(7 days)
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
The subject device, Bronchovideoscope Olympus XBF-D160HM, is basically identical to the predicate device, EVIS EXERA Bronchovideoscope Olympus BF type 160, except that the subject device is equipped with an optical system for high magnification observation in addition to an optical system for normal observation.
When compared to the predicate device, this high magnification bronchoscope enables more detailed observation of the target area. For example, a run of the capillary blood vessel in the bronchial mucosa can be observed, which is not observable with the predicate device.
This is a 510(k) premarket notification for a medical device, the Bronchovideoscope Olympus XBF-D160HM. The document asserts substantial equivalence to a predicate device, the EVIS EXERA Bronchovideoscope Olympus BF type 160 (K023984). The core of a 510(k) submission is to demonstrate that a new device is as safe and effective as a legally marketed predicate device, not necessarily to prove absolute safety and effectiveness through extensive clinical trials.
Therefore, the information regarding acceptance criteria and a study proving the device meets them will be limited, as this type of submission relies on a comparison to an already approved device rather than new performance studies with specific statistical endpoints.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present specific quantitative acceptance criteria or detailed performance metrics against those criteria in the way a clinical trial for a novel device would. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device. The performance is assessed by comparing technological characteristics and intended use.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit Comparison) |
|---|---|
| Intended Use Equivalence | The subject device (XBF-D160HM) has the identical intended use to the predicate device (BF-160). Both are designed for endoscopy and endoscopic surgery within the airways and tracheobronchial tree with ancillary equipment. |
| Technological Equivalence (Safety & Effectiveness) | The XBF-D160HM is basically identical to the BF-160, with the key difference being the addition of an optical system for high magnification. The document states, "When compared to the predicate device, the XBF-D160HM does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety and effectiveness." The differences in physical dimensions (distal end and insertion tube outer diameter) are considered not to affect safety and effectiveness negatively, as the inner channel diameter remains the same, implying similar accessory compatibility. |
| Material Equivalence | All patient contact materials are identical to those used in previously cleared 510(k) devices. |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or associated sample size is mentioned in this 510(k) summary. The submission relies on a comparison of technical specifications and intended use against a previously cleared device. There is no independent "test set" of data from patients to evaluate performance. Therefore, data provenance (country, retrospective/prospective) is not applicable in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as there was no "test set" and thus no ground truth established by experts in the context of this 510(k) submission. The FDA reviews the provided technical documentation and comparisons to the predicate device.
4. Adjudication Method for the Test Set
Not applicable, as there was no "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is a conventional medical device (bronchoscope), not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or required for this type of submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a hardware medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in a 510(k) for substantial equivalence is the safety and effectiveness of the legally marketed predicate device. The new device's performance is not directly measured against an independent ground truth but rather by its similarity and lack of new safety/effectiveness concerns compared to the predicate. Therefore, no pathology, outcomes data, or expert consensus specific to the subject device was used as a ground truth.
8. The Sample Size for the Training Set
Not applicable. This is a hardware medical device, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.