(62 days)
Not Found
Not Found
No
The summary describes a nebulizer, a mechanical device for delivering medication, and explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes
This device administers prescribed medication to patients, which is a therapeutic function.
No
The device is described as a nebulizer intended to administer aerosolized medication, not to diagnose a medical condition.
No
The device description explicitly states "AeroEclipse® II Breath Actuated Nebulizer," which is a hardware device used for administering medication. There is no mention of any software component being the primary or sole medical device.
Based on the provided information, the AeroEclipse® II Breath Actuated Nebulizer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to administer aerosolized medication to patients. This is a therapeutic function, not a diagnostic one.
- Device Description: It's a nebulizer, a device used for drug delivery.
- 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 diagnostic, monitoring, or screening purposes. The AeroEclipse® II falls under the category of a drug delivery device.
N/A
Intended Use / Indications for Use
The AeroEclipse® II Breath Actuated Nebulizer is intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.
Product codes
CAF
Device Description
Not Found
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
licensed health care provider or physician / home, hospitals and clinics
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)
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
Public Health Service
DE
FEB 2 7 2006
Mr. John Straatman Director, Quality and Regulatory Affairs 725 Third Street London, Ontario Canada N5V 5G4
Re: K053605
Trade/Device Name: AeroEclipse® II Breath Actuated Nebulizer Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: January 30,2006 Received: February 2, 2006
Dear Mr. Straatman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 will), it ind), be also of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1
Page 2 – Mr. John Straatman
Please be advised that FDA's issuance of a substantial equivalence determination does not I Ticast be advisod that 1 Dr. o to the your device complies with other requirements modifine in any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I outstal states requirements, including, but not limited to: registration 1 od inust comply with a 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), mostiting systems (QS) regulation (21 CFR Part 820); and if requirences as better product radiation control provisions (Sections 531-542 of the Act);
21 CFR 1000-1050.
!
This letter will allow you to begin marketing your device as described in your Section This letter will and w Jour to begin IRDA 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), rr you desire speemo as Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj overni of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runoe
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital , Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number :
AeroEclipse® II Breath Actuated Nebulizer Device Name:
Indications for Use:
The AeroEclipse® II Breath Actuated Nebulizer is intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE) an General Hos. Over the Counter Use: _ Prescription Use: _ or
DED)
(per 21CFR 801.109)