(90 days)
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No
The description focuses on standard ultrasonic nebulizer technology and explicitly states the device contains common components and functions identically to existing devices. There is no mention of AI or ML.
Yes.
The device is used to deliver bronchodilator medication to individuals with asthma and emphysema, which is a therapeutic intervention.
No
The device is described as an ultrasonic nebulizer used to deliver medication, not to diagnose a condition.
No
The device description explicitly lists hardware components such as a circuit board, piezoelectric ceramic, medicine cup, plastic case, switch, and electrical cord, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver aerosolized medication to patients with respiratory conditions. This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on the mechanism of creating and delivering the aerosol, the components of the device, and its similarity to existing nebulizers. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases
In summary, the device's function is to administer medication, which falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This product is an ultrasonic nebulizer that is used to provide acrosolized broncho dialator medication to persons with asthma and emphysema. The device creates acrosolized particles of the prescribed medication via ultrasound that is forced via a vacuum or draw into disposable tubing. The aerosolized medication travels up the lubing and into either a nasal or oral mask. The patient then inhales the medication as per his/her physician's orders.
Product codes
73 CAF
Device Description
The product consists of a thermally protected, simplistic circuit board, a piczcoelectric ceramic, a medicine cup, an ABS plastic case, a switch, an electrical cord.
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).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 1998
Bremed Italia, S.R.L. c/o Mr. Mark Hebensteit Consultant 1337 Rockwood Forest Drive Arnold, MO 63010
Re : K974379 ULTRANEB Regulatory Class: II (Two) Product Code: 73 CAF Dated: October 24, 1997 Received: November 20, 1997
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 (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, Druq, 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 reqistration, 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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: -------------
1
Page 2 - Mr. Mark Hebenstreit
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 requlation 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.qov/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
2
INDICATIONS FOR USE STATEMENT
510(k) Number: Pending K4743 79
Device Name: ULTRANEB ULTRASONIC Indications for Use:
This product is an ultrasonic nebulizer that is used to provide acrosolized broncho dialator medication to persons with asthma and emphysema. The device creates acrosolized particles of the prescribed medication via ultrasound that is forced via a vacuum or draw into disposable tubing. The aerosolized medication travels up the lubing and into either a nasal or oral mask. The patient then inhales the medication as per his/her physician's 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 distribution in the United States and Europe.
The components found within this product are common items. The product consists of a thermally protected, simplistic circuit board, a piczcoelectric ceramic, a medicine cup, an ABS plastic case, a switch, an electrical cord.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use XXXXX 1
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Over-The-Counter
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number__ K474379