(152 days)
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No
The description details a purely mechanical nebulizer system with no mention of AI or ML components.
Yes
The device delivers medication to treat specific medical conditions (asthma or emphysema), which is a therapeutic function.
No
The device is described as a nebulizer used to deliver medication, not to diagnose a condition.
No
The device description clearly outlines physical components like a hand held nebulizer, compressor, tubing, baffle, and mouthpiece, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a nebulizer used to deliver aerosolized medication directly to the patient's respiratory system. It does not involve the analysis of any biological specimens.
Therefore, this device falls under the category of a therapeutic or drug delivery device, not an IVD.
N/A
Intended Use / Indications for Use
This product is a hand held nebulizer that is used to provide aerosolized bronch dialator medication to persons with asthma or emphysema. The device creates aerosolized particles of the prescribed medication via interface with a nebulizer compressor. The compressor creates air pressure which is forced up disposable tubing and into the hand held nebulizer. Inside the hand held nebulizer, the medication is forced via a vacuum created by the air pressure up into the baffle which mixes the medication with the air, creating the aerosolized particles. The patient inhales the aerosolized prescribed medication via a mouthpiece which is attached to the hand held nebulizer. The treatment lasts as per his/her physicians orders.
Product codes
73 CAF
Device Description
This product is a hand held nebulizer that is used to provide aerosolized bronch dialator medication to persons with asthma or emphysema. The device creates aerosolized particles of the prescribed medication via interface with a nebulizer compressor. The compressor creates air pressure which is forced up disposable tubing and into the hand held nebulizer. Inside the hand held nebulizer, the medication is forced via a vacuum created by the air pressure up into the baffle which mixes the medication with the air, creating the aerosolized particles. The patient inhales the aerosolized prescribed medication via a mouthpiece which is attached to the hand held nebulizer. The treatment lasts as per his/her physicians orders.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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 contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on a single line and are easily readable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
9 1998 NOV
Bremed Italia c/o Mr. Mark Hebenstreit 1337 Rockwood Forest Drive Arnold, MO 63010
Re: K982043 BRENEB Regulatory Class: II (two) Product Code: 73 CAF September 27, 1998 Dated: Received: October 6, 1998
Dear Mr. Hebenstreit:
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 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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If vou purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, the
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Page 2 - Mr. Mark Hebenstreit
Food and Drug Administration (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.
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 the 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,
/ Art. A. Cinder
7% Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT
510(k) Number: Pending K982043
BRENEB HAND HELD NEBULIZER Device Name: Indications for Use:
This product is a hand held nebulizer that is used to provide aerosolized broncho dialator medication to persons with asthma or emphysema. The device creates aerosolized particles of the prescribed medication via interface with a nebulizer compressor.
The compressor creates air pressure which is forced up disposable tubing and into the hand held nebulizer. Inside the hand held nebulizer, the medication is forced via a vacuum created by the air pressure up into the baffle which mixes the medication with the air, creating the aerosolized particles.
The patient inhales the aerosolized prescribed medication via a mouthpiece which is attached to the hand held nebulizer. The treatment lasts as per his/her physicians orders.
This product contains the exact same technological characteristics of similar devices currently on the market. The product functions exactly as these similar devices.
The product is designed with similar performance characteristics as devices currently on the market. The performance of the device allows it to be used in conjunction with various nasal and oral masks that are currently in the United States and Europe.
The components found within this product are safe and common items.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use XXXXXX
OR
Over-The-Counter
Mark Kramer
Division of Cardiova and Neurological D 510(k) Number