(212 days)
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.
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.
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) | 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 ( |
§ 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.