SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer

Q: Who is the manufacturer of SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer?

Sleep Group Solutions filed the 510(k) submission for SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer (K170071).

Q: What is the FDA product code for SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer?

BXQ. It is classified under 21 CFR 868.1800 as a Class 2 device in the Anesthesiology panel.

Q: What is the regulatory pathway for SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer?

SGS Eccovision Rhinometer (K011329); SGS Eccovision Pharyngometer (K921452).

Q: Who can help prepare an FDA 510(k) submission like SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K170071 · Sleep Group Solutions · BXQ · Nov 9, 2017 · Anesthesiology

Device Facts

Record ID	K170071
Device Name	SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer
Applicant	Sleep Group Solutions
Product Code	BXQ · Anesthesiology
Decision Date	Nov 9, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1800
Device Class	Class 2

Intended Use

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

Device Story

Eccovision measures upper respiratory airway patency using acoustic reflection technology. System includes control unit, wave tubes (pharyngometer/rhinometer), electronic platform, mouthpieces, and nose tips. Device connects to customer-provided PC running Eccovision application software. Operation involves passing acoustic signals through a probe positioned in the mouth or nose; two microphones in the wave tube capture reflected signals. Software processes incident and reflected sound signals to generate area-distance curves, minimal cross-sectional area, and volume measurements. Used in clinical settings to provide objective airway data; output displayed on screen or printed. Healthcare providers use these measurements to assess airway dimensions and patency, aiding in clinical decision-making regarding respiratory health.

Clinical Evidence

Bench testing only. Validation included electrical safety testing (IEC 60601-1, IEC 60601-1-2), black/white box software testing, and comparative analysis against the legacy core. Oral and nasal measurement accuracy was validated using statistical methods including scatter plots, regression analysis, Bland-Altman analysis, ANOVA, and descriptive statistics to demonstrate volume measurement acceptance criteria within 10%.

Technological Characteristics

Acoustic reflection measurement system. Components: control unit, wave tubes, electronic platform, mouthpieces (Santoprene 281-55), nose tips (Silicone G2705). Connectivity: connects to customer-provided PC. Software: Windows-based application with GUI. Electrical safety: IEC 60601-1, IEC 60601-1-2. Sterilization: uses filter strips.

Indications for Use

Indicated for measuring the upper respiratory airway via acoustic reflection in patients requiring airway patency assessment.

Regulatory Classification

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.

Predicate Devices

SGS Eccovision Rhinometer (K011329)
SGS Eccovision Pharyngometer (K921452)

Related Devices

K972140 — A1 ACOUSTIC RHINOMETER · G.M. Instruments , Ltd. · Sep 30, 1998
K123896 — CCS-200 SPIROMETER · Benson Medical Instruments Co. · Sep 10, 2013
K133428 — MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO · Medikro OY · May 21, 2014
K193058 — SonarMed AirWave Airway Monitoring System · Sonarmed, Inc. · May 15, 2020
K180867 — AmCAD-UO · Amcad Biomed Corporation · Dec 28, 2018

Submission Summary (Full Text)

{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 Solutions 2035 Harding Street, #200/201 Hollywood, Florida 33020 Phone: 305-830-0327 | | Contact: | Stephen Inglese Consultant Quality Solutions and Support, LLC Phone: 561-251-0876 Email: swi@qss-llc.com | | Date Prepared: | December 11, 2016 | | Classification Regulation: | 21 CFR §868.1800 Rhinoanemometer Class II | | Panel: | Anesthesiology | | Product Code: | BXQ | | Predicate Device: | K011329 – SGS Eccovision Rhinometer and K921452 - SGS Eccovision Pharyngometer (Submitter's previously cleared devices) | | Description of Device | 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. | | 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 - 2. Summary: Test 2 □ Certificate of Electrical Safety for IEC 60601-1 {5}------------------------------------------------ - □ C170450.01 General Requirements Basic Safety and Essential Performance - 3. 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 - 4. 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 - 5. 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 or Rhinometer) | K921452 – SGS Pharyngometer | K011329 – SGS Rhinometer | | Submitter | Sleep Group Solutions | Sleep Group Solutions - Hood Laboratories | Sleep Group Solutions - Hood Laboratories | | Classification Regulation | 868.1800 | 868.1800 | 868.1800 | | Product Code | BXQ | BXQ | BXQ | {7}------------------------------------------------ | System Function to capture data | Both Mouth piece or Nose tip via the Wave Tube | Mouth piece via the Wave Tube | Nose tip via the Wave Tube | |--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | Indication | Intended to measure the upper respiratory airway by acoustic reflection | Intended to measure the upper respiratory airway by acoustic reflection | Intended to measure the upper respiratory airway by acoustic reflection | | Computer Requirements - Hardware and Software (Operating System, device application software) | A customer owned computer with the Eccovision software application loaded by the customer. | A provided computer with installed device application software | A provided computer with installed device application software | | Control Unit - Hardware | Provided hardware which connects to the Computer. Modified with the redesign of the PCB (Print Circuit Board) configuraton | Provided hardware which connects to the Computer. | Provided hardware which connects to the Computer | | Wave Tube - Hardware | • Supporting the Pharyngometer - Connects to the Electronic Platform • Supporting the Rhinomenter - Connects to the Control Unit | Supporting the Pharyngometer -Connects to the Electronic Platform | Supporting the Rhinomenter - Connects to the Control Unit | | Electronic Platform - Hardware | Supporting the Pharyngometer - Connects to the Control Unit | Supporting the Pharyngometer – Connects to the Control Unit | NA | | Application Software - Language | Windows with GUI | DOS | DOS | | User Manual – General Instructions | Instructions to support combined Oral (Pharyngometer) and Nasal (Rhinometer) airway data capture | Instructions to support Oral (Pharyngometer) airway data capture | Instructions to support Nasal (Rhinometer) airway data capture | | Filters | The Wave Tube filter design and material remains the same as originally indicated | 3M polypropylene filter | NA | | Mouth Piece Design and Material | The Mouth piece design and material remains the same as originally indicated. | Mouth piece design developed with Santoprene®, 281-55 thermoplastic rubber medical grade. | NA | | Nose Tip Design and Material | The Nose tip design and material remains the same as originally indicated. | NA | Silicone G2705 from Kraton | 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.