The Aerobika* Oscillating Positive Expiratory Pressure device is 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* Oscillating Positive Expiratory Pressure (PEP) device is indicated as a single patient use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when a patient exhales through the device. The Aerobika* device may be used simultaneously with aerosol drug delivery from a nebulizer.

AI/ML Overview

The Aerobika* Oscillating Positive Expiratory Pressure (PEP) Device was found substantially equivalent to a predicate device (Acapella, K002768) based on mechanical testing and biocompatibility.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Measure)	Reported Device Performance (Aerobika* PEP Device)
Mechanical Operating Parameters
Oscillation Frequency	Ranges of data for oscillation frequency are similar to the predicate device, showing clear overlap. The mean frequency value is within 15% of the predicate device. The slightly lower minimum frequency observed for Aerobika* is considered clinically insignificant, citing therapeutic effectiveness of other devices down to 3Hz and 6Hz, and previous predicate evaluations showing 8.0 Hz.
Oscillation Amplitude	Ranges of data for oscillation amplitude are similar to the predicate device, showing clear overlap. The mean amplitude value is within 15% of the predicate device.
Biocompatibility
Cytotoxicity	Patient-contacting components meet the requirements of ISO 10993-5.
Sensitization	Patient-contacting components meet the requirements of ISO 10993-10.
Irritation/Intracutaneous Reactivity	Patient-contacting components meet the requirements of ISO 10993-10.
Aerosol Drug Delivery (Cascade Impactor)	Performance comparable to the Acapella device when used with a nebulizer and three different drugs. No new safety or efficacy issues raised.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for mechanical testing. The submission mentions "ranges of data" and "mean Frequency and Amplitude values," implying multiple measurements were taken and statistically compared. For cascade impactor testing, three different drugs were used with the nebulizer.
Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by Trudell Medical International. This is a pre-market submission, so the data would be prospective in the context of the device's clearance, but retrospective for the performed tests themselves (i.e., tests were concluded before submission). Country of origin is Canada (manufacturer).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission focuses on demonstrating substantial equivalence through mechanical and biocompatibility testing, not on diagnostic accuracy requiring expert interpretation of results. The "ground truth" here is the measured physical properties and biological reactions against established standards and the predicate device's performance.

4. Adjudication Method for the Test Set

Not applicable. As the tests are objective mechanical and biological evaluations, there is no human adjudication of results in the traditional sense. The comparison is made against quantitative measurements from the predicate device and established ISO standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This was not a clinical performance study involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence. The mechanical and biocompatibility testing can be considered standalone performance evaluations of the device's characteristics against a predicate device and predetermined standards, without human interaction influencing the measurement results themselves. The "algorithm" here is the device's inherent mechanical function.

7. The Type of Ground Truth Used

Objective measurements against established standards and predicate device performance.
- For mechanical parameters (frequency, amplitude): The ground truth was the measured performance of the predicate device (Acapella) and the statistical comparison of the Aerobika* device's performance to it. Clinical insignificance was supported by literature (Volsko et al, 2003; Okeson and McGowen, 2007) indicating acceptable oscillation ranges for similar devices.
- For biocompatibility: The ground truth was compliance with ISO 10993-1, 10993-5, and 10993-10 standards.
- For aerosol drug delivery: The ground truth was the comparative performance against the predicate device in cascade impactor testing.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical medical device, not an AI/machine learning model that typically requires a training set. The "training" for such a device would be its engineering design and manufacturing process.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, this is not an AI/ML device.

Summary

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K123400

Premarket Notification 510(k) Aerobika* Oscillating Positive Expiratory Pressure (PEP) Device

Trudell Medical International

MAY 1 6 2013

Section 5 – 510(k) Summary

Prepared: 10 May 2013

510(k) Owner

Trudell Medical International
725 Third Street
London, Ontario N5V 5G4
CANADA
Contact Person	Darryl Fischer
	Associate Director, Global Regulatory Affairs
Phone	1-519-455-7060 ext 2140
Fax	1-519-455-6329
e-mail	dfischer@trudellmed.com

Device Name

Proprietary	Aerobika* Oscillating Positive Expiratory Pressure (PEP)Device
Common/Classification	Spirometer, Therapeutic (Incentive)

Product Code

Classification Regulation 868.5690

Predicate Device 510(k) Number K002768

Trade/Model Name Acapella

BWF

Manufacturer DHD Healthcare Corp.

Device Description

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Section 5 – 510(k) Summary

Intended Use

Technological Characteristic Comparison to Predicate Device(s)

Common Device Characteristics
Aerobika* PEP Device	Acapella (predicate device - K002768) PEP Device
• combines PEP therapy with oscillations upon exhalation	• combines PEP therapy with oscillations upon exhalation
• may be used with a nebulizer to deliver aerosol drug	• may be used with a nebulizer to deliver aerosol drug
• mechanically driven using only the patient's exhaled breath	• mechanically driven using only the patient's exhaled breath
• not orientation dependent	• not orientation dependent
• can be adjusted to increase or decrease the exhalation resistance	• can be adjusted to increase or decrease the exhalation resistance
• the device has a removable mouthpiece	• the device has a removable mouthpiece
• the device can remain in the mouth through the treatment	• the device can remain in the mouth through the treatment
Relevant Differences in Device Characteristics
• The Aerobika* Oscillating PEP can be disassembled for cleaning	• Only the mouthpiece of the Acapella device can be disassembled for cleaning
• The Aerobika* Oscillating PEP may be used for patients with an exhalation flow of 10 lpm and above	Two devices are available.• The green or high flow device suitable for most patients. The expiratory flow of the patient must be 15 lpm or greater• The blue or low flow device is for those patients who have low expired lung volumes / less than 15 lpm

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Premarket Notification 510(k) Aerobika* Oscillating Positive Expiratory Pressure (PEP) Device Trudell Medical International

Section 5 - 510(k) Summary

Non-Clinical Test Summary

Mechanical testing was conducted to characterize the operating parameters (amplitude and frequency) of the Aerobika* device to the predicate device.

The test parameters evaluated are a) oscillation frequency and b) oscillation amplitude. It was observed that the ranges of data for each parameter are similar for both devices, showing clear overlap. The mean Frequency and Amplitude values for the Aerobika* device are also within 15% of the respective mean values of the predicate device.

The slightly lower minimum frequency value observed for the Aerobika* device is considered clinically insignificant in terms of therapeutic effect. In addition to the fact that the predicate device has exhibited lower frequencies of 8.0 Hz in previous evaluations (Volsko et al, 2003), it is also known that other medical devices utilizing wave oscillation to aid mucocillary clearance are effective down to 3Hz (Vest device, Douglas and Bond-Kendall) and 6Hz (Quake device, Okeson and McGowen, 2007).

The patient contacting components of the Aerobika* oscillating positive expiratory pressure device meets the requirements of ISO 10993-1:2009, Biological evaluation of medical devices, and are classified according to the within ISO 10993-1 as follows;

. Category: Surface device
. Contact: Mucosal membranes
Contact Duration: A - Limited Exposure (≤ 24hrs)
Evaluation Testing for Biological Effect
- o Cytotoxicity - according to ISO 10993-5
- o Sensitization - according to ISO 10993-10
- Irritation or Intracutaneous Reactivity according to ISO 10993-10 o

Section 15 of this submission contains the information regarding the biocompatibility profile of the device under review.

Cascade impactor testing was also conducted comparing the Aerobika* oscillating positive expiratory pressure device to the Acapella using a nebulizer and three (3) different drugs. The results demonstrate that the Aerobiko* device performs comparably to the Acapella device, and does not raise any new safety or efficacy related issues.

Clinical Performance Summary

Not applicable, the determination of substantial equivalence is not based on Clinical Performance Data.

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Premarket Notification 510(k) Aerobika* Oscillating Positive Expiratory Pressure (PEP) Device Trudell Medical International

Section 5 – 510(k) Summary

Conclusions from Testing

The Aerobika* oscillating positive expiratory pressure device has been evaluated against the currently marketed (predicate) Acapella PEP device for the determination of substantial equivalency. The Aerobika* oscillating positive expiratory pressure 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 Aerobica* PEP device raises no new issues regarding safety or efficacy.

Section 5 Page 4 of 4

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DEPARTMENT OF HEALTH & HUMAN SERVICES .

Public Health Service

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

May 16, 2013

Mr. Darryl Fischer Associate Director, Global Regulatory Affairs Trudell Medical International 725 Third Street LONDON Ontario N5V 5G4

Re: K123400

Trade/Device Name: Aerobika* Oscillating Positive Expiratory Pressure (PEP) Device Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: II Product Code: BWF Dated: January 29, 2013 Received: April 17, 2013

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.

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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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Image /page/5/Picture/8 description: The image shows the text "Kwame O. Ulmer for -S FDA". The text is arranged in three lines. The first line contains the name "Kwame O. Ulmer" followed by the word "for". The second line contains the letters "FDA" in a stylized font. The third line contains the text "-S".

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use

510(k) Number:

K123400

Device Name: Aerobika* Oscillating Positive Expiratory Pressure (PEP) Device

Indications for Use:

Prescription Use: (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Paul H. Shin=S
2013.05.15(10:10:35)-04'00'

'Division Sign-Off) Juvision of Anesthesiology, General Hospital -mection Control, Dental Devices

510(k) Number: K123400

Page 1 of

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).