AirPhysio vibrates the airway walls to assist in loosening mucus and intermittently increases endobronchial pressure so that the airway patency can be maintained during exhalation, reducing the potential of mucus becoming trapped as it moves up the airways.

The device may also be useful in the removal of mucus from patients who have chronic bronchitis or bronchiectasis and in conjunction with a medical need for positive expiratory pressure (PEP) therapy.

Device Description

AirPhysio is a small, handheld expiration resistance device, consisting of a hardened plastic mouthpiece at one end, a plastic cover with an opening at the other end, and a valve on the inside created by a high- density stainless-steel ball resting in a plastic conical cone. Exhalation through the device causes vibrations, assisting to loosen mucus from the airways. The resistance is increased by tilting the device.

The subject device is provided non-sterile for reprocessing in a home environment and has no accessories or configuration options.

AI/ML Overview

The provided document is a 510(k) premarket notification for the AirPhysio Positive Expiratory Pressure (PEP) Device. It focuses on demonstrating substantial equivalence to a predicate device (Flutter D - Clement Clarke - K972859) rather than establishing novel acceptance criteria for a new type of device or conducting a performance study against a predefined clinical endpoint.

Therefore, the document does not contain the information required to populate all the sections of acceptance criteria and study details as requested. Specifically, it does not outline a clinical study with quantifiable acceptance criteria for a new device, a defined test set of patient data, expert ground truth establishment for medical images, MRMC studies, or standalone algorithm performance.

However, based on the information provided, here's what can be extracted and inferred regarding the "acceptance criteria" through the lens of substantial equivalence and the "study" conducted for AirPhysio:

Acceptance Criteria for Substantial Equivalence (Inferred from regulatory context)

For devices seeking 510(k) clearance, the "acceptance criteria" are typically demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved by showing that it has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The performance tests conducted are to support this demonstration of similarity.

Table of Acceptance Criteria and Reported Device Performance (Inferred/Extracted from the document)

Acceptance Criteria (Demonstrated Equivalence to Predicate)	Reported Device Performance (AirPhysio)
Biocompatibility: No cytotoxic, sensitization, or irritation effects.	Passed: Biocompatibility evaluation on 9 complete assemblies (in accordance with FDA ISO 10993-1) concluded no cytotoxic effects, no sensitization reactions, and no irritation (based on erythema and edema scores). Contact type: Surface device (exhalation only), Contact Duration: Permanent Exposure (>30 days).
Reprocessing Effectiveness/Safety: Sufficiently clean and hygienic after reprocessing.	Passed: Independent laboratory tests verified that when reprocessing guidelines are followed, AirPhysio is sufficiently clean, hygienic, and as safe to use as the legally marketed predicate device.
Functional Performance (Bench Testing): Comparable performance characteristics (Mean PEP, Peak PEP, Amplitude PEP, Oscillation Frequency) across different flow rates.	Passed: Comparative bench testing showed AirPhysio and predicate device have comparable characteristics and substantially similar output specifications. Bland Altman Analysis performed to support equivalence.
Usability/Human Factors: Safe and effective use by target users in the intended environment, without adverse risks.	Passed: Usability testing demonstrated the device is safe and effective for intended use, users, and environments. Followed FDA's "Applying Human Factors and Usability Engineering to Medical Devices" (Feb 3, 2016) guidance.
Intended Use Equivalence: Same indications for use as the predicate device.	Demonstrated: Indicated for use as a Positive Expiratory Pressure (PEP) Device for improving the clearance of mucus secretions from the airways, vibrating airway walls to loosen mucus, maintaining airway patency during exhalation, and reducing mucus trapping. Also useful for chronic bronchitis/bronchiectasis with medical need for PEP therapy.
Technological Characteristics Equivalence: Similar design principles (pipe-like shape, metal ball, cone, mouthpiece, vented cover), same operating principles (OPEP, PEP generation).	Demonstrated: Based on same technological characteristics (pipe-like shape, metal ball, cone, mouthpiece, vented cover). Operates on same principles: oscillating high frequency PEP (OPEP), generating PEP with a moveable steel ball that opposes exhalation, causing vibrations to loosen mucus.
Contraindication Equivalence: Similar contraindications.	Demonstrated: AirPhysio's contraindications largely align with the predicate, including pneumothorax, tuberculosis, haemoptysis, right-sided heart failure (with added oesophageal surgery and middle ear pathology).

Study Details (as presented in the document):

Sample size used for the test set and the data provenance:
- Biocompatibility: 9 complete assemblies. Data provenance not explicitly stated, but implied to be laboratory testing for regulatory submission.
- Reprocessing: Not specified, but involved independent laboratory tests.
- Comparative Bench Testing: Not specified, but involved comparing "the AirPhysio device with the legally marketed predicate across different flow rates." This typically involves a range of controlled in-vitro conditions.
- Usability Testing: Not specified for the number of participants, but it's human factors validation testing involving the "target user population." Data provenance not explicitly stated (e.g., country of origin), assumed to be for regulatory submission.
- Note: This is not a clinical study on patient data but rather engineering and human factors testing on the device itself or typical users.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth here is the performance of the predicate device and established engineering/biocompatibility standards, not clinical labeling by expert readers of medical images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring reader adjudication of clinical data.
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:
- No MRMC study was conducted. This device is a mechanical PEP device, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical medical device, not an algorithm. Bench testing evaluates the "standalone" performance of the mechanical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Biocompatibility: Established international standards (e.g., ISO 10993-1) and in-vitro testing results (cellular response, skin reactions).
- For Reprocessing: Established hygiene and safety standards, verified by independent lab.
- For Functional Performance: Performance characteristics (Mean PEP, Peak PEP, Amplitude PEP, Oscillation Frequency) of the predicate device served as the performance target/ground truth for comparison. Bench test measurements against engineering specifications.
- For Usability: FDA human factors guidance and user interaction studies to ensure safe and effective operation based on predefined tasks and risk analysis.
The sample size for the training set:
- Not applicable. This is not an AI/ML device requiring a training set. The device is mechanical.
How the ground truth for the training set was established:
- Not applicable.

Summary

{0}------------------------------------------------

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

January 15, 2021

AirPhysio Pty Ltd % Rafael Aguila Responsible Third-Party Official Accelerated Device Approval Services 6800 S.W. 40th Street, Ste. 403 Ludlum, Florida 33155

Re: K203209

Trade/Device Name: AirPhysio Positive Expiratory Pressure (PEP) Device Regulation Number: 21 CFR 868.5665 Regulation Name: Powered Percussor Regulatory Class: Class II Product Code: BYI Dated: January 5, 2021 Received: January 6, 2021

Dear Rafael Aguila:

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

{1}------------------------------------------------

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 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 medical devices and radiation-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,

Rachana Visaria, 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K203209

Device Name

AirPhysio Positive Expiratory Pressure (PEP) Device

Indications for Use (Describe)

AirPhysio is indicated for use as a Positive Expiratory Pressure (PEP) Device for improving the clearance of mucus secretions from the airways.

The device may also be useful in the removal of mucus from patients who have chronic bronchiectasis and in conjunction with a medical need for positive expiratory pressure (PEP) therapy.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Date Prepared:	15 JANUARY 2021
Official Contact:	Paul O'BrienAirPhysio Pty LtdUnit 1, 43 Greenway DriveTweed Heads South NSW 2486, AustraliaTel: +61-7-3535-0640
Proprietary / Trade Name:	AirPhysio Positive Expiratory Pressure (PEP) Device
Regulation Description:	Powered Percussor
Regulation Number:	21 CFR 868.5665, Class II
Product Code:	BYI
Predicate Device:	Flutter D - Clement Clarke - K972859

Device Description:

The subject device is provided non-sterile for reprocessing in a home environment and has no accessories or configuration options.

Indications for Use:

AirPhysio is indicated for use as a Positive Expiratory Pressure (PEP) Device for improving the clearance of mucus secretions from the airways.

Technological Characteristics

The principle of the AirPhysio as a mucus clearance device is its ability to vibrate the airways (which loosens mucus from airway walls) and intermittently increase endobronchial pressure (which maintains patency duringexhalation).

The moveable stainless-steel ball inside the device opposes the patient's exhalation which creates a resistance due to the weight of the ball. During exhalation, the force of gravity on the ball and the pressure of the exhaled air causes the ball to vibrate (bounce) up and down. This cycle repeats itself throughout each exhalation.

During the exhalation, the positive expiratory pressure (PEP) combined with the vibrations of the rapidly oscillating steel ball, help to loosen mucus and mobilize secretions from deep within the airways to the throat for expectoration.

{4}------------------------------------------------

Comparison of Technological Characteristics with the Predicate Device

Oscillatinghigh frequency PEP (OPEP) devices combine both PEP and airway oscillation techniques and is the technological principle being employed in both the subject and predicate devices.

In both subject and predicate devices, as exhaled gas passes through the device, a steel ball vibrates vertically within its casing, causing airflow vibrations or oscillations. The angle at which the subject or predicate devices are held by the patient affects the amount of effort needed to cause the steel ball to vibrate, which affects the expiratory flow and thus controls the frequency, amplitude of the oscillations and the positive expiratory pressure (PEP).

In comparison, both the subject and predicate devices are based on the same technological characteristics including:

Same pipe-like shape and similar size ●
Both devices use a weighted metal ball resting in a cone to create the PEP .
The same weighted metal ball is used to create oscillations in both ● devices
Both devices use a tilt angle to modify the PEP and oscillation frequency .

The following technological differences exist between the subject and predicate device:

. Material composition of predicate device is made from polypropylene, while to subject is made from polycarbonate, but appears similar in operation for both the predicate and subject devices
The devices have non-critical variations to their internal dimensions ●
The subject uses a dual cone instead of the single cone used in the predicate
. The subject device includes a mouthpiece cover for improved hygiene
The subject device includes a child-resistant protective cover . .

{5}------------------------------------------------

Product Characteristics

	PREDICATE DEVICE - Flutter D	SUBJECT DEVICE - AirPhysio
510k Number	K972859	K203209
Manufacturer	Clement Clarke	AirPhysio Pty Ltd
Device Design	Image: Predicate Device DesignDevice Components:1 – Main body & mouthpiece(Poly-propylene plastic)2 – Circular Cone (Poly-propylene plastic)3 – Stainless Steel Ball (StainlessSteel) 4 – Protective Cover (Poly-propylene plastic)	Image: Subject Device DesignDevice Components:1 – Mouthpiece cap (Poly-urethane plastic)2 – Main body & mouthpiece(Poly-carbonate plastic)3 – Circular cone (Poly-carbonateplastic) 4 – Stainless steel ball(stainless steel)5 – Child resistant protectivecover (Poly-carbonateplastic)
SubstantialEquivalenceDiscussion	The predicate and subject devices are designed using similar design principlesconsisting of the same pipe-like shape and incorporating a metal ball, cone,mouthpiece and vented cover.

{6}------------------------------------------------

	PREDICATE DEVICE - Flutter D	SUBJECT DEVICE - AirPhysio
Indications for Use/ PatientPopulation	The efficacy of the Flutter D as amucus clearance device for cysticfibrosis patients is based on itsability to:Vibrate the airway (whichloosens mucus from theairway walls). Intermittentlyincrease endobronchialpressure (to maintain thepatency of airways duringexhalation, so that mucusdoes not become trapped as itmoves up the airways); accelerate expiratory airflow tofacilitate the upwardmovement of mucus throughairways so that it can becoughed out; It may also be used forremoval of mucus from theairways of patients who havechronic bronchitis orbronchiectasis and inconjunction with medical needfor Positive ExpiratoryPressure (PEP) Therapy.	AirPhysio is indicated for use as aPositive Expiratory Pressure (PEP)Device for improving the clearanceof mucus secretions from theairways.AirPhysio vibrates the airwaywalls to assist in loosening mucusand intermittently increasesendobronchial pressure so thatthe airway patency can bemaintained during exhalation,reducing the potential of mucusbecoming trapped as it moves upthe airways. The device may also be useful inthe removal of mucus from patientswho have chronic bronchitis orbronchiectasis and in conjunctionwith a medical need for positiveexpiratory pressure (PEP) therapy.
SubstantialEquivalenceDiscussion	The predicate and subject devices are substantially equivalent in their intended use. Both devices are designed to assist patients to mobilise mucussecretionsusing positive expiratory pressure (PEP) therapy and to assist inthe treatment of similar respiratory conditions.
	PREDICATE DEVICE - Flutter D	SUBJECT DEVICE - AirPhysio
Principles ofOperation /TechnologicalCharacteristics	The principle of the FLUTTER®as a mucus clearance device isbased on its ability to:	The principle of the AirPhysio as amucus clearance device is its abilityto:
	(1) vibrate the airways (whichloosens mucus from the airwaywalls);	(1) vibrate the airways (which loosensmucus from airway walls);
	(2) intermittently increaseendobronchial pressure (whichhelps maintain the patency of	(2) intermittently increaseendobronchial pressure (maintainspatency duringexhalation).
	the airways during exhalation sothat mucus does not becometrapped as it moves up theairways); and	(3) The moveable stainless-steel ballinside the device opposes thepatient's exhalation whichcreates a resistance due to theweight of the ball. Duringexhalation, the force of gravityon the ball and the pressure ofthe exhaled air causestheballtovibrate(bounce)upand down.
	(3) accelerate expiratory airflow(which facilitates the upwardmovement of mucus throughthe airways so that it can bemore easily cleared).	(4) This cycle repeats itselfthroughout each exhalation.
		(5) During the exhalation, thepositive expiratory pressure (PEP)combined with the vibrations ofthe rapidly oscillating steel ball,helps to loosen mucus andmobilise secretions from theairways to the throat forexpectoration.
SubstantialEquivalenceDiscussion	The principles of operation in both the predicate and subject devices focuson generating positive expiratory pressure (PEP) with a moveable steelball that opposes a patient's exhalation. PEP is created in the same way inboth devices.
	The force of gravity on the ball and the pressure of the patient's exhaled aircauses the ball to vibrate up and down rapidly, helping to loosens mucusand mobilise secretions.
	This principle, known as oscillating high frequency PEP (OPEP) combineboth PEP and airway oscillation techniques and is the technological principlebeing employed in both the subject and predicate devices.
	PREDICATE DEVICE - Flutter D	SUBJECT DEVICE - AirPhysio
Contraindications	The FLUTTER® iscontraindicated for patientsknown to have pneumothorax orovert right-sided heart failure.FLUTTER should Not be used bypatients with the followingconditions:-• pneumothorax• severe tuberculosis• right-sided heart failure• haemoptysis (coughing-upblood)	AirPhysio is contraindicated forpatients known to have:• Pneumothorax• Tuberculosis• Haemoptysis (coughing up blood)• Oesophageal surgery• Right-sided heart failure• Middle ear pathology (i.e.ruptured tympanic membrane)
Environment of Use	Home / Healthcare facility	Home / Healthcare facility
Material of Use /Duration contact	Polypropylene, stainless steel /<24 hours	Polycarbonate, stainless steel / <24hours
ContactingComponent	Mouthpiece of body made fromPolypropylene	Mouthpiece of body made fromPolycarbonate
Power Source	Exhalation- Manual, mechanicalpowered device	Exhalation- Manual, mechanicalpowered device
OTC / Prescriptive	Prescriptive	Prescriptive
SubstantialEquivalenceDiscussion	Both subject and predicate devices have the same contraindications,made from similar plastic materials, same power source and having thesame patient contacting component.

{7}------------------------------------------------

510(k) Summary

{8}------------------------------------------------

510(k) Summary

Page 6 of 7

Performance Data

Biocompatibility evaluation for AirPhysio device was conducted on 9 complete assemblies and in accordance with the FDA Use of International Standard I SO 10993-1. The studies concluded that the test article was not considered to have any cytotoxic effects, did not elicit any sensitization reactions and based on erythema and edema scores, no irritations were observed.

The subject device is considered:

. Contact type: Surface device (exhalation only)
. Contact Duration: A - Permanent Exposure (>30 days)

In support of the reprocessing quidelines, independent laboratory tests verified that when followed, the AirPhysio is sufficiently clean, hygienic and as safe to use as the legally marketed predicate device.

AirPhysioconductedcomparativebenchtesting to assess the performance characteristics of the AirPhysio device with thelegally marketed predicate across different flow rates. The following performance measures were compared a) Mean PEP, b) Peak PEP, c) Amplitude PEP, d) Oscillation Frequency Comparison. A Bland Altman Analysis was performed to further support the equivalence of the performance measures. Theresultsshowed that the AirPhysio and predicate device have comparable characteristics and substantially similar output specifications.

AirPhysio also undertook usability testing to demonstrate that the use of the device in the target user population and environment was safe, and that a patient's interaction with the device did

{9}------------------------------------------------

510(k) Summary Page 7 of 7

not pose any adverse risks. AirPhysio's human factors validation testing followed FDA's human factors quidance document, Applying Human Factors and Usability Engineering to Medical Devices (Feb 3, 2016). Based on the findings of the study, it was concluded that the AirPhysio device is as safe and effective for the intended use, its users and the user environments as the predicate device.

Substantial Equivalence

The AirPhysiodevice is substantially equivalent to the predicate device Flutter D (K972859).

The conclusions drawn from our reviews demonstrate that the subject, AirPhysio device is as effective and performs as well as the legally marketed predicate device.

The subject device has the same intended use as the predicate, operates on the same technological principles and has the same technological characteristics in design and is as safe to use as the predicate device.

Performance data demonstrates that the AirPhysio is substantially equivalent to the predicate device across a range of performance measures.

Regulation Number and Section

§ 868.5665 Powered percussor.

(a)
Identification. A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.(b)
Classification. Class II (performance standards).