(90 days)
Not Found
Not Found
No
The summary describes a simple mechanical device for administering medication and contains no mention of AI, ML, or related concepts.
No
The device is described as an accessory for administering medication, not as a therapeutic device itself that directly treats a condition.
No
Explanation: The device is intended for the administration of medication, not for diagnosing any medical condition.
No
The device description explicitly states it is a "single patient, disposable device" and a "Ventilation Chamber," indicating it is a physical hardware component used for administering medication. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the administration of medication (metered dose inhaler) to patients on mechanical ventilation. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description reinforces its function as a device for medication delivery.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the AeroChamber mini Ventilation Chamber is a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AeroChamber mini Ventilation Chamber is a single patient, disposable device, intended to be used for the administration of metered dose inhaler medication prescribed by a physician or health care professional. The device is intended for use with patients on mechanical ventilation via resuscitation bag or ventilator circuit. The intended environments for use include the home, hospitals and clinics.
Product codes
CAF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician or health care professional. The intended environments for use include the 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 9 2009
Mr. Darryl Fisher Associate Director, Quality & Regulatory Afairs Trudell Medical International 725 Third Street London Ontario, Canada N5V 5G4
Re: K090065
Trade/Device Name: AeroChamber Mini Ventilation Chamber Regulation Number: 21 CFR 868.5630 Regulatory Class: II Product Code: CAF Dated: November 24, 2008 Received: January 9, 2009 .
Dear Mr. Fisher:
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.
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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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Page 2- Mr. Fisher
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0110. Also, please note the regulation entitled, "Misbranding by . reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anthony v. Watson for
Susan Runner, D.D.S., M.A.
Acting 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:
AeroChamber mini Ventilation Chamber Device Name:
auvulal
Indications for Use:
Street, I
The AeroChamber mini Ventilation Chamber is a single patient, disposable device, intended to be used for the administration of metered dose inhaler medication prescribed by a physician or health care professional. The device is intended for use with patients on mechanical ventilation via resuscitation bag or ventilator circuit. 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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K094465 |
|---|---|
| ---------------- | --------- |
| Prescription Use: | ✓ |
|---|---|
| (per 21CFR 801.109) | or Over the Counter Use: |
London, Ontario, CANADA N5V 5G4 • Telephone: +1(519) 455-7060 • Facsimile: +1(519) 455-6329 • www.trudellmed.com
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