(207 days)
The single-use cystoscope is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The single-use is intended to provide visualization via image processor and can be used with endoscopic accessories. The cystoscope system is intended for use in a hospital environment or medical office environment. The cystoscope system is designed for use for adult patients requiring cystoscopy.
The Cystoscope System consists of a single-use Cystoscope to provide illumination and intuitive images in endoscopic surgery of the lower urinary tract and serves as a guide to diagnosis and management with accessories and an image processor for clinical image processing. The single-use Cystoscope is a sterile single-use flexible Cystoscope. The image processor is a reusable monitor. The single-use Cystoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The image processor processes the images from the Cystoscope and outputs video signals to a display.
This FDA 510(k) summary (K231118) describes the substantial equivalence of the "Cystoscope System" to a predicate device, the "Ambu aScope 4 Cysto." The submission primarily relies on bench performance testing and compliance with voluntary standards rather than clinical or AI performance studies to establish substantial equivalence.
Therefore, the requested information about acceptance criteria and study data for an AI/device performance assessment is largely not applicable to this specific submission, as it concerns a physical medical device (cystoscope) and its image processing unit, not an AI-driven diagnostic or treatment algorithm.
However, I can extract and present the types of performance data that were provided, framed in a way that attempts to answer your questions where possible, though direct "acceptance criteria" for AI performance or "effect size of human readers with AI" are not present.
Here's a breakdown based on the provided text, indicating "N/A" where the requested information is not relevant to this traditional medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (Implied / Standard) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with FDA guidance "Use of International Standard ISO 10993-1" and ISO 10993-1. | Evaluated in accordance with referenced guidance and standards. |
| Sterilization & Shelf Life | Sterile (SAL 10-6), 3-year shelf life, compliance with ISO 11135:2014, ISO 10993-7:2008 (EO/ECH residual), ASTM F1980-16 (accelerated aging), ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1886/F1886M-16, ASTM F88/F88M-15, ASTM F1929-15 (packaging). | Single-use Cystoscope is provided sterile and its shelf-life is 3 years. Sterilization Process validated accordance with ISO 11135:2014. EO/ECH residual test performed according to ISO 10993-7:2008. Shelf life determined based on optical testing and product performance testing after accelerated aging test. Package validation conducted according to ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1886/F1886M-16, ASTM F88/F88M-15, ASTM F1929-15. |
| Electrical Safety & EMC | Compliance with IEC 60601-1, IEC 60601-2-18 (safety), and IEC 60601-1-2 (EMC). | The system complies with IEC 60601-1 and IEC60601-2-18 for safety and IEC 60601-1-2 for EMC. |
| Software Verification & Validation | Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for "moderate" level of concern. | Software verification and validation testing were conducted, and documentation was provided as recommended by FDA guidance. The software was considered a "moderate" level of concern. |
| Bench Performance - Optical | Compliance with ISO 8600 series; comparable to predicate device for color reproduction, geometric distortion, resolution, depth of field, image intensity uniformity, SNR, dynamic range, image frame frequency, system delay. | Optical performance testing conducted according to ISO 8600 series. Color performance, geometric distortion, optical performance (resolution, depth of field and image intensity uniformity), SNR and dynamic range, image frame frequency and system delay test compared with the predicate device. (Specific comparison results not detailed but implied to be acceptable for substantial equivalence) |
| Bench Performance - Mechanical | Demonstrated functionality and integrity for force/bending/tensile stress, electrical cable connection, irrigation flow, valve functionality, suction joint functionality, image capture/video recording, and compatibility with accessories. | Force/bending/tensile stress testing of the insertion portion, force testing of the electrical cable, irrigation flow testing, functionality of Type T valve, functionality of the suction joint, functionality of the image capture and video recording functions, and compatibility with endoscopic accessories without damage to the cystoscope were performed. (Specific results not detailed but implied to be acceptable for substantial equivalence) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The submission focuses on verification and validation of engineering performance and regulatory compliance, not clinical or image-based diagnostic accuracy. Bench tests would use a sample of manufactured devices.
- Data Provenance: Not applicable for a clinical test set. The data originates from laboratory testing, engineering assessments, and quality control processes conducted by the manufacturer (Shenzhen HugeMed Medical Technical Development Co., Ltd. in China).
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. This is not an AI/diagnostic algorithm submission requiring expert-established ground truth on medical images.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no clinical test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This submission does not involve an AI component that would necessitate an MRMC study comparing human readers with and without AI assistance. The device is a direct visualization tool.
- Effect Size of Human Readers with AI: Not applicable.
6. If a Standalone (Algorithm Only) Performance Study Was Done
- Standalone Study: No. There is no AI algorithm being submitted for standalone performance evaluation in this context. The "software" mentioned relates to the image processor's operational software, not a diagnostic AI.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable for clinical ground truth. The "ground truth" for this device's performance is established by engineering specifications, international consensus standards (ISO, IEC, ASTM), and comparison to the predicate device's characteristics. For example, optical performance is measured against ISO 8600 series standards.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This product is a medical device (cystoscope system), not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable.
§ 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.