The ETView Tracheoscopic Ventilation Tube (TVT) is intended for intubation procedures. The ETView Tracheoscopic Ventilation Tube (TVT) 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 tube placement and repositioning, for viewing during suctioning and for general inspection of the airway.

Device Description

The ETView Tracheoscopic Ventilation Tube (TVT) System is a visualized endotracheal tube The ETV10 Pacelleosooped Pulmonx VETT System (K973191), except that the ETView System same as tiny CMOS video camera and light source and the Pulmonx device uses fiberoptic components.

AI/ML Overview

The provided document is a 510(k) summary for the ETView Tracheoscopic Ventilation Tube (TVT) System, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves acceptance criteria for a new AI/software device. As such, information regarding acceptance criteria and performance studies in the context of AI/software device evaluation (e.g., sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not present in this document.

However, I can extract information about the performance testing conducted for this device, which might be considered the "acceptance criteria" based on the substantial equivalence pathway.

Here's a summary based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Testing)	Reported Device Performance
Functional Equivalence to Predicate Device:	"Bench testing demonstrated that the Tracheoscopic Ventilation Tube (TVT) System is at least as safe and effective as the Pulmonx VETT System for oral and nasal intubation and in providing visualization of the airway."
Cuff Resting Diameter	Results "attached to this submission" (details not provided in the summary)
Resistance to Tube Collapse	Results "attached to this submission" (details not provided in the summary)
Resistance to Cuff Herniation	Results "attached to this submission" (details not provided in the summary)
Cuff Symmetry	Results "attached to this submission" (details not provided in the summary)
Air Flow Resistance	Results "attached to this submission" (details not provided in the summary)
Thermal Safety	Results "attached to this submission" (details not provided in the summary)
Imaging Performance (Higher Resolution compared to predicate)	The TVT System "provides higher video resolution and thus accuracy compared to the existing cleared device." (Specific quantitative performance details not provided in the summary).
Cuff Leak Resistance Integrity	Results "attached to this submission" (details not provided in the summary)
Mechanical Integrity (Fatigue, Burst, Cuff Compliance)	Results "attached to this submission" (details not provided in the summary)
Efficacy of Selective Suctioning	Results "attached to this submission" (details not provided in the summary)
Software Validation	Results "attached to this submission" (details not provided in the summary)
Adherence to Standards	Conforms to ISO 5361 and ANSI/AAMI/ISO 11135.

The study described is a series of bench tests and a comparison to a predicate device (Pulmonx Visualized Endotracheal Tube - VETT). The core of the "proof" is the demonstration of substantial equivalence, meaning the TVT is at least as safe and effective as the legally marketed predicate.

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

Sample Size: Not specified in the provided text. The testing was bench testing, not clinical studies with patients.
Data Provenance: Not applicable in the context of clinical data. The tests would have been performed in a laboratory setting by the manufacturer (ETView Ltd. in Israel).

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

Not applicable as this is bench testing comparing physical and functional characteristics, not evaluation of AI/software performance with human expert ground truth.

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

Not applicable as this is bench testing.

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:

No, an MRMC comparative effectiveness study was not done. This device is a physical endotracheal tube with an integrated camera, not an AI/software diagnostic tool for image interpretation.

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

Not applicable. The "imaging performance" listed refers to the camera's ability to produce an image, not an algorithm's performance.

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

For the bench tests, the "ground truth" would be the established engineering and medical device standards (e.g., ISO 5361, ANSI/AAMI/ISO 11135) and the performance characteristics of the predicate device.

8. The sample size for the training set:

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

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

Not applicable.

Summary

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DEC 13 2005

K052233

Image /page/0/Picture/2 description: The image shows the logo for "ETView Endotracheal Management". The logo is black and white. The "ET" is in a bold, blocky font, and the "View" is in a cursive font with a circle of dots above the "i". "Endotracheal Management" is written in a smaller, sans-serif font to the right of "View".

510(k) Summary

Applicant's Name	Yoram LevyConsultant
	ETView Ltd.
	Misgav Technological Center
	6 Kahol Street,
	Teradion Industrial Park
	ISRAEL 20179
	Telephone: (972)4-999-1996
	Fax: (972)4-999-1901
Contact Person:	Yoram Levy, QSite
	31 Haavoda St.
	Binyamina, Israel 30500
	Tel (972)4-638-8837; Fax (972)4-638-0510
	Yoram@qsitemed.com
A. Trade Name:	Tracheoscopic Ventilation Tube (TVT) System
B. Manufacturer:	ETView Ltd.
	Misgav Technological Center
	6 Kahol Street,
	Teradion Industrial Park
	ISRAEL 20179
	Telephone: (972)4-999-1996
	Fax: (972)4-999-1901
C. Classification:	Classification name: (1) Tracheal Tube, adult, cuffed(2) Bronchoscope, flexible
	Common/usual name: (1) Tracheal Tube (or Endotracheal Tube) with(2) image transmission, (3) integral video imager (4) external monitor, (5) Integral light source
	Class II device
	Product Code: BTR
	Regulation No.: 868.5730
D. Contract Sterilizer:	Mediplast Israel Ltd.
	7 Hayarkon St.,
	P.O.B. 13214 Yavne 81227

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Image /page/1/Picture/0 description: The image shows the logo for "ETView Endotracheal Management". The logo is black and white and features the letters "ET" in a stylized font, with a graphic of a circle with smaller circles inside it. The words "Endotracheal Management" are written in a smaller font to the right of the logo.

Tel (972)8-932-7766 Fax (972)8-932-7992

E. Reason for the Premarket Notification Submission:

New device

ETV ev intends to market the Tracheoscopic Ventilation Tube (TVT) System as an endotracheal tube that enables intubation and at the same time viewing of the airways during non-difficult and difficult intubation procedures, for verifying tube placement and repositioning, for viewing during suctioning and for general inspection of the airway. The TVT System provides higher video resolution and thus accuracy compared to the existing cleared device.

F. Identification of Legally Marketed Predicate Devices:

Pulmonx Visualized Endotracheal Tube (VETT) (K973191) Parker Medical Flex -Tip Endotracheal Tube (K984528)

G. Performance Standards or Special Controls:

The ETView TVT conforms to ISO 5361 (Dated December 15, 1999) and to Anaesthetic and Respiratory Equipment - Tracheal Tubes and Connectors. This standard replaces ASTM F 1242-96, "Standard Specification for Cuffed and Uncuffed Tracheal Tubes for the same devices, except where stated

The TVT conforms to ANSI/AAMI/ISO 11135 (Medical devices - Validation and routine control of ethylene oxide sterilization).

H. Indications for Use:

The ETView Tracheoscopic Ventilation Tube (TVT) is intended for oral and nasal intubation.

The ETView Tracheoscopic Ventilation Tube (TVT) System has the following specific indications:

Temporary artificial airway in adults requiring mechanical ventilation, for oral and . nasal intubation.
Viewing during non-difficult and difficult intubation procedures, for verifying tube . placement and repositioning, for viewing during suctioning and for general inspection of the airway.

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Image /page/2/Picture/0 description: The image shows the logo for "ETview Endotracheal Management". The logo is black and white and features the text "ETview" in a stylized font. To the right of the text is the phrase "Endotracheal Management" in a smaller, simpler font. The logo is likely used to represent a company or product related to endotracheal management.

I. Technological Characteristics:

J. Performance Testing

Bench testing demonstrated that the Tracheoscopic Ventilation Tube (TVT) System is at least as Donor loomig demonstrations and Pulmonx VETT System for oral and nasal intubation and in providing visualization of the airway.

The following performance tests have been done and the results are attached to this submission: Determination of Cuff Resting Diameter, Resistance to Tube Collapse, Resistance to Cuff Herniation, Cuff Symmetry, Air Flow Resistance, Thermal Safety, Imaging Performance, Cuff Leak Resistance Integrity, Mechanical Integrity ( Fatigue, Burst, and Cuff Compliance as part of the Mechanical Integrity test), Efficacy of Selective Suctioning, Software Validation.

K. Comparison to the Predicate Device

The ETView Tracheoscopic Ventilation Tube (TVT) System has the same intended use, general and specific indications and principles of operation as the cleared Pulmonx Visualized Endotracheal Tube (VETT) System.

In addition, the TVT employs similar technology as the cleared VETT except for the different type of camera and illumination.

The TVT has two Murphy eyes like the Parker Medical Flex -Tip Endotracheal Tube (K984528), and an additional lens clearing lumen. The inherent radiopacity of the TVT obviates the need for a radiopaque strip.

The minor differences between the TVT and the VETT do not raise any new questions of safety or efficacy. Moreover, bench testing of the TVT System (bench testing is provided in Attachments 6B, and 6C) demonstrated that the TVT is as safe and effective as the VETT. Thus, the ETView TVT System is substantially equivalent to the already cleared VETT System.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2005

ETView Limited Mr. Yoram Levy QSite 31 Haavoda Street Binyamina, ISRAEL 30500

Re: K052233

Trade/Device Name: Tracheoscopic Ventilation Tube (TVT) Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: November 28, 2005 Received: December 7, 2005

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Please be advised that FDA Sissuance of a sabstanter and busether Fodarel agencies mean that FDA has made a decemmance in administered by other Federal agencies.
of the Act or any Federal statutes and regulations and regulations negistration of the Act of ally rederal statutes and regirements, including, but not limited to: registration
You must comply with all the Act's requirements, including and recurse You must comply with an the Act 3 requirements (100); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing (21 CFR Part 8 and listing (21 CFR Part 807), laocing (21 OFF Parvals on (21 CFR Patt 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Patt 820); and if requirements as set form in the quality systems (QD) regained (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k)
the success of the consisted on the first of the spinsions of your device to a I his letter will anow you to begin maliceant 5 your device of your device to a
premarket notification. The FDA finding of substantial equivalence and thus, pa premarket notification. The PDA miding of substants of Submitted on the spermits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), If you desire specific advice for your device of our our and on please note the regulation please contact the Office or Comphanes an (210) - 11 CFR Part 807.97). You
entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free DIVIsion of Simall Manufactar (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sylte y. Michael Oms.

Chiu Lin, Ph.D. 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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Image /page/5/Picture/0 description: The image shows the logo for ETView Endotracheal Management. The logo is in black and white and features the letters "ET" in a stylized font. To the right of the letters is the word "View" with a graphic of a circle with dots inside. The words "Endotracheal Management" are to the right of the logo.

510(k) Number (if known): イインS223

Tracheoscopic Ventilation Tube (TVT) Device Name: for . Indications The ETView Tracheoscopic Ventilation Tube (TVT) is intended Use: for intubation procedures. The ETView Tracheoscopic Ventilation Tube (TVT) 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 tube placement and repositioning, for viewing during suctioning and for general inspection of the airway.

AND/OR Use X ________________________________________________________________________________________________________________________________________________________________________ Prescription (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 Cardiovascular, Respiratory and Neurological Devices 510(k) Number

ાયન mon dign-Of ) trian of Aheathesicingy, General Hospital, John Control, Dantal Devices - Nomber

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ETView Ltd., Misgav Technological Center, Teradion Industrial Zone, 20179 israel

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).