(220 days)
The aScope 3 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 is for use in a hospital environment. The aScope 3 is a single-use device designed for use in adults. It has been clinically evaluated for the following minimum endotracheal tubes (ETT) and double lumen tubes (DLT) sizes:
| Scope | Minimum ETT inner diameter | Minimum DLT, size |
|---|---|---|
| aScope 3 Slim | ||
| 3.8/1.2 | 5.0mm | 37Fr |
| aScope 3 | ||
| 5.0/2.2 | 6.0mm | 41Fr |
Endoscopic accessories designed for a minimum working channel width up to 2.0mm can be used with the aScope 3-5. Endoscopic accessories designed for a minimum working channel width up to 1.2mm can be used with the aScope 3-Slim.
The system consists of Ambu aScope 3 ( Ambu aScope 3 5.0/2.2 or Ambu aScope 3 Slim 3.8/1.2) and Ambu aView Monitor. Ambu aScope 3 has been designed for airway management within the larynx and the tracheobronchial tree. This includes endoscopic observation to assess airway anatomy, endotracheal/endobronchial intubation and management. Ambu aScope 3 is for single use and it is sterile. The Ambu aScope 3 must be connected to Ambu aView Monitor. The monitor displays the image and it is reusable. Ambu aScope 3 has the following physical and performance characteristics; - Maneuverable tip controlled by the clinician ・ - Flexible insertion cord . - Camera and LED light source at the distal tip ・ - Working channel . - Sterile by Ethylene Oxide sterilization • - . For Single Use The differences between_Ambu aScope 3 5.0/2.2 and Ambu aScope 3 Slim 3.8/1.2 are as follows: - Distal end outer diameter י - -Insertion tube outer diameter - Working channel inner diameter - - Angulation range . Ambu aView Monitor has the following physical and performance characteristics: - Displays the image from Ambu aScope on the screen. - - Can record snapshot or video of image from aScope . - Can be fixed to e.g. an IV pole. . - Reusable device. -
The provided 510(k) application describes the acceptance criteria and the studies conducted for the Ambu® aScope™ 3 and Ambu® aView™ Monitor.
It's important to note that this document is for a medical device (a flexible bronchoscope system), not an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria (like multi-reader multi-case studies with AI assistance, standalone AI performance, training set details, or human expert involvement in ground truth for AI) are not applicable to this submission.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and reported performance are largely based on engineering and manufacturing specifications, as well as adherence to national and international standards for medical devices.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material/Design Conformance Standards | Conformance to ISO 8600-1, ISO 8600-3, ISO 8600-4 (Optics and optical instruments - medical endoscopes and certain accessories) | All tests were passed. |
| Conformance to ISO 594-1 (Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment) | All tests were passed. | |
| Ambu aScope 3 (Single Use) Performance | Bending Angle & Endurance (aScope 3 Slim 3.8/1.2): Bending to maximum 130° up and down. | All tests were passed. |
| Bending Angle & Endurance (aScope 3 5.0/2.2): Bending to maximum 150° up and 130° down. | All tests were passed. | |
| General Performance: Product specifications fulfilled according to Final Quality Inspection Procedure of Ambu aScope 3. | All tests were passed. | |
| Sterile Packaging Integrity: Seal strength > 0.4 N when tested per ASTM F88. | All tests were passed. | |
| Ambu aView Monitor (Reusable) Performance | Imaging Performance: Evaluation of colors, flickering, contrast, and haze rated on a scale of 1-3 (1 being best). | |
| Acceptance: Rating 1 with a maximum of two ratings of 2. | All tests were passed. | |
| Chemical Endurance: Monitor can withstand contact with cleaning and disinfection chemicals (reprocessing). | All tests were passed. | |
| Battery Capacity: At least 70% battery capacity after 150 charging cycles. | All tests were passed. | |
| Environmental Testing (Transportation & Handling) | Transportation (in packaging): Withstand EN 60068-2-27 (Shock: 500 repetitive shocks, 400 m/s^2), EN 60068-2-64 (Vibration: 1.6 grms), EN 60068-2-31 (Rough handling: 12 falls from 1.2m). | |
| Post-test: Packaging integrity and device inspection, performance test of device. | All products and packaging passed the tests. | |
| Handling (without packaging): Withstand EN 60608-2-6 (Vibration: 5Hz, 1grms, 1 hour), EN 60068-2-31 (Free fall: 2 falls per relevant orientation from 1.2m to concrete). | ||
| Post-test: Device inspection, performance test of device. | All products and packaging passed the tests. | |
| Biocompatibility | Compliance with ISO 10993-1, including specific tests for Cytotoxicity (ISO 10993-5), Ethylene oxide sterilization residuals (ISO 10993-7), Sensitization (ISO 10993-10), and Intracutaneous reactivity (ISO 10993-10). | All tests were passed. |
| General Requirements | Cleaning & Disinfection Validation: Compliance with AAMI TIR12 and AAMI TIR30 for Ambu aView Monitor. | All tests were passed. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2. | All tests were passed. | |
| Electrical Safety: Compliance with IEC 60601-1 and IEC 60601-2-18. | All tests were passed. |
Regarding AI/ML Specific Questions:
As this 510(k) application is for a conventional medical device (flexible bronchoscope and monitor) and does not involve AI/ML technology, the following questions are not applicable.
- Sample size used for the test set and the data provenance: Not applicable, as there is no "test set" in the context of an AI/ML algorithm. Performance tests are done on physical devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Device ground truth is based on engineering specifications and standard measurements.
- Adjudication method for the test set: Not applicable.
- 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. No AI component.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on objective measurements against engineering specifications, adherence to recognized consensus standards (ISO, ASTM, IEC), and physical performance tests (e.g., bending angles, battery life, resistance to chemicals/environmental stresses).
- The sample size for the training set: Not applicable. No training set for an AI/ML algorithm.
- 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.