LungVision Tool by Body Vision Medical Ltd.

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.

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.

AI/ML Overview

The provided text describes the LungVision Tool, a medical device intended to be used with standard bronchoscopes, endotherapy accessories, and ultrasound probes to guide them to a target area within the respiratory system. The submission demonstrates substantial equivalence to predicate devices K060243 (Olympus Guide Sheath) and K151315 (Boston Scientific Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle).

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a tabulated format with numerical targets for each test, but it does list the tests performed and implies that the device "met all requirements specifications." The comparison table on pages 4 and 5 highlights the features and specifications for the predicate, reference, and subject device.

Feature / Test Category	Predicate K060243 (Olympus Guide Sheath)	Reference K151315 (Boston EPEUTAN)	Subject Device K172955 (LungVision Tool)	Reported Performance (LungVision Tool)	Acceptance Criteria (Implied)
Intended Use	Guide endo-therapy accessories/ultrasound probe	Guide endo-therapy accessories/ultrasound probe	Guide endo-therapy accessories/ultrasound probe	Substantially equivalent to predicate	To be substantially equivalent to predicate
Anatomical location	Respiratory organs	Respiratory organs	Respiratory organs	Substantially equivalent to predicate	To be substantially equivalent to predicate
Components	Handle-like, Stopper, Sheath	Handle, Adaptor/Connector, Sheath, Wire/Stylet	Handle, Adaptor/Connector, Sheath, Wire	Similar components to predicate/reference	To be similar to predicate/reference
Works with endo-therapy instruments	Yes	Yes	Yes	Yes	Yes
Classification	Bronchoscope (flexible or rigid) and accessories. 21CFR 874.4680, Procut Code: EOQ	Bronchoscope (flexible or rigid) and accessories. 21CFR 874.4680, Procut Code: EOQ	Bronchoscope (flexible or rigid) and accessories. 21CFR 874.4680, Procut Code: EOQ	Substantially equivalent to predicate	To be substantially equivalent to predicate
Target anatomy	Respiratory Organs	Respiratory Organs	Respiratory Organs	Substantially equivalent to predicate	To be substantially equivalent to predicate
Anatomy access	Bronchial airways	Bronchial airways	Bronchial airways	Substantially equivalent to predicate	To be substantially equivalent to predicate
Patient Population	Not specified (undergoing endoscopic procedures)	Not specified (undergoing endoscopic procedures)	Patients undergoing endoscopic procedures	Substantially equivalent to predicate	To be substantially equivalent to predicate
Environment of use	Where endoscopic procedures performed	Where endoscopic procedures performed	Where endoscopic procedures performed	Substantially equivalent to predicate	To be substantially equivalent to predicate
Single Use	Yes	Yes	Yes	Yes	Yes
Sterile	Yes	Yes	Yes	Yes	Yes
Mechanism of action	Manual attachment	Manual attachment	Manual attachment	Substantially equivalent to predicate	To be substantially equivalent to predicate
Number of device passes during a procedure	Multiple passes	Multiple passes	Multiple passes	Substantially equivalent to predicate	To be substantially equivalent to predicate
X-ray detection	Yes	No	Yes	Yes (similar to predicate)	Yes
Sheath Max Outer Diameter	2.7 mm	N/A	2.72 mm	2.72 mm (comparable to predicate)	< 2.8 mm (consistent with recommended channel size)
Sheath Min Inner Diameter	2.1 mm	N/A	2.08 mm	2.08 mm (comparable to predicate)	> 1.9 mm (to accommodate accessories)
Working Length	900 mm	N/A	1000 mm	1000 mm (comparable to predicate)	Sufficient for intended use
Biocompatibility	Surface Contact Skin and Breached Limited duration (<24 hours)	Surface Contact Skin and Breached Limited duration (<24 hours)	Surface Contact Skin and Breached Limited duration (<24 hours)	Non-cytotoxic, non-sensitizers, non-irritants	To meet ISO 10993 requirements
Bench Testing	Not listed	Passability, Tensile strength, Durability, Removal Force, Rotation	Bronchoscope Compatibility, Simulated Use, Fluoroscopy, Tensile Tests, Repeatability Use, Sheath Insertion/Withdrawal, Twisting, Drop, Accelerated Aging, Package integrity, Package Stability	Met all requirements specifications	Functional and safety requirements comparable to predicate
Sterilization	Sterile (Yes)	Sterile (Yes)	Sterile (Yes)	Met SAL of at least 10-6	To achieve SAL of at least 10-6

2. Sample Sizes used for the Test Set and Data Provenance:

The document describes non-clinical/bench testing, biocompatibility testing, and sterilization validation. It does not refer to a "test set" in the context of clinical or performance data from human subjects.

Bench Testing: The sample sizes for each specific bench test (e.g., Bronchoscope Compatibility, Tensile Test) are not explicitly mentioned. The testing would involve multiple units of the LungVision Tool.
Biocompatibility: The specific number of samples for cytotoxicity, sensitization, irritation, and acute systemic toxicity tests are not provided, but these tests (ISO 10993) involve standardized sample sizes for in-vitro and animal testing.
Sterilization: "Single Lot Release validation" was performed, indicating testing on one lot of devices.
Data Provenance: The data is generated from non-clinical (bench) studies likely conducted in laboratories within the submitting company's or contractor's facilities. There is no mention of country of origin for the non-clinical data, nor whether it is retrospective or prospective, though bench testing is inherently prospective.

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

This information is not applicable as there was no test set involving human subjects or expert assessment to establish ground truth. The device is a medical instrument (tool), and its performance was evaluated through non-clinical testing against engineering specifications and comparison to predicate devices, not against a "ground truth" derived from human experts.

4. Adjudication method for the test set:

This information is not applicable as there was no test set involving human experts requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical testing was performed."

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

This device is a physical medical tool, not an algorithm or software. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. Its performance is assessed through its physical and functional characteristics in bench testing.

7. The type of ground truth used:

The "ground truth" for this device's performance is established through:

Engineering specifications and design requirements: For bench testing (e.g., tensile strength, dimensions, compatibility).
International standards (e.g., ISO 10993 for biocompatibility) and regulatory requirements: For safety evaluations.
Comparison to legally marketed predicate devices: For demonstrating substantial equivalence in intended use, technology, and performance.

8. The sample size for the training set:

This information is not applicable. The device is a physical tool, not an AI/ML algorithm that requires a training set.

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

This information is not applicable as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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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Official Contact:	Dorian AverbuchBody Vision Medical Ltd.34 Sokolov St.Ramat Hasharon IsraelTel: 646- 863-7848 (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 accessoriesEOQ, Class II, CFR 874.4680
Predicate Device:Reference Device:	K060243 - Olympus Sheath GuideK151315 - Boston Scientific Expect™ Pulmonary EndobronchialUltrasound Transbronchial Aspiration Needle ("EPEUTAN")

Device Description:

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.

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:

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	PredicateK060243Olympus Guide Sheath	ReferenceK151315Boston EPEUTAN	Subject deviceK172955LungVision Tool
Intended Use	To be used withbronchoscopes and endo-therapy accessories	To be used withbronchoscopes and endo-therapy accessories	To be used withbronchoscopes and endo-therapy accessories
Anatomical location	Respiratory organs	Respiratory organs	Respiratory organs
Components
Handle	Handle-like	Yes	Yes
Connector / Adaptor toattach to working channel	Stopper	Yes	Yes
Sheath	Yes	Yes	Yes
Wire / stylet to stiffen orprotect the sheath	No	Yes	Yes
Works with endo-therapyinstruments	Yes	Yes	Yes
Feature	PredicateK060243Olympus Guide Sheath	ReferenceK151315Boston EPEUTAN	Subject DeviceK172955LungVision Tool
Indications for Use	This instrument has been designed to be usedwith Olympus bronchoscopes, endo-therapyaccessories and ultrasound probe to guidethe endo-therapy accessories or ultrasoundprobe to the target area within the respiratoryorgans.	The Expect™ Pulmonary EndobronchialUltrasound Transbronchial Aspiration Needleis designed to be used with endobronchialultrasound endoscopes for ultrasound guidedfine needle aspiration (FNA) of thesubmucosal and extramural lesions of thetracheobronchial tree. Do not use thisinstrument for any purpose other than itsintended use.	LungVision Tool is an instrument designedas a working channel intended to be usedwith standard bronchoscopes, endotherapyaccessories and ultrasound probe to guidethe endotherapy accessories or ultrasoundprobe to the target area, specifically withinthe respiratory system.
Classification	Bronchoscope (flexible or rigid) andaccessories.21CFR 874.4680Procut Code: EOQ	Bronchoscope (flexible or rigid) andaccessories.21CFR 874.4680Procut Code: EOQ	Bronchoscope (flexible or rigid) andaccessories.21CFR 874.4680Procut 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 undergoingendoscopic procedures	Not specified but for patients undergoingendoscopic procedures	Patients undergoing endoscopic procedures
Environment of use	Not specified but where endoscopicprocedures are performed: hospitals, sub-acute and physician office settings	Not specified but where endoscopic proceduresare performed: hospitals, sub-acute andphysician office settings	Not specified but where endoscopicprocedures are performed: hospitals, sub-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 devicepasses during aprocedure	Multiple passes	Multiple passes	Multiple passes
Echogenic	No	Yes	No
X-ray detection	Yes	No	Yes
Components	Handle-likeStopper (Connector)Sheath	HandleAdaptor / ConnectorSheathWire / Stylet	HandleAdaptor / ConnectorSheathWire
Sheath Max OuterDiameter	2.7 mm	N/A	2.72 mm
Sheath Min InnerDiameter	2.1 mm	N/A	2.08 mm
Feature	PredicateK060243Olympus Guide Sheath	ReferenceK151315Boston EPEUTAN	Subject DeviceK172955LungVision Tool
Working Length	900 mm	N/A	1000 mm
Length extendedbeyond the scope	27.5 mm	N/A	17 mm
Sheath lengthadjustable	Yes	Yes	Yes
RecommendedChannel 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 ContactSkin and BreachedLimited duration (<24 hours)	Surface ContactSkin and BreachedLimited duration (<24 hours)	Surface ContactSkin and BreachedLimited duration (<24 hours)
Testing			CytotoxicitySensitizationIrritation or Intracutaneous ReactivityAcute Systemic ToxicityMaterial Mediated Pyrogenicity – no claimof non-pyrogenic
Bench testing	Not listed	PassabilityTensile strength - Stylet (wire)DurabilityRemoval ForceRotation	Bronchoscope Compatibility TestSimulated UseFluoroscopyTensile Test for Sheath and WireTensile Test for Wire Distal EndRepeatability UseSheath Insertion/WithdrawalTwisting TestDrop TestAccelerated Aging Verification TestPackage integrity TestPackage 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.

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
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.(b)
Classification. Class II.