(165 days)
Not Found
No
The description focuses on video imaging for visualization and verification of tube placement, with no mention of AI or ML for image analysis, diagnosis, or other functions.
No.
The device's intended use is to isolate the left or right lung, verify tube placement, and reposition, which are diagnostic and procedural functions rather than direct therapeutic treatments.
No
The device is primarily intended for isolating a lung and verifying/repositioning a tube, which are procedural and functional tasks. While it provides a video image to aid in these tasks, its main purpose is not to diagnose a disease or condition. The "video image of the patient's bronchus" is used to "verify placement and repositioning," not to assess or diagnose the state of the bronchus for medical conditions.
No
The device description explicitly states it is a "standard 37 French size endobronchial tube that additionally has an embedded video imaging device in its tracheal lumen." This indicates the device is a physical medical device with integrated hardware (the endobronchial tube and the video imaging device). The performance studies also include tests related to the physical properties of the tube and cuff.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The ETView Double Lumen Video Tracheoscope (DLVT™) is a medical device used directly within the patient's body (in vivo) to facilitate ventilation and visualize the bronchus during surgical procedures or intensive care. It does not analyze samples taken from the body.
- Intended Use: The intended use is for isolating lungs, ventilation, anesthesia, and verifying/repositioning the tube within the patient.
The device is an in vivo medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The ETView Double Lumen Video Tracheoscope (DLVT™) 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 DLVT™ System is indicated for verifying tube placement and repositioning.
Product codes (comma separated list FDA assigned to the subject device)
CBI
Device Description
The ETView Double Lumen Video Tracheoscope (DLVT™) System functions as a standard 37 French size 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 DLVT™ 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 device is indicated for non-MRI environment only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video image
Anatomical Site
Bronchus, 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 testing demonstrated that the Double Lumen Video Tracheoscope (DLVT™) is as safe and effective as the cleared predicate devices.
The following performance tests were conducted:
- Determination of Cuff Resting Diameter
- Cuff Leak Resistance Integrity
- Resistance to Cuff Herniation
- Cuff Symmetry
- Resistance to tube collapse
- Air Flow Resistance
- Thermal Safety
- Determination of effective inside diameter
- Tracheal Seal
- Determination of the bronchial segment
- Cadaver Test
- MR Environment Non-Clinical Test
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
§ 868.5740 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).
0
(ETVIEW Airway Management _
MAY 1 8 2012
510(K) SUMMARY
Double Lumen Video Tracheoscope (DLVT™) System 510(k) Number K113576
Applicant's Name: ETView Ltd.
Misgav Business Park
M.P Misgav 20174
Israel
Tel: (972)72-260-7063
Fax: (972)72-260-7263
- Contact Person: Yoram Levy, Qsite
31 Haavoda St.
Binyamina, Israel 30500
Tel (972)4-638-8837
Fax (972)4-638-0510
Double Lumen Video Tracheoscope (DLVT™) System Trade Name:
Endobronchial tube (EBT) Device Type:
Preparation Date: November 23, 2011
Regulatory Name: Tracheal/bronchial differential ventilation Classification:
tube
Product Code: CBI Regulation No: 21 CFR 868.5740 Class: II Classification Panel: Anesthesiology
Device Description:
The ETView Double Lumen Video Tracheoscope (DLVT™) System functions as a standard 37 French size endobronchial tube that additionally has an embedded video imaging device in its tracheal lumen. The system provides a video image of the patient's
İ
1
bronchus, which is displayed on the monitor, for as long as the DLVTTM 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 device is indicated for non-MRI environment only.
Intended Use Statement:
The ETView Double Lumen Video Tracheoscope (DLVT™) 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 DLVT' " System is indicated for verifying tube placement and
repositioning.
Predicate Devices: claimed:
Substantial equivalence to the following predicate devices is
| Device Name | 510k No | Date of Clearance |
|---|---|---|
| ETView Tracheoscopic Ventilation | ||
| Tube (TVT™) | K082420 | October 8, 2008 |
| Well LEAD Endobronchial Tubes | K092886 | March 11, 2010 |
Performance Standards
Double Lumen Video Tracheoscope (DLVT™) was tested and
complies with the following standards:
- ISO 5361:1999 Anaesthetic 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
- AAMI TIR28:2001 Product adoption and process equivalency . for ethylene oxide sterilization
- ISO 14971-1:2007 Risk management for medical devices .
2
- ISO 10993-1:2003(E), Biological evaluation of medical . devices -- Part 1: Evaluation and testing
A detailed description appears in Section 14.
Performance Testing
Performance testing demonstrated that the Double Lumen Video
Tracheoscope (DLVT™). is as safe and effective as the cleared predicate devices.
The following performance tests were conducted:
- Determination of Cuff Resting Diameter
- Cuff Leak Resistance Integrity
- Resistance to Cuff Herniation .
- Cuff Symmetry .
- Resistance to tube collapse ●
- Air Flow Resistance ●
- Thermal Safety
- Determination of effective inside diameter
- Tracheal Seal
- Determination of the bronchial segment
- Cadaver Test
- MR Environment Non-Clinical Test
Comparison to the Predicate Devices
The intended use of the DLVTTM is similar to the intended use of Well LEAD Endobronchial Tubes, previously cleared under K092886. The indication for use of the DLVTTM system is similar to the indication of ETView Tracheoscopic Ventilation Tube (TVTTM), previously cleared under K082420.
Both the DLVT™ and the TVT™ systems integrate imaging and lighting components into the wall of a tube for patient ventilation. The structure, the material, the dimensions and the sterilization method of the DLVT™ are similar to the cleared Well LEAD Endobronchial Tubes. The light source, the imaging sensor, the video transfer and format, the display and the power supply of the DLVT™ System are identical to the cleared ETView TVT™
3
The minor differences between the DLVT™ System and its predicate devices do not raise any new questions of safety or efficacy. Moreover, performance testing demonstrated that the DLVT™ is as safe and effective as the predicate devices. Thus, the DLVT™ System is substantially equivalent to Well LEAD Endobronchial Tubes and ETView TVT™.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 8 2012
ETView Ltd. C/O Mr. Yoram Levy Osite 31 Haavoda Street Binvamina ISREAL 30500
Re: K113576
Trade/Device Name: Double Lumen Video Tracheoscope (DLVTTM) System Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: II Product Code: CBI Dated: April 19, 2012 Received: April 24, 2012
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.
5
Page 2 – Mr. Levy
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 device-related.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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.html 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/Resourcesfor You/Industry/default.htm.
Sincerely vours,
for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
T VIEW Airway Management
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Double Lumen Video Tracheoscope (DLVTTM) System
Indications for Use:
The ETView Double Lumen Video Tracheoscope (DLVT™) 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 DLVT"M System is indicated for verifying tube placement and repositioning.
Prescription Use AND/OR X (Part 21 CFR 801 Subpart D)
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 Anesthesiology, General Hospital, Infection Control and Dental Devi 510(k) Number
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:_____________________________
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Double Lumen Video Tracheoscope (DLVT™) System – 510k Notification