(22 days)
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No
The document describes a standard ultrasonic nebulizer and contains no mention of AI, ML, or related concepts.
Yes
The device is intended for the treatment of asthma, COPD, and other respiratory ailments, which indicates a therapeutic purpose.
No
The device is an ultrasonic nebulizer intended for delivering aerosolized medication for respiratory therapy. It is not described as being used to identify or analyze diseases or conditions.
No
The device description explicitly states "MABIS NB-02 Ultrasonic Nebulizer," which is a hardware device used to aerosolize medication. The summary does not mention any software component as the primary or sole function.
Based on the provided information, the MABIS NB-02 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for the treatment of respiratory ailments by aerosolizing medication. This is a therapeutic function, not a diagnostic one.
- Device Description: It's described as an ultrasonic nebulizer, which is a device used to deliver medication to the lungs.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Using reagents or assays.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. The MABIS NB-02 is a medical device used for delivering medication, which is a treatment, not a diagnostic process.
N/A
Intended Use / 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.
Product codes
73 CAF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines that suggest the head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
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)