasonic nebulizer intended for use in the treatment of asthma, COPD, and other respiratory ailments in which an aerosolized medication is required during therapy. It may be necessary to perform respiratory therapy at anytime and anywhere the patient needs it. The MABIS NB-02 nebulizer is not intended for use with Pentamidine. It is intended for single patient use.
MABIS NB-02 Ultrasonic Nebulizer
The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "MABIS NB-02 Ultrasonic Nebulizer." This type of document is a clearance letter, not a study report or technical specification document, and therefore does not contain the detailed information requested regarding acceptance criteria and study particulars for device performance.
The letter states that the device is substantially equivalent to legally marketed predicate devices, meaning it has met the regulatory requirements for clearance based on its similarity to existing devices. However, it does not include:
- A table of acceptance criteria and reported device performance: This information would typically be found in a performance data section of a 510(k) submission, not in the FDA's clearance letter. The letter only broadly states equivalence, implying that performance is similar to predicate devices.
- Sample size used for the test set and data provenance: Not mentioned.
- Number of experts used to establish ground truth and qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- MRMC comparative effectiveness study results: Not mentioned. This type of study is more common for diagnostic devices where human reader performance is a key metric. A nebulizer is a therapeutic device.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not applicable for this type of device and clearance.
- How ground truth for the training set was established: Not applicable.
In summary, the provided document ("K990506 Re: MABIS NB-02 Ultrasonic Nebulizer") is a regulatory clearance letter and does not contain the detailed technical or clinical study data requested about acceptance criteria and device performance.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 1999
Mr. Steven M. Bisulca MABIS Healthcare, Inc. 28690 N. Ballard Drive Lake Forest, IL 60045
K990506 Re: MABIS NB-02 Ultrasonic Nebulizer Regulatory Class: II (two) Product Code: 73 CAF February 16, 1999 Dated: February 17, 1999 Received:
Dear Mr. Bisulca:
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 Requlation (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. Steven M. Bisulca
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/dsma/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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510(k) Number: k 990501
Device Name: MABIS NB-02 Ultrasonic Nebulizer
Indications for Use:
The MABIS NB-02 is an ultrasonic nebulizer intended for use in the treatment of asthma, COPD, and other respiratory ailments in which an aerosolized medication is required during therapy. It may be necessary to perform respiratory therapy at anytime and anywhere the patient needs it. The MABIS NB-02 nebulizer is not intended for use with Pentamidine. It is intended for single patient use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark Kramer
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 1980506 510(k) Number_
Perscription Use__
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 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).