(122 days)
Not Found
No
The description focuses on the device's function as a standard endobronchial tube with an embedded video for visualization, and the performance studies are related to the physical characteristics and safety of the tube, not image analysis or algorithmic processing. There is no mention of AI, ML, or image processing.
No
The device is primarily used for isolation of the lung and verification of tube placement, not for treating a disease or condition.
Yes
The device is used to verify tube placement and repositioning by providing a video image of the patient's bronchus. This act of "verifying" internal status to guide medical action fits the definition of a diagnostic device.
No
The device description explicitly states it functions as a standard endobronchial tube with an embedded video imaging device, indicating it is a hardware device with integrated software for video display. The performance studies also focus on physical characteristics of the tube.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The ETView VivaSight-DLTM System is a device that is inserted into the patient's body (in vivo) to facilitate lung isolation and provide real-time visualization of the bronchus for tube placement and repositioning. It does not perform any tests on samples taken from the body.
The device's function is related to surgical and intensive care procedures involving the respiratory system, not laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The ETView VivaSight-DL™ 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-DL™ System is indicated for verifying tube placement and repositioning.
Product codes
CBI
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video imaging
Anatomical Site
patient's bronchus, left or right lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
The modification was validated successfully.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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 Ventilation | ||
| Tube (DLVTTM) | K113576 | May 18, 2012 |
| Weal lead Endobronchial tube | K092886 | Mar 11 2011 |
| Silbroncho tubes (Double | ||
| Lumen 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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ETVIEW Airway Management -
| Technological
Characteristics | Proposed
VivaSight-DLTM System | Double Lumen Video
Tracheoscope (DLVTTM)
(K113576) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Basic Structure | Standard EBT | Same |
| Use | Single use | Same |
| Method of
sterilization | Ethylene Oxide | Same |
| EBT Material | Thermo-sensitive flexible
medical grade Poly Vinyl
Chloride (PVC) | Same |
| Imaging Sensor | CMOS video camera | Same |
| Tube Dimensions | 35FR, 12.5x13.5mm
37FR: 13.0x14.0mm
39FR, 13.5x14.5mm
41FR, 14.0x15.0mm | 37FR: 13.0x14.0mm |
| Video Transfer | Real time image acquisition on
a continuous or intermittent
basis without disconnection the
patients from the mechanical
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
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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:
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: