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).

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.

AI/ML Overview

The provided FDA 510(k) summary for the VISIONAIR™ system offers details on its intended use and comparison to a predicate device, as well as a list of non-clinical tests performed. However, it does not explicitly state specific acceptance criteria (e.g., minimum accuracy thresholds) or present the detailed results of a study designed to prove the device meets those criteria with statistical significance.

Instead, it lists tests performed, implying that these tests confirmed design specifications and functionality. The "Substantial Equivalence Table" focuses on comparing attributes to a predicate device and concluding that differences do not raise new safety or effectiveness concerns.

Therefore, many of the requested details about acceptance criteria, specific study results, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not present in the provided text.

Based on the available information, here's what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria (e.g., "accuracy > 90%"). Instead, the "Non-clinical Performance Data" section lists various tests performed to ensure the device functions according to design specifications and for substantial equivalence in terms of safety and effectiveness. The "reported device performance" is largely implied by the statement that these tests were "performed" and that the device is deemed "substantially equivalent."

Acceptance Criteria Category (Implied)	Reported Device Performance (Implied from document)
System Functionality	Confirmed successful operation across various components: - System Level Test: Confirmation of Windows OS, processor, RAM, ports, wireless connectivity. - System Interface and Connectivity Test: Confirmation of application to USB device (cloud key, credits) and connections to other devices. - VISIONAIR™ Application Test: Confirmed connectivity to external endoscopes, cloud server, successful launch, and interaction tests. - Endoscopic Display Test: Endoscopic view verification of image capture, video recording, and other functions.
Data Management & Security	Confirmed successful execution of data handling and security features: - Patient Database Verification Test: Confirmation of data stored, anatomical marking, and successful encryption/decryption of the database. - Report Generation Test: Confirmation of successful report generation in pdf, csv, and other formats.
AI (Segmentation) Accuracy	Evidence of comparison and verification: - Nasal Respiratory Airway Analysis Test: VISIONAIR™ AI application confirmation of successful segmentation of the Internal Nasal Valve and Nasal Cavum, and image manipulation/loading functions. - CT vs Segmentation Accuracy Test: Comparison of endoscopic image cross-sectional areas segmented by VISIONAIR™ vs. cross-sectional areas of the same anatomical regions marked on CT scans (details of comparison not provided). - VISIONAIR™ AI Segmentation Accuracy Test: Comparison of segmented endoscopic images by VISIONAIR™ vs. segmented endoscopic images by experienced clinicians (details of comparison not provided).
User Validation	User Validation Test: Validation of the entire VISIONAIR™ system by clinicians, including successful verification of all accessible features.
Substantial Equivalence	Concluded to be substantially equivalent to the predicate device in indication for use, performance, technology, features, principles of operation, and components.

Detailed Study Information (Based on available text):

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any of the listed tests.
- Data Provenance: Not specified (e.g., country of origin). The document mentions "endoscopic images" and "CT scans" were used, but no details on their origin or whether they were retrospective/prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Number of Experts: Not specified.
- Qualifications of Experts: The "VISIONAIR™ AI Segmentation Accuracy Test" mentions "experienced clinicians" were used for comparison, but their specific qualifications (e.g., specialty, years of experience) are not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. The document only mentions "comparison" in the segmentation accuracy tests.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: Not explicitly described as an MRMC comparative effectiveness study where human readers' performance with and without AI assistance is measured.
- Effect Size: Not provided. The document mentions "User Validation Test" by clinicians and "comparison of segmented endoscopic images by VISIONAIR™ application vs. segmented endoscopic images by experienced clinicians," but not an assessment of human reader improvement.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "VISIONAIR™ AI application confirmation of successful segmentation" in the Nasal Respiratory Airway Analysis Test, and the "CT vs Segmentation Accuracy Test" and "VISIONAIR™ AI Segmentation Accuracy Test" imply a standalone evaluation of the algorithm's performance in segmentation against various ground truths (CT scans, experienced clinicians' segmentations). However, exact methodology and metrics are not detailed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- CT Scans: Used as a ground truth for cross-sectional areas in the "CT vs Segmentation Accuracy Test." This implies measurements from CT scans were considered the reference.
- Experienced Clinician Segmentations: Used as a ground truth for segmented endoscopic images in the "VISIONAIR™ AI Segmentation Accuracy Test." This suggests individual or consensus segmentations by clinicians served as the reference.
- Implicitly, other tests depend on functional specifications and user observation.
The sample size for the training set:
- Not specified in the document. The document refers to the "trained AI algorithm" but does not give details about its training data.
How the ground truth for the training set was established:
- Not specified in the document.

Summary

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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

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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)

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 Biotech3195 Saint Rose PkwySuite 210Henderson, NV, 89052Tel.: 201-819-8685Fax: 702-780-6912
Contact Person:	David LockeRegulatory ConsultantCanyon Labs16217 South Bringhurst Blvd.,Suite 600 Bluffdale, UT 84065David.locke@canyonlabs.com
Authored by:	David LockeRegulatory ConsultantCanyon LabsPhone: 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 PredicateDevice:	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.

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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-clinicalPerformance 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.

1. Report Generation Test: Confirmation of successful report generation in pdf, csv, and other formats.
1. 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.
1. 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.
1. 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 PredicateDevice (K170071):Eccovision™	Subject Device:VISIONAIR™	Substantial EquivalenceRationale
510(k) number	K170071	K221892	N/A
Manufacturer	Sleep GroupSolutions	PacificMD Biotech	N/A
Trade Name	Eccovision™	VISIONAIR™	N/A
Common Name	Eccovision™	VISIONAIR™	N/A
Class	II	II	Same
ClassificationProduct Code	BXQ	BXQEOB	Same
SubsequentProduct 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™ isintended to measure theupper respiratory airwayby acoustic reflection.	The VISIONAIR™system is a softwareapplication intended to beused with third-partyendoscopic systems in themeasurement of the nasalrespiratory airway. TheVISIONAIR™ systemmeasures the nasalrespiratory airway fromthe endoscopic imagestaken in the region of theinternal nasal valve (INV)and nasal cavum (NC).	The IFU and Indicationsof the subjectVISIONAIR™ System isaligned with the predicatedevices. The change inthe manner in which datais captured and processeddoes not bring about anynew concerns with respectto substantial equivalence,and the safety andeffectiveness of thesubject device issupported by completeddevice testing.
System Functionto Capture Data	Both mouthpiece ornose tip via the WaveTube.	Applicable FDAcleared endoscopes.	These are different but thedifferences do not raiseany new concerns withrespect to safety andeffectiveness.
Attribute	Primary PredicateDevice (K170071):EccovisionTM	Subject Device:VISIONAIRTM	Substantial EquivalenceRationale
ComputerRequirements:Hardware andSoftware(OperatingSystem, deviceapplicationsoftware)	A customer ownedcomputer with theEccovision softwareapplication loaded bythe customer.	Windows 10 or lateroperating system (OS)computer is providedby PacificMD Biotech.	Same with the onlyexception being systemversion.
Control Unit -Hardware	Provided hardwarewhich connects to thecomputer.Modified with theredesign of the PCB(Print Circuit Board)configuration.	Windows 10 or lateroperating system (OS)computer is providedwith theVISIONAIRTMapplication installedand tested prior to itsrelease to the market.	Same with the onlyexception being systemversion.
ElectronicPlatform -Hardware	Supporting thePharyngometer andconnects to theControl Unit.	Endoscopic System –Connects to theWindows 10 computervia the USB port.	These are different but thedifferences do not raiseany new concerns withrespect to safety andeffectiveness.
ApplicationSoftware(Language)	Windows with GUI	Windows based GUIand AI written inPython 3.6 language.	Same as compared toapplicable devices.

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Attribute	Primary PredicateDevice (K170071):Eccovision™	Subject Device:VISIONAIR™	Substantial EquivalenceRationale
TechnologicalCharacteristics /Principles ofOperation	The Eccovisiondevice uses acousticreflection technologyto accurately map thesize and structure ofthe nasal airway.Sound waves are sentup the nasalpassageway and arereflected back toaccurately map outthe topography of thenasal airway.	The VISIONAIR™system uses theendoscopic image,which is created fromlight reflectiontechnology, toaccurately map thesize and structure ofthe nasalairway. Light is sentup the nasalpassageway andreflected to accuratelymap out thetopography of thenasal airway. Eachpixel brightnesscorrespondents to howmuch light is beingreflected thusdetermining theproximity of the tissuerelative to theendoscopic optics andultimately result on a2-D image that mapsthe size and structureof the nasal anatomy.	The technologicalcharacteristics have beentested through nonclinicaltesting and they do notimpact substantialequivalence. Moreover,the minor technologicaldifferences do not raiseany new concerns withrespect to safety andeffectiveness.

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Conclusion:	The VISIONAIRTM device is substantially equivalent tothe predicate device in indication for use, performance,technology, features, principles operation andcomponents.
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Regulation Number and Section

§ 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).