(124 days)
Not Found
No
The description focuses on standard video imaging and visualization for tube placement verification, with no mention of AI/ML terms or functionalities like automated analysis or interpretation of the video feed.
No.
The device is used for isolating lungs and verifying tube placement and repositioning, as well as providing visualization, which are diagnostic and procedural support functions, not direct therapeutic interventions.
Yes
The device is indicated for verifying tube placement and repositioning by providing a video image of the patient's bronchus. This visualization helps in determining a medical condition (correct tube placement) during procedures, which falls under diagnostic activity.
No
The device description explicitly states that the system functions as a standard endobronchial tube with an embedded video imaging device, indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This includes tests performed on blood, urine, tissue, etc.
- Device Function: The ETView VivaSight-DL is an endobronchial tube with an embedded video imaging device. It is used directly on the patient (in vivo) to visualize the bronchus and verify tube placement. It does not analyze specimens derived from the body.
- Intended Use: The intended use is for isolating the lung, one lung ventilation/anesthesia, and verifying/repositioning the tube during a medical procedure. This is a procedural and visualization tool, not a diagnostic test performed on a sample.
Therefore, the ETView VivaSight-DL falls under the category of a medical device used for direct patient care and visualization, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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-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-DLTM 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung, bronchus
Indicated Patient Age Range
Adult
Intended User / Care Setting
trained personnel only
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)
ETView performed a set of performance tests in order to demonstrate that the device met its specifications. Performance testing demonstrated that the ETView VivaSight-DLTM is substantially equivalent to the cleared predicate device. The addition of the new cable adapter for connection to Ambu aView Monitor was tested through electrical safety and EMC testing and demonstrates that this addition is substantially equivalent to the predicate device.
In addition, bench tests were conducted in order to demonstrate the compatibility of the proposed adapter and Ambu aView monitor with the ETView VivaSight-DL™. The bench tests include: Video signal test, time restriction test, electronics test, image quality, IP rating and mechanical test.
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ETView Ltd. % Yoram Levy Osite General Manager Osite 31 Haavoda St. Binyamina, 3054431 Il
Re: K181886
Trade/Device Name: VivaSight-DL System Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: Class II Product Code: CBI Dated: October 26, 2018 Received: October 30, 2018
Dear Yoram 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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Todd D. Courtney -S
for Tina Kiang, Ph.D. Acting 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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Indications for Use
510(k) Number (if known) K181886
Device Name VivaSight-DL System
Indications for Use (Describe)
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-DL System is indicated for verifying tube placement and repositioning.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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VIVASIGHT
510(K) SUMMARY
VivaSight-DL™ System 510(k) Number K181886
| Applicant's Name: | ETView Ltd.
2 Orange St.
Rabin House
Misgav Business Park
M.P Misgav 2017900
Israel
Tel: (972)72-260-7063
Fax: (972)72-260-7263 |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yoram Levy, Qsite
31 Haavoda Street
Binyamina, Israel 3054431
Tel (972)4-638-8837; Fax (972)4-638-0510
Yoram@qsitemed.com |
| Trade Name: | VivaSight-DLTM System |
| Preparation Date: | November 10, 2018 |
| Classification: | Regulatory Name: Tracheal/bronchial differential ventilation tube
Product Code: CBI
Regulation No: 21 CFR 868.5740
Class: II
Panel: Anesthesiology |
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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.
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-DL™ System is indicated for verifying tube placement and repositioning.
- The device is intended to be used only on Adult and by trained Intended users: personnel only.
Predicate Devices:
Substantial equivalence to the following predicate device is claimed:
| Device Name | 510k No | Date of Clearance |
|---|---|---|
| VivaSight-DLTM | ||
| System | K123853 | April 15, 2013 |
The following table summarizes the similarities and differences between the VivaSight-DLTM and its predicate device VivaSight-DLTM System (K123853):
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| Characteristics | Proposed
VivaSight-DL TM System | VivaSight-DL System
(K123853) |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The ETView VivaSight-DL TM 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 TM System is
indicated for verifying tube
placement and repositioning. | Same |
| Product Code | CBI | Same |
| Regulation No. | 21 CFR 868.5740 | Same |
| Basic Structure | Standard EBT | Same |
| Use | Single use | Same |
| Method of
sterilization | Ethylene Oxide | Same |
| Performance Tests | Non clinical, laboratory
performance testing was
performed according to ISO
5361 and ISO 16628 | 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 | Same |
| Video Transfer | Real time image acquisition on
a continuous or intermittent
basis without disconnection the
patients from the mechanical
ventilator | Same |
| System Display | VivaSight display system
available in the following
configurations: | VivaSight display system
available in the following
configurations: |
| Characteristics | Proposed
VivaSight-DL TM System | VivaSight-DL System
(K123853) |
| | VivaSight- Max Monitor- 7" monitor VivaSight Direct- RCA cable configuration for connection to external medical display. Ambu aView monitor (not part of ETView product) - VivaSight is provided with an adapter cable to integrate the DL tubes to Ambu aView Monitor. | VivaSight- Max Monitor- 7" monitor VivaSight Direct- RCA cable configuration for connection to external medical display. |
| Shelf life | 3 years from date of sterilization | 5 years from date of sterilization |
| Packaging | Pouch, complies with EtO sterilization | Same |
| Operation
Environment | Temperature: 0 ÷ 42°C
Humidity: 10 ÷ 100% RH
Atmospheric pressure: 7.5 ÷ 15.5 PSI | Same |
| Storage Environment | Temperature: 0 ÷ 42°C
Humidity: 10 ÷ 100% RH
Atmospheric pressure: 7.5 ÷ 15.5 PSI | Same |
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Table No. 1: Comparison between the modified ETView VivaSight-DLTM and the FDA cleared ETVIEW VivaSight-DL System (K123853)
Performance Standards:
VivaSight-DL™ was tested and complies with the following standards:
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- IEC 60601-1 "Medical Electrical Equipment, General ● Requirements for Safety"
- IEC 60601-1-2 "Medical Electrical Equipment - Part 1-2: General Requirements for Safety, Collateral Standard: Electromagnetic Compatibility"
- IEC 60601-2-18 Medical Electrical Equipment Part ● 2-18: Particular requirements for the safety of endoscopic equipment
- ISO 10993-1 "Biological Evaluation of Medical ● Devices, Evaluation and Testing"
- ISO 14971 "Medical devices Application of risk ● management to medical devices"
- . ISO 5361 Anesthetic and respiratory equipment --Tracheal tubes and connectors
- ISO 16628 Tracheobronchial Tubes Sizing and ● marking.
- ISO 11135 Sterilization Of Health-Care Products . Ethylene Oxide - Requirements For The Development, Validation And Routine Control of Sterilization Process For Medical Devices.
- IEC 60601-2-18 Medical Electrical Equipment Part . 2-18: Particular requirements for the safety of endoscopic equipment
Principle of Operation:
The operation principle of VivaSight-DL System is similar to the use of standard endotracheal tubes. The use of the device should be performed according to the currently accepted medical technique.
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The ETView VivaSight-DL System enables visual navigation of the airway during intubation. Once the VivaSight-DL is in position, the airways can be inspected for accumulation of secretions and for efficacy of suctioning.
The aView adapter cable is an integrated single use video/power cable with connector between VivaSight-DL and Ambu's aView monitor. VivaSight-DL displays images of the airway onto the Ambu's aView monitor, for as long as the device remains in place during intubation.
Performance Testing
ETView performed a set of performance tests in order to demonstrate that the device met its specifications. Performance testing demonstrated that the ETView VivaSight-DLTM is substantially equivalent to the cleared predicate device. The addition of the new cable adapter for connection to Ambu aView Monitor was tested through electrical safety and EMC testing and demonstrates that this addition is substantially equivalent to the predicate device.
In addition, bench tests were conducted in order to demonstrate the compatibility of the proposed adapter and Ambu aView monitor with the ETView VivaSight-DL™. The bench tests include: Video signal test, time restriction test, electronics test, image quality, IP rating and mechanical test.
Biocompatibility:
Materials of the ETView VivaSight-DLTM system that are in contact with the human body, are identical to the predicate (K123853) and were tested and found to be biocompatible in accordance with ISO 10993-1.
9
HT
Conclusion:
ETView believes that, based on the information provided in this submission, the proposed ETView ETView VivaSight-DLTM System is substantially equivalent to its predicate device (K123853) and does not raise different questions of safety and/or effectiveness.