The ETView Tracheoscopic Ventilation Tube (TVTM) is intended for intubation procedures. The ETView Tracheoscopic Ventilation Tube (TVTM) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations.

The TVT" 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.

Device Description

The ETView Tracheoscopic Ventilation Tube (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 TVTTM is inside the patient's trachea.

AI/ML Overview

The provided text does not contain information about acceptance criteria or specific studies detailing device performance against those criteria. It focuses on regulatory approval (510(k) submission) for the ETView Tracheoscopic Ventilation Tube System (TVT™).

Here's an analysis of what is available:

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

This information is not present in the provided text. The document states that the device was "tested and complies with" several ISO and ANSI/AAMI standards, and that "Performance testing demonstrated that the ETView Tracheoscopic Ventilation Tube (TVT™) is as safe and effective as the cleared predicate device." However, it does not specify the acceptance criteria for these tests or the quantitative results of the performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not present in the provided text. The document refers to "Performance Testing" in general terms but does not detail the methodology, sample sizes, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not present in the provided text. The document does not describe any specific studies relying on expert ground truth for a test set.

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

This information is not present in the provided text.

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:

This information is not present in the provided text. The device described is an endotracheal tube with an embedded video imaging device, not an AI-powered diagnostic tool for which an MRMC study would typically be conducted.

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

This information is not present in the provided text. The device provides a video image to a human user, implying human-in-the-loop performance, rather than standalone algorithmic performance.

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

This information is not present in the provided text.

8. The sample size for the training set:

This information is not present in the provided text. If any training was done for an embedded system, it is not described.

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

This information is not present in the provided text.

Summary of what is discussed in the provided text regarding device performance and compliance:

The ETView Tracheoscopic Ventilation Tube (TVT™) was found to be "substantially equivalent" to its predicate device (ETView Tracheoscopic Ventilation Tube K082420 and Coopdech Endobronchial Blocker tube K093888).

The device "was tested and complies with the following standards":

ISO 5361:1999 Anesthetic 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

The document states that "Performance testing demonstrated that the ETView Tracheoscopic Ventilation Tube (TVT™) is as safe and effective as the cleared predicate device" and that "the minor addition to the indication for use is safe and effective." Additionally, materials in contact with the human body were "tested and found to be biocompatible in accordance with ISO 10993-1." However, the specific details of these performance tests, including acceptance criteria, sample sizes, and quantitative results, are not provided in this summary.

Summary

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K 121028 510(K) SUMMARY

ETVIEW TRACHEOSCOPIC VENTILATION TUBE SYSTEM (TVT™)

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@gsitemed.com

Trade Name:

ETView Tracheoscopic Ventilation Tube System (TVTM)

Device Type: Tracheal tube Preparation Date: April 01, 2012

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 Tracheoscopic Ventilation Tube (TVT™) is intended for intubation procedures. The ETView Tracheoscopic Ventilation Tube (TVTM) is indicated for use as a temporary

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

Device Description:

substantially equivalent to the following predicate devices: Predicate Device:

ETView Tracheoscopic Ventilation Tube (TVTTM)	K082420	October 8,2008
Coopdech Endobronchial Blocker tube	K093888	March 16.2010

Performance Standards

ETView Tracheoscopic Ventilation Tube (TVT™) was tested and complies with the following standards:

ISO 5361:1999 Anesthetic 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

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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 ETView Tracheoscopic Ventilation Tube (TVT™) is as safe and effective as the cleared predicate device. The performance testing demonstrated that the minor addition to the indication for use is safe and effective. A detailed description appears in Section 14.

Technological Characteristics

Both the proposed ETView Tracheoscopic Ventilation Tube (TVTTM) device and its predicate device (ETView Tracheoscopic Ventilation Tube K082420) 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 Tracheoscopic Ventilation Tube (TVTIM) system that are in contact with the human body, are identical to the predicate (K082420) and were tested and found to be biocompatible in accordance with ISO 10993-1.

Conclusion:

ETView Ltd. believes that, based on the information provided in this submission, the proposed ETView Tracheoscopic Ventilation Tube (TVTTM) System is substantially equivalent to its predicate device without raising any new safety and/or effectiveness concerns.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a base resembling intertwined snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 2 1 2012

Etview Limited C/O Mr. Yoram Levy Regulatory Consultant Osite 31 Haavoda Street Binyamina 30500 Israel

Re: K121028

Trade/Device Name: ETView Tracheoscopic Ventilation Tube (TVT™) Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: April 1, 2012 Received: April 5, 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.

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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 foc

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

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name:

ETView Tracheoscopic Ventilation Tube (TVTTM)

Indications for Use:

The TVT 14 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.

Prescription Use AND/OR X (Part 21 CFR 801 Subpart D)

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

Schalk

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K121028

ETView. | TVT™ 510k Notification

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510(k) Number:

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).