ETView VivaSight-SL (TVT) system

K152438 · Etview , Ltd. · BTR · Feb 25, 2016 · Anesthesiology

Device Facts

• Record ID: K152438
• Device Name: ETView VivaSight-SL (TVT) system
• Applicant: Etview , Ltd.
• Product Code: BTR · Anesthesiology
• Decision Date: Feb 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ETView VivaSight-SL (TVT™) is intended for intubation procedures. The ETView VivaSight-SL (TVT™) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations. The VivaSight-SL (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. VivaSight-SL (TVT™) System is compatible for use with standard Laryngeal Mask Airway (LMA).

Device Story

Single-use cuffed endotracheal tube (ETT) with embedded video imaging device in dedicated lumen; provides real-time tracheal video feed to external monitor; used by clinicians for intubation, tube placement verification, and airway inspection; compatible with Laryngeal Mask Airway (LMA); facilitates continuous visualization during mechanical ventilation; aids in repositioning and suctioning; benefits patient by ensuring correct tube placement and monitoring airway patency.

Clinical Evidence

Bench testing only. Performance testing verified compatibility with LMA, including insertion, operation, resistance to tube collapse, and safe LMA removal. Additional testing (cuff integrity, airflow resistance, thermal safety, camera durability, and imaging performance) was leveraged from identical predicate K121028.

Technological Characteristics

Single-use cuffed ETT with integrated video camera; materials identical to K121028, biocompatible per ISO 10993-1; complies with ISO 5361 (tracheal tubes), IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60601-2-18 (endoscopic equipment); sterilized via Ethylene Oxide (ISO 11135).

Indications for Use

Indicated for adults requiring mechanical ventilation as a temporary artificial airway; for use in oral and nasal intubations; for airway visualization during intubation, verification of tube/blocker placement, suctioning, and general airway inspection; compatible with Laryngeal Mask Airway (LMA).

Regulatory Classification

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.

Predicate Devices

• VivaSight-SL (TVT™) (K121028)
• IntubaidFlex (K090777)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure composed of three curved lines, representing the department's mission of protecting the health of all Americans and providing essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.

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

February 25, 2016

ETView Ltd. % Yoram Levy General Manager Qsite 31 Haavoda St. Binvamina. Israel 30500

Re: K152438

Trade/Device Name: ETView VivaSight-SL System (TVT™) Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: January 19, 2016 Received: January 27, 2016

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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

the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

*Tejashri Purohit-Sheth, M.D.*

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known) K152438

#### Device Name ETView VivaSight-SL System (TVT)

#### Indications for Use (Describe)

The ETView VivaSight-SL (TVT) is intended for intubation procedures. The ETView VivaSight-SL (TVT) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal 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 during and for general inspection of the airway. VivaSight-SL (TVT) System is compatible for use with Laryngeal Mask Airway (LMA).

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

ETVIEW Airway Management

## 510(K) SUMMARY

## ETVIEW VIVASIGHT-SL SYSTEM (TVT™) WITH LMA

## 510(k) Number K152438

| Applicant's Name: | ETView Ltd. |
|-------------------|-------------------------|
| | 17 Tchelet Street |
| | Misgav Business Park |
| | M.P Misgav 20174 |
| | Israel |
| | Tel: [phone] |
| | Fax: [phone] |
| Contact Person: | Yoram Levy, Qsite |
| | 31 Haavoda St. |
| | Binyamina, Israel 30500 |
| | Tel [phone] |
| | Fax [phone] |
| | [e-mail] |

ETView VivaSight-SL System (TVTTM) Trade Name:

Device Type: Tracheal tube Preparation Date: August 18, 2015

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"M) is intended for intubation procedures. The ETView VivaSight-SL (TVT™) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations.

The VivaSight-SL (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

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

# ETVIEW Airway Management

of the airway. VivaSight-SL (TVT™) System is compatible for use with standard Laryngeal Mask Airway (LMA).

## 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 (TVTM) is inside the patient's trachea.

Predicate Device: Substantially equivalent to the following predicate devices:

| Device Name | Manufacturer | 510k No | Date of<br>Clearance |
|----------------------|--------------|---------|----------------------|
| VivaSight-SL (TVTTM) | ETView | K121028 | October 8,<br>2008 |
| IntubaidFlex | EZC Medical | K090777 | August 04,<br>2009 |

### Standards Compliance

ETView VivaSight-SL (TVT™) complies with the following standards:

- ISO 5361 Anesthetic and respiratory equipment --● Tracheal tubes and connectors
- ISO 14971-1 Risk management for medical devices .

Testing in accordance with the following standards were conducted with the VivaSight-SL (TVT™) K121028 which is identical to the subject device with the applicable parameters:

- ISO 11135 Sterilization of health care products -● Ethylene oxide
- . 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

## ETView VivaSight-SL (TVT™) - 510K Submission

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

Image /page/5/Picture/0 description: The image shows the logo for "ETVIEW Airway Management". The logo consists of a stylized blue circle with a white center, followed by the text "ETVIEW" in a sans-serif font. To the right of "ETVIEW" is the text "Airway Management" in a bold, sans-serif font.

- IEC 60601-2-18 Medical Electrical Equipment Part 2-18: . Particular requirements for the safety of endoscopic equipment
### Performance Testing

Performance tests were conducted on ETView VivaSight-SL (TVT™)'s predicate (K121028) and provided in that submission. The two devices are identical; therefore the tests are applicable to both devices.

A performance test was conducted in order to demonstrate that ETView VivaSight-SL (TVT™) is compatible for use with a Laryngeal Mask Airway (LMA) with a minimum ID (Inside Diameter according to VivaSight-SL IFU). The performance test includes inspections of the insertion of VivaSight-SL tube through the LMA tube; the ability to operate the VivaSight-SL tube and the LMA according to their specifications (while the device is inserted through LMA tube); resistance to tube collapse; and the ability to safely remove the LMA, while the VivaSight-SL tube remains in place.

Determination of Cuff Resting Diameter, Cuff Leak Resistance Integrity, Resistance to Cuff Herniation, Cuff symmetry, Air Flow Resistance, Thermal Safety, Camera EtO Durability and Camera Imaging Performance were conducted for the K121028 which is identical for these parameters.

The performance testing demonstrated that the ETView VivaSight-SL (TVT™) is substantially equivalent to the cleared predicate device.

## Technological Characteristics

Both the proposed ETView VivaSight-SL (TVT™) device and its predicate device (ETView VivaSight-SL K121028) function as a 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

## 2-3

#### ETView VivaSight-SL (TVT™) - 510K Submission

{6}------------------------------------------------

ETVIEW Airway Management

trachea that is displayed for as long as the ETT is inside the patient's trachea. The proposed VivaSight-SL (TVTTM) device and its predicate device (EZC Medical, IntubaidFlex K090777) are compatible for use with a standard Laryngeal Mask Airway (LMA).

### 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 tests were provided in K121028 submission.

#### Conclusion:

ETView believes that, based on the information provided in this submission, the proposed ETView VivaSight-SL (TVTM) System is substantially equivalent to its predicate device without raising any new safety and/or effectiveness concerns.