(49 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest the use of such technologies.
Yes
The device is described as an ultrasonic nebulizer intended for use in the treatment of asthma, COPD, and other respiratory ailments, indicating its use in therapy.
No
Explanation: The device is a nebulizer used for administering medication for respiratory ailments, not for diagnosing them.
No
The device description explicitly states "Mystique ultrasonic nebulizer," which is a hardware device used for aerosolizing medication. The summary does not mention any software component as the primary or sole function.
Based on the provided information, the Airsep Mystique ultrasonic nebulizer is not an IVD (In Vitro Diagnostic).
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 device, not a diagnostic one.
- Device Description: It's described as a nebulizer, which is a device used to deliver medication in a mist form.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Airsep Mystique nebulizer's function is to deliver medication, which is a treatment, not a diagnostic process.
N/A
Intended Use / Indications for Use
The Airsep Mystique ultrasonic nebulizer is 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 Mystique nebulizer is not intended for use with Pentamidine. It is intended for single patient use.
Product codes
73 CAF
Device Description
Mystique Ultrasonic Nebulizer
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
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 U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a thick, black line. The image is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 16 1998
Mr. Edward Vrana AirSep Corporation 290 Creekside Drive Buffalo, NY 14228
Re: K983002 Mystique Ultrasonic Nebulizer Regulatory Class: II (two) Product Code: 73 CAF Dated: August 25, 1998 Received: August 28, 1998
Dear Mr. Vrana:
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 A substantially equivalent determination assumes compliance to 895. 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 regulation 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.
1
Page 2 - Mr. Edward Vrana
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 regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other qeneral 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. Callahon
Thomas .. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number:
Mystique ultrasonic nebulizer by Airsep Device Name:
3 Indications For Use:
The Airsep Mystique ultrasonic nebulizer is 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 Mystique 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)
Mr. Puf
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
K983002 510(k) Number_
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)