(28 days)
The endoscope is a sterile, single endoscope intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is intended to provide visualization via a monitor.
The endoscope is intended for use in a hospital environment. It is designed for use in adults.
The Ambu® aScope™ 4 RhinoLaryngo Slim is a sterile single use flexible endoscope for examination of the nasal lumens and upper airway anatomy.
Ambu® aScope™ 4 RhinoLaryngo Slim has the following physical and performance characteristics:
Maneuverable tip controlled by the user Flexible insertion cord Camera and LED light source at the distal tip Sterilized by Ethylene Oxide For single use
This document is a 510(k) Summary for the Ambu aScope 4 RhinoLaryngo Slim, indicating that it is a sterile, single-use, flexible endoscope for examination of the nasal lumens and upper airway anatomy. It provides an overview of the device's characteristics and a comparison to predicate devices to establish substantial equivalence.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by compliance with recognized consensus standards and performance tests. The device performance is reported as meeting these standards.
| Acceptance Criteria (Test Category) | Specific Standard/Test | Reported Device Performance |
|---|---|---|
| Product Specific Standards | ISO 8600-1 | All tests were passed. |
| ISO 8600-3 | All tests were passed. | |
| ISO 8600-4 | All tests were passed. | |
| ISO 594-1 | All tests were passed. | |
| Performance Tests | Length and diameters of insertion cord | All tests were passed. |
| Bending angle, endurance and radius | All tests were passed. | |
| Image Sharpness | All tests were passed. | |
| Shelf Life and Sterile Barrier | ASTM F1980 (Accelerated Aging) | All tests were passed. |
| ASTM D4169 (Shipping Containers) | All tests were passed. | |
| ASTM F1886/F1886M (Seal Integrity - Visual) | All tests were passed. | |
| ASTM F2096 (Gross Leaks - Bubble Test) | All tests were passed. | |
| EN 868-5 (Seal Strength) | All tests were passed. | |
| ASTM F88 (Seal Strength) | All tests were passed. | |
| Electromagnetic Compatibility | IEC 60601-1-2 | All tests were passed. |
| Electrical Safety | IEC 60601-1 | All tests were passed. |
| IEC 60601-2-18 | All tests were passed. | |
| Biocompatibility | ISO10993 (cytotoxicity, irritation, sensitization) | Compliant |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data or human subject studies. The data provenance described is primarily bench testing data for device performance, compliance with standards, and material properties. There is no information about country of origin for any human subject data, nor whether it was retrospective or prospective, as no such data is presented.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for this submission is established through bench testing and compliance with recognized industry standards. There is no mention of expert consensus based on human clinical data for a "test set."
4. Adjudication Method for the Test Set
Not applicable. As described above, there is no "test set" in the context of clinical data requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The document explicitly states "Not applicable" under the "Performance Data - Clinical" section, indicating no clinical studies were performed. This submission relies on substantial equivalence based on technological characteristics and bench testing compared to predicate devices.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is an endoscope, a physical medical instrument, not a software algorithm that would have standalone performance in the absence of a human operator. The device's performance is intrinsically linked to its physical properties and intended use by a clinician.
7. Type of Ground Truth Used
The ground truth used for demonstrating compliance and performance is based on engineering specifications, compliance with international and national standards (e.g., ISO, ASTM, IEC), and results from bench testing. For example, the measurement of bending angles, image sharpness, and seal integrity tests against predefined limits or standards constitute the ground truth.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device that requires a "training set." The device is a physical medical instrument.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied for this device.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.