Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a video-enabled endotracheal tube for visualization during intubation and airway inspection. There is no mention of AI, ML, image processing for analysis, or any data processing beyond displaying the video feed. The performance studies focus on standard device functionality and compatibility, not algorithmic performance.

Therapeutic

No.
The device is described as an artificial airway for intubation procedures and for viewing the airway, which are diagnostic and procedural support functions rather than direct therapeutic interventions to treat a disease or condition.

Diagnostic

Yes

The device aids in verifying the placement of endotracheal tubes and endobronchial blockers, and for general inspection of the airway, which are diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "single use, cuffed device that functions as a standard endotracheal tube (ETT) and additionally has an embedded video imaging device embedded in a dedicated lumen." This indicates the device includes physical hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The intended use is for intubation procedures, providing a temporary artificial airway, viewing during intubation, verifying tube placement, and general airway inspection. These are all procedures performed in vivo (within the living body).
Device Description: The device is an endotracheal tube with an embedded video imaging device. It functions as an airway device and provides video of the trachea while inside the patient.
Anatomical Site: The anatomical site is the trachea and airway, which are internal structures of the body.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information about a patient's health status, diagnosis, or treatment.

IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is used directly within the body for procedural and visualization purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ETView VivaSight-SL (TVT) is intended for intubation procedures. The ETView VivaSight-SL (TVTM) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral intubations. The VivaSight-SL (TVT) System is indicated for viewing during non-difficult intubation procedures, for verifying endotracheal tube and endobronchial blocker placement and repositioning, for viewing and for general inspection of the airway.

Product codes (comma separated list FDA assigned to the subject device)

BTR

Device Description

The ETView VivaSight-SL (TVT™) is a single use, cuffed device that functions as a standard endotracheal tube (ETT) and additionally has an embedded video imaging device embedded in a dedicated lumen. The system provides a video image of the patient's trachea, which is displayed on the monitor, for as long as the VivaSight-SL (TVT™) is inside the patient's trachea.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Video

Anatomical Site

Trachea, Airway

Indicated Patient Age Range

Adults

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)

ETView performed a set of performance test according to ISO5361 requirements. Performance testing demonstrated that the ETView VivaSight-SL (TVT™) is substantially equivalent to the cleared predicate device.

The addition of the new adapter for connection to Ambu aView Monitor was tested through electrical safety and EMC testing and demonstrates that this addition does not raise different questions of safety or effectiveness.

In addition, bench tests were conducted in order to demonstrate the compatibility of the proposed adapter and Ambu aView monitor with the ETView VivaSight-SL (TVT™). 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): 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.

K121028

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

Regulation Number and Section

§ 868.5730 Tracheal tube.

(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

ETView Ltd. % Yoram Levy Osite General Manager Osite 31 Haavoda St. Binyamina. 30500 Il

Re: K181880

Trade/Device Name: VivaSight-SL (TVT) system Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (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

Tina Kiang, Ph.D. for 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) K181880

Device Name VivaSight-SL

Indications for Use (Describe)

The ETView VivaSight-SL (TVT) is intended for intubation procedures. The ETView VivaSight-SL (TVTM) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral intubations.

The VivaSight-SL (TVT) System is indicated for viewing during non-difficult intubation procedures, for verifying endotracheal tube and endobronchial blocker placement and repositioning, for viewing and for general inspection of the airway.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for VivaSight. The word "VIVA" is in blue, and the word "SIGHT" is in orange. There is an orange dot above the letter "I" in "VIVA."

510(K) SUMMARY

ETVIEW VIVASIGHT-SL SYSTEM (TVTTM)

510(k) Number K181880

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 St. Binyamina, Israel 3054431 Tel (972)4-638-8837 Fax (972)4-638-0510 Yoram@qsitemed.com
ETView VivaSight-SL System (TVTTM) Trade Name:

Device Type: Tracheal tube Preparation Date: November 7, 2018 Classification and Classification Name:

Name: Tracheal tube Product Code: BTR Regulation No: 21 868.5730 Class: II Panel: Anesthesiology

Indications for Use Statement:

The ETView VivaSight-SL (TVT™) is intended for intubation procedures. The ETView VivaSight-SL (TVT™) is indicated for use as a temporary

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artificial airway in adults requiring mechanical ventilation. It is intended for oral intubations.

The VivaSight-SL (TVT™) System is indicated for viewing during nondifficult and difficult intubation procedures, for verifying endotracheal tube and endobronchial blocker placement and repositioning, for viewing during suctioning and for general inspection of the airway.

Device Description:

The ETView VivaSight-SL (TVT™) is a single use, cuffed device that functions as a standard endotracheal tube (ETT) and additionally has an embedded video imaging device embedded in a dedicated lumen. The system provides a video image of the patient's trachea, which is displayed on the monitor, for as long as the VivaSight-SL (TVT™) is inside the patient's trachea.

Predicate Device: Substantially equivalent to the following predicate devices:

| Device Name | Manufacturer | 510k No | Date of
Clearance |
|----------------------|--------------|---------|----------------------|
| VivaSight-SL (TVTTM) | ETView | K121028 | June 21, 2012 |

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| Characteristics | Proposed ETView VivaSight-
SL(TVT) system | ETView VivaSight-SL(TVT)
system (K121028) |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The ETView VivaSight-SL
( TVT TM) is intended for
intubation procedures. The
ETView VivaSight-SL ( TVT TM)
is indicated for use as a temporary
artificial airway in adults
requiring mechanical ventilation.
It is intended for oral intubations.

The VivaSight-SL ( TVT TM)
System is indicated for viewing
during non-difficult and difficult
intubation procedures, for
verifying endotracheal tube and
endobronchial blocker placement
and repositioning, for viewing
during suctioning and for general
inspection of the airway. | The ETView VivaSight-SL
( TVT TM) is intended for
intubation procedures. The
ETView VivaSight-SL
( TVT TM) is indicated for use as
a temporary artificial airway in
adults requiring mechanical
ventilation. It is intended for
oral and nasal intubations.

Substantial Equivalence to Predicate device

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г

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Performance Standards

ETView VivaSight-SL (TVT™) was tested and complies with the following standards:

. ISO 5361 Anesthetic and respiratory equipment -- Tracheal tubes and connectors
ISO 11135 Sterilization of health care products Ethylene . oxide
ISO 14971-1 Risk management for medical devices
ISO 10993-1 Biological evaluation of medical devices -- Part ● 1: Evaluation and testing
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

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.

The ETView VivaSight-DL System enables visual navigation of the airway during intubation, reducing the need for direct laryngoscopy and providing absolute verification of tube position, while enabling uninterrupted ventilation. 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.

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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 test according to ISO5361 requirements. Performance testing demonstrated that the ETView VivaSight-SL (TVT™) is substantially equivalent to the cleared predicate device.

The addition of the new adapter for connection to Ambu aView Monitor was tested through electrical safety and EMC testing and demonstrates that this addition does not raise different questions of safety or effectiveness.

In addition, bench tests were conducted in order to demonstrate the compatibility of the proposed adapter and Ambu aView monitor with the ETView VivaSight-SL (TVT™). The bench tests include: Video signal test, time restriction test, electronics test, image quality, IP rating and mechanical test.

Technological Characteristics

Both the proposed ETView VivaSight-SL (TVT™) device and its predicate device (ETView VivaSight-SL K121028) function as a standard endotracheal tube (ETT) that additionally has an embedded video imaging device in a dedicated lumen. The system provides video image of patient's trachea that is displayed for as long as the ETT is inside the patient's trachea.

Biocompatibility:

Materials of the ETView VivaSight-SL (TVT™) system that are in contact with the human body, are identical to the predicate

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(K121028) and were tested and found to be biocompatible in accordance with ISO 10993-1.

Conclusion:

ETView believes that, based on the information provided in this submission, the proposed ETView VivaSight-SL (TVT™) System is substantially equivalent to its predicate device without raising different questions of safety and/or effectiveness.