(159 days)
Broncoflex® Agile and Broncoflex® Vortex
This video-bronchoscope is intended to provide an optical display of the pulmonary tract using a monitor (Screeni®) and to be used with endotherapy accessories and instruments.
This video-bronchoscope is designed for use exclusively in a hospital environment.
Endotherapy accessories and instruments
The effective length of an endoscopic instrument should be at least 30 cm greater than the effective length of the endoscope.
| Model | Minimum compatible
endotracheal tube size | Minimum compatible dual
lumen endo-bronchial tube size | Maximum size of
endotherapy instruments |
|-------------------|----------------------------------------------|-----------------------------------------------------------|--------------------------------------------|
| Broncoflex Agile | $\ge 5.0$ mm | $\ge 35$ Fr. | $\le 1.2$ mm |
| Broncoflex Vortex | $\ge 6.0$ mm | $\ge 41$ Fr. | $\le 2.6$ mm |
Patient Population
The Broncoflex can only be used on adult patients.
Screeni®
This device is designed for use exclusively in a hospital environment, in combination with an Axess Vision Broncoflex® video-bronchoscope.
Broncoflex Agile and Broncoflex Vortex are a single-use video-bronchoscope which is part of a system made up of the endoscope (Broncoflex) and its reusable display monitor (Screeni). The videobronchoscope is intended to provide an optical display of the pulmonary tract using a monitor (Screeni) and to be used with endotherapy accessories and instruments. The applied part of the medical device is the whole of the flexible tubing containing the insertion tube, the articulated section and the distal tip (BF type applied part: BF). Broncoflex is sterile and supplied ready to use in its sealed packaging (sterilization method ethylene oxide). The Screeni is a reusable nonsterile medical device and is a video processor with integrated touch interface designed to display live imaging data captured by Broncoflex Agile and Broncoflex Vortex. The consumables (Broncoflex) are supplied in sets of 5 in a carton. Inside this box, each sterilized consumable is placed in a single sterile pouch. Screeni is supplied in a carton with all the accessories (quick mounting bracket, knurled screw, power supply, EU/US/UK/AU adaptors and video cable (HDMI/DVI)). Broncoflex Agile and Broncoflex Vortex are the same devices except for some dimensional aspects such as external diameter of insertion tube, distal tip outer diameter and working channel inner diameter. Indeed, Broncoflex Agile has an applied part with a smaller diameter than the Broncoflex Vortex.
The provided text does not contain information about acceptance criteria for a device's performance that would typically be described in a study. Instead, it describes a 510(k) submission for the Broncoflex Agile, Broncoflex Vortex, and Screeni devices, asserting their substantial equivalence to a predicate device.
The document focuses on:
- Device Description: Details the components of the Broncoflex system (single-use video-bronchoscope and reusable display monitor).
- Indications for Use: Specifies the medical application and patient population.
- Comparison to Predicate Device: Highlights and tabulates the technological characteristics of the subject device and the predicate device (which is a previously cleared version of the same product). It explicitly states that "The Broncoflex Vortex and Broncoflex Agile are the same as the predicate devices" in most listed areas, and the Screeni "is the same as the predicate device" in most areas, with one difference (HDMI port) that "has no impact on performance, safety nor effectiveness."
- Non-Clinical Performance Data: Mentions that the system "meets all the requirements for overall design, sterilization, biocompatibility, sterile packaging integrity, shelf life, transportation, electromagnetic compatibility and electrical safety results confirming that the design output meets the design inputs and specifications for the device." It also lists the standards against which testing was performed (IEC 60601-1:2012, IEC 60601-2-18:2009, IEC 60601-1-2:2014/A1:2020 (Ed. 4.1), and IEC 62304:2006/A1 & FDA Guidance for software).
The information provided does not include:
- A specific table of acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) nor reported device performance against such criteria.
- Details of a study involving a test set, including sample size, data provenance, number of experts for ground truth, or adjudication methods.
- Any multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Training set sample size or how its ground truth was established.
The document primarily demonstrates substantial equivalence through technical comparison and compliance with relevant safety and performance standards for medical devices, rather than through a clinical performance study with specific acceptance criteria for diagnostic or algorithmic performance.
§ 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.