(62 days)
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.
AeroEclipse® II Breath Actuated Nebulizer
The provided text is a 510(k) clearance letter from the FDA for the AeroEclipse® II Breath Actuated Nebulizer. It indicates that the device has been found substantially equivalent to a legally marketed predicate device. However, this document does not contain specific details about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in a study report.
The 510(k) clearance process primarily evaluates substantial equivalence based on the device's technological characteristics and intended use compared to a predicate device. It doesn't typically require a separate clinical study with detailed performance metrics and statistical analyses as would be needed for a PMA or de novo submission.
Therefore,Based on the provided text, I cannot complete the table or answer most of the questions as the information is not present within this FDA clearance letter. The letter confirms clearance but does not detail the specific studies, acceptance criteria, or performance data used to demonstrate substantial equivalence internally.
Here's an explanation of what can be inferred or what is missing:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify any acceptance criteria or reported device performance metrics (e.g., nebulization rate, particle size distribution, drug delivery efficiency) from a performance study. The 510(k) is a regulatory clearance, not a performance report.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not mention any specific test set sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. This information is not relevant to a 510(k) clearance letter for a nebulizer. Ground truth establishment with experts is typically for diagnostic devices, not for a device like a nebulizer.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. This is not applicable or mentioned in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be provided. MRMC studies are typically for AI-enabled diagnostic devices. This is a nebulizer and does not involve human readers or AI assistance in a diagnostic capacity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This device is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be provided. Ground truth, in the context of diagnostic performance, is not applicable to this device and is not mentioned. For a nebulizer, performance is evaluated against engineering specifications and standards (e.g., aerosol output, particle size), not against a "ground truth" derived from patient data in the same way a diagnostic device would.
8. The sample size for the training set
- Cannot be provided. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable to this device.
What the document does tell us:
- Trade/Device Name: AeroEclipse® II Breath Actuated Nebulizer
- Regulation Number: 868.5630
- Regulation Name: Nebulizer
- Regulatory Class: II
- Product Code: CAF
- Intended Use: To be used by patients under the care or treatment of a licensed healthcare provider or physician to administer aerosolized medication prescribed by a physician or healthcare professional. Intended environments include home, hospitals, and clinics.
- Regulatory Mechanism: 510(k) premarket notification, cleared based on substantial equivalence to a legally marketed predicate device.
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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
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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
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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)
§ 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).