(112 days)
The AeroChamber MAX™ Valved Holding Chamber is intended to be used by patients who are under the care of treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.
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The provided document is a 510(k) premarket notification letter from the FDA to Trudell Medical International regarding the AeroChamber Max Valved Holding Chamber. This type of document declares substantial equivalence to a legally marketed predicate device, rather than detailing specific acceptance criteria and study results in the manner requested for an AI/ML device.
Therefore, the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for an AI/ML device is not available in this document.
The document primarily focuses on:
- Device: AeroChamber Max Valved Holding Chamber
- Classification: Class II
- Regulation Number: 21 CFR 868.5630 (Nebulizer)
- FDA Determination: Substantially equivalent to predicate devices.
- Intended Use: Administer aerosolized medication from Metered Dose Inhalers for patients under licensed health care provider care, in home, hospitals, and clinics.
This document does not contain the detailed performance metrics and study design typically found in a clinical trial report or a submission for AI/ML-based diagnostic/screening devices.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 2004
Mr. Tom Holbrook Director, Regulatory Affairs Trudell Medical International 725 Third Street London, Ontario Canada, N5V 5G4
Re: K032972
Trade/Device Name: AeroChamber Max Valved Holding Chamber Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: 73 CAF Dated: December 19, 2003 Received: December 22, 2003
Dear Mr. Holbrook:
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 reguire 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 your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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Page 2 - Mr. Tom Holbrook
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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 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), please contact the Office of Compliance at (301) 594-4646. 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 Division 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/dsma/dsmamain.html
Sincerely yours,
Cluls
Chiu Lin, Ph.D. Director Division of Anesthesiology, Gencral Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K032972
AeroChamber MAX™ Valved Holding Chamber Device Name:
Indications For Use:
The AeroChamber MAX™ Valved Holding Chamber is intended to be used by patients who are under the care of treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
AWwh
510(k) Number: K032972
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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).