The ETView VivaSight-DLTM System is intended to isolate the left or right lung of a patient for intensive care or surgery, one lung ventilation or one lung anesthesia. The VivaSight-DLTM System is indicated for verifying tube placement and repositioning.

Device Description

The ETView VivaSight-DLTM System functions as a standard endobronchial tube that additionally has an embedded video imaging device in its tracheal lumen. The system provides a video image of the patient's bronchus, which is displayed on the monitor, for as long as the VivaSight-DL™ is inside the patient's bronchus. Visualization of the bronchus is used to verify placement and repositioning of the endobronchial tube during the intubation procedure or throughout surgery.

AI/ML Overview

The provided text is a 510(k) summary for the VivaSight-DL™ System, a medical device. It describes the device, its intended use, and claims substantial equivalence to predicate devices. The "Performance Testing" section outlines various tests conducted to demonstrate safety and effectiveness.

Here’s an breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or specific performance values against those criteria for each test. Instead, it states that "Performance tests were performed in order to demonstrate that the new tube dimension of the VivaSight-DLTM is as safe and effective as the market-cleared ETView DLVT™ system."

It concludes that "The results of the performance tests clearly demonstrate that the ETView VivaSight-DLTM device is as safe and effective as its predicate without raising any new safety and/or effectiveness concerns." This implies that the device met all unstated acceptance criteria for each test by demonstrating equivalence to the predicate.

The tests conducted are listed as:

Determination of Cuff Resting Diameter
Cuff Leak Resistance Integrity
Cuff Symmetry
Resistance to tube collapse
Determination of effective inside diameter
Determination of the bronchial segment
Resistance to cuff herniation
Air flow resistance
Thermal safety
Tracheal seal

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

The document does not specify the sample size used for the performance tests. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for these tests. All tests appear to be laboratory or bench tests, not involving direct patient data.

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

Since the performance tests are physical/mechanical tests of the device's characteristics (e.g., cuff diameter, leak resistance), there is no mention of "experts" in the context of establishing ground truth in the way one would for clinical diagnostic studies. The ground truth for these tests would inherently be the measured physical properties of the device components.

4. Adjudication Method for the Test Set

Not applicable. The performance tests are objective measurements of physical properties, not subjective assessments requiring adjudication by experts.

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

No, an MRMC comparative effectiveness study was not done. The testing focused on the physical characteristics and performance of the device itself, not on human reader interpretation or the impact of the device on human reader performance.

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

This device is not an algorithm or AI system. It is a physical medical device (an endobronchial tube with an embedded camera). Therefore, the concept of "standalone algorithm performance" is not applicable. The device's "standalone" performance is assessed through the physical performance tests mentioned.

7. The Type of Ground Truth Used

The ground truth for the performance tests was based on objective physical measurements of the device's properties (e.g., diameters, resistance, symmetry) against established standards and equivalence to a predicate device.

8. The Sample Size for the Training Set

This device is a physical medical device, not an AI or machine learning system that requires a "training set." Therefore, this question is not applicable.

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

Not applicable, as there is no training set for this type of device.

Summary

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ETVIEW Airway Management

510(K) SUMMARY

VivaSight-DL™ System 510(k) Number K123853

ETView Ltd. Applicant's Name: Misgav Business Park M.P Misgav 20174 lsrael Tel: (972)72-260-7063 Fax: (972)72-260-7263

Yoram Levy, Qsite Contact Person: 31 Haavoda Street Binyamina, Israel 30500 Tel (972)4-638-8837; Fax (972)4-638-0510 Yoram@qsitemed.com

Trade Name:

VivaSight-DL™ System

Preparation Date: November 11, 2012

Classification:

Regulatory Name: Tracheal/bronchial differential ventilation tube Product Code: CBI Regulation No: 21 CFR 868.5740

Class: II

Panel: Anesthesiology

Device Description:

The ETView VivaSight-DLTM System functions as a standard endobronchial tube that additionally has an embedded video imaging device in its tracheal lumen. The system provides a video

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ETVIEW Airway Management

image of the patient's bronchus, which is displayed on the monitor, for as long as the VivaSight-DL™ is inside the patient's bronchus. Visualization of the bronchus is used to verify placement and repositioning of the endobronchial tube during the intubation procedure or throughout surgery.

The VivaSight-DLTM is a modification of ETView cleared DLVT™, which was cleared on May 18, 2012 under K113576 (the name changed for marketing reasons). The only difference between the VivaSight-DLTM and the market-cleared DLVTTM system is an addition of three new endobronchial tube sizes (35FR, 39FR and 41FR).

The device is indicated for non-MRI environments only.

Intended Use Statement: .

The ETView VivaSight-DL™ is intended to isolate the left or right lung of a patient for intensive care or surgery, one lung ventilation or one lung anesthesia.

The VivaSight-DLTM System is indicated for verifying tube placement and repositioning.

Predicate Devices:

Substantial equivalence to the following predicate device is claimed:

Device Name	510k No	Date of Clearance
Double Lumen VentilationTube (DLVTTM)	K113576	May 18, 2012
Weal lead Endobronchial tube	K092886	Mar 11 2011
Silbroncho tubes (DoubleLumen tube)	K051522	Aug 17 2005

Performance Standards:

VivaSight-DLTM was tested and complies with the following standards:

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ISO 5361:1999 Anesthetic and respiratory equipment --. Tracheal tubes and connectors
ISO 16628:2008 Tracheobronchial Tubes -- Sizing and . marking
ANSI/AAMI/ISO 11135-1:2007 Sterilization of health care . products - Ethylene oxide
ISO 14971-1:2007 Risk management for medical devices .
. ISO 10993-1:2003(E), Biological evaluation of medical devices -- Part 1: Evaluation and testing
. EN 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety-1. Collateral Standard: Safety Requirements for Medical Electrical Systems.
IEC 60601-1-2 Medical Electrical Equipment Part 1-2: . Collateral Standard: Electromagnetic Compatibility -Requirements and Tests

A detailed description appears in Section 14.

Technological Characteristics

The VivaSight-DLTM System functions as a a standard endobronchial tube (EBT) that has an additional embedded video imaging device in its tracheal lumen. The modified device has the same technological characteristics as the cleared predicate device. The system provides a video image of the patient's bronchus, which is displayed on the monitor, for as long as the ETView VivaSight-DLTM is inside the patient's bronchus.

Visualization of the bronchus is used to verify placement and repositioning of the EBT during intubation procedure.

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TechnologicalCharacteristics	ProposedVivaSight-DLTM System	Double Lumen VideoTracheoscope (DLVTTM)(K113576)
Basic Structure	Standard EBT	Same
Use	Single use	Same
Method ofsterilization	Ethylene Oxide	Same
EBT Material	Thermo-sensitive flexiblemedical grade Poly VinylChloride (PVC)	Same
Imaging Sensor	CMOS video camera	Same
Tube Dimensions	35FR, 12.5x13.5mm37FR: 13.0x14.0mm39FR, 13.5x14.5mm41FR, 14.0x15.0mm	37FR: 13.0x14.0mm
Video Transfer	Real time image acquisition ona continuous or intermittentbasis without disconnection thepatients from the mechanicalventilator	Same
System Display	Standard NTSC TV Screen	Same

Performance Testing

Performance tests were performed in order to demonstrate that the new tube dimension of the VivaSight-DLTM is as safe and effective as the market-cleared ETView DLVT™ system.

The following performance tests were conducted:

Determination of Cuff Resting Diameter .
Cuff Leak Resistance Integrity .
Cuff Symmetry .
Resistance to tube collapse .
Determination of effective inside diameter .
Determination of the bronchial segment ●
Resistance to cuff herniation .
Air flow resistance
Thermal safety
Tracheal seal

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Comparison to Predicate Device:

The ETView VivaSight-DLTM is a modification to its predicate device, the market-cleared ETView DLVTIM (K113576).

The ETView VivaSight-DLTM has the same intended use and indication for use, utilizes the same technology and is made of the same material as the market-cleared ETView DLVT™.

The only difference between the VivaSight-DLTM and the market-cleared DLVT™ system is an addition of three new endobronchial tube sizes (35FR, 39FR and 41FR).

The modification was validated successfully.

The new tube's sizes of the VivaSight-DL are equivalence to the market-cleared and well established in the market endobronchial tubes devices: The ETView VivaSight's 41FR is equivalent to Weal lead Endobronchial tube (K092886). The ETView VivaSight 35 FR and 39FR are equivalent the Silbronco tubes Double Lumen tube (K051522) system.

The results of the performance tests clearly demonstrate that the ETView VivaSight-DLTM device is as safe and effective as its predicate without raising any new safety and/or effectiveness concerns.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circle around the eagle. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 15, 2013

ETView Limited C/O Mr. Yoram Levy General Manager Qsite 31 Haavoda Street Binyamina, Israel 30500

Re: K123853

Trade/Device Name: VivaSight-DL "M System Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: II Product Code: CBI Dated: March 13, 2013 Received: March 18, 2013

Dear Mr. Levy:

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.

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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 (QS) regulation (21 CFR Part 820); and if applicable. the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer -S

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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ETVIEW Airway Management _____________________________________________________________________________________________________________________________________________________

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K123853

Device Name:

VivaSight-DLTM System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-off) Division of General, Restorative and Neurological Devices 510(k) Number

Lester W. Schultheis Jr 2013.04.08 17:04:48 -04'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Regulation Number and Section

§ 868.5740 Tracheal/bronchial differential ventilation tube.

(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).