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.

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.

AI/ML Overview

This FDA 510(k) summary for the VivaSight-DL System focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for a novel AI device. Therefore, much of the requested information regarding AI device acceptance criteria, study design, and performance cannot be extracted from this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific performance criterion (e.g., accuracy, sensitivity, specificity) for the device's diagnostic or assistive capabilities (like verifying tube placement) are provided in a quantitative manner. The document asserts that the device "met its specifications" and performed "substantially equivalent" to the predicate, but it does not detail those specifications or present performance data against them.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This document describes performance testing primarily through bench tests and engineering evaluations, not a clinical test set with patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No clinical ground truth establishment is described for a test set.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not mentioned. The document primarily focuses on demonstrating substantial equivalence through technical comparisons and bench testing.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

No standalone performance of an AI algorithm is described. The device, a video-enabled endotracheal tube, provides visual information to a human user for verification of tube placement.

7. Type of Ground Truth Used

The ground truth for the device's function (providing a video image for placement verification) implicitly relies on established medical practice for observing and confirming tube placement. However, for the performance testing described in the document, the "ground truth" was likely derived from engineering specifications, successful completion of bench tests (e.g., video signal clarity, mechanical integrity), and compliance with standards.

8. Sample Size for the Training Set

Not applicable. This device is not described as an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of Relevant Information from the Document:

While the document doesn't provide the requested AI-specific details, it does state the following regarding device performance and testing:

Acceptance Criteria (Implied / Indirectly stated):
- Compliance with various international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, ISO 10993-1, ISO 14971, ISO 5361, ISO 16628, ISO 11135).
- Functional equivalence to the predicate device (K123853).
- Satisfactory results from bench tests to demonstrate compatibility of the new adapter with the Ambu aView monitor (including Video signal test, time restriction test, electronics test, image quality, IP rating, and mechanical test).
- Biocompatibility in accordance with ISO 10993-1.
Study Proving Acceptance Criteria:
- Type of Study: Performance testing, primarily non-clinical laboratory performance testing and bench tests.
- Details:
  - Non-clinical, laboratory performance testing performed according to ISO 5361 and ISO 16628.
  - Electrical safety and EMC testing for the new cable adapter.
  - Bench tests for compatibility with the Ambu aView monitor, including:
    - Video signal test
    - Time restriction test
    - Electronics test
    - Image quality
    - IP rating
    - Mechanical test
  - Biocompatibility testing (for materials in contact with the human body, found to be identical to the predicate and compliant with ISO 10993-1).
Device Performance (as reported): The performance testing "demonstrated that the ETView VivaSight-DLTM is substantially equivalent to the cleared predicate device." The new cable adapter and its integration were also demonstrated to be substantially equivalent.

This 510(k) submission focuses on demonstrating substantial equivalence to a previously cleared device, rather than presenting a novel AI algorithm's performance. The "acceptance criteria" are therefore framed around meeting established standards and demonstrating technical and functional similarity to the predicate, with bench testing as the primary method of proof.

Summary

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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

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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)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

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VIVASIGHT

510(K) SUMMARY

VivaSight-DL™ System 510(k) Number K181886

Applicant's Name:	ETView Ltd.2 Orange St.Rabin HouseMisgav Business ParkM.P Misgav 2017900IsraelTel: (972)72-260-7063Fax: (972)72-260-7263
Contact Person:	Yoram Levy, Qsite31 Haavoda StreetBinyamina, Israel 3054431Tel (972)4-638-8837; Fax (972)4-638-0510Yoram@qsitemed.com
Trade Name:	VivaSight-DLTM System
Preparation Date:	November 10, 2018
Classification:	Regulatory Name: Tracheal/bronchial differential ventilation tubeProduct Code: CBIRegulation No: 21 CFR 868.5740Class: IIPanel: Anesthesiology

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Device Description:

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-DLTMSystem	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	ProposedVivaSight-DL TM System	VivaSight-DL System(K123853)
Indications for Use	The ETView VivaSight-DL TM is intended to isolate the left orright lung of a patient for intensive care or surgery, onelung ventilation or one lunganesthesia.The VivaSight-DL TM System isindicated for verifying tubeplacement and repositioning.	Same
Product Code	CBI	Same
Regulation No.	21 CFR 868.5740	Same
Basic Structure	Standard EBT	Same
Use	Single use	Same
Method ofsterilization	Ethylene Oxide	Same
Performance Tests	Non clinical, laboratoryperformance testing wasperformed according to ISO5361 and ISO 16628	Same
EBT Material	Thermo-sensitive flexiblemedical grade Poly VinylChloride (PVC)	Same
Imaging Sensor	CMOS video camera	Same
Tube Dimensions	35FR, 12.5x13.5mm37FR: 13.0x14.0mm39FR, 13.5x14.5mm41FR, 14.0x15.0mm	Same
Video Transfer	Real time image acquisition ona continuous or intermittentbasis without disconnection thepatients from the mechanicalventilator	Same
System Display	VivaSight display systemavailable in the followingconfigurations:	VivaSight display systemavailable in the followingconfigurations:
Characteristics	ProposedVivaSight-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
OperationEnvironment	Temperature: 0 ÷ 42°CHumidity: 10 ÷ 100% RHAtmospheric pressure: 7.5 ÷ 15.5 PSI	Same
Storage Environment	Temperature: 0 ÷ 42°CHumidity: 10 ÷ 100% RHAtmospheric 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.

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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.

Regulation Number and Section

§ 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).