AEROCHAMBER MINI VENTILATION CHAMBER by TRUDELL MEDICAL INTL.

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.

Device Description

AI/ML Overview

Here's the analysis of the provided text regarding the acceptance criteria and study for the AeroChamber Mini Ventilation Chamber:

Analysis of Acceptance Criteria and Study for AeroChamber Mini Ventilation Chamber

The provided FDA 510(k) summary (K090065) for the AeroChamber Mini Ventilation Chamber primarily focuses on establishing substantial equivalence to a predicate device. It certifies that the device can be legally marketed based on its comparison to existing devices.

However, this document does not contain information about specific acceptance criteria or an analytical study proving the device meets those criteria, as one would typically find for a new, novel AI/ML-driven medical device requiring performance validation.

The document states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This heavily implies that the device's acceptable performance is based on its similarity to already approved devices, rather than a de novo clinical or analytical study with defined performance metrics and acceptance thresholds.

Therefore, most of the requested information regarding acceptance criteria and performance studies for an AI/ML device cannot be extracted from this document.

Summary Table (Based on available information):

Aspect	Acceptance Criteria (Not explicitly stated for performance)	Reported Device Performance (Implied)
Primary Goal of Submission	Substantial Equivalence to a predicate device	Demonstrated substantial equivalence. Indications for Use (administered metered dose inhaler medication to patients on mechanical ventilation via resuscitation bag or ventilator circuit).
Key Performance Indicator	(Not provided in this document)	(Not provided in this document)
Threshold for Acceptance	(Not provided in this document)	(Not provided in this document)

Detailed Breakdown (Responding to your specific questions):

A table of acceptance criteria and the reported device performance:
- As noted above, explicit quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy, or other measurable outcomes) are not present in this 510(k) letter. The "acceptance" is based on the FDA's determination of substantial equivalence to a predicate device. The reported performance is implicitly that it functions similarly to the predicate for its intended use.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The document does not describe a test set or a study conducted to evaluate the device's performance against defined metrics. The decision is based on a comparison to a predicate device, which would involve reviewing documentation and design specifications, not experimental data collection with a "test set" in the context of an AI/ML device.
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):
- Not applicable / Not provided. No ground truth establishment is described for this type of submission.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No test set or adjudication method is described.
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:
- Not applicable. This device is a mechanical ventilation chamber, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device (ventilation chamber), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided. No ground truth is described.
The sample size for the training set:
- Not applicable / Not provided. This is a physical medical device, not an AI algorithm requiring a training set.
How the ground truth for the training set was established:
- Not applicable / Not provided. No training set or ground truth establishment is described.

In conclusion, the provided FDA letter confirms the substantial equivalence of the AeroChamber Mini Ventilation Chamber to a predicate device, enabling its market authorization. It is not a document detailing the performance validation of a novel device, particularly an AI/ML-driven one, against specific acceptance criteria through a dedicated study.

Summary

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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

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510(k) Number:

AeroChamber mini Ventilation Chamber Device Name:

auvulal

Indications for Use:

Street, I

(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
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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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Regulation Number and Section

§ 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).