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.

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.

AI/ML Overview

The provided text describes a medical device, the ETView VivaSight-SL (TVT) system, and its substantial equivalence to a predicate device, but it does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or the detailed aspects of such a study as requested in your prompt.

The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria in the way you've outlined.

Based on the provided text, I can extract the following limited information:

1. A table of acceptance criteria and the reported device performance:

The document mentions compliance with several standards but does not provide a table of specific acceptance criteria for performance metrics or reported device performance in quantitative terms. Instead, it states that "Performance testing demonstrated that the ETView VivaSight-SL (TVT™) is substantially equivalent to the cleared predicate device."

2. Sample sized used for the test set and the data provenance:

Not specified. The document refers to "performance testing" and "bench tests" but does not give sample sizes or details on data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as a study with expert-established ground truth is not described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The device is a video-enabled endotracheal tube, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The device is a physical medical instrument with an embedded video imaging device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. The performance testing mentioned primarily relates to compliance with engineering and safety standards (ISO, IEC).

8. The sample size for the training set:

Not applicable, as this is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary of available information related to performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (ETView VivaSight-SL K121028) by comparing "Technological Characteristics" and stating compliance with recognized performance and safety standards.

Performance Standards Mentioned:
- 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
Performance Testing Done:
- "ETView performed a set of performance test according to ISO5361 requirements." These tests "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" to ensure it "does not raise different questions of safety or effectiveness."
- "Bench tests were conducted in order to demonstrate the compatibility of the proposed adapter and Ambu aView monitor with the ETView VivaSight-SL (TVT™)." These tests included: Video signal test, time restriction test, electronics test, image quality, IP rating, and mechanical test.
Biocompatibility:
- "Materials of the ETView VivaSight-SL (TVT™) system that are in contact with the human body, are identical to the predicate (K121028) and were tested and found to be biocompatible in accordance with ISO 10993-1."

The document concludes that the device is substantially equivalent to its predicate without raising different questions of safety and/or effectiveness based on this testing. Specific quantitative acceptance criteria or detailed study results are not provided in this 510(k) summary.

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)

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)

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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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:

Predicate Device: Substantially equivalent to the following predicate devices:

Device Name	Manufacturer	510k No	Date ofClearance
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 forintubation procedures. TheETView VivaSight-SL ( TVT TM)is indicated for use as a temporaryartificial airway in adultsrequiring mechanical ventilation.It is intended for oral intubations.The VivaSight-SL ( TVT TM)System is indicated for viewingduring non-difficult and difficultintubation procedures, forverifying endotracheal tube andendobronchial blocker placementand repositioning, for viewingduring suctioning and for generalinspection of the airway.	The ETView VivaSight-SL( TVT TM) is intended forintubation procedures. TheETView VivaSight-SL( TVT TM) is indicated for use asa temporary artificial airway inadults requiring mechanicalventilation. It is intended fororal and nasal intubations.The VivaSight-SL ( TVT TM)System is indicated for viewingduring non-difficult anddifficult intubation procedures,for verifying endotracheal tubeand endobronchial blockerplacement and repositioning,for viewing during suctioningand for general inspection ofthe airway.
Product Code	BTR	Same
Regulation No.	21 CFR 868.5730	Same
Classification	Class II	Same
Supplied/use	Single use	Same
Method ofSterilization	EtO	Same
Characteristics	Proposed ETView VivaSight-SL(TVT) system	ETView VivaSight-SL(TVT)system (K121028)
Basic structure	Standard ETT	Same
ETT Material	Medical grade Polyvinyl Chloride(PVC)	Same
Imaging sensor	CMOS video camera	Same
Tube Dimensions:Internal Diameter	Three models:• ID 7.0 mm• ID 7.5 mm• ID 8.0 mm	Same
Tube Dimensions:Outer Diameter	• OD 10.0 mm• OD 10.5 mm• OD 11.0 mm	Same
Cuff	Medical grade PVC, High volume,low pressure	Same
Bevel	Opening to the bottom with thecamera on the top	Same
Video transfer	Video transfer: Colored real timeimage acquisition from the apertureof the tracheal lumen on a continuousor intermittent basis withoutdisconnecting the patient from themechanical ventilator	Same
Video Format	Composite Video Baseband Signal(CVBS)-NTSC	Same
Characteristics	Proposed ETView VivaSight-SL(TVT) system	ETView VivaSight-SL(TVT)system (K121028)
Display system	VivaSight display systemavailable in the followingconfigurations:VivaSight- Max Monitor- 7"monitor VivaSight Direct- RCA cableconfiguration for connection toexternal medical display. Ambu aView monitor (not partof ETView product) -VivaSight is provided with anadapter cable to integrate theSL tubes to Ambu aViewmonitor.	VivaSight display systemavailable in the followingconfigurations:VivaSight- Max Monitor- 7"monitor VivaSight Direct- RCAcable configuration forconnection to externalmedical display.
Number of MurphyEyes	2	2
Shelf life/life cycle	3 years	5 years
Packaging	EtO pouch	Same
Electrical Safety	Electrical Safety andElectromagnetic Compatibility datademonstrates that the system (tubeand display system) is compliancewith IEC 60601-1 and IEC 60601-1-2	Same
Performance tests	Nonclinical laboratoryperformance testing wasperformed according to ISO 5361	Same

Substantial Equivalence to Predicate device

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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.

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).