The Aerobika* Oscillating Positive Expiratory Pressure device intended for use as a Positive Expiratory Pressure (PEP) device. The Aerobika* Oscillating PEP device may also be used simultaneously with nebulized aerosol drug delivery. The device is intended to be used by patients capable of generating an exhalation flow of 10 lpm for 3 – 4 seconds.

Device Description

The Aerobika* OPEP with Manometer device combines Positive Expiratory Pressure (PEP) with oscillations upon exhalation with visual feedback relative to the patient's expiratory pressure. The device is mechanically driven using only the energy from the patient's exhaled breath. Upon exhalation, a portion of the patient's exhaled breath is routed through the manometer device and exits through it. While the manometer is pressurized by the patient's exhaled breath, an indicator contained within the manometer housing indicates the patient's exhaled pressure. The manometer adapter consists of plastic components constructed of polypropylene material, and the manometer is a purchased component to TMI, and is previously cleared under K040991.

AI/ML Overview

This document, a 510(k) Premarket Notification for the Aerobika* OPEP with Manometer, describes non-clinical testing performed to establish substantial equivalence to a predicate device. It does not contain information about clinical studies with human participants. Therefore, many of the requested details about acceptance criteria for clinical performance, ground truth, expert adjudication, or MRMC studies are not applicable or available in this document.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document details several non-clinical tests performed. While explicit "acceptance criteria" are not numerically stated in a table format, the narrative indicates that the device "meets specifications and performs comparably to the predicate Aerobika* OPEP device." The performance reported is that the device did meet these specifications.

Test	Reported Device Performance
Materials: Cytotoxicity, Sensitization, Intracutaneous Reactivity	Meets the requirements of ISO 10993-1:2009.
Mechanical: Manometer pressure accuracy	Meets specifications and performs comparably to the predicate device.
Mechanical: Plug retention	Meets specifications and performs comparably to the predicate device.
Mechanical: Inhalation resistance	Meets specifications and performs comparably to the predicate device.
Mechanical: Lifecycle	Meets specifications and performs comparably to the predicate device.
Mechanical: Cleaning and disinfection cycle testing	Meets specifications and performs comparably to the predicate device.
Mechanical: Drop tests	Meets specifications and performs comparably to the predicate device.
Mechanical: Aerosol drug delivery	Meets specifications and performs comparably to the predicate device.
Environmental: Performance after exposure to high and low temperatures	Meets its performance specifications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes non-clinical laboratory testing. Specific sample sizes for each mechanical or environmental test are not provided in this summary. The data provenance is Trudell Medical International, located in London, ON, Canada, conducting design verification and validation activities. The studies are prospective in nature as they are conducted for the purpose of the 510(k) submission.

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)

Not applicable. This document describes non-clinical mechanical and material testing, not diagnostic or clinical performance requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This document describes non-clinical mechanical and material testing, not diagnostic or clinical performance requiring adjudication.

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

Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a mechanical OPEP device, not an algorithm. The "standalone" performance refers to the device's inherent mechanical function. The non-clinical testing evaluates this.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is established by engineering specifications, recognized standards (like ISO 10993-1:2009 for materials), and the performance characteristics of the legally marketed predicate device (Aerobika* OPEP device, K123400).

8. The sample size for the training set

Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for a mechanical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, composed of three human profiles facing right, suggesting a sense of community and support. The bird symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 15, 2015

Trudell Medical International Darryl Fischer Associate Director, Global Regulatory Affairs 725 Third Street London, Ontario NSV 5G4 CANADA

Re: K150173

Trade/Device Name: Aerobika* OPEP Device with Manometer Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: Class II Product Code: BWF Dated: September 14, 2015 Received: September 15, 2015

Dear Mr. Fischer:

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. You must comply

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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 devicerelated 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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				Device Name
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Image /page/3/Picture/0 description: The image shows the logo for Trudell Medical International. The logo includes a crest with the word "TRUDELL" written on it. The text "Trudell Medical International" is written in a large font next to the logo. Below the logo and text, the words "Special 510(k) Premarket Submission" are written.

Aerobika* OPEP with Manometer Accessory 510(k) Summary

510(k) Number (if known): K150173

1. Device Identification

Aerobika* OPEP Manometer

Trade/Proprietary Name: Aerobika* OPEP with Manometer Common/Usual Name: Spirometer, Therapeutic (Incentive) Classification / Name: 21 CFR 868.5690 / Incentive Spirometer Product Code: BWF Device Class: Class II Classification Panel: Anesthesiology

2. Submitter and Contact

Trudell Medical International 725 Third Street London, ON Canada N5V 5G4 Phone: 1 519 455 7060 ext. 2140 1 519 455 6329 Fax: Contact: Darryl Fischer, Associate Director - Global Regulatory Affairs Email: dfischer@trudellmed.com

Date Prepared

14 Oct 2015

4. Predicate Device

The Aerobika* OPEP with Manometer device is substantially equivalent to Trudell Medical International's Aerobika* OPEP device, which was classified under product code BWF, regulation 868.5690, Incentive Spirometer, and cleared on May 16, 2013 under 510(k) number K123400. The predicate Aerobika* OPEP device was found to be substantially equivalent to DHD Healthcare Corp's Acapella Spirometer, 510(k) K002768.

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Image /page/4/Picture/0 description: The image shows the logo for Trudell Medical International. The logo includes a crest with the word "TRUDELL" in the center and the words "AMULLIS" and "SUPERATUR" on the top and bottom, respectively. The text "Trudell Medical International" is written in a large, bold font to the right of the logo. Below the company name, the text "Special 510(k) Promarket Submission" is written in a smaller font.

5. Device Description

Image /page/4/Figure/4 description: The image shows a line drawing of a medical device, possibly a spirometer or peak flow meter. The device has a cylindrical mouthpiece on the left side, connected to a larger body with a handle. On the right side, there is a vertical cylinder with numerical markings, possibly indicating volume or flow rate, with numbers such as 60, 30, 15, and 5 visible.

The Aerobika* OPEP with Manometer device is mechanically driven using only the energy from the patient's exhaled breath. Upon exhalation, a portion of the patient's exhaled breath is routed through the manometer device and exits through it. While the manometer is pressurized by the patient's exhaled breath, an indicator contained within the manometer housing indicates the patient's exhaled pressure.

The manometer adapter consists of plastic components constructed of polypropylene material, and the manometer is a purchased component to TMI, and is previously cleared under K040991.

6. Intended Use

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Image /page/5/Picture/0 description: The image shows the logo for Trudell Medical International. The logo includes a shield with the word "TRUDELL" written vertically down the center. The shield is surrounded by a wreath of leaves. The text "Trudell Medical International" is written to the right of the logo.

7. Summary of Substantial Equivalence

The Aerobika* OPEP with Manometer and the Aerobika* OPEP device share the same: Intended use; Indications for use; Fundamental technology and operating principle; Materials of construction

Substantial Equivalence Comparison Table

Common Device Characteristics
Aerobika* OPEP with Manometer	Aerobika* OPEP Device (K123400)
combines PEP therapy with oscillations upon exhalation may be used with a nebulizer to deliver aerosol drug mechanically driven using only the patient's exhaled breath not orientation dependent the device has a removable mouthpiece the device can remain in the mouth through the treatment can be adjusted to increase or decrease the exhalation resistance	combines PEP therapy with oscillations upon exhalation may be used with a nebulizer to deliver aerosol drug mechanically driven using only the patient's exhaled breath not orientation dependent the device has a removable mouthpiece the device can remain in the mouth through the treatment can be adjusted to increase or decrease the exhalation resistance
Relevant Differences in Device Characteristics
provides visual feedback to patient with regard to exhalation resistance The Aerobika* OPEP with manometer can be disassembled for the cleaning process. The manometer indicator is not intended to be cleaned	does not provide visual feedback regarding resistance The Aerobika* Oscillating PEP can be disassembled for cleaning

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Image /page/6/Picture/0 description: The image shows the logo for Trudell Medical International. The logo includes a shield with the word "TRUDELL" written across the middle. The shield is surrounded by a wreath of leaves. Next to the logo is the text "Trudell Medical International".

8. Summary of Conformance Assessment and Conclusion

Risk analysis and design verification and validation activities were conducted by Trudell Medical International to confirm that the Aerobika* OPEP with Manometer meets the same requirements as the current, legally marketed Aerobika* OPEP device.

The test results have demonstrated that the design outputs continue to meet the design inputs, and that the Aerobika* OPEP with Manometer is substantially equivalent to the current, legally marketed Aerobika* OPEP device.

The use of the Aerobika* OPEP with Manometer device does not affect the intended use or indications for use of the original Aerobika* OPEP device.

Furthermore, Trudell Medical International has demonstrated that the addition of this accessory does not modify the fundamental scientific technology of the original device, which is using only the energy derived from the patient's exhaled breath to operate the device.

Non-Clinical Testing Summary

Materials:

The patient contacting components of the Aerobika* OPEP with Manometer device meet the requirements of ISO 10993-1:2009 - Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, for Cytotoxicity, Sensitization and Intracutaneous Reactivity.

Mechanical:

Mechanical testing was conducted to characterize the operating parameters of the Aerobika* OPEP with Manometer device.

Manometer pressure accuracy
Plug retention
Inhalation resistance
Lifecycle
Cleaning and disinfection cycle testing
Drop tests
. Aerosol drug delivery

The results show that the Aerobika* OPEP with Manometer device meets specifications and performs comparably to the predicate Aerobika* OPEP device (K123400).

Environmental:

The Aerobika* OPEP with Manometer was exposed to various environmental conditions of high and low temperatures over time. The results of the device performance was evaluated and compared before and after these tests to confirm that the proposed device meets its performance specifications.

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Image /page/7/Picture/0 description: The image shows the logo for Trudell Medical International. The logo includes a crest with the word "TRUDELL" in the center. The text "Trudell Medical International" is written in a large, bold font to the right of the crest.

Clinical Performance:

A clinical performance summary is not applicable. The determination of substantial equivalence of the subject device is not based on clinical performance data.

Substantial Equivalence Conclusion

The Aerobika* OPEP with Manometer device and the predicate device share common indications for use, operating characteristics and usage environments. The devices are both single patient use, non-sterile and are available by prescription.

The subject Aerobika* OPEP device with Manometer raises no new issues of safety and/or effectiveness.

Based on the above analysis, Trudell Medical International considers that the performance of the Aerobika* OPEP with Manometer device to be substantially equivalent to the Aerobika* OPEP device, and that the addition of this accessory does not change the fundamental scientific technology, nor the intended use of the device.

Regulation Number and Section

§ 868.5690 Incentive spirometer.

(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).