VivaSight-DL System

K181886 · Etview , Ltd. · CBI · Nov 14, 2018 · Anesthesiology

Device Facts

• Record ID: K181886
• Device Name: VivaSight-DL System
• Applicant: Etview , Ltd.
• Product Code: CBI · Anesthesiology
• Decision Date: Nov 14, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5740
• Device Class: Class 2

Intended Use

The ETView VivaSight-DL is intended to isolate the left or right lung of a patient for intensive care or surgery, one lung ventilation or one lung anesthesia. The VivaSight-DL System is indicated for verifying tube placement and repositioning.

Device Story

Endobronchial tube with embedded CMOS video camera in tracheal lumen; provides real-time airway visualization. Used in OR/ICU by trained clinicians for intubation, tube placement verification, and repositioning. System displays video on VivaSight monitors or external displays via RCA/adapter cables (including Ambu aView monitor). Enables continuous airway inspection for secretions and suctioning efficacy without disconnecting mechanical ventilation. Benefits include improved accuracy of tube placement and ongoing monitoring during surgery.

Clinical Evidence

Bench testing only. Testing included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), endoscopic equipment safety (IEC 60601-2-18), biocompatibility (ISO 10993-1), and performance testing per ISO 5361 and ISO 16628. Compatibility testing for the Ambu aView monitor adapter included video signal, electronics, image quality, IP rating, and mechanical tests.

Technological Characteristics

Thermo-sensitive flexible medical grade PVC; CMOS video camera sensor. Dimensions: 35FR to 41FR. Connectivity: Wired video output via proprietary adapter cables to dedicated monitors or external displays. Sterilization: Ethylene Oxide. Standards: ISO 5361, ISO 16628, ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18.

Indications for Use

Indicated for adult patients requiring lung isolation for intensive care or surgery, including one-lung ventilation or anesthesia. Used for verifying tube placement and repositioning.

Regulatory Classification

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.

Predicate Devices

• VivaSight-DL System (K123853)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

ETView Ltd. % Yoram Levy Osite General Manager Osite 31 Haavoda St. Binyamina, 3054431 Il

Re: K181886

Trade/Device Name: VivaSight-DL System Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: Class II Product Code: CBI 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

## Todd D. Courtney -S

for Tina Kiang, Ph.D. 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) K181886

Device Name VivaSight-DL System

Indications for Use (Describe)

The ETView VivaSight-DL is intended to isolate the left or right lung of a patient for intensive care or surgery, one lung ventilation or one lung anesthesia. The VivaSight-DL System is indicated for verifying tube placement and repositioning.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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# VIVASIGHT

## 510(K) SUMMARY

## VivaSight-DL™ System 510(k) Number K181886

| Applicant's Name: | ETView Ltd.<br>2 Orange St.<br>Rabin House<br>Misgav Business Park<br>M.P Misgav 2017900<br>Israel<br>Tel: [phone]<br>Fax: [phone] |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yoram Levy, Qsite<br>31 Haavoda Street<br>Binyamina, Israel 3054431<br>Tel [phone]; Fax [phone]<br>[e-mail] |
| Trade Name: | VivaSight-DLTM System |
| Preparation Date: | November 10, 2018 |
| Classification: | Regulatory Name: Tracheal/bronchial differential ventilation tube<br>Product Code: CBI<br>Regulation No: 21 CFR 868.5740<br>Class: II<br>Panel: Anesthesiology |

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### Device Description:

The ETView VivaSight-DLTM System functions as a standard endobronchial tube that additionally has an embedded video imaging device in its tracheal lumen. The system provides a video image of the patient's bronchus, which is displayed on the monitor, for as long as the VivaSight-DL™ is inside the patient's bronchus. Visualization of the bronchus is used to verify placement and repositioning of the endobronchial tube during the intubation procedure or throughout surgery.

#### Intended Use Statement:

The ETView VivaSight-DL™ is intended to isolate the left or right lung of a patient for intensive care or surgery, one lung ventilation or one lung anesthesia. The VivaSight-DL™ System is indicated for verifying tube placement and repositioning.

- The device is intended to be used only on Adult and by trained Intended users: personnel only.
### Predicate Devices:

Substantial equivalence to the following predicate device is claimed:

| Device Name | 510k No | Date of Clearance |
|--------------------------|---------|-------------------|
| VivaSight-DLTM<br>System | K123853 | April 15, 2013 |

The following table summarizes the similarities and differences between the VivaSight-DLTM and its predicate device VivaSight-DLTM System (K123853):

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#

| Characteristics | Proposed<br><i>VivaSight-DL</i> TM System | <i>VivaSight-DL</i> System<br>(K123853) |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The ETView <i>VivaSight-DL</i> TM is intended to isolate the left or<br>right lung of a patient for intensive care or surgery, one<br>lung ventilation or one lung<br>anesthesia.<br>The <i>VivaSight-DL</i> TM System is<br>indicated for verifying tube<br>placement and repositioning. | Same |
| Product Code | CBI | Same |
| Regulation No. | 21 CFR 868.5740 | Same |
| Basic Structure | Standard EBT | Same |
| Use | Single use | Same |
| Method of<br>sterilization | Ethylene Oxide | Same |
| Performance Tests | Non clinical, laboratory<br>performance testing was<br>performed according to ISO<br>5361 and ISO 16628 | Same |
| EBT Material | Thermo-sensitive flexible<br>medical grade Poly Vinyl<br>Chloride (PVC) | Same |
| Imaging Sensor | CMOS video camera | Same |
| Tube Dimensions | 35FR, 12.5x13.5mm<br>37FR: 13.0x14.0mm<br>39FR, 13.5x14.5mm<br>41FR, 14.0x15.0mm | Same |
| Video Transfer | Real time image acquisition on<br>a continuous or intermittent<br>basis without disconnection the<br>patients from the mechanical<br>ventilator | Same |
| System Display | <i>VivaSight</i> display system<br>available in the following<br>configurations: | <i>VivaSight</i> display system<br>available in the following<br>configurations: |
| Characteristics | Proposed<br><i>VivaSight-DL</i> TM System | VivaSight-DL System<br>(K123853) |
| | VivaSight- Max Monitor- 7" monitor VivaSight Direct- RCA cable configuration for connection to external medical display. Ambu aView monitor (not part of ETView product) - VivaSight is provided with an adapter cable to integrate the DL tubes to Ambu aView Monitor. | VivaSight- Max Monitor- 7" monitor VivaSight Direct- RCA cable configuration for connection to external medical display. |
| Shelf life | 3 years from date of sterilization | 5 years from date of sterilization |
| Packaging | Pouch, complies with EtO sterilization | Same |
| Operation<br>Environment | Temperature: 0 ÷ 42°C<br>Humidity: 10 ÷ 100% RH<br>Atmospheric pressure: 7.5 ÷ 15.5 PSI | Same |
| Storage Environment | Temperature: 0 ÷ 42°C<br>Humidity: 10 ÷ 100% RH<br>Atmospheric pressure: 7.5 ÷ 15.5 PSI | Same |

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Table No. 1: Comparison between the modified ETView VivaSight-DLTM and the FDA cleared ETVIEW VivaSight-DL System (K123853)

Performance Standards:

VivaSight-DL™ was tested and complies with the following standards:

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- 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
- ISO 10993-1 "Biological Evaluation of Medical ● Devices, Evaluation and Testing"
- ISO 14971 "Medical devices Application of risk ● management to medical devices"
- . ISO 5361 Anesthetic and respiratory equipment --Tracheal tubes and connectors
- ISO 16628 Tracheobronchial Tubes Sizing and ● marking.
- ISO 11135 Sterilization Of Health-Care Products . Ethylene Oxide - Requirements For The Development, Validation And Routine Control of Sterilization Process For Medical Devices.
- 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.

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The ETView VivaSight-DL System enables visual navigation of the airway during intubation. 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. 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 tests in order to demonstrate that the device met its specifications. Performance testing demonstrated that the ETView VivaSight-DLTM is substantially equivalent to the cleared predicate device. The addition of the new cable adapter for connection to Ambu aView Monitor was tested through electrical safety and EMC testing and demonstrates that this addition is substantially equivalent to the predicate device.

In addition, bench tests were conducted in order to demonstrate the compatibility of the proposed adapter and Ambu aView monitor with the ETView VivaSight-DL™. The bench tests include: Video signal test, time restriction test, electronics test, image quality, IP rating and mechanical test.

#### Biocompatibility:

Materials of the ETView VivaSight-DLTM system that are in contact with the human body, are identical to the predicate (K123853) and were tested and found to be biocompatible in accordance with ISO 10993-1.

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# HT

### Conclusion:

ETView believes that, based on the information provided in this submission, the proposed ETView ETView VivaSight-DLTM System is substantially equivalent to its predicate device (K123853) and does not raise different questions of safety and/or effectiveness.