(59 days)
UE BRONCHO Single-Use Bronchoscope: The UE BRONCHO Single-Use Bronchoscopes has been designed to be used with the UE Display, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The UE BRONCHO Single-Use Bronchoscopes is for use in a hospital environment. The UE BRONCHO Single-Use Bronchoscopes is single-use device designed for use in adults.
UE Display: The UE Display is reusable digital monitor, intended to display live imaging data from UE Medical visualization devices.
The bronchoscope system consists of UE BRONCHO Single-Use Bronchoscopes and UE Display. The UE BRONCHO Single-Use Bronchoscopes (the bronchoscopes) are sterile, single-use flexible video bronchoscopes available in three sizes (Slim, Regular, Large). The bronchoscopes have been designed to be used with the UE Display (reusable, non-sterile), endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The bronchoscope system is designed for use by adults in a hospital environment.
The provided FDA 510(k) clearance letter details the clearance of the UE BRONCHO Single-Use Bronchoscopes and UE Display. However, it does not contain specific acceptance criteria or details of a clinical study that demonstrates the device's performance against such criteria. The document explicitly states "Clinical study: Not applicable."
The clearance is based on non-clinical data, specifically performance testing and compliance with voluntary standards, which demonstrates substantial equivalence to a predicate device (Ambu® aScope™ 4 Broncho, Ambu® aView™ Monitor - K173727).
Therefore, I cannot populate the requested table and answer questions 2-9 with the provided text. The document refers to "bench performance testing" which includes optical performance, color reproduction, geometric distortion, resolution, depth of field, image intensity uniformity, noise, dynamic range, and frame rate, comparing these aspects with the predicate device. However, it does not specify quantitative acceptance criteria for these tests nor provide the reported device performance against such criteria in the detail requested.
Here's an attempt to populate the table and address the questions based only on the information available in the provided text. Where information is missing, it will be stated as "Not provided in the text."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Expected Value/Range) | Reported Device Performance | Comments from Text |
|---|---|---|---|
| Optical Performance | Not provided in the text (but implies compliance with ISO 8600 series) | Complies with ISO 8600 series | Bench testing performed according to ISO 8600. |
| Color Performance | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Color reproduction: compared with the predicate device. |
| Geometric Distortion | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Geometric distortion: compared with the predicate device. |
| Resolution | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Resolution: compared with the predicate device. |
| Depth of Field | 6-50 mm (same as predicate device) | 6-50 mm (same as predicate device) | Depth of view is 6-50 mm. |
| Image Intensity Uniformity | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Image intensity uniformity: compared with the predicate device. |
| Noise | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Noise: compared with the predicate device. |
| Dynamic Range | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Dynamic range: compared with the predicate device. |
| Frame Rate | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Frame rate: compared with the predicate device. |
| Field of View | Not provided in the text (Predicate: 85°) | 90° | Field of view (degree): 90° (subject device) vs 85° (predicate). Deemed "Similar". |
| Deflection Angle | Up: 180°, Down: 180° (for Slim/Regular sizes) | 180° up, 180° down | "Same" as predicate for Slim/Regular, "Similar" for Large (predicate Large is 160° down). |
| Insertion Tube Outer Diameter | Matches predicate (Slim: 3.8mm, Regular: 5.0mm, Large: 5.8mm) | EBS-380C: 3.8 mm, EBS-500C: 5.0 mm, EBS-600C: 5.8 mm | "Same". |
| Insertion Portion Maximum Diameter | Equivalent to predicate (Slim: 4.3mm, Regular: 5.5mm, Large: 6.3mm) | EBS-380C: 4.4 mm, EBS-500C: 5.5 mm, EBS-600C: 6.5 mm | "Equivalent". |
| Minimum Working Channel Diameter | Equivalent to predicate (Slim: 1.2mm, Regular: 2.0mm, Large: 2.6mm) | EBS-380C: 1.15 mm, EBS-500C: 2.15 mm, EBS-600C: 2.75 mm | "Equivalent". |
| Average Working Channel Diameter | Matches predicate (Slim: 1.2mm, Regular: 2.2mm, Large: 2.8mm) | EBS-380C: 1.2 mm, EBS-500C: 2.2 mm, EBS-600C: 2.8 mm | "Same". |
| Minimum ETT Inner Diameter Size | Matches predicate (Slim: 5.0mm, Regular: 6.0mm, Large: 7.0mm) | EBS-380C: 5.0 mm, EBS-500C: 6.0 mm, EBS-600C: 7.0 mm | "Same". |
| Minimum DLT Inner Diameter Size | Similar to predicate (Slim: 35 Fr, Regular: 41 Fr, Large: N/A) | EBS-380C: 35 Fr, EBS-500C: N/A, EBS-600C: N/A | "Similar". |
| Biocompatibility | Compliance with ISO 10993-1 | Evaluated and in accordance with ISO 10993-1 and FDA guidance. | Biocompatibility testing performed. |
| Sterilization Process | Compliance with ISO 11135:2014 | Validated in accordance with ISO 11135:2014. | Sterilization and shelf life testing performed. |
| EO/ECH Residual | Compliance with ISO 10993-7 | Test performed according to ISO 10993-7. | Sterilization and shelf life testing performed. |
| Shelf Life | 3 years (based on accelerated aging) | 3 years | Shelf life determined by accelerated aging (ASTM F1980). |
| Package Validation | Compliance with ISO 11607-1 and ISO 11607-2 | Conducted according to ISO 11607-1 and ISO 11607-2. | Package validation performed. |
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-2-18 | System complies with IEC 60601-1 and IEC 60601-2-18. | Electrical safety and EMC testing performed. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | System complies with IEC 60601-1-2. | Electrical safety and EMC testing performed. |
| Software Verification and Validation | Compliance with FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions" | Conducted and documentation provided as recommended by FDA guidance. | Software V&V testing performed. |
2. Sample size used for the test set and the data provenance
Not provided in the text. The document refers to "bench performance testing" which typically uses a limited number of physical units or simulated conditions, rather than a "test set" of patient data as might be relevant for AI/ML devices. No human patient data was used for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical study or expert-based ground truth establishment for a test set is mentioned. The testing was non-clinical bench testing.
4. Adjudication method for the test set
Not applicable, as no clinical study involving expert interpretation or adjudication is mentioned.
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
No. The document explicitly states "Clinical study: Not applicable." Therefore, an MRMC study was not performed. This device is a bronchoscope system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a bronchoscope system. While it has software and display capabilities, it is not an algorithm that performs a diagnostic or analytical function independently of a human operator, and no standalone performance study in this context was mentioned.
7. The type of ground truth used
For the non-clinical bench tests (e.g., optical performance, physical dimensions, electrical safety), the "ground truth" would be established by direct physical measurements, adherence to engineering specifications, and compliance with recognized international standards (e.g., ISO 8600, IEC 60601 series, ISO 10993 series). There is no "ground truth" in the clinical sense (e.g., pathology, outcomes data, expert consensus) as no clinical studies were performed.
8. The sample size for the training set
Not applicable. This device is a bronchoscope system and not an AI/ML device that requires a training set of data for model development.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 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.