The ETView Viva EB is designed to administer one-lung ventilation, by using a conventional endotracheal tube and a fiber optic bronchoscope. The device consists of a bronchial blocker tube, advanced through an endotracheal tube, and a joint connector, connecting the bronchial blocker tube to the endotracheal catheter. A cuff, incorporated at the distal tip of the tube, is inflated to block the targeted bronchus.

AI/ML Overview

The provided document is a 510(k) summary for the ETView Viva EB, an endobronchial blocker. This type of regulatory submission primarily focuses on establishing "substantial equivalence" to predicate devices, rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way a clinical trial for a novel drug or a high-risk device might.

Therefore, the information available in the document does not include the detailed breakdown of acceptance criteria and a study proving those criteria were met in the typical sense for an AI/algorithm-based device. Instead, it focuses on demonstrating that the device is as safe and effective as previously cleared devices through performance testing against established standards and a comparison of features.

Here's an analysis based on the provided text, addressing your points where possible, and noting limitations:

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

The document does not explicitly state "acceptance criteria" and "reported device performance" in a quantitative table format for a clinical outcome. Instead, it states that the device was tested and complies with several ISO/ANSI standards. These standards inherently contain performance criteria that must be met. The "Performance Testing" section lists the types of tests conducted, implying that the device met the requirements outlined in those tests and standards.

Since specific quantitative acceptance criteria and their corresponding reported performance values are not provided in the text for clinical outcomes, I will list the types of performance tests conducted, implying they met the underlying standard requirements.

Performance Test Category	Reported Device Performance (Implicitly Met)
Analysis of cuff to shaft bond strength and burst test	Complies with relevant requirements (e.g., ISO 5361)
Analysis of deflection angle	Complies with relevant requirements (e.g., ISO 5361)
Analysis of cuff shape at various pressure	Complies with relevant requirements (e.g., ISO 5361)
Analysis of cuff dimension at various volumes	Complies with relevant requirements (e.g., ISO 5361)
Analysis of balloon cuff inflation retention	Complies with relevant requirements (e.g., ISO 5361)
The dimension and the ports of the joint connector	Complies with relevant requirements (e.g., ISO 5361)
Cuff Herniation	Complies with relevant requirements (e.g., ISO 5361)
Cuff Resting Diameter	Complies with relevant requirements (e.g., ISO 5361)
Cuff Symmetry	Complies with relevant requirements (e.g., ISO 5361)
Resistance to Tube Collapse	Complies with relevant requirements (e.g., ISO 5361)
VivaSight-SL (TVTTM) Blocker Compatibility	Demonstrated compatibility

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

The document describes performance testing which refers to engineering and bench testing relevant to the physical properties and functionality of the device (e.g., cuff strength, dimensions, inflation). It does not describe a clinical study in humans or animals with a "test set" sample size for evaluating clinical efficacy or safety in a patient population. Therefore, this information is not available in the provided text. The "data provenance" similarly refers to the bench testing environment, not patient data.

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 N/A. The testing described is physical performance testing, not involving expert interpretation or "ground truth" establishment in a clinical context.

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

This N/A for the same reasons as above.

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 N/A. The device is an endobronchial blocker, a physical medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies are not applicable.

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

This N/A. The device is a physical medical device, not an algorithm.

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

For the physical performance tests, the "ground truth" would be established by the engineering specifications and established standards (e.g., ISO 5361). The device's performance is compared against these predetermined specifications to ensure compliance.

8. The sample size for the training set

This N/A. The device is a physical medical device, and the testing described is not related to machine learning or AI.

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

This N/A. (See point 8)

Summary of what the document does provide regarding meeting criteria:

The primary method for "proving" the device meets acceptance criteria, in the context of this 510(k) submission, is through:

Compliance with recognized international standards: ISO 5361:1999, ANSI/AAMI/ISO 11135-1:2007, ISO 14971-1:2007, and ISO 10993-1:2003(E). These standards define performance and safety requirements.
Performance Testing: A series of specific engineering tests (listed under "Performance Testing" in section {2}) were conducted to demonstrate that the device functions as intended and meets the requirements stipulated by the standards, and is comparable to predicate devices.
Substantial Equivalence: The overarching study and argument is that the Viva EB is "as safe and effective as the cleared predicate devices" and that its "minor differences...do not raise any new questions of safety or efficacy." This is the core of a 510(k) submission.

In essence, for this type of device and regulatory pathway, the "acceptance criteria" are the requirements outlined in the referenced standards and the implicit performance demonstrated by predicate devices, and the "study" is the battery of engineering/bench tests confirming the device's physical properties and functionality meet these criteria.

Summary

{0}------------------------------------------------

SETVIEW Airway Management ----------------------------------------------------------------------------------------------------------------------------------------------------

K120334

510(K) SUMMARY

JUN - 8 2012

Viva EB

510(k) Number K_______________________________________________________________________________________________________________________________________________________________

Applicant's Name:	ETView Ltd.17 Tchelet StreetMisgav Business ParkM.P Misgav 20174IsraelTel: (972)72-260-7063Fax: (972)72-260-7263
Contact Person:	Yoram Levy, Qsite31 Haavoda St.Binyamina, Israel 30500Tel (972)4-638-8837Fax (972)4-638-0510Yoram@qsitemed.com
Trade Name:	Viva EB
Device Type:	Endobronchial Blocker
Preparation Date:	January 31, 2012
Classification:	Regulatory Name: Tracheal/bronchial differential ventilation tubeProduct Code: CBIRegulation No: 21 CFR 868.5740Class: IIClassification Panel: Anesthesiology

Viva EB – 510k Notification

{1}------------------------------------------------

Device Description:

Intended Use Statement:

The ETView Viva EB is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.

Substantial equivalence to the following predicate devices is claimed: Predicate Devices:

Device Name	510k No	Date ofClearance
Daiken Medical CoopdechEndobronchial Blocker Tube	K071694	March 20, 2008
Cook Incorporated 7.0 Fr.Endobronchial Blocker	K021920	August 14, 2002

Performance Standards

Viva EB was tested and complies with the following standards:

ISO 5361:1999 Anaesthetic 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

A detailed description appears in Section 14.

Performance Testing

Performance testing demonstrated that the Viva EB is as safe and effective as the cleared predicate devices.

The following performance tests were conducted:

Viva EB - 510k Notification

{2}------------------------------------------------

Analysis of cuff to shaft bond strength and burst test .
Analysis of deflection angle .
Analysis of cuff shape at various pressure ●
Analysis of cuff dimension at various volumes .
Analysis of balloon cuff inflation retention .
The dimension and the ports of the joint connector ●
. Cuff Herniation
Cuff Resting Diameter .
Cuff Symmetry .
Resistance to Tube Collapse ●
VivaSight-SL (TVTTM) Blocker Compatibility .

Comparison to the Predicate Devices

The intended use of the Viva EB is identical to the intended use of Daiken Medical Coopdech Endobronchial Blocker Tube, cleared under K071694.

Both the ETView Viva EB and Daiken Medical Coopdech Endobronchial Blocker Tube are designed to administer one-lung ventilation, by using a conventional endotracheal tube and a fiber optic bronchoscope. The device parts, the structure, the principle of operation and the sterilization method of the Viva EB are similar to the cleared Coopdech Endobronchial Blocker Tube.

The minor differences between the Viva EB and its predicate devices do not raise any new questions of safety or efficacy. Moreover, performance testing demonstrated that the Viva EB is as safe and effective as the predicate devices. Thus, the Viva EB is substantially

equivalent to Daiken Medical Coopdech Endobronchial Blocker

Tube and Cook Incorporated 7.0 Fr. Endobronchial Blocker.

Viva EB - 510k Notification

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

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

JUN - 8 2012

Re: K120334

Trade/Device Name: Viva EB Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: II Product Code: CBI Dated: May 23, 2012 Received: May 29, 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.

{4}------------------------------------------------

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 for

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

{5}------------------------------------------------

SETVIEW Airway Management

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name:

Viva EB

Indications for Use:

The ETView Viva EB is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.

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

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

L. Shutte
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K120334

Viva EB - 510k Notification

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).