(98 days)
Yes
The device description explicitly states that the VISIONAIR™ application automatically analyzes endoscopic images using its "trained AI algorithm". Furthermore, the "Mentions AI, DNN, or ML" section directly references "VISIONAIR™ AI application" and "VISIONAIR™ AI Segmentation Accuracy Test".
No
The device is a software application that measures the nasal respiratory airway from endoscopic images; it does not provide any therapeutic intervention.
Yes
Explanation: The device is described as a "software application intended to be used with third-party endoscopic systems in the measurement of the nasal respiratory airway." It measures cross-sectional areas and surface areas, which are objective measurements used to assess a patient's condition, directly fitting the definition of a diagnostic device.
No
The device description explicitly lists hardware components beyond just the software, including a smart device (tablet or laptop), a USB memory device, and interfaces with third-party endoscopic systems. While the core functionality is software-based analysis, it is not solely software.
Based on the provided information, the VISIONAIR™ system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens derived from the human body. The VISIONAIR™ system analyzes images of the nasal respiratory airway obtained directly from an endoscopic system. It does not process or analyze biological samples like blood, urine, tissue, etc.
- The intended use is for measurement of anatomical structures. The system is designed to measure the cross-sectional area of the internal nasal valve and nasal cavum from endoscopic images. This is a form of anatomical measurement and analysis, not a diagnostic test performed on a biological specimen.
- The device description focuses on image processing and analysis. The components and functionality described relate to image acquisition, processing, segmentation, and measurement.
While the system is used in a clinical setting and provides information that can be used by clinicians, its function is based on analyzing visual data of anatomical structures, not on performing tests on biological samples. This aligns with the definition of a medical device that processes imaging data, rather than an IVD.
No
The provided text does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The VISIONAIR™ system is a software application intended to be used with third-party endoscopic systems in the measurement of the nasal respiratory airway. The VISIONAIR™ system measures the nasal respiratory airway from the endoscopic images taken in the region of the internal nasal valve (INV) and nasal cavum (NC).
Product codes (comma separated list FDA assigned to the subject device)
BXQ, EOB
Device Description
The VISIONAIR™ software can be utilized to automatically measure the cross-section area of the Internal Nasal Valve (INV) and Nasal Cavum (NV) and measure the nasal respiratory airway in this region of the anatomy. The VISIONAIR™ system consists of the following components: - The VISIONAIR™ algorithm which performs the Internal Nasal Valve and Nasal Cavum cross-section area segmentations. - The VISIONAIR™ Graphical User Interface (GUI) used for data entry, view the endoscopic image from third party endoscopes and display the data analysis to the user. - A smart device such as tablet or laptop which runs on Windows 10 or a later operating system with the VISIONAIR™ application installed. - A cloud service that runs in the background and can be activated by the user when a particular dataset for a case is desired to securely and anonymously be stored to the Cloud Server (REAI). - USB memory used to encrypt and anonymize the patient information, whether the data is stored locally or to the cloud, and stores the credits needed to activate the VISIONAIR™ software for each case. The VISIONAIR™ application interfaces with third-party endoscopic systems via the ports located on the smart device. The smart device ports enable the third-party systems endoscopic video display to be streamed on the VISIONAIR™ application endoscopic video display. In this 510(k) submission, a FDAcleared endoscope (K970247) was selected as the reference device to support the scientific methodology. The VISIONAIR™ application automatically analyzes the endoscopic images using its trained AI algorithm to measure the nasal valve and nasal cavum surface areas. The VISIONAIR™ application also provides a database file system to manage the data and interface securely and anonymously with the cloud server via the REAl module.
Mentions image processing
Yes
Mentions AI, DNN, or ML
The VISIONAIR™ application automatically analyzes the endoscopic images using its trained AI algorithm to measure the nasal valve and nasal cavum surface areas.
Input Imaging Modality
endoscopic images
Anatomical Site
internal nasal valve (INV) and nasal cavum (NC)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Performance Data: The VISIONAIR™ system was tested to ensure that it functions in accordance with the device design specifications related to substantial equivalence in terms of device safety and effectiveness. The following nonclinical tests were performed:
- System Level Test: Confirmation of system components such as Windows OS, processor, RAM requirements, ports, wireless connectivity, and other items required to operate the VISIONAIR™ application.
- System Interface and Connectivity Test: Confirmation of the VISIONAIR™ application to the USB device containing the cloud key and application credits and system connections to other devices.
- VISIONAIR™ Application Test: VISIONAIR™ connectivity to external endoscopes, cloud server, successful launch, and other interaction tests of the VISIONAIR™ application.
- Patient Database Verification Test: Confirmation of the data stored, anatomical marking, and successful encryption/decryption of the database verification.
- Endoscopic Display Test: Endoscopic view verification of the image capture, video recording and other functions.
- Nasal respiratory airway Analysis Test: VISIONAIR™ AI application confirmation of successful segmentation of the Internal Nasal Valve and Nasal Cavum. This test also verifies the ability of manipulating images, loading new images, removing unwanted images and other functions related to the analysis phase.
- Report Generation Test: Confirmation of successful report generation in pdf, csv, and other formats.
- User Validation Test: Validation of the entire VISIONAIR™ system by the clinicians. This test includes successful verification of all the features of the VISIONAIR™ application which the user will have access and visibility.
- CT vs Segmentation Accuracy Test: Comparison of endoscopic image cross-sectional areas which were segmented by the VISIONAIR™ application vs. the crosssectional areas of the same anatomical regions marked on the CT scans.
- VISIONAIR™ AI Segmentation Accuracy Test: Comparison of segmented endoscopic images by the VISIONAIR™ application vs. segmented endoscopic images by experienced clinicians.
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.
Eccovision™ System (K170071)
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.
Smith & Nephew Image Video System (K970247)
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
§ 868.1800 Rhinoanemometer.
(a)
Identification. A rhinoanemometer is a device used to quantify the amount of nasal congestion by measuring the airflow through, and differential pressure across, a patient's nasal passages.(b)
Classification. Class II (performance standards).
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October 5, 2022
PacificMD Biotech Llc % David Locke Regulatory Consultant Canyon Labs 6217 South Bringhurst Blvd, Suite 600 Bluffdale, Utah 84065
Re: K221892
Trade/Device Name: VISIONAIR Regulation Number: 21 CFR 868.1800 Regulation Name: Rhinoanemometer Regulatory Class: Class II Product Code: BXQ, EOB Dated: September 3, 2022 Received: September 7, 2022
Dear David Locke:
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
1
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 (OS) 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,
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221892
Device Name VISIONAIR™
Indications for Use (Describe)
The VISIONAIR™ system is a software application intended to be used with third-party endoscopic systems in the measurement of the nasal respiratory airway. The VISIONAIR™ system measures the nasal respiratory airway from the endoscopic images taken in the region of the internal nasal valve (INV) and nasal cavum (NC).
| 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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510(K) SUMMARY
[807.92(a)(1)] Submitter Information
| Applicant: | PacificMD Biotech
3195 Saint Rose Pkwy
Suite 210
Henderson, NV, 89052
Tel.: 201-819-8685
Fax: 702-780-6912 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David Locke
Regulatory Consultant
Canyon Labs
16217 South Bringhurst Blvd.,
Suite 600 Bluffdale, UT 84065
David.locke@canyonlabs.com |
| Authored by: | David Locke
Regulatory Consultant
Canyon Labs
Phone: 419-233-2611 |
| Date Summary | October 4, 2022 |
|---|---|
| Prepared: |
[807.92(a)(2)] Name of Device
| Device Trade Name: | VISIONAIR™ |
|---|---|
| Device Common Name: | VISIONAIR™ |
| Classification Name: | Rhinoanemometer (Measurement of Nasal Decongestion) |
| Regulation Number: | 868.1800 |
| Device Classification: | Class II |
| Product Code: | BXQ |
| Secondary Code: | EOB |
| Primary Review Panel: | Anesthesia |
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[807.92(a)(3)] Legally Marketed Devices
| Primary Predicate
| Device: | Eccovision™ System (K170071) |
|---|---|
| Reference Device: | Smith & Nephew Image Video System (K970247) |
[807.92(a)(4)] Device Description
Device Description: The VISIONAIR™ software can be utilized to automatically measure the cross-section area of the Internal Nasal Valve (INV) and Nasal Cavum (NV) and measure the nasal respiratory airway in this region of the anatomy. The VISIONAIR™ system consists of the following components: - The VISIONAIR™ algorithm which performs the Internal Nasal Valve and Nasal Cavum cross-section area segmentations. - The VISIONAIR™ Graphical User Interface (GUI) used for data entry, view the endoscopic image from third party endoscopes and display the data analysis to the user. - A smart device such as tablet or laptop which runs on Windows 10 or a later operating system with the VISIONAIR™ application installed. - A cloud service that runs in the background and can be activated by the user when a particular dataset for a case is desired to securely and anonymously be stored to the Cloud Server (REAI). - USB memory used to encrypt and anonymize the patient information, whether the data is stored locally or to the cloud, and stores the credits needed to activate the VISIONAIR™ software for each case. The VISIONAIR™ application interfaces with third-party endoscopic systems via the ports located on the smart device. The smart device ports enable the third-party systems endoscopic video display to be streamed on the VISIONAIR™ application endoscopic video display. In this 510(k) submission, a FDAcleared endoscope (K970247) was selected as the reference device to support the scientific methodology. The VISIONAIR™ application automatically analyzes the endoscopic images using its trained AI algorithm to measure the nasal valve and nasal cavum surface areas. The VISIONAIR™ application also provides a database file system to manage the data and interface securely and anonymously with the cloud server via the REAl module.
5
The USB KEY adds another level of security for the data management file system by allowing the user to physically have possession of the database encryption kev all the time.
In addition, the segmented cross-section areas by the VISIONAIR™ application, of the internal nasal valve and nasal cavum on the endoscopic images are captured on a report which consists of quantitative and qualitative information related to the assessment of the nasal respiratory airway.
The VISIONAIR™ application manages the data by creating for each patient a directory with a unique encrypted ID where the patient endoscopic anatomical images and videos are stored anonymously. The smart device and USB KEY both consist of encryption keys which are used to translate unique IDs to patient information and vice versa. The database, whether stored locally on the smart device, or to the cloud via the REA1 module, never stores any of the patient's information without encrypting them. The only patient information captured during the procedure, which is encrypted using the VISIONAIR™ application, are the patient's name, patient Date of Birth (DOB) and optionally their ethnicity, which is used to compare the measured results of the patient against the normative published data of the nasal respiratory airway and apex angle measurements.
[807.92(a)(5)] Intended Use and Predicate Device Comparison
Indications for Use: The VISIONAIR™ system is a software application intended to be used with third-party endoscopic systems in the measurement of the nasal respiratory airway. The VISIONAIR™ system measures the nasal respiratory airway from the endoscopic images taken in the region of the internal nasal valve (INV) and nasal cavum (NC).
[807.92(a)(6)] Technical Characteristics
System Characteristics: The VISIONAIR™ application comes installed into a windowsbased operating system smart device. The HDMI and USB ports of the smart device can be utilized to connect the external third-party endoscopic system to the VISIONAIR™ application. The user can use the HDMI, DISPLAY or DVI output port from the third-party endoscopic system, to connect it to the USB port of the smart device. A standard adapter to convert the output of the endoscopic system to the USB port may be utilized and is provided with the smart device.
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| The smart device which comes with the VISIONAIR™ software installed is programmed with an encryption key to encode and anonymize the data acquired. In addition, a separate USB KEY is provided which adds a second layer of encryption for the database. The USB KEY is plugged into the smart device prior to starting the VISIONAIR™ application otherwise the data will remain on its encryption and anonymized state, resulting on the VISIONAIR™ application not being able to read the data. | |
|---|---|
| Once, the smart device, the third-party endoscopic system and the USB KEY are connected, the user is ready to start the VISIONAIR™ application. The VISIONAIR™ application can be used pre-, during, or post- procedure to measure the cross section of the internal nasal valve and nasal cavum to measure the nasal respiratory airway. In addition, the application will store the data locally or to the cloud, depending on the clinician's preference in a secure manner so the clinician can access them at any time by using the dedicated smart device and the USB KEY. | |
| Prior to each use of the VISIONAIR™ application, credits are required for the VISIONAIR™ application to be used for image analysis and processing. A USB TOKEN can be plugged into the smart device and used until the credits are fully used. | |
| Non-clinical | |
| Performance Data: | The VISIONAIR™ system was tested to ensure that it functions in accordance with the device design specifications related to substantial equivalence in terms of device safety and effectiveness. The following nonclinical tests were performed: |
| 1. | System Level Test: Confirmation of system components such as Windows OS, processor, RAM requirements, ports, wireless connectivity, and other items required to operate the VISIONAIR™ application. |
|---|---|
| 2. | System Interface and Connectivity Test: Confirmation of the VISIONAIR™ application to the USB device containing the cloud key and application credits and system connections to other devices. |
| 3. | VISIONAIR™ Application Test: VISIONAIR™ connectivity to external endoscopes, cloud server, successful launch, and other interaction tests of the VISIONAIR™ application. |
| 4. | Patient Database Verification Test: Confirmation of the data stored, anatomical marking, and successful encryption/decryption of the database verification. |
| 5. | Endoscopic Display Test: Endoscopic view verification of the image capture, video recording and other functions. |
| 6. | Nasal respiratory airway Analysis Test: VISIONAIR™ AI application confirmation of successful segmentation of the Internal Nasal Valve and Nasal Cavum. This test also |
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verifies the ability of manipulating images, loading new images, removing unwanted images and other functions related to the analysis phase.
-
- Report Generation Test: Confirmation of successful report generation in pdf, csv, and other formats.
-
- User Validation Test: Validation of the entire VISIONAIR™ system by the clinicians. This test includes successful verification of all the features of the VISIONAIR™ application which the user will have access and visibility.
-
- CT vs Segmentation Accuracy Test: Comparison of endoscopic image cross-sectional areas which were segmented by the VISIONAIR™ application vs. the crosssectional areas of the same anatomical regions marked on the CT scans.
-
- VISIONAIR™ AI Segmentation Accuracy Test: Comparison of segmented endoscopic images by the VISIONAIR™ application vs. segmented endoscopic images by experienced clinicians.
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Substantial Equivalence Table
| Attribute | Primary Predicate
Device (K170071):
Eccovision™ | Subject Device:
VISIONAIR™ | Substantial Equivalence
Rationale |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K170071 | K221892 | N/A |
| Manufacturer | Sleep Group
Solutions | PacificMD Biotech | N/A |
| Trade Name | Eccovision™ | VISIONAIR™ | N/A |
| Common Name | Eccovision™ | VISIONAIR™ | N/A |
| Class | II | II | Same |
| Classification
Product Code | BXQ | BXQ
EOB | Same |
| Subsequent
Product Code | 868.1800 | 868.1800 | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
| Packaging | Provided non-sterile | Provided non-sterile | Same |
| Single Patient Use | No | No | Same |
| Indications for Use | The Eccovision™ is
intended to measure the
upper respiratory airway
by acoustic reflection. | The VISIONAIR™
system is a software
application intended to be
used with third-party
endoscopic systems in the
measurement of the nasal
respiratory airway. The
VISIONAIR™ system
measures the nasal
respiratory airway from
the endoscopic images
taken in the region of the
internal nasal valve (INV)
and nasal cavum (NC). | The IFU and Indications
of the subject
VISIONAIR™ System is
aligned with the predicate
devices. The change in
the manner in which data
is captured and processed
does not bring about any
new concerns with respect
to substantial equivalence,
and the safety and
effectiveness of the
subject device is
supported by completed
device testing. |
| System Function
to Capture Data | Both mouthpiece or
nose tip via the Wave
Tube. | Applicable FDA
cleared endoscopes. | These are different but the
differences do not raise
any new concerns with
respect to safety and
effectiveness. |
| Attribute | Primary Predicate
Device (K170071):
EccovisionTM | Subject Device:
VISIONAIRTM | Substantial Equivalence
Rationale |
| Computer
Requirements:
Hardware and
Software
(Operating
System, device
application
software) | A customer owned
computer with the
Eccovision software
application loaded by
the customer. | Windows 10 or later
operating system (OS)
computer is provided
by PacificMD Biotech. | Same with the only
exception being system
version. |
| Control Unit -
Hardware | Provided hardware
which connects to the
computer.
Modified with the
redesign of the PCB
(Print Circuit Board)
configuration. | Windows 10 or later
operating system (OS)
computer is provided
with the
VISIONAIRTM
application installed
and tested prior to its
release to the market. | Same with the only
exception being system
version. |
| Electronic
Platform -
Hardware | Supporting the
Pharyngometer and
connects to the
Control Unit. | Endoscopic System –
Connects to the
Windows 10 computer
via the USB port. | These are different but the
differences do not raise
any new concerns with
respect to safety and
effectiveness. |
| Application
Software
(Language) | Windows with GUI | Windows based GUI
and AI written in
Python 3.6 language. | Same as compared to
applicable devices. |
9
10
| Attribute | Primary Predicate
Device (K170071):
Eccovision™ | Subject Device:
VISIONAIR™ | Substantial Equivalence
Rationale |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics /
Principles of
Operation | The Eccovision
device uses acoustic
reflection technology
to accurately map the
size and structure of
the nasal airway.
Sound waves are sent
up the nasal
passageway and are
reflected back to
accurately map out
the topography of the
nasal airway. | The VISIONAIR™
system uses the
endoscopic image,
which is created from
light reflection
technology, to
accurately map the
size and structure of
the nasal
airway. Light is sent
up the nasal
passageway and
reflected to accurately
map out the
topography of the
nasal airway. Each
pixel brightness
correspondents to how
much light is being
reflected thus
determining the
proximity of the tissue
relative to the
endoscopic optics and
ultimately result on a
2-D image that maps
the size and structure
of the nasal anatomy. | The technological
characteristics have been
tested through nonclinical
testing and they do not
impact substantial
equivalence. Moreover,
the minor technological
differences do not raise
any new concerns with
respect to safety and
effectiveness. |
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| Conclusion: | The VISIONAIRTM device is substantially equivalent to
the predicate device in indication for use, performance,
technology, features, principles operation and
components. |
| ------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|