(304 days)
Not Found
No
The description focuses on acoustic signal processing and software processing of incident and reflected sound signals to generate graphical representations and measurements. There is no mention of AI, ML, or related concepts.
No
The device is used to measure the upper respiratory airway and provide a graphical representation of airway patency; it does not treat or cure a disease or condition.
Yes
The device is intended to "measure the upper respiratory airway by means of acoustic reflection" to provide "graphical representation of the airway patency," which helps in assessing the condition of the airway. This measurement and assessment indicate a diagnostic purpose.
No
The device description explicitly states that the system consists of a control unit, wave tube, electronic platform, mouthpieces, nose tips, and filter strips in addition to the software application. This indicates the presence of significant hardware components.
Based on the provided information, the ECCOVISION™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "measure the upper respiratory airway by means of acoustic reflection." This is a measurement of a physical characteristic (airway size) within the body, not an analysis of a biological sample (like blood, urine, tissue, etc.) outside the body.
- Device Description: The description details the use of acoustic signals to measure the airway lumen and provide graphical representations. This is a physical measurement technique, not a method for analyzing biological samples.
- Lack of Biological Sample Analysis: The entire description focuses on the interaction of sound waves with the airway and the processing of those reflected signals. There is no mention of collecting or analyzing any biological material from the patient.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This is typically done by examining specimens derived from the human body, such as blood, urine, or tissue.
The ECCOVISION™ device is a diagnostic device that uses a physical method (acoustic reflection) to assess a physiological characteristic (airway size) in vivo (within the living body). It does not perform in vitro (outside the living body) analysis of biological samples.
N/A
Intended Use / Indications for Use
The ECCOVISION™ is intended to measure the upper respiratory airway by means of acoustic reflection.
Product codes (comma separated list FDA assigned to the subject device)
BXO, BXQ
Device Description
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 cross-sectional 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper respiratory airway
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Four general tests (Test 1 - 4) and one UI test (Test 5) were performed:
- Test 1: Certificate of Electrical Safety for IEC 60601-1-2 and ITL Product Testing Certificate of Compliance: K170460.00 -Electromechanical Safety
- Test 2: Certificate of Electrical Safety for IEC 60601-1 and C170450.01 General Requirements Basic Safety and Essential Performance
- Test 3: Oral and Nasal testing was conducted separately. Test description: 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: Black box testing focuses on external interfaces; White box testing focuses on internal interfaces.
- 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: Show equivalency between new core & legacy core using a model (fixed ADP); Show that the new system is equivalent to legacy system on real patients.
- 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.
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
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
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.
Not Found
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).
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."
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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:
-
- Summary: Test 1
- □ Certificate of Electrical Safety for IEC 60601-1-2
- I ITL Product Testing Certificate of Compliance: K170460.00 -Electromechanical Safety
-
- Summary: Test 2
□ Certificate of Electrical Safety for IEC 60601-1
5
- □ C170450.01 General Requirements Basic Safety and Essential Performance
-
- 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
-
- 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
-
- 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.