(149 days)
Ambu® USR is a sterile, single use flexible cystoscope designed for removal of double loop ureteral stents accessible in the bladder via a urethral insertion in adults. Ambu® USR has been designed to be used with the reusable Ambu® M to visualize the observations obtained by Ambu® USR.
The system consists of Ambu® USR and Ambu® M Monitor. Ambu® USR is a single use flexible cystoscope with an integrated grasper designed for removal of double loop ureteral stents accessible in the bladder via a urethral insertion. Ambu® USR is connected to the reusable Ambu® M Monitor that displays the video image from Ambu® USR. Ambu® USR has the following physical and performance characteristics: Maneuverable tip controlled by the user. Integrated grasper controlled by the user. Flexible insertion cord. Camera and LED light source at the distal tip. Luer lock connector for irrigation and aspiration. Sterilized by Ethylene Oxide sterilization. For single use. Ambu® M Monitor has the following physical and performance characteristics: Displays the image from Ambu® USR on the screen. Records snapshots or video of image from Ambu® USR.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria, formatted as requested:
This document is a 510(k) summary for a medical device (Ambu® USR and Ambu® M). It describes the device, its intended use, and its equivalence to predicate devices, supported by various performance data. However, this document does NOT describe the performance of software/AI-based medical device that predicts/diagnoses/detects disease based on images/data. Therefore, many of the requested fields are not applicable.
Acceptance Criteria and Study for Ambu® USR and Ambu® M
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Length and diameters of insertion cord | All tests were passed. |
| Bending angle and durability of bending section | All tests were passed. | |
| Grasper functionality and image quality | All tests were passed. | |
| Grasper stent pull force | All tests were passed. | |
| Optical/Imaging Performance | Image quality during 1 hour operation | All tests were passed. |
| Fluid Management | Irrigation system functionality | All tests were passed. |
| Sterility | Ethylene Oxide sterilization (implied by method) | Compliance declared. |
| Shelf Life | Performance test of Ambu® USR | All tests were passed. |
| Sterile Packaging Integrity | All tests were passed. | |
| Biocompatibility | Cytotoxicity (ISO 10993-5) | All tests were passed. |
| Sensitization (ISO 10993-10) | All tests were passed. | |
| Intracutaneous reactivity test (ISO 10993-10) | All tests were passed. | |
| Electrical Safety | Electrical Safety in compliance with IEC 60601-1 and IEC 60601-2-18 | All tests were passed. |
| Electromagnetic Compatibility (EMC) | EMC in compliance with IEC 60601-1-2 | All tests were passed. |
| Reusable Component (Ambu® M) Cleaning | Cleaning and Low Level Disinfection validation | The test was passed. |
| Consensus Standards | ISO 8600-1, ISO 8600-3, ISO 8600-4 (Optics and medical endoscopes) | All tests were passed. |
| ISO 594-1 (Luer fittings) | All tests were passed. |
Explanation: The document does not explicitly list "acceptance criteria" with numerical thresholds for each test. Instead, it states that "All tests were passed" or "The test was passed" for various performance and safety assessments, indicating the device met the requirements of these tests and relevant standards. These tests collectively demonstrate that the device performs as intended and is equivalent to the predicate devices.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Specific sample sizes for individual bench tests are not provided in this summary. The tests were performed on "finished, sterilized, shipped and aged products" for shelf life, and on the device components for various other tests.
- Data Provenance: The data appears to be retrospective (tests conducted on manufactured devices as part of product verification and validation) and originated from internal testing by the manufacturer (Ambu A/S), likely in Denmark (country of origin for Ambu A/S).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a hardware medical device (flexible cystoscope and monitor), not an AI/software device that requires expert ground truth for image/data interpretation. Performance was assessed through physical testing against engineering specifications and recognized standards.
4. Adjudication method for the test set
- Not Applicable. See point 3. Testing involved objective measurements and compliance against standards, not subjective expert 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 is a hardware device; no AI component or human reader study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device; no algorithm is described.
7. The type of ground truth used
- Ground Truth Type: For the physical and performance tests, the "ground truth" was established by engineering specifications, recognized consensus standards (e.g., ISO, IEC), and documented test protocols designed to assess the device's functionality, safety, and performance characteristics.
8. The sample size for the training set
- Not Applicable. This document describes a traditional medical device, not an AI/machine learning product that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.