The Eccovision™ device is used to obtain an objective measurement of the upper respiratory airway. The device uses acoustic signal processing technology to provide graphical representation of the airway patency as a function of distance from the airway opening. The system consists of a control unit (which connects to customer owned personal computer), and software application, wave tube (one each for the Pharyngometer and Rhinometer) and electronic platform, mouthpieces and nose tips and filter strips. The device performs a dynamic test that determines the dimension of the oral airway past the glottis while the patient is breathing thorough either the mouthpiece or nose tip. A customer provided computer with the loaded Eccovision™ application software then processes the incident and reflected sound signals provides an area-distance curve representing the lumen together with minimal crosssectional area and volume. A measurement is obtained by passing a signal along a probe positioned in the mouth or nose then recover a signal by use of two (2) microphones in the wave tube. The signal is processed by the software and displayed on a screen or relayed to a printer, detailing the cross-sectional area of the airway as a function of distance from the teeth.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Volume measurements within 10%	Demonstrated through analysis events C1-C7 for oral and C8-C14 for nasal functionality. (Specific performance values within the 10% criterion are not explicitly stated in this document but the reports are cited as demonstrating it)

2. Sample Size Used for the Test Set and Data Provenance

The text explicitly mentions:

Approach to show equivalency between new core & legacy core using a model (fixed ADP)
Approach to show that the new system is equivalent to legacy system on real patients.

However, the sample size for "real patients" is not specified in this document. The data provenance (country of origin, retrospective or prospective) is also not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document mentions that testing was performed by an "Evaluator" familiar with the business case, but does not specify the number of experts, nor their qualifications (e.g., medical specialists, years of experience).

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned in the provided text. The study focuses on demonstrating equivalence to predicate devices, not on comparing human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is an "ECCOVISION™ Pharyngometer, SGS Eccovision™ Rhinometer, SGS Eccovision™ Rhino/Pharyngometer" which is a measurement device, not an AI algorithm generating readings for humans to interpret. Therefore, the concept of "standalone performance" in the context of an AI algorithm doesn't directly apply here. The device itself performs measurements; the software processes the signals and displays results. The tests aimed to show that the new system's measurements are equivalent to the predicate devices.

7. The Type of Ground Truth Used

The ground truth for the "fixed ADP model" test would be based on the characteristics of that model. For the "real patients" test, the ground truth for "volume measurements" would likely be derived from the predicate devices, as the goal was to show equivalence to the measurements produced by those established devices. The document implies that the measurements from the predicate devices served as a reference for establishing the acceptability of the new device's measurements. There is no mention of pathology or outcomes data as ground truth.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This device is described as an acoustic reflection measurement device, and the testing focuses on its measurement accuracy compared to predicate devices, not on training a machine learning model.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned in the context of machine learning, this question is not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.

November 9, 2017

Sleep Group Solutions % Stephen W. Inglese Owner, CEO Ouality Solutions and Support, LLC Po Box 8271 Holland, MI 49422

Re: K170071

Trade/Device Name: Sgs Eccovision™ Pharyngometer, Sgs Eccovision™ Rhinometer, Sgs Eccovision™ Rhino/Pharyngometer

Regulation Number: 21 CFR 868.1800 Regulation Name: Rhinoanemometer Regulatory Class: Class II Product Code: BXO Dated: September 25, 2017 Received: October 3, 2017

Dear Stephen W. Inglese:

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. 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.

{1}------------------------------------------------

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 yours,

Srinivas Nandkumar -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use Statement 4.0

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

51 O(k) Number (if known) K170071

Device Name ECCOVISIONTM

Indications for Use (Describe)

The ECCOVISION™ is intended to measure the upper respiratory airway by means of acoustic reflection.

Type of Use (Select one or both, as applicable)

IZI Prescription Use (Part 21 CFR 801 Subpart D)

O Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information, Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC .Publishing Services (301) 443-6740 EF

{3}------------------------------------------------

5.0 510(k) Summary

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the

Device Common Name:	Rhinoanemometer and Pharyngometer
Device Proprietary Name:	ECCOVISION™
Submitter:	Sleep Group Solutions2035 Harding Street, #200/201Hollywood, Florida 33020Phone: 305-830-0327
Contact:	Stephen IngleseConsultantQuality Solutions and Support, LLCPhone: 561-251-0876Email: swi@qss-llc.com
Date Prepared:	December 11, 2016
Classification Regulation:	21 CFR §868.1800 RhinoanemometerClass II
Panel:	Anesthesiology
Product Code:	BXQ
Predicate Device:	K011329 – SGS Eccovision Rhinometer andK921452 - SGS Eccovision Pharyngometer(Submitter's previously cleared devices)
Description of Device	The Eccovision™ device is used to obtain anobjective measurement of the upper respiratoryairway. The device uses acoustic signal processingtechnology to provide graphical representation ofthe airway patency as a function of distance fromthe airway opening.
Indication for Use:	To measure the upper respiratory airway by means
	of acoustic reflection

{4}------------------------------------------------

The system consists of a control unit (which connects to customer owned personal computer), and software application, wave tube (one each for the Pharyngometer and Rhinometer) and electronic platform, mouthpieces and nose tips and filter strips. The device performs a dynamic test that determines the dimension of the oral airway past the glottis while the patient is breathing thorough either the mouthpiece or nose tip. A customer provided computer with the loaded Eccovision™ application software then processes the incident and reflected sound signals provides an area-distance curve representing the lumen together with minimal crosssectional area and volume. A measurement is obtained by passing a signal along a probe positioned in the mouth or nose then recover a signal by use of two (2) microphones in the wave tube. The signal is processed by the software and displayed on a screen or relayed to a printer, detailing the cross-sectional area of the

airway as a function of distance from the teeth.

Summary of Technological Characteristics

The Eccovision™ device has been designed and manufactured with the same indications for use as the predicate devices. The technical changes apply to the software. The application language being changed from DOS to Windows. This along with minor hardware changes to the Controller allows for a more efficient device.

The testing performed on the device is described as follows:

1. Summary: Test 1
- □ Certificate of Electrical Safety for IEC 60601-1-2
- I ITL Product Testing Certificate of Compliance: K170460.00 -Electromechanical Safety
1. Summary: Test 2

□ Certificate of Electrical Safety for IEC 60601-1

{5}------------------------------------------------

□ C170450.01 General Requirements Basic Safety and Essential Performance
1. Summary: Test 3

(Oral and Nasal testing was conducted separately)

Test description

D Each test case specifies the test pre-conditions, steps & post conditions
□ Test traceability i.e. success or deviations will be recorded in Data sheet & Deviation log sheet in the Appendix section

Approach

To show that the new core complies with the specification the following approach will be applied

□ Black box testing focuses on external interfaces
□ White box testing focuses on internal interfaces
1. Summary: Test 4

Purpose

This protocol outlines design validation testing to show that the new (Eccovision) system is equivalent to the cleared predicate system. Testing will be performed by an "Evaluator" who is familiar with the business case

Approach

To show equivalency between cleared predicate system & new (Eccovision) system the following approach will be applied

□ Show equivalency between new core & legacy core using a model (fixed ADP)
D Show that the new system is equivalent to legacy system on real patients
1. Summary Test 5

Purpose

This protocol outlines design validation testing for the Eccovision UI. Testing will be performed by an "Evaluator" who is familiar with the business case

Approach

Run a series of test cases made of most common UI use case with known expected results and capture the actual results

{6}------------------------------------------------

Testing To Prove Acceptance Criterion: Oral and Nasal 6.
To demonstrate the justification of the acceptance criterion of the volume measurements within 10%, analysis was performed on both the Oral and Nasal aspects of the device.

Analysis Events - Oral

Reports C1 - C7 Demonstrates the oral analysis performed:

C1 Oral Analysis Report Summary RPT 0180
C2 Oral Scatter Plots RPT 0100
C3 Oral Regular Regression Analysis RPT 0110
C4 Oral Multi Variate Mix Regression Analysis RPT 0120
C5 Oral Bland Altman Analysis RPT 0140
C6 Oral Anova RPT 0150
C7 Oral Descriptive Statistics Analysis RPT 0160

Analysis Events - Nasal

Reports C8 - C14 Demonstrates the nasal analysis performed:

C8 Nasal Analysis Report Summary RPT 0280
C9 Nasal Scatter Plots RPT 0200
C10 Nasal Regular Regression Analysis RPT 0210
C11 Nasal Multi-Variate Mix Regression Analysis RPT 0220
C12 Nasal Bland Altman Analysis RPT 0240
C13 Nasal Anova RPT 0250
C14 Nasal Descriptive Statistics Analysis RPT 0260

Substantial Equivalence:

Based on the identical indication, similar technological characteristics, and results of performance testing, the Eccovision System is substantially equivalent to the previously cleared in both K011329 and K921452 demonstrated in Table 1:

Table 1: Device Comparison Table

	Proposed Device	Predicate Device	Predicate Device
510(k) Number	TBD – Eccovision™(Pharyngometer orRhinometer)	K921452 – SGSPharyngometer	K011329 – SGSRhinometer
Submitter	Sleep Group Solutions	Sleep Group Solutions -Hood Laboratories	Sleep Group Solutions -Hood Laboratories
ClassificationRegulation	868.1800	868.1800	868.1800
Product Code	BXQ	BXQ	BXQ

{7}------------------------------------------------

System Function tocapture data	Both Mouth piece or Nosetip via the Wave Tube	Mouth piece via the WaveTube	Nose tip via the WaveTube
Indication	Intended to measure theupper respiratory airwayby acoustic reflection	Intended to measure theupper respiratory airwayby acoustic reflection	Intended to measurethe upper respiratoryairway by acousticreflection
ComputerRequirements -Hardware andSoftware (OperatingSystem, deviceapplication software)	A customer ownedcomputer with theEccovision softwareapplication loaded by thecustomer.	A provided computerwith installed deviceapplication software	A provided computerwith installed deviceapplication software
Control Unit -Hardware	Provided hardware whichconnects to the Computer.Modified with the redesignof the PCB (Print CircuitBoard) configuraton	Provided hardwarewhich connects to theComputer.	Provided hardwarewhich connects to theComputer
Wave Tube - Hardware	• Supporting thePharyngometer -Connects to theElectronic Platform• Supporting theRhinomenter - Connectsto the Control Unit	Supporting thePharyngometer -Connectsto the Electronic Platform	Supporting theRhinomenter -Connects to theControl Unit
Electronic Platform -Hardware	Supporting thePharyngometer - Connectsto the Control Unit	Supporting thePharyngometer – Connectsto the Control Unit	NA
Application Software- Language	Windows with GUI	DOS	DOS
User Manual –General Instructions	Instructions to supportcombined Oral(Pharyngometer) andNasal (Rhinometer)airway data capture	Instructions to supportOral (Pharyngometer)airway data capture	Instructions tosupport Nasal(Rhinometer) airwaydata capture
Filters	The Wave Tube filterdesign and materialremains the same asoriginally indicated	3M polypropylene filter	NA
Mouth Piece Designand Material	The Mouth piece designand material remains thesame as originallyindicated.	Mouth piece designdeveloped withSantoprene®, 281-55thermoplastic rubbermedical grade.	NA
Nose Tip Design andMaterial	The Nose tip design andmaterial remains the sameas originally indicated.	NA	Silicone G2705 fromKraton

Changes are noted in BOLD

{8}------------------------------------------------

Substantial Equivalence Summary

The results of the testing as demonstrated in Test 1 through Test 5 of electrical safety, application (supporting both hardware and software) and proven acceptance criterion testing reports C1 - C8 for the oral functionality and reports C9 - 14 for the nasal functionality of the Eccovision System that the device is safe and as effective, and performs as or better than the predicate devices cleared in K011329 and K921452.

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).