(147 days)
Ambu® aScope™ 4 Cysto is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The Ambu® aScope™ 4 Cysto is intended to provide visualization via Ambu® displaying unit and can be used with endoscopic accessories.
Ambu® aScope™ 4 Cysto is intended for use in a hospital environment or medical office environment. Ambu® aScope™ 4 Cysto is designed for use in adults.
Ambu® aScope™ 4 Cysto is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. Visualization will be achieved by Ambu® displaying unit. The Ambu® aScope™ 4 Cysto is intended to be used with a reusable Ambu® displaying unit to visualize the urethra and the bladder. The Ambu® aScope™ 4 Cysto can be operated by either the left or right hand. The optical module in the distal tip consists of a camera housing containing camera and LED light sources.
Ambu® aScope™ 4 Cysto has the following physical and performance characteristics:
Maneuverable tip controlled by the user
Flexible insertion cord
Working channel that can be used for graspers or other instrumentation
Camera and LED light source at the distal tip
Luer lock connector for irrigation and aspiration
Sterilized by Ethylene Oxide sterilization
For single use
The provided text describes the 510(k) summary for the Ambu® aScope™ 4 Cysto, a medical device. It focuses on demonstrating substantial equivalence to predicate devices through various performance tests and compliance with recognized standards.
However, the document specifically states "Performance Data - Clinical: Not applicable." This indicates that a clinical study with human subjects, which would typically involve assessing how human readers (like radiologists) improve with or without AI assistance, or the performance of an AI algorithm in a clinical setting, was not performed or required for this 510(k) submission.
Therefore, many of the requested elements for describing the acceptance criteria and study that proves the device meets the acceptance criteria (specifically in the context of AI performance or human reader improvement) cannot be directly extracted from this document, as the device is a physical endoscope, not an AI/software device.
I will provide the information that can be extracted or reasonably inferred from the provided text regarding the device's performance, focusing on the physical and functional aspects tested.
Acceptance Criteria and Device Performance for Ambu® aScope™ 4 Cysto
The acceptance criteria for the Ambu® aScope™ 4 Cysto are based on compliance with recognized consensus standards and meeting specified physical and performance characteristics, demonstrating substantial equivalence to predicate devices. The study proving these criteria were met involved a series of bench tests and a declaration of conformity to relevant standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Standard Applied | Reported Device Performance (Result) |
|---|---|---|
| Declaration of Conformity | ISO 8600-1 (Optics & Optical Inst. - Medical Endoscopes) | All tests were passed. |
| ISO 8600-3 (Optics & Optical Inst. - Medical Endoscopes) | All tests were passed. | |
| ISO 8600-4 (Optics & Optical Inst. - Medical Endoscopes) | All tests were passed. | |
| IEC 60601-2-18 ED 3.0:2009 (Medical Electrical Equipment - Endoscopic Equipment) | All tests were passed. | |
| Physical/Performance Characteristics | Insertion cord working length | Tested and passed. (Noted as 390 mm, predicate 380 mm) |
| Insertion cord outer diameter | Tested and passed. (Noted as 5.4 mm, predicate 4.8 mm) | |
| Maximum diameter of the insertion portion | Tested and passed. | |
| Distal end outer diameter | Tested and passed. (Noted as 5.4 mm, predicate 4.8 mm) | |
| Minimum diameter of the working channel | Tested and passed. | |
| Irrigation possible | Tested and passed. | |
| Luer Lock Connector to working channel | Tested and passed. | |
| Angulations range (Distal bending section) | Tested and passed. (Noted as larger than predicate due to no integrated grasper) | |
| Field of view | Tested and passed. | |
| Depth of field | Tested and passed. (Noted as 3-100 mm, predicate 3-50 mm) | |
| Direction of View | Tested and passed. | |
| Sterilization | ISO 11135:2014 (Ethylene Oxide Sterilization) | Sterility Assurance Level (SAL) of 10-6 achieved using half-cycle overkill approach. |
| Shelf Life | Performance and Sterile Packaging Integrity after aging | Tested and passed. |
| Biocompatibility | ISO 10993-1 (Biological evaluation of medical devices) | All tests were passed. |
| ISO 10993-5 (Cytotoxicity) | All tests were passed. | |
| ISO 10993-10 (Sensitization) | All tests were passed. | |
| ISO 10993-10 (Intracutaneous reactivity test) | All tests were passed. | |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | All tests were passed. |
| Electrical Safety | IEC 60601-1 and IEC 60601-2-18 | All tests were passed. |
Regarding the AI-specific questions (2-7), the supplied document explicitly states "Performance Data - Clinical: Not applicable." This means no clinical study involving human readers, AI assistance, or standalone AI performance was conducted or submitted for this specific 510(k) clearance, as the device is a physical endoscope and not an AI/software product.
Therefore, I cannot provide information for the following points based on the provided text, as they are not relevant to this device's 510(k) submission:
- Sample sized used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
Conclusion stated in the document:
Based on the indication for use, technological characteristics, performance data, and comparison to predicate devices, it was concluded that the functionality and intended use of Ambu® aScope™ 4 Cysto is equivalent to the predicate and reference devices. The device is concluded to be as safe and effective and performs as well as the chosen legally marketed predicate device.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.