LungVision Tool

K172955 · Bodyvision Medical , Ltd. · EOQ · Apr 26, 2018 · Ear, Nose, Throat

Device Facts

• Record ID: K172955
• Device Name: LungVision Tool
• Applicant: Bodyvision Medical , Ltd.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Apr 26, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2

Intended Use

LungVision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endotherapy accessories and ultrasound probe to guide the endotherapy accessories or ultrasound probe to the target area, specifically within the respiratory system.

Device Story

LungVision Tool functions as a working channel for standard bronchoscopes; enables guidance of endotherapy accessories or ultrasound probes to target areas within respiratory system. Operated by pulmonologists or thoracic surgeons in hospitals, sub-acute care, or physician offices. Device consists of handle, adaptor, sheath, and wire/stylet. Physician connects tool to bronchoscope instrument port; inserts accessories through sheath. Provides mechanical pathway for instruments; facilitates navigation to target anatomy. Benefits patient by enabling targeted diagnostic or therapeutic access during bronchoscopy. Single-use, sterile device.

Clinical Evidence

No clinical data. Bench testing only. Testing included biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity), mechanical performance (tensile strength, sheath insertion/withdrawal, twisting, drop tests), and sterilization validation (ETO, SAL 10^-6).

Technological Characteristics

Working channel for bronchoscopes; includes handle, adaptor, sheath, and wire. Sheath max OD 2.72 mm, min ID 2.08 mm. Materials biocompatible per ISO 10993. Manual attachment mechanism. Single-use. Sterile (Ethylene Oxide).

Indications for Use

Indicated for patients undergoing endoscopic procedures in the respiratory system, serving as a working channel to guide endotherapy accessories or ultrasound probes to target areas.

Regulatory Classification

Identification

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

Predicate Devices

• Olympus Sheath Guide (K060243)

Reference Devices

• Boston Scientific Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle (K151315)

Submission Summary (Full Text)

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April 26, 2018

Body Vision Medical Ltd. % Paul Dryden Consultant ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704

Re: K172955

Trade/Device Name: LungVision Tool Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOQ Dated: March 22, 2018 Received: March 23, 2018

Dear Paul Dryden:

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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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 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.

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.

For comprehensive regulatory information about medical devices and radiation-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 yours,

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K172955

Device Name LungVision Tool

Indications for Use (Describe)

Lung Vision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endotherapy accessories and ultrasound probe to guide the endotherapy accessories or ultrasound probe to the target area, specifically within the respiratory system.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| <span style="padding-right: 5px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="padding-right: 5px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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| Official Contact: | Dorian Averbuch<br>Body Vision Medical Ltd.<br>34 Sokolov St.<br>Ramat Hasharon Israel<br>Tel: [phone] (US) |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | April 19, 2018 |
| Proprietary or Trade Name: | LungVision Tool |
| Common/Usual Name: | Bronchoscope (flexible or rigid) and accessories |
| Classification Name: | Bronchoscope (flexible or rigid) and accessories<br>EOQ, Class II, CFR 874.4680 |
| Predicate Device:<br>Reference Device: | K060243 - Olympus Sheath Guide<br>K151315 - Boston Scientific Expect™ Pulmonary Endobronchial<br>Ultrasound Transbronchial Aspiration Needle ("EPEUTAN") |

#### Device Description:

Lung Vision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the target area, specifically within the respiratory system.

LungVision tool is designed to be used by pulmonologists or thoracic surgeons during pulmonary procedures.

The LungVision Tool is designed to be connected to a standard Bronchoscope Instrument Port.

The Lung Vision Bronchoscope Adaptor is used to connect the LungVision Handle to the Bronchoscope instrument port / working channel entrance, and to allow the physician to release the tool from the bronchoscope. The current adaptor is for the Olympus Bronchoscope Model BF-1T160.

More types of Bronchoscope Adaptors for other bronchoscopy brands and models.

Lung Vision Tool Sheath can accommodate endo-therapy accessories and ultrasound probes with an outer diameter up to 1.9 mm.

#### Indications for Use:

Lung Vision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endotherapy accessories and ultrasound probe to guide the endotherapy accessories or ultrasound probe to the target area, specifically within the respiratory system.

#### Patient Population

Patients undergoing endoscopic procedures.

#### Contraindications

Contraindications are limited to those of the use of a bronchoscope of the endotherapy instruments that the clinician may desire to use.

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#### Environments of use

Anywhere a patient may undergo a bronchoscopy procedure, e.g., hospital, sub-acute care or physician office settings.

#### Device Comparison

The following tables compare the subject device to the predicate and reference devices.

| Feature | Predicate<br>K060243<br>Olympus Guide Sheath | Reference<br>K151315<br>Boston EPEUTAN | Subject device<br>K172955<br>LungVision Tool |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To be used with<br>bronchoscopes and endo-<br>therapy accessories | To be used with<br>bronchoscopes and endo-<br>therapy accessories | To be used with<br>bronchoscopes and endo-<br>therapy accessories |
| Anatomical location | Respiratory organs | Respiratory organs | Respiratory organs |
| Components | | | |
| Handle | Handle-like | Yes | Yes |
| Connector / Adaptor to<br>attach to working channel | Stopper | Yes | Yes |
| Sheath | Yes | Yes | Yes |
| Wire / stylet to stiffen or<br>protect the sheath | No | Yes | Yes |
| Works with endo-therapy<br>instruments | Yes | Yes | Yes |
| Feature | Predicate<br>K060243<br>Olympus Guide Sheath | Reference<br>K151315<br>Boston EPEUTAN | Subject Device<br>K172955<br>LungVision Tool |
| Indications for Use | This instrument has been designed to be used<br>with Olympus bronchoscopes, endo-therapy<br>accessories and ultrasound probe to guide<br>the endo-therapy accessories or ultrasound<br>probe to the target area within the respiratory<br>organs. | The Expect™ Pulmonary Endobronchial<br>Ultrasound Transbronchial Aspiration Needle<br>is designed to be used with endobronchial<br>ultrasound endoscopes for ultrasound guided<br>fine needle aspiration (FNA) of the<br>submucosal and extramural lesions of the<br>tracheobronchial tree. Do not use this<br>instrument for any purpose other than its<br>intended use. | LungVision Tool is an instrument designed<br>as a working channel intended to be used<br>with standard bronchoscopes, endotherapy<br>accessories and ultrasound probe to guide<br>the endotherapy accessories or ultrasound<br>probe to the target area, specifically within<br>the respiratory system. |
| Classification | Bronchoscope (flexible or rigid) and<br>accessories.<br>21CFR 874.4680<br>Procut Code: EOQ | Bronchoscope (flexible or rigid) and<br>accessories.<br>21CFR 874.4680<br>Procut Code: EOQ | Bronchoscope (flexible or rigid) and<br>accessories.<br>21CFR 874.4680<br>Procut Code: EOQ |
| Target anatomy | Respiratory Organs | Respiratory Organs | Respiratory Organs |
| Anatomy access | Bronchial airways | Bronchial airways | Bronchial airways |
| Patient Population | Not specified but for patients undergoing<br>endoscopic procedures | Not specified but for patients undergoing<br>endoscopic procedures | Patients undergoing endoscopic procedures |
| Environment of use | Not specified but where endoscopic<br>procedures are performed: hospitals, sub-<br>acute and physician office settings | Not specified but where endoscopic procedures<br>are performed: hospitals, sub-acute and<br>physician office settings | Not specified but where endoscopic<br>procedures are performed: hospitals, sub-<br>acute and physician office settings |
| Single Use | Yes | Yes | Yes |
| Sterile | Yes | Yes | Yes |
| Mechanism of action | Manual attachment | Manual attachment | Manual attachment |
| Number of device<br>passes during a<br>procedure | Multiple passes | Multiple passes | Multiple passes |
| Echogenic | No | Yes | No |
| X-ray detection | Yes | No | Yes |
| Components | Handle-like<br>Stopper (Connector)<br>Sheath | Handle<br>Adaptor / Connector<br>Sheath<br>Wire / Stylet | Handle<br>Adaptor / Connector<br>Sheath<br>Wire |
| Sheath Max Outer<br>Diameter | 2.7 mm | N/A | 2.72 mm |
| Sheath Min Inner<br>Diameter | 2.1 mm | N/A | 2.08 mm |
| Feature | Predicate<br>K060243<br>Olympus Guide Sheath | Reference<br>K151315<br>Boston EPEUTAN | Subject Device<br>K172955<br>LungVision Tool |
| Working Length | 900 mm | N/A | 1000 mm |
| Length extended<br>beyond the scope | 27.5 mm | N/A | 17 mm |
| Sheath length<br>adjustable | Yes | Yes | Yes |
| Recommended<br>Channel Size | 2.8 mm | 2.0 mm (this device is inserted into a sheath | 2.8mm |
| Curved distal tip | No, but endotherapy instruments do | N/A | Yes |
| Performance - Non-clinical | | | |
| Biocompatibility | Surface Contact<br>Skin and Breached<br>Limited duration (<24 hours) | Surface Contact<br>Skin and Breached<br>Limited duration (<24 hours) | Surface Contact<br>Skin and Breached<br>Limited duration (<24 hours) |
| Testing | | | Cytotoxicity<br>Sensitization<br>Irritation or Intracutaneous Reactivity<br>Acute Systemic Toxicity<br>Material Mediated Pyrogenicity – no claim<br>of non-pyrogenic |
| Bench testing | Not listed | Passability<br>Tensile strength - Stylet (wire)<br>Durability<br>Removal Force<br>Rotation | Bronchoscope Compatibility Test<br>Simulated Use<br>Fluoroscopy<br>Tensile Test for Sheath and Wire<br>Tensile Test for Wire Distal End<br>Repeatability Use<br>Sheath Insertion/Withdrawal<br>Twisting Test<br>Drop Test<br>Accelerated Aging Verification Test<br>Package integrity Test<br>Package Stability Test |

As can be seen the predicate, reference and subject device have similar intended uses, conditions of use, and components.

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### Substantial Equivalence Discussion

#### Indications for Use / Patient Population / Environment of Use:

As in comparison of Indications For Use above, we can conclude that the indications for use for the LungVision Tool and the predicate are substantially equivalent.

Discussion - The differences in proposed indications for use relate to associating the specific sheath to that bronchoscope manufacturer's own instrument of scope. The subject device is intended for use with the compatible bronchoscopes with equivalent working channel and instrument diameters.

This difference does not raise new risk or safety concerns, and the subject device can be found substantially equivalent.

#### Prescriptive:

Both the LungVision Tool and predicate are prescription devices. Discussion -There are no differences.

#### Design and Technology:

The LungVision Tool is constructed of similar materials and components to both the predicate and reference.

Discussion -There are no differences in design, technology, or principle of operation which would raise new safety or effectiveness concerns thus the subject device can be found substantially equivalent.

#### Performance and Specifications:

We performed the equivalent tests and used the predicate for reference of acceptance criteria. Discussion -There are no differences which would raise safety or effectiveness concerns compared to the predicate, thus the subject device can be found substantially equivalent.

#### Performance Testing:

#### Nonclinical / Bench

We have performed bench tests and found that the Lung Vision Tool met all requirements specifications and can be found to be substantially equivalent to the predicate.

- Bronchoscope Compatibility Test
- Simulated Use ●
- Fluoroscopy ●
- Tensile Test for Sheath and Wire ●
- Tensile Test for Wire Distal End ●
- Repeatability Use
- Sheath Insertion/Withdrawal ●
- Twisting Test ●
- Drop Test ●
- Accelerated Aging Verification Test ●

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## Biocompatibility

- We assessed the patient contact type and performed the applicable ISO 10993 tests which . included:
- o Cytotoxicity
- O Sensitization
- Irritation or Intracutaneous Reactivity o
- Acute Systemic Toxicity O
- Material Mediated Pyrogenicity but no claim the device is non-pyrogenic o

The test results supported the materials as non-cytotoxic, non-sensitizers, and non-irritants.

## Sterilization and Packaging

- We have performed Single Lot Release validation which includes the following tests:
- Bioburden
- Bioburden Validation ●
- Fractional Cycle – BI show no growth
- Fractional Cycle - Sterility Test
- Sterility Validation
- Full Cycle – BI show no growth
- Full Cycle - ETO Residual
- Bacterial Endotoxin test as per LAL method ●
- Package integrity Test
- Package Stability Test ●
- . The results confirm that the single lot Ethylene Oxide sterilization process capability has achieved SAL of at least 10-6

## Animal

No animal testing was performed

## Clinical

No clinical testing was performed

## Substantial Equivalence Conclusion

Based upon the foregoing performance testing and comparison to the legally marketed predicate device for indications for use, technology, and performance we believe we have demonstrated that the Lung Vision Tool is substantially equivalent in safety and effectiveness to the predicate device.