(77 days)
Not Found
No
The device description and performance studies focus on mechanical principles and physical testing, with no mention of AI/ML algorithms, data processing, or training/test sets.
Yes
Explanation: The device is indicated for improving the clearance of mucus secretions from the airways, specifically for conditions like chronic bronchitis or bronchiectasis, by vibrating airway walls and maintaining airway patency. This directly addresses health conditions, fulfilling the definition of a therapeutic device.
No
Explanation: The device is indicated for improving the clearance of mucus secretions and treating conditions like chronic bronchitis, not for diagnosing them. It is a therapeutic device.
No
The device description clearly states it is a "small, handheld expiration resistance device" consisting of physical components like a mouthpiece, cover, and a stainless-steel ball. This indicates it is a hardware device, not software only.
Based on the provided information, the AirPhysio device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- AirPhysio's Function: The AirPhysio device is a mechanical device used externally by the patient to assist with clearing mucus from the airways through positive expiratory pressure and vibration. It does not analyze any biological samples.
- Intended Use: The intended use clearly describes a physical therapy technique for mucus clearance, not a diagnostic test.
- Device Description: The description details a mechanical device with a mouthpiece, cover, and internal valve. There is no mention of reagents, sample collection, or analysis of biological material.
Therefore, the AirPhysio device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
BYI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airways
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home / Healthcare facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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.
- 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.
- AirPhysio conducted comparative bench testing to assess the performance characteristics of the AirPhysio device with the legally 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. The results showed 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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.
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 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)
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3
| Date Prepared: | 15 JANUARY 2021 |
|---|---|
| Official Contact: | Paul O'Brien |
| AirPhysio Pty Ltd | |
| Unit 1, 43 Greenway Drive | |
| Tweed Heads South NSW 2486, Australia | |
| Tel: +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:
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.
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.
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.
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 Design |
Device Components:
1 – Main body & mouthpiece
(Poly-propylene plastic)
2 – Circular Cone (Poly-
propylene plastic)
3 – Stainless Steel Ball (Stainless
Steel) 4 – Protective Cover (Poly-
propylene plastic) | Image: Subject Device Design
Device Components:
1 – Mouthpiece cap (Poly-
urethane plastic)
2 – Main body & mouthpiece
(Poly-carbonate plastic)
3 – Circular cone (Poly-carbonate
plastic) 4 – Stainless steel ball
(stainless steel)
5 – Child resistant protective
cover (Poly-carbonate
plastic) |
| Substantial
Equivalence
Discussion | The predicate and subject devices are designed using similar design principles
consisting 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 | ||
| / Patient | ||
| Population | The efficacy of the Flutter D as a | |
| mucus clearance device for cystic | ||
| fibrosis patients is based on its | ||
| ability to: | ||
| Vibrate the airway (which | ||
| loosens mucus from the | ||
| airway walls). Intermittently | ||
| increase endobronchial | ||
| pressure (to maintain the | ||
| patency of airways during | ||
| exhalation, so that mucus | ||
| does not become trapped as it | ||
| moves up the airways); accelerate expiratory airflow to | ||
| facilitate the upward | ||
| movement of mucus through | ||
| airways so that it can be | ||
| coughed out; It may also be used for | ||
| removal of mucus from the | ||
| airways of patients who have | ||
| chronic bronchitis or | ||
| bronchiectasis and in | ||
| conjunction with medical need | ||
| for Positive Expiratory | ||
| Pressure (PEP) Therapy. | AirPhysio is indicated for use as a | |
| Positive Expiratory Pressure (PEP) | ||
| Device for improving the clearance | ||
| of mucus secretions from the | ||
| airways. | ||
| 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. | ||
| Substantial | ||
| Equivalence | ||
| Discussion | The predicate and subject devices are substantially equivalent in their intended use. Both devices are designed to assist patients to mobilise mucus | |
| secretionsusing positive expiratory pressure (PEP) therapy and to assist in | ||
| the treatment of similar respiratory conditions. | ||
| PREDICATE DEVICE - Flutter D | SUBJECT DEVICE - AirPhysio | |
| Principles of | ||
| Operation / | ||
| Technological | ||
| Characteristics | The principle of the FLUTTER® | |
| as a mucus clearance device is | ||
| based on its ability to: | The principle of the AirPhysio as a | |
| mucus clearance device is its ability | ||
| to: | ||
| (1) vibrate the airways (which | ||
| loosens mucus from the airway | ||
| walls); | (1) vibrate the airways (which loosens | |
| mucus from airway walls); | ||
| (2) intermittently increase | ||
| endobronchial pressure (which | ||
| helps maintain the patency of | (2) intermittently increase | |
| endobronchial pressure (maintains | ||
| patency duringexhalation). | ||
| the airways during exhalation so | ||
| that mucus does not become | ||
| trapped as it moves up the | ||
| airways); and | (3) 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 causestheballto | ||
| vibrate(bounce)upand down. | ||
| (3) accelerate expiratory airflow | ||
| (which facilitates the upward | ||
| movement of mucus through | ||
| the airways so that it can be | ||
| more easily cleared). | (4) This cycle repeats itself | |
| throughout each exhalation. | ||
| (5) During the exhalation, the | ||
| positive expiratory pressure (PEP) | ||
| combined with the vibrations of | ||
| the rapidly oscillating steel ball, | ||
| helps to loosen mucus and | ||
| mobilise secretions from the | ||
| airways to the throat for | ||
| expectoration. | ||
| Substantial | ||
| Equivalence | ||
| Discussion | The principles of operation in both the predicate and subject devices focus | |
| on generating positive expiratory pressure (PEP) with a moveable steel | ||
| ball that opposes a patient's exhalation. PEP is created in the same way in | ||
| both devices. | ||
| The force of gravity on the ball and the pressure of the patient's exhaled air | ||
| causes the ball to vibrate up and down rapidly, helping to loosens mucus | ||
| and mobilise secretions. | ||
| This principle, known as oscillating high frequency PEP (OPEP) combine | ||
| both PEP and airway oscillation techniques and is the technological principle | ||
| being employed in both the subject and predicate devices. | ||
| PREDICATE DEVICE - Flutter D | SUBJECT DEVICE - AirPhysio | |
| Contraindications | The FLUTTER® is | |
| contraindicated for patients | ||
| known to have pneumothorax or | ||
| overt right-sided heart failure. | ||
| FLUTTER should Not be used by | ||
| patients with the following | ||
| conditions:- | ||
| • pneumothorax | ||
| • severe tuberculosis | ||
| • right-sided heart failure | ||
| • haemoptysis (coughing-up | ||
| blood) | AirPhysio is contraindicated for | |
| patients 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 / | |
| 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.