(238 days)
No
The summary describes a mechanical device for positive airway pressure and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for the "treatment and prevention of atelectasis" and provides "positive airway pressure", which are therapeutic actions.
No
The device is indicated for treatment and prevention of atelectasis, and to provide supplemental oxygen, which are therapeutic functions. It also monitors airway pressure, which is for monitoring and controlling the treatment, not for diagnosing a condition.
No
The device description clearly outlines multiple physical components (mouthpiece, backpiece, manometer adapter, manometer gauge, oxygen tubing) that constitute the VersaPAP* device, indicating it is a hardware device, not software-only.
Based on the provided information, the VersaPAP* device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment and prevention of atelectasis and providing supplemental oxygen. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a hand-held respiratory therapy device that creates positive airway pressure. This is a physical therapy device, not a device used to analyze biological samples.
- No mention of analyzing samples: There is no mention of the device being used to analyze blood, urine, tissue, or any other biological sample.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The VersaPAP* device does not fit this description.
N/A
Intended Use / Indications for Use
VersaPAP* is indicated for the treatment and prevention of atelectasis. VersaPAP* 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 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.
Product codes
BWF
Device Description
The VersaPAP* device is a hand held respiratory therapy device that creates a positive airway pressure. The VersaPAP* device is intended to be used by pediatric (ages 5 years and above) and adult patients in the hospital environment, under the supervision of a healthcare professional. The VersaPAP* device is a single patient use device and may be used for two treatments per day for 7 days. A manometer gauge is included to monitor airway pressure while operating the VersaPAP* device.
The VersaPAP* device consists of seven components: a mouthpiece, the VersaPAP* backpiece (includes 3 components: the baffle, body and end cap), a manometer adapter, a manometer gauge, and oxygen tubing.
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
5 years and above
Intended User / Care Setting
under the supervision of a healthcare professional.
in a hospital environment.
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
Performance testing included comparative testing against the predicate device using representative patient generated breathing patterns. Testing confirmed that the VersaPAP* device is substantially equivalent to the predicate.
Key Metrics
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
Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 17, 2018
Trudell Medical International Marianne Tanton Director, Quality and Regulatory Affairs 725 Third Street London, n5V 5G4 Ca
Re: K173918
Trade/Device Name: VersaPAP Positive Airway Pressure (PAP) Device Regulation Number: 21 CFR 868,5690 Regulation Name: Incentive Spirometer Regulatory Class: Class II Product Code: BWF Dated: July 18, 2018 Received: July 19, 2018
Dear Ms. Tanton:
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/cdrl/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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Amy K. Levelle -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173918
Device Name
VersaPAP* Positive Airway Pressure (PAP) Device
Indications for Use (Describe)
VersaPAP* is indicated for the treatment and prevention of atelectasis. VersaPAP* 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 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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Traditional 510(k) - K173918/S002 VersaPAP* Positive Airway Pressure (PAP) Device Interactive Review - dated 17 Aug 2018
Section 5 - 510(k) Summary
Prepared: 17-Aug-2018
1. Submitter
Trudell Medical International 725 Third Street London, Ontario N5V 5G4, Canada
Contact: Marianne Tanton Director, Quality and Regulatory Affairs Tel: 1-519-455-7060 Email: mtanton@trudellmed.com
2. Device
| Trade Name: | VersaPAP* Positive Airway Pressure (PAP) Device |
|---|---|
| Common Name: | Positive Airway Pressure (PAP) Device |
| Classification Name: | Incentive Spirometer 21 CFR 868.5690 |
| Regulatory Class | II |
| Product Code: | BWF |
3. Predicate Device
Boeing, Positive Airway Pressure (PAP) Therapy Device, K991300 DHD Healthcare Corp
DHD Healthcare Corp was purchased by Smith Medical has changed the device name to EzPAP. The predicate device is referred to as EzPAP throughout the submission.
The predicate device has not been subject to a recall.
4. Reference Device
MC 300* R Nebulizer - K173825 Trudell Medical International
Aerobika* OPEP with Manometer Accessory - K150173 Trudell Medical International
The reference devices have not been subject to a recall.
5. Device Description
The VersaPAP* device is a hand held respiratory therapy device that creates a positive airway pressure. The VersaPAP* device is intended to be used by pediatric (ages 5 years and above) and adult patients in the hospital environment, under the supervision of a healthcare professional. The VersaPAP* device is a single patient use device and may be used for two treatments per day
4
Traditional 510(k) – K173918/S002 VersaPAP* Positive Airway Pressure (PAP) Device Interactive Review - dated 17 Aug 2018
Section 5 - 510(k) Summary
for 7 days. A manometer gauge is included to monitor airway pressure while operating the VersaPAP* device.
The VersaPAP* device consists of seven components: a mouthpiece, the VersaPAP* backpiece (includes 3 components: the baffle, body and end cap), a manometer adapter, a manometer gauge, and oxygen tubing.
6. Principle of Operation
The VersaPAP* device creates positive airway pressure using the Venturi-vacuum principle. Compressed air or compressed oxygen is driven through an orifice where it accelerates and emerges at a high velocity creating a vacuum (Venturi effect). The vacuum draws additional air from the atmosphere through a cylindrical channel where it combines with the orifice airstream and flows out the mouthpiece. This flow creates a net positive airway pressure during the breathing cycle.
7. Indications for Use
VersaPAP™ is indicated for the treatment and prevention of atelectasis. VersaPAP™ 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.
8. Comparison to predicate device
The VersaPAP* device and predicate EzPAP (K991300), are identical in purpose, function, core technology and method of operation. Only minor differences exist between the VersaPAP* device and predicate, which do not affect the safety or effectiveness of the subject device. Table 1 provides a comparison of the subject and predicate devices.
5
Section 5 - 510(k) Summary
Table 1: Comparison to Predicate Device
| Element of Comparison | VersaPAP* device
(Subject Device) | EzPAP device
(Predicate - K991300) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | VersaPAPTM is indicated for the
treatment and prevention of
atelectasis. VersaPAPTM also has
the ability to provide supplemental
oxygen when used with
compressed oxygen. The
VersaPAPTM 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
VersaPAPTM device is a single
patient, multiple use device
intended to be used under the
supervision of a healthcare
professional. | EzPAP is indicated for the treatment
and prevention of atelectasis. EzPAP
facilitates opening of airways in
patients requiring prevention or
treatment of atelectasis. EzPAP also
has the ability to provide
supplemental oxygen when used with
compressed oxygen. |
| Technology | Pneumatic | |
| Environment of Use | Hospital | |
| Patient population | Pediatric (ages 5 years and above)
and adult patients | Patient population not specified |
| Single Patient Use | Yes | |
| Therapy Type | Lung expansion therapy for patients with spontaneous breathing | |
| Type of Device | Single patient use, prescription only, non-sterile | |
| Manufacturing Process | Plastic Molding | |
| Patient Interface | Mouthpiece | Mouthpiece, Face Mask |
| Flow rate (L/min) | 5-15 | |
| Type of gas source | Compressed air or compressed oxygen | |
| Manometer Gauge | Included with device to monitor airway pressure | |
| Principle of Operation | Venturi-vacuum principle | |
9. Performance Data
9.1 Summary of Performance Testing
Performance testing included comparative testing against the predicate device using representative patient generated breathing patterns. Testing confirmed that the VersaPAP* device is substantially equivalent to the predicate.
*Trade marks and registered trademarks of Trudell Medical International
6
Traditional 510(k) - K173918/S002 VersaPAP* Positive Airway Pressure (PAP) Device Interactive Review - dated 17 Aug 2018
Section 5 - 510(k) Summary
9.2 Biocompatibility Testing Summary
To evaluate the biological safety of the VersaPAP* device, consideration was given to the following: type of patient contact, potential hazards of the materials of construction, the history of clinical use and testing of the materials of construction, biocompatibility and chemical characterization testing on a similar device, and other information available in the literature.
When used as intended, the VersaPAP* device has direct contact with the mucosal membrane and indirect contact with tissue in the patient respiratory pathway. It is considered externally communicating by way of gas pathway. In accordance with ISO 10993-1, the VersaPAP* device is considered to be an externally communicating, with limited (≤ 24 hours) indirect contact with tissue.
The materials of the VersaPAP* device components are identical to materials used in the following reference devices: MC300R Nebulizer (K173825) and Aerobika OPEP device (K150173)
| VersaPAP* | Reference Device (K Number) |
|---|---|
| Component | |
| Mouthpiece | Aerobika* OPEP Device with Manometer |
| Manometer Adapter | |
| and Plug | Aerobika* OPEP Device with Manometer |
| Manometer Gauge | Aerobika* OPEP Device with Manometer |
| Oxygen Tubing | MC300*R Nebulizer |
| Backpiece - End cap | MC300*R Nebulizer |
| Backpiece - Baffle | MC300*R Nebulizer |
| Backpiece - Body | MC300*R Nebulizer |
Comparison to Reference Devices:
9.3 Dry Gas Pathway Testing
Testing pertaining to the dry gas pathway and associated risk assessments/conclusions were conducted by an independent source. Testing included the following assessments:
- . Emissions of volatile organic compounds (VOCs)
- . Fine particles (particulate matter PM2.5)
7
Traditional 510(k) – K173918/S002 VersaPAP* Positive Airway Pressure (PAP) Device Interactive Review - dated 17 Aug 2018
Section 5 - 510(k) Summary
10. Clinical Performance Summary
Not applicable, the determination of substantial equivalence is not based on Clinical Performance data.
11. Conclusion
The non-clinical data demonstrate that the VersaPAP* device is as safe and effective as the predicate and therefore substantially equivalent to the cleared predicate device (K991300) and does not raise any new issues of safety and efficacy.