(189 days)
The Ambu aScope is intended for use as an aid in the placement of an Endotracheal Tube (ETT) directly or through an intubating laryngeal mask during non difficult and difficult intubation procedures. The Ambu aScope achieves its purpose by providing the user with a visual confirmation of where the tip of the Ambu aScope is in the human anatomy. The flexible tip of the Ambu aScope allows the user to guide the ETT in the desired direction.
The system is for use in a hospital environment. The target population is adults/children that have been clinically evaluated for ETT size 6 or larger.
Topical anesthetics can be administered via a channel with a luer connector
Ambu aScope System consist of Ambu aScope and Ambu aScope Monitor.
Ambu aScope is for placement of an endotracheal tube (ETT), an ETT size 6 or larger can be used. A camera at the distal tip of the aScope provides the user with an indication of the placement of the aScope. The manoeuvrable tip allows the user to guide the ETT in the desired direction. Ambu aScope is for single patient use and it is sterile.
The Ambu aScope must be connected to Ambu aScope Monitor. The monitor displays the image and it is reusable.
Ambu aScope has the following physical and performance characteristics:
- Manoeuvrable tip controlled by the clinician
- Flexible insertion cord
- Camera and LED light source at the distal tip
- Topical Anaesthetics can be administered to the patient via a channel, with standard luer connector
- Sterile by Ethylene Oxide sterilisation
- For Single Patient Use
Ambu aScope Monitor has the following physical and performance characteristics:
- Displays the image from Ambu aScope on the screen.
- Can be fixed to e.g. an IV pole.
- By connecting a Video Out Cable to the Ambu aScope Monitor the image can be displayed and/or recorded on an external monitor and/or video recorder.
- Reusable device.
Ambu aScope and aScope Monitor 510(k) Summary (K093186)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided in the document primarily relate to the physical and performance characteristics of the Ambu aScope and Ambu aScope Monitor, as well as adherence to recognized consensus standards. There is no specific acceptance criteria for diagnostic accuracy or clinical outcomes that would typically be seen for AI/ML devices. Instead, the focus is on the device's functionality, durability, safety, and manufacturing quality.
| Acceptance Criteria (Ambu aScope) | Reported Device Performance |
|---|---|
| Manoeuvrability of tip: min 120° to each side | All tests were passed (implies criteria met). |
| Endurance of bending section: 50 bends to each side of minimum 90° and 10 bends to each side of minimum 120° | All tests were passed (implies criteria met). |
| Channel for topical anaesthetics: when 1 ml injected, at least 0.8 ml expelled at distal end | Verification of ability to administer topical anaesthetics through the channel was passed (implies criteria met). |
| Temperature at distal end of Ambu aScope: below 41 °C | All tests were passed (implies criteria met). |
| Shelf life: Product specifications fulfilled (after aging) | All tests were passed (implies criteria met). |
| Sterile packaging integrity: Seal strength > 0.4 N (ASTM F88) | All tests were passed (implies criteria met). |
| Acceptance Criteria (Ambu aScope Monitor) | Reported Device Performance |
|---|---|
| Imaging performance: rating 1, and max 2 ratings of 2 (on a scale of 1-3 where 1 is best) when 32 scopes evaluated for 4 properties (128 evaluations) | All tests were passed (implies criteria met). |
| Cleaning endurance: withstand prescribed cleaning/disinfection 150 times | All tests were passed (implies criteria met). |
| Battery capacity: at least 70% capacity after 150 charging/discharging cycles | All tests were passed (implies criteria met). |
| Acceptance Criteria (General/Standard Compliance) | Reported Device Performance |
|---|---|
| Compliance to ISO 8600-1, ISO 8600-3, ISO 8600-4 (Optics and optical instruments - medical endoscopes) | Declaration of conformity based on test data. All tests were passed. |
| Compliance to ISO 594-1 (Conical fittings - luer taper) | Declaration of conformity based on test data. All tests were passed. |
| Biocompatibility: Compliance with ISO 10993-1 (Cytotoxicity, Sensitization, Intracutaneous reactivity) | All tests were passed. |
| Cleaning validation and Liquid Chemical Sterilization and Disinfection Validation: According to AAMI TIR12 and AAMI TIR30 | All tests were passed. |
| Electro Magnetic Compatibility: 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. |
| Environmental (Transport, Handling, Free Fall) tests: Compliance with EN 60068-2-27, EN 60068-2-64, EN 60068-2-31, EN 60608-2-6 (specific parameters detailed in the document) | All products and packaging passed the tests. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of an AI/ML device evaluating data. Instead, it refers to performance tests on the physical device.
- Ambu aScope: No specific "sample size" is mentioned for individual components, but tests were conducted on various units to verify physical and performance characteristics, endurance, and shelf life.
- Ambu aScope Monitor: For "Imaging performance," 32 scopes were evaluated, leading to 128 evaluations (32 scopes x 4 properties). No information is provided regarding the origin or retrospective/prospective nature of this data as it relates to device functionality rather than clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The document describes engineering and physical performance tests, and compliance with standards, not a study involving experts to establish ground truth for image or diagnostic data interpretation.
4. Adjudication Method for the Test Set
Not applicable. The tests described are objective measurements or pass/fail criteria based on engineering specifications and recognized standards, not subjective evaluations 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 device is a physical intubation scope and monitor system, not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by engineering specifications, physical benchmarks, and recognized consensus standards (e.g., ISO, IEC, ASTM) which define acceptable ranges or outcomes for various physical and functional tests.
8. The Sample Size for the Training Set
Not applicable. This device does not involve AI/ML and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. This device does not involve AI/ML and therefore does not have a "training set" or corresponding ground truth establishment process in that context.
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).