(281 days)
No
The summary describes a mechanical device for airway pressure and secretion clearance, with no mention of AI or ML capabilities in its function, description, or performance studies.
Yes
The device is described as aiding in secretion clearance and maintaining positive airway pressure for the treatment and prevention of atelectasis, which are therapeutic actions.
No
The device is described as a Positive Airway Pressure (PAP) device and a Positive Expiratory Pressure (PEP) device intended for therapy (treatment and prevention of atelectasis, aid in secretion clearance), not for diagnosing conditions.
No
The device description clearly describes a physical device ("Combined VersaPAP™ and Aerobika® OPEP device") that provides positive airway pressure and positive expiratory pressure, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The description of this device clearly states its intended use is for providing Positive Airway Pressure (PAP) and Positive Expiratory Pressure (PEP) to patients to aid in secretion clearance and treat/prevent atelectasis. This is a therapeutic and supportive function, not a diagnostic one based on analyzing biological samples.
The device description focuses on mechanical functions related to breathing and airway pressure, not on analyzing biological specimens.
N/A
Intended Use / Indications for Use
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.
Product codes
BWF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
ages 5 years and above
Intended User / Care Setting
hospital environment under the supervision of a healthcare professional.
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)
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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
1
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
2
Indications for Use
510(k) Number (if known)
K183108
Device Name
Combined VersaPAP™ device and Aerobika® OPEP
Indications for Use (Describe)
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.
| 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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3
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 | | Proposed
Combined
Aerobika® OPEP and
VersaPAP™ device | Predicate
Aerobika® OPEP
K150173 | Predicate
VersaPAP™ device
K173918 |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------|
| Common/Usual Name: | Incentive Spirometer | CFR
Classification | | 868.5690
BWF | |
| Classification Code/Name: | BWF – Incentive Spirometer
21 CFR 868.5690
Class II | Classification name | | | |
| Predicate Devices: | K150173 – Trudell – Aerobika® OPEP
K173918 – Trudell – VersaPAPTM device | Intended Use | Intended for use as a Positive
Expiratory Pressure (PEP) device
(exercise patient's lungs and to
improve secretion clearance) | Incentive Spirometer
Intended for use as a
Positive Expiratory
Pressure (PEP) device. | |
| Reference Device: | K151689 – Hill-Rom – MetaNeb® | | Intended for use as a Positive
Airway Pressure (PAP) device
(Treatment and prevention of
atelectasis) | | Treatment and prevention of
atelectasis |
| Indications for Use | 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 | 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 exhalation flow
of 10 lpm for 3-4 seconds. | The VersaPAP™ device is
indicated for the treatment and
prevention of atelectasis. The
VersaPAP™ device also has
the ability to provide
supplemental oxygen when
used with compressed oxygen.
The VersaPAP™ device is for
patients (ages 5 years and
above) who are capable of
following directions for
Positive Airway Pressure
Therapy in a hospital
environment. The
VersaPAP™ device is a single
patient, multiple use device
intended to be used under the
supervision of a healthcare
professional. | | |
| Patient Population | Patients capable of generating
exhalation flow of 10 lpm for 3-4
seconds.
Patients (ages 5 years and above)
who are capable of following | Patients capable of
generating exhalation flow
of 10 lpm for 3-4 seconds. | Patients (ages 5 years and
above) who are capable of | | |
| | directions. | | following directions. | | |
Device Description:
Date Prepared
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.
Indications for Use:
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.
4
Table 1 – Comparison to Predicates
5
| | Proposed
Combined
Aerobika® OPEP and
VersaPAP™ device | Predicate
Aerobika® OPEP
K150173 | Predicate
VersaPAP™ device
K173918 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Environments | Hospital settings | Hospital and clinical
Home settings | Hospital settings |
| Operating principles
OPEP | Oscillations generated by patient's exhaled breath.
Adjustable exhalation resistance
Visual feedback via manometer | Oscillations generated by patient's exhaled breath.
Adjustable exhalation resistance
Visual feedback only when used with the manometer | |
| PAP | Venturi principle created by compressed gas source
Supplemental oxygen
Measures airway pressure with manometer | | Venturi principle created by compressed gas source
Supplemental oxygen
Measures airway pressure with manometer |
| Single patient, multi-use | Components may be cleaned and reused by the same patient | | |
6
| | Proposed
Combined
OPEP + PAP | Reference
Hill-Rom - MetaNeb®
K151689 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | BWF
868.5690
Incentive Spirometer | NHJ
868.5905
Device, positive pressure breathing, intermittent
(IPPB) |
| Intended use | Intended for use as a Positive Expiratory
Pressure (PEP) device (exercise patient's
lungs and to improve secretion clearance)
Intended for use as a Positive Airway
Pressure (PAP) device (Treatment and
prevention of atelectasis) | Intended for use as a Positive Expiratory Pressure
(PEP) device.
Treatment and prevention of atelectasis |
| Indications for Use | The Combined VersaPAPTM 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 | The MetaNeb® System is indicated for
mobilization of secretions, lung expansion therapy,
the treatment and prevention of pulmonary
atelectasis, and also has the ability to provide
supplemental oxygen when used with compressed
oxygen. |
| Patient Population | Patients capable of generating exhalation
flow of 10 lpm for 3-4 seconds.
Patients (ages 5 years and above) who are
capable of following directions. | Patient 5 years and older |
| Environments of Use | Hospital | Hospital
sub-acute facilities
Nursing care
Homecare |
Table 2 - Comparison of the Subject vs. the Reference Hill-Rom MetaNeb (K151689)
7
| Reference | ||
|---|---|---|
| Proposed | ||
| Combined | Hill-Rom - MetaNeb® | |
| OPEP + PAP | K151689 | |
| Mode of | ||
| Operation | OPEP | |
| Oscillations generated by patient's exhaled | ||
| breath. | ||
| Adjustable exhalation resistance | ||
| Visual feedback via manometer | Can deliver continuous expiratory pressure | |
| (CPEP) combined with medicated aerosol. | ||
| Oscillations generated by device | ||
| PAP | ||
| Venturi vacuum created by compressed gas | ||
| source | ||
| Supplemental oxygen | ||
| Measures airway pressure with manometer | Venturi from compressed gas source continuous |
Supplemental oxygen
Measures airway pressure with manometer |
| Therapy | OPEP
PAP | CPEP
CHFO
Aerosol |
| Patient Interface | Mouthpiece | Disposable circuit includes connection for in-line
nebulizer with mouthpiece |
| Gas source | Compressed air or oxygen | Pneumatic and air or oxygen |
| Control settings | OPEP resistance adjustable
PAP flow rate: 5-15 L/min. | Mode selection
Frequency selection for CHFO mode
Pressure 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.
8
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.
9
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.