VIVASIGHT-DL SYSTEM

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 Ventilation<br>Tube (DLVTTM) | K113576 | May 18, 2012 | | Weal lead Endobronchial tube | K092886 | Mar 11 2011 | | Silbroncho tubes (Double<br>Lumen tube) | K051522 | Aug 17 2005 | Performance Standards: VivaSight-DLTM was tested and complies with the following standards: {2}------------------------------------------------ ETVIEW Airway Management ----------------------------------------------------------------------------------------------------------------------------------------------------- - 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. {3}------------------------------------------------ ETVIEW Airway Management - | Technological<br>Characteristics | Proposed<br>VivaSight-DLTM System | Double Lumen Video<br>Tracheoscope (DLVTTM)<br>(K113576) | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------| | Basic Structure | Standard EBT | Same | | Use | Single use | Same | | Method of<br>sterilization | Ethylene Oxide | Same | | EBT Material | Thermo-sensitive flexible<br>medical grade Poly Vinyl<br>Chloride (PVC) | Same | | Imaging Sensor | CMOS video camera | Same | | Tube Dimensions | 35FR, 12.5x13.5mm<br>37FR: 13.0x14.0mm<br>39FR, 13.5x14.5mm<br>41FR, 14.0x15.0mm | 37FR: 13.0x14.0mm | | Video Transfer | Real time image acquisition on<br>a continuous or intermittent<br>basis without disconnection the<br>patients from the mechanical<br>ventilator | 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 {4}------------------------------------------------ #### 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. {5}------------------------------------------------ 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. {6}------------------------------------------------ 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 {7}------------------------------------------------ ETVIEW Airway Management _____________________________________________________________________________________________________________________________________________________ # INDICATIONS FOR USE STATEMENT 510(k) Number (if known): K123853 Device Name: VivaSight-DLTM System Indications for Use: 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. 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: