(77 days)
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Not Found
No
The summary describes a nebulizer, a device for delivering aerosolized medication. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the device's function and intended use.
Yes
The device "deliver[s] medicinal aerosol and diagnostic formulation," implying its direct involvement in treatment (therapeutic) and diagnosis.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used to deliver "diagnostic formulation."
No
The device description explicitly names a "Model 1005," which strongly suggests a physical hardware component (a nebulizer). The intended use also describes delivering medicinal aerosol, which requires a physical device to generate and deliver the aerosol.
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 medicinal aerosol and diagnostic formulation." This describes a device that administers substances to a patient, not a device that tests samples taken from a patient (which is the core function of an IVD).
- Device Description: The description "EZflow Continuous Nebulizer™ Model 1005" further supports that it's a device for delivering medication or diagnostic formulations via inhalation.
- Lack of IVD Characteristics: The provided information 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 based on sample analysis
In summary, the device's function is to deliver substances, not to perform diagnostic tests on biological samples. Therefore, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To be used under proper medical supervision to deliver medicinal aerosol and diagnostic formulation.
Product codes
73 CAF
Device Description
EZflow Continuous Nebulizer™ Model 1005
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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
under proper medical supervision
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three heads, representing the department's focus on health, human services, and the well-being of the population. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 1999
Mr. Samuel David Piper Piper Medical Products 4007 Seaport Blvd. West Sacramento, CA 95691
Re: K990384 EZflow Continuous Nebulizer™ Model 1005 Regulatory Class: II (two) Product Code: 73 CAF February 5, 1999 Dated: Received: February 8, 1999
Dear Mr. Piper:
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 leqally 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 requlations 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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP requlation may result in assumptions. 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. Samuel David Piper
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 diaqnostic 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. Callehan
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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Page 1 of 1
1990394 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
EZflow Continuous Nebulizer™ Device Name:
Indication for Use:
To be used under proper medical supervision to deliver medicinal aerosol and diagnostic formulation.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use : (Per 21 CFR 810.109)
Over-the-Counter Use
Arth A. Garkowski.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 10344 k T 510(k) Number .
(Optional Format 1-2-96)
INTNDUSE.DOC