The Combined VersaPAP™ and Aerobika® OPEP device is intended for use as a Positive Airway Pressure (PAP) device and a Positive Expiratory Pressure (PEP) device. The combined device has the ability to provide supplemental oxygen when used with compressed oxygen. The combined device is for patients (ages 5 years and above) who are capable of following directions for Positive Airway Pressure Therapy and capable of generating exhalation flow of 10 lpm for 3 - 4 seconds. The combined device is a single patient, multiple use device intended to be used in a hospital environment under the supervision of a healthcare professional.

Device Description

The Aerobika® OPEP device and VersaPAP™ device can be used independently or combined. When combined for ease of use. The combined device creates oscillations during the exhalation phase (OPEP) to aid in secretion clearance and during the inhalation phase (PAP) helps to maintain positive airway pressure for the treatment and prevention of atelectasis.

AI/ML Overview

The provided text is a 510(k) summary for the "Combined VersaPAP™ device and Aerobika® OPEP" and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria in the format requested.

Therefore, I cannot directly extract "acceptance criteria and the study that proves the device meets the acceptance criteria" in the detailed format you requested (table, sample size, expert information, MRMC study, standalone performance, ground truth). The document is a regulatory submission for a medical device that performs a physical function (providing positive airway pressure and positive expiratory pressure), not an AI/software as a medical device (SaMD) that typically undergoes rigorous performance studies with the criteria you outlined.

However, I can extract the information relevant to what I can infer as "acceptance criteria" and "study" within the context of this device application:

The "acceptance criteria" for this type of device are primarily demonstrating substantial equivalence to existing legally marketed predicate devices, meaning it is as safe and effective as the predicates. The "study" that proves this involves bench testing and comparison of features and performance characteristics to the predicates.

Here's how I can reframe the information based on the provided text:

Inferred Acceptance Criteria and Study to Prove Device Meets Them:

For this device, "acceptance criteria" are not reported as specific numerical thresholds for diagnostic performance (like sensitivity/specificity for AI), but rather as proof of substantial equivalence to legally marketed predicate devices. The "study" involves bench testing and a detailed comparison of technical and performance characteristics to demonstrate this equivalence.

1. Table of Acceptance Criteria (as inferred) and Reported Device Performance:

Acceptance Criteria Category (Inferred from S.E. requirements)	Reported Device Performance (from text)
Indications for Use Identity	Identical: "The proposed indications for use... are identical to the predicate and reference devices."
Patient Population Identity	Identical: "The patient population is identical to the predicates."
Environment of Use Similarity	Similar: "The environments of use are similar to the predicates." (Note: Combined device only in hospital, not home like individual OPEP).
Technology Identity	Identical: "The technology for generating OPEP and PAP is identical to the predicates. The technology of having a device which offers the combination of OPEP and PEP is similar to the reference device."
Performance - Pressure	Acceptable: "The pressure... is less than that of the reference device, [but] higher than that of the predicates when they are tested as standalone devices." "The difference in performance is within the range of the separate predicate devices and the reference device and does not raise new safety or effectiveness concerns."
Performance - Frequency (Oscillations)	Comparable/Acceptable: "The frequency of the combined device is higher than that of the reference MetaNeb device, however, the measured frequency is comparable to the Aerobika® OPEP predicate device and is within acceptable clinical frequency efficacy range." "The frequency generated by the subject device does not add risk to the patient compared to other FDA cleared devices."
Biocompatibility	Met: Materials in patient contact/gas pathway are the same as predicates. "Additionally testing was performed. ISO 18562, which supported patient exposure in new configurations."

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

Sample Size: Not applicable in the context of an FDA 510(k) for this type of physical device; there isn't a "test set" of patient data for diagnostic performance. The "testing" refers to bench testing of the device's physical performance. The document states, "We performed comparative testing at adult and child breathing setting to the predicates and reference." However, no specific number of test runs or 'samples' is given.
Data Provenance: Not applicable in the way it would be for an AI model (e.g., retrospective/prospective patient data, country of origin). The data provenance is from bench testing conducted by the manufacturer, Trudell Medical International (located in London, ON, Canada).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This is not a study requiring expert consensus for ground truth as it's a physical device, not an AI diagnostic tool.

4. Adjudication Method for the Test Set:

Not applicable. There's no "test set" that requires adjudication by human readers/experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is typically done for AI-assisted diagnostic tools to assess human reader improvement. This is a physical medical device.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is a physical device, not an algorithm. Its "standalone" performance would refer to its physical output which is measured via bench testing as described in bullet 1.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance is established by engineering and physiological measurement standards (e.g., measuring pressure, flow rate, and frequency) during bench testing, and comparing these measurements to the established performance of predicate devices and expected physiological ranges.

8. Sample Size for the Training Set:

Not applicable. This is a manufactured physical device, not a machine learning model.

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

Not applicable. There is no concept of a "training set" or "ground truth establishment" in the AI sense for this device. Its design and manufacturing (analogous to "training") are based on engineering principles and regulatory requirements for medical devices.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 16, 2019

Trudell Medical International c/o Paul Dryden Consultant 725 Third Street London, N5V 5G4 CA

Re: K183108

Trade/Device Name: Combined VersaPAP device and Aerobika OPEP Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: Class II Product Code: BWF Dated: July 18, 2019 Received: July 19, 2019

Dear Paul Dryden:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

James Lee, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K183108

Device Name

Combined VersaPAP™ device and Aerobika® OPEP

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
XX Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

16-Aug-19

Trudell Medical International 725 Third Street London, ON N5V 5G4 CANADA Tel – 519-455-7060 Official Contact: Marianne Tanton - Director, Quality and Regulatory Affairs

Proprietary or Trade Name:	Combined VersaPAPTM device and Aerobika® OPEP		ProposedCombinedAerobika® OPEP andVersaPAP™ device	PredicateAerobika® OPEPK150173	PredicateVersaPAP™ deviceK173918
Common/Usual Name:	Incentive Spirometer	CFRClassification		868.5690BWF
Classification Code/Name:	BWF – Incentive Spirometer21 CFR 868.5690Class II	Classification name
Predicate Devices:	K150173 – Trudell – Aerobika® OPEPK173918 – Trudell – VersaPAPTM device	Intended Use	Intended for use as a PositiveExpiratory Pressure (PEP) device(exercise patient's lungs and toimprove secretion clearance)	Incentive SpirometerIntended for use as aPositive ExpiratoryPressure (PEP) device.
Reference Device:	K151689 – Hill-Rom – MetaNeb®		Intended for use as a PositiveAirway Pressure (PAP) device(Treatment and prevention ofatelectasis)		Treatment and prevention ofatelectasis
Indications for Use	The Combined VersaPAP™ andAerobika® OPEP device isintended for use as a PositiveAirway Pressure (PAP) device anda Positive Expiratory Pressure(PEP) device. The combineddevice has the ability to providesupplemental oxygen when usedwith compressed oxygen. Thecombined device is for patients(ages 5 years and above) who arecapable of following directions forPositive Airway Pressure Therapyand capable of generatingexhalation flow of 10 lpm for 3 -4 seconds. The combined deviceis a single patient, multiple usedevice intended to be used in ahospital environment under thesupervision of a healthcareprofessional	The Aerobika® OscillatingPositive ExpiratoryPressure device is intendedfor use as a PositiveExpiratory Pressure (PEP)device. The Aerobika®Oscillating PEP devicemay also be usedsimultaneously withnebulized aerosol drugdelivery. The device isintended to be used bypatients capable ofgenerating exhalation flowof 10 lpm for 3-4 seconds.	The VersaPAP™ device isindicated for the treatment andprevention of atelectasis. TheVersaPAP™ device also hasthe ability to providesupplemental oxygen whenused with compressed oxygen.The VersaPAP™ device is forpatients (ages 5 years andabove) who are capable offollowing directions forPositive Airway PressureTherapy in a hospitalenvironment. TheVersaPAP™ device is a singlepatient, multiple use deviceintended to be used under thesupervision of a healthcareprofessional.
Patient Population	Patients capable of generatingexhalation flow of 10 lpm for 3-4seconds.Patients (ages 5 years and above)who are capable of following	Patients capable ofgenerating exhalation flowof 10 lpm for 3-4 seconds.	Patients (ages 5 years andabove) who are capable of
	directions.		following directions.

Device Description:

Date Prepared

Indications for Use:

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Table 1 – Comparison to Predicates

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	ProposedCombinedAerobika® OPEP andVersaPAP™ device	PredicateAerobika® OPEPK150173	PredicateVersaPAP™ deviceK173918
Environments	Hospital settings	Hospital and clinicalHome settings	Hospital settings
Operating principlesOPEP	Oscillations generated by patient's exhaled breath.Adjustable exhalation resistanceVisual feedback via manometer	Oscillations generated by patient's exhaled breath.Adjustable exhalation resistanceVisual feedback only when used with the manometer
PAP	Venturi principle created by compressed gas sourceSupplemental oxygenMeasures airway pressure with manometer		Venturi principle created by compressed gas sourceSupplemental oxygenMeasures airway pressure with manometer
Single patient, multi-use	Components may be cleaned and reused by the same patient

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	ProposedCombinedOPEP + PAP	ReferenceHill-Rom - MetaNeb®K151689
Classification	BWF868.5690Incentive Spirometer	NHJ868.5905Device, positive pressure breathing, intermittent(IPPB)
Intended use	Intended for use as a Positive ExpiratoryPressure (PEP) device (exercise patient'slungs and to improve secretion clearance)Intended for use as a Positive AirwayPressure (PAP) device (Treatment andprevention of atelectasis)	Intended for use as a Positive Expiratory Pressure(PEP) device.Treatment and prevention of atelectasis
Indications for Use	The Combined VersaPAPTM andAerobika® OPEP device is intended foruse as a Positive Airway Pressure (PAP)device and a Positive Expiratory Pressure(PEP) device. The combined device hasthe ability to provide supplemental oxygenwhen used with compressed oxygen. Thecombined device is for patients (ages 5years and above) who are capable offollowing directions for Positive AirwayPressure Therapy and capable ofgenerating exhalation flow of 10 lpm for 3– 4 seconds. The combined device is asingle patient, multiple use deviceintended to be used in a hospitalenvironment under the supervision of ahealthcare professional	The MetaNeb® System is indicated formobilization of secretions, lung expansion therapy,the treatment and prevention of pulmonaryatelectasis, and also has the ability to providesupplemental oxygen when used with compressedoxygen.
Patient Population	Patients capable of generating exhalationflow of 10 lpm for 3-4 seconds.Patients (ages 5 years and above) who arecapable of following directions.	Patient 5 years and older
Environments of Use	Hospital	Hospitalsub-acute facilitiesNursing careHomecare

Table 2 - Comparison of the Subject vs. the Reference Hill-Rom MetaNeb (K151689)

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		Reference
	ProposedCombined	Hill-Rom - MetaNeb®
	OPEP + PAP	K151689
Mode ofOperation	OPEPOscillations generated by patient's exhaledbreath.Adjustable exhalation resistanceVisual feedback via manometer	Can deliver continuous expiratory pressure(CPEP) combined with medicated aerosol.Oscillations generated by device
	PAPVenturi vacuum created by compressed gassourceSupplemental oxygenMeasures airway pressure with manometer	Venturi from compressed gas source continuousSupplemental oxygenMeasures airway pressure with manometer
Therapy	OPEPPAP	CPEPCHFOAerosol
Patient Interface	Mouthpiece	Disposable circuit includes connection for in-linenebulizer with mouthpiece
Gas source	Compressed air or oxygen	Pneumatic and air or oxygen
Control settings	OPEP resistance adjustablePAP flow rate: 5-15 L/min.	Mode selectionFrequency selection for CHFO modePressure adjustment for CPEP mode

Predicate, Reference and Proposed Device Comparison and Substantial Equivalence Discussion:

The proposed and predicates are similar in the following categories:

Indications for Use ●
Patient Population ●
Technological Characteristics
Materials in patient contact
Shelf-life
. Cleaning methods

The Combined Aerobika® OPEP and VersaPAP™ device is substantially equivalent to the predicate and reference devices because:

Indications -

The proposed indications for use for secretions clearance and the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen are identical to the predicate and reference devices. Discussion - There are no differences between the subject and predicate devices.

Patient Population -

The patient population is identical to the predicates. Discussion - There are no differences between the subject and predicate devices.

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Environment of Use -

The environments of use are similar to the predicates. Noting that the OPEP also includes the home setting when used individually, but the home setting is not intended for the subject device. Discussion - There are no differences between the subject and predicate devices except the combined device will not be used in the home setting.

Technology -

The technology for generating OPEP and PAP is identical to the predicates. The technology of having a device which offers the combination of OPEP and PEP is similar to the reference device. Discussion - There are no differences between the subject and predicate devices.

Performance -

The pressure was compared to the reference device. While the pressure of the subject device is less than that of the reference device, it is higher than that of the predicates when they are tested as standalone devices.

Discussion - The difference in performance is within the range of the separate predicate devices and the reference device and does not raise new safety or effectiveness concerns.

The frequency of the combined device is higher than that of the reference MetaNeb device, however, the measured frequency is comparable to the Aerobika® OPEP predicate device and is within acceptable clinical frequency efficacy range.

Discussion - The frequency of the subject device is comparable to the Aerobika® OPEP predicate device. As such, the frequency generated by the subject device does not add risk to the patient compared to other FDA cleared devices.

Non-clinical Comparative Performance

Biocompatibility -

The materials that are patient contacting and gas pathway are same as K150173 - Trudell -Aerobika® OPEP and K173918 – Trudell – VersaPAP™ device

Discussion - Additionally testing was performed. ISO 18562, which supported patient exposure in new configurations.

Bench Testing -

We performed comparative testing at adult and child breathing setting to the predicates and reference. The results demonstrate that the subject device is substantially equivalent to the predicate and reference devices.

Discussion of Differences

The only differences are:

. Environment is only hospital setting
- Where the Aerobika® OPEP device when used individually can also be used in the о home setting
Certain performance categories differ when the devices are combined vs. when they are used ● separately.
- These differences relate to pressure and frequency (oscillations) when they are o combined. When compared to the predicates and reference device, these differences in pressure and frequency are within the performance specifications of the cleared predicates and reference device.

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Any differences do not raise new or different concerns of safety and effectiveness.

Substantial Equivalence Conclusion

Based upon the comparative performance testing we have demonstrated that the proposed device compared to the predicate and reference devices can be found to substantially equivalent.

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).