(126 days)
No
The description focuses on mechanical components and performance testing related to physical properties, with no mention of AI/ML terms or functionalities.
No
The device is used to isolate a lung for surgical procedures or ventilation, which is a supportive and interventional function, not a therapeutic one in itself.
No
The device is used to isolate a lung for surgery, ventilation, or anesthesia, which are therapeutic or procedural actions, not diagnostic ones.
No
The device description clearly outlines physical components such as a bronchial blocker tube, a joint connector, and a cuff, indicating it is a hardware device. The performance studies also focus on physical characteristics and performance of these hardware components.
Based on the provided information, the ETView Viva EB is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to isolate a lung for surgical procedures, ventilation, or anesthesia. This is a direct intervention on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a physical tube with a cuff designed to be inserted into the airway. It's a medical device used for a therapeutic or procedural purpose.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The ETView Viva EB does not fit this description.
N/A
Intended Use / Indications for Use
The ETView Viva EB is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
Product codes
CBI
Device Description
The ETView Viva EB is designed to administer one-lung ventilation, by using a conventional endotracheal tube and a fiber optic bronchoscope. The device consists of a bronchial blocker tube, advanced through an endotracheal tube, and a joint connector, connecting the bronchial blocker tube to the endotracheal catheter. A cuff, incorporated at the distal tip of the tube, is inflated to block the targeted bronchus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Performance testing demonstrated that the Viva EB is as safe and effective as the cleared predicate devices.
The following performance tests were conducted:
- Analysis of cuff to shaft bond strength and burst test.
- Analysis of deflection angle.
- Analysis of cuff shape at various pressure
- Analysis of cuff dimension at various volumes.
- Analysis of balloon cuff inflation retention.
- The dimension and the ports of the joint connector
- . Cuff Herniation
- Cuff Resting Diameter.
- Cuff Symmetry.
- Resistance to Tube Collapse
- VivaSight-SL (TVTTM) Blocker Compatibility.
Key Metrics
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).
0
SETVIEW Airway Management ----------------------------------------------------------------------------------------------------------------------------------------------------
510(K) SUMMARY
:
JUN - 8 2012
:
Viva EB
--
:
510(k) Number K_______________________________________________________________________________________________________________________________________________________________
| Applicant's Name: | ETView Ltd.
17 Tchelet Street
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
Yoram@qsitemed.com |
| Trade Name: | Viva EB |
| Device Type: | Endobronchial Blocker |
| Preparation Date: | January 31, 2012 |
| Classification: | Regulatory Name: Tracheal/bronchial differential ventilation tube
Product Code: CBI
Regulation No: 21 CFR 868.5740
Class: II
Classification Panel: Anesthesiology |
Viva EB – 510k Notification
1
Device Description:
The ETView Viva EB is designed to administer one-lung ventilation, by using a conventional endotracheal tube and a fiber optic bronchoscope. The device consists of a bronchial blocker tube, advanced through an endotracheal tube, and a joint connector, connecting the bronchial blocker tube to the endotracheal catheter. A cuff, incorporated at the distal tip of the tube, is inflated to block the targeted bronchus.
Intended Use Statement:
The ETView Viva EB is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
Substantial equivalence to the following predicate devices is claimed: Predicate Devices:
| Device Name | 510k No | Date of
Clearance |
|-------------------------------------------------------|---------|----------------------|
| Daiken Medical Coopdech
Endobronchial Blocker Tube | K071694 | March 20, 2008 |
| Cook Incorporated 7.0 Fr.
Endobronchial Blocker | K021920 | August 14, 2002 |
Performance Standards
Viva EB was tested and complies with the following standards:
- ISO 5361:1999 Anaesthetic and respiratory equipment -- Tracheal . tubes and connectors
- 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
A detailed description appears in Section 14.
Performance Testing
Performance testing demonstrated that the Viva EB is as safe and effective as the cleared predicate devices.
The following performance tests were conducted:
Viva EB - 510k Notification
2
- Analysis of cuff to shaft bond strength and burst test .
- Analysis of deflection angle .
- Analysis of cuff shape at various pressure ●
- Analysis of cuff dimension at various volumes .
- Analysis of balloon cuff inflation retention .
- The dimension and the ports of the joint connector ●
- . Cuff Herniation
- Cuff Resting Diameter .
- Cuff Symmetry .
- Resistance to Tube Collapse ●
- VivaSight-SL (TVTTM) Blocker Compatibility .
Comparison to the Predicate Devices
The intended use of the Viva EB is identical to the intended use of Daiken Medical Coopdech Endobronchial Blocker Tube, cleared under K071694.
Both the ETView Viva EB and Daiken Medical Coopdech Endobronchial Blocker Tube are designed to administer one-lung ventilation, by using a conventional endotracheal tube and a fiber optic bronchoscope. The device parts, the structure, the principle of operation and the sterilization method of the Viva EB are similar to the cleared Coopdech Endobronchial Blocker Tube.
The minor differences between the Viva EB and its predicate devices do not raise any new questions of safety or efficacy. Moreover, performance testing demonstrated that the Viva EB is as safe and effective as the predicate devices. Thus, the Viva EB is substantially
equivalent to Daiken Medical Coopdech Endobronchial Blocker
Tube and Cook Incorporated 7.0 Fr. Endobronchial Blocker.
Viva EB - 510k Notification
3
Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Etview Limited C/O Mr. Yoram Levy Regulatory Consultant Osite 31 Haavoda Street · Binyamina, Israel 30500
JUN - 8 2012
Re: K120334
Trade/Device Name: Viva EB Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: II Product Code: CBI Dated: May 23, 2012 Received: May 29, 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.
4
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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh 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
5
SETVIEW Airway Management
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Viva EB
Indications for Use:
The ETView Viva EB is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
Use X Prescription (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 Anesthesiology, General Hospital, Infection Control and Dental Devices 510(k) Number
L. Shutte
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K120334
Viva EB - 510k Notification