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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.

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