(191 days)
Sensor-Ureterorenoscopes are used within the scope of therapeutic interventions. The products are active, sterile and for single-use. They are used for visualizing body cavities via natural passages and for the insertion of auxiliary instruments through the working channel as well as the supply of irrigation fluid.
The Sensor-Ureterorenoscope is used in Urology for examination, diagnostics and/or therapy of the upper urinary tract.
ADAPTER FOR CONTROLLER 5525
The products are used for operating a sensor endoscope in conjunction with an ENDOCAM Logic 5525 Camera Controller, for the mechanical connection to the sensor endoscope as well as for controlling the signals generated.
The Sensor-Ureterorenoscope features a semi-rigid instrument sheath and a flexible and actively deflectable tip. It is equipped with two separate working channels for applications with laser fibers and/or flexible auxiliary instruments. The two working channels have different diameters, allowing the insertion of the laser fiber via working channel (2) and a stone-extraction basket or flexible auxiliary instruments via working channel (1)
Irrigation is effected via working channel (1) and is connected via the luer connector marked in blue on the housing.
A third channel integrated in the instrument sheath allows the return flow via distal holes on the instrument head. The drain is effected via the lower luer connector marked in gray.
The flexible deflectable tip can be controlled in both directions (upward and downward) +/-300° via the control wheel on the handle. Thanks to the high torsional stiffness of the semi-rigid instrument sheath the sheath movements are transmitted directly in radial and axial directions. The working channel (2) permits the insertion of laser fibers up to a diameter of 272 µm.
For visualization the Sensor-Ureterorenoscope is connected to an endoscopy camera controller. The Sensor-Ureterorenoscope is sterile and for single-use.
The ADAPTER FOR CONTROLLER 5525 is an accessory to the RIWO D-URS, which serves as an interface to connect the RIWO D-URS to an ENDOCAM Logic 5525 Camera Controller (not part of this submission).
This FDA 510(k) summary describes a new medical device, the SENSOR-URETERORENOSCOPE 9 FR WL 600 MM and its ADAPTER FOR CONTROLLER 5525, and compares it to a predicate device. The document focuses on demonstrating substantial equivalence, primarily through non-clinical testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly presented in a clear, quantitative, pass/fail table format common for AI/Software as a Medical Device (SaMD) clearances. Instead, the document discusses various types of non-clinical testing performed to demonstrate safety and effectiveness and compare the subject device to the predicate. The "reported device performance" is framed in terms of successful completion of tests and compliance with standards, rather than specific performance metrics (e.g., accuracy, sensitivity, specificity).
The document states that the testing "proved that the RIWO D-URS is as safe as the predicate device" and "can be deemed substantially equivalent."
Here's an attempt to extract the closest equivalents to acceptance criteria and reported performance:
| Acceptance Criterion (Inferred from testing) | Reported Device Performance (Summary from text) |
|---|---|
| Sterility & Packaging Integrity: Maintain sterility and packaging integrity under various conditions (environmental, accelerated aging, transportation). | All tests (Environmental conditioning ASTM D4169-16 and D4332-14, Accelerated aging ASTM F1980-16, Transportation Simulation ASTM D4169-16, Visual Inspection ASTM F1886-16, Packaging Challenging Testing [Bubble Test] ASTM F2096-11, Seal Integrity Test [Liquid Dye] ASTM F1929-15, Seal Strength Test ASTM F88-15) were applied to non-aged and accelerated aged products, and results "proved that the RIWO D-URS is as safe as the predicate device." |
| Biocompatibility: Meet biological safety requirements for direct and indirect patient contact. | Biological testing and chemical characterization were performed, and results "proved that the RIWO D-URS is as safe as the predicate device." |
| Electromagnetic Compatibility (EMC) & Electrical Safety: Comply with relevant medical electrical equipment standards. | Testing proved compliance with IEC 60601-1, IEC 60601-1-6, IEC 60601-1-2, and IEC 60601-2-18, demonstrating devices are "as safe and effective" and "substantially equivalent." |
| Functional Performance (Interface Compatibility): Ensure compatibility of adapter with camera controller. | Bench testing and electromagnetic compatibility testing were done, proving compatibility. "Every functional performance test was done using the ADAPTER FOR CONTROLLER 5525 as otherwise no image would have been visible." |
| Usability: Demonstrate safe and effective operation despite handle design differences. | A usability study was performed which "proved that the subject device can be operated as safe and effective as the predicate device." |
| Performance (Technical Characteristics): Deviations in technical characteristics (sheath diameter, working channel diameter, working length, deflection range, LED positioning, pixel size) have no negative impact on safety and effectiveness and perform within specifications. | Evaluated by bench testing, "proving that the deviations have no negative impact on the safety and effectiveness of the device and that it can perform within its specifications." Optical performance was evaluated and parameters without defined acceptance criteria were compared to the predicate device to prove equivalence. |
| Overall Design, Basic Safety, and Essential Performance: Verification and validation confirm the product meets all requirements and specifications. | "The efficacy and safety... is documented by the verification and validation testing, which confirms that the product meets all the requirements and specifications for overall design, basic safety and essential performance, and that the design inputs and specifications are met." |
Detailed Study Information (Based on provided text):
1. A table of acceptance criteria and the reported device performance:
(Provided above)
2. Sample sized used for the test set and the data provenance:
- Sample Size: The document does not specify exact numerical sample sizes for most of the engineering or non-clinical tests (e.g., how many units were tested for sterility, biocompatibility, or functional performance). It refers to "several tests" or "bench testing."
- Data Provenance: Not explicitly stated. These are non-clinical (laboratory/bench) tests conducted by the manufacturer to demonstrate compliance with standards and equivalence. No patient data or geographical origin is mentioned as it's a device clearance, not an AI/SaMD clearance. The manufacturer is Richard Wolf GmbH, located in Germany, so it's likely testing was conducted there or at partner labs.
- Retrospective/Prospective: Not applicable in the context of these non-clinical device tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not an AI/SaMD study involving human expert review for ground truth establishment. The "ground truth" for these tests is defined by compliance with established engineering standards (e.g., ISO, ASTM, IEC).
- For the usability study, while not explicitly stating "experts establishing ground truth," it involved assessing the ease and safety of operation by "medically qualified and adequately instructed persons" (as per the "User" statement in the Indications for Use), who implicitly serve as the evaluators in a usability context. The number or qualifications of these users are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This is not a study requiring adjudication of expert interpretations (e.g., medical image reads). Test outcomes are determined by adherence to predefined technical specifications and standards.
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:
- No. An MRMC study was not conducted as this is a traditional medical device (urorenoscope) and not an AI/SaMD requiring assessment of human reader performance with or without AI assistance.
- A usability study was performed to compare the operational aspects of the subject device to the predicate device, implying a comparison of human interaction/performance, but this is distinct from an MRMC study for diagnostic accuracy.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. The device (ureterorenoscope) does not contain a standalone algorithm. The device itself is the "standalone" component being tested for its physical and functional performance characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: For this type of device, the "ground truth" is defined by adherence to engineering specifications, national/international standards (e.g., ISO, ASTM, IEC), and the ability to perform its stated function (visualization, instrument insertion, fluid irrigation) effectively and safely as confirmed by non-clinical bench testing. It's not a diagnostic device where pathology or outcome data would be the ground truth.
8. The sample size for the training set:
- Not Applicable. This is not an AI/Machine Learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As no training set is used, no ground truth for a training set was established.
Summary of the Study Approach:
The study presented in this 510(k) summary is a series of non-clinical, benchtop, and laboratory tests designed to demonstrate that the new ureterorenoscope and its adapter are as safe and effective as a previously cleared predicate device. The primary method for proving "substantial equivalence" is through demonstrating compliance with recognized safety and performance standards (e.g., for sterilization, biocompatibility, EMC, and functional performance) and by conducting a usability study comparing the subject device's operation to the predicate. No clinical trials or AI/ML-specific performance studies with human readers or large datasets were conducted or required for this device type.
§ 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.