(113 days)
The aScope 3 and aScope 4 Broncho endoscopes have been designed to be used with the aView monitor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The aScope 3 system and aScope 4 Broncho system are for use in a hospital environment.
The aScope 3 and aScope 4 Broncho are single-use designed for use in adults. They have been evaluated for the following endotracheal tubes (ETT), double lumen tubes (DLT) and endoscopic accessories (EA) sizes:
| | Minimum ETT
inner diameter | Minimum
DLT size | EA minimum working
channel width |
|----------------------------------------------|-------------------------------|---------------------|-------------------------------------|
| aScope 3 Slim and
aScope 4 Broncho Slim | 5.0 mm | 35 Fr | Up to 1.2 mm |
| aScope 3 Regular
aScope 4 Broncho Regular | 6.0 mm | 41 Fr | Up to 2.0 mm |
| aScope 3 Large
aScope 4 Broncho Large | 7.0 mm | - | Up to 2.6 mm |
The Ambu® aScope™ 3 system consists of: Ambu® aScope™ 3 Slim 3.8/1.2, Ambu® aScope™ 3 Regular 5.0/2.2, Ambu® aScope™ 3 Large 5.8/2.8, Ambu® aView™ Monitor. The Ambu® aScope™ 4 Broncho System consists of: Ambu® aScope™ 4 Broncho Slim 3.8/1.2, Ambu® aScope™ 4 Broncho Regular 5.0/2.2, Ambu® aScope™ 4 Broncho Large 5.8/2.8, Ambu® aView™ Monitor. Ambu® aScope™ 3 and Ambu® aScope™ 4 Broncho is a sterile single use flexible bronchoscope and Ambu Ambu® aView™ is a reusable monitor. Ambu® aScope™ 3 and Ambu® aScope™ 4 Broncho endoscopes have the following physical and performance characteristics: Maneuverable tip controlled by the user, Flexible insertion cord, Camera and LED light source at the distal tip, Working channel, Sterilized by Ethylene Oxide, For single use. The differences between sizes in both the Ambu® aScope™ 3 endoscope and Ambu® aScope™ 4 Broncho endoscope are as follows: Distal end outer diameter, Insertion tube outer diameter, Working channel inner diameter, Anqulation range. Ambu® aView™ Monitor has the following physical and performance characteristics: Displays the image from Ambu® aScope™ 3 endoscope and Ambu® aScope™ 4 Broncho endoscope on the screen, Can record snapshots or video of image from Ambu® aScope™ 3 and Ambu® aScope™ 4 Broncho endoscope, Can connect to an external monitor, Reusable device.
The provided text is a 510(k) summary for the Ambu® aScope™ 3, Ambu® aScope™ 4 Broncho, and Ambu® aView™ Monitor. This document is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed devices, it is not a study that proves a device meets specific acceptance criteria in the context of an AI/ML algorithm.
Therefore, the requested information regarding acceptance criteria and a study proving a device meets them (as would be relevant for an AI/ML device) is not present in the provided text. The document refers to the physical and performance characteristics of flexible bronchoscopes and a monitor, and demonstrates their equivalence to predicate devices based on bench performance tests.
Here's a breakdown of what is available concerning performance and equivalence, and an explanation of why the requested AI/ML specific information is absent:
Acceptance Criteria and Reported Device Performance (Non-AI/ML Context)
The document outlines the characteristics of the Ambu® aScope™ 3 and 4 Broncho endoscopes and the Ambu® aView™ Monitor, and states that these were evaluated against various standards and performance tests to demonstrate substantial equivalence to predicate devices.
| Acceptance Criterion (Implicit/Standard-based) | Reported Device Performance (Ambu aScope 4 Broncho System) |
|---|---|
| Compliance with ISO 8600-1, ISO 8600-3, ISO 8600-4, ISO 594-1 | Declaration of Conformity with these product-specific standards. |
| Properties of bending angle, endurance, and radius of the bending section | Performance tests passed. |
| Depth of field | Performance tests passed. |
| Image quality (clearer visibility) | Performance tests passed. |
| Aging performance | Performance tests passed. |
| Sterile packaging integrity | Performance tests passed. |
| Electrical Compatibility (IEC 60601-1-2) | Performance tests passed. |
| Electrical Safety (IEC 60601-1 and IEC 60601-2-18) | Performance tests passed. |
| Functionality and intended use equivalence to predicate devices | Concluded to be equivalent/better than predicate devices. |
Note: The document explicitly states "Results: All tests were passed." for the listed performance data.
Explanation for Missing AI/ML Specific Information:
The device described (a flexible bronchoscope and monitor) is a traditional medical device, not an AI/ML powered one. Therefore, the questions related to AI/ML specific study design elements (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this submission.
The document indicates "Performance Data – Clinical: Not applicable," further confirming that this submission relies on bench testing and comparison to predicate devices, rather than clinical studies (which would be more common for software or AI/ML-driven devices needing to demonstrate clinical utility).
§ 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.