(28 days)
Intended for use in patients requiring endoscopic surgery for general urological tissue resection, ablation, and excision and hemostasis of blood vessels. These procedures include Bladder Tumor Diagnosis and Resection, Transurethral Prostatic and Bladder Biopsy, Transurethral Prostatic Resection, and Treatment of Vesical Neck Constriction.
The USA Elite Bipolar Resectoscope consists of a Telescope, Sheath, Bipolar Working Element, and Obturator. The USA Elite Bipolar Resectoscope is designed to work with currently marketed Electrosurgery Systems consisting of a electrosurqical generator called the Controller, a disposable Bipolar Loop, and a reusable or disposable Loop Cable or Cord.
Here's an analysis of the provided text regarding the ACMI Bipolar Resectoscope, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary for a modification to an existing device, not a de novo clearance or a 510(k) for a completely new device. This means the primary evidence presented is for substantial equivalence to a predicate device, rather than extensive clinical efficacy or performance studies with specific numerical acceptance criteria. Therefore, many of the requested data points (like sample sizes for test/training sets, expert ground truth details, MRMC studies, standalone performance studies with quantitative metrics) are not typically present or required in a 510(k) of this nature and are absent from this document.
The "acceptance criteria" here refer to demonstrating that the modified device remains as safe and effective as the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Status / Reported Performance |
|---|---|
| Safety and Effectiveness | Demonstrated to be substantially equivalent to the predicate device. The modifications (performance specifications, dimensional specifications, materials, labeling) are not substantial changes or modifications and do not significantly affect the safety or efficacy of the devices. |
| Indications for Use (General) | Remains the same as the predicate device. Intended for endoscopic surgery for general urological tissue resection, ablation, excision, and hemostasis of blood vessels. |
| Indications for Use (Specific Procedures) | Remains the same as the predicate device. Includes Bladder Tumor Diagnosis and Resection, Transurethral Prostatic and Bladder Biopsy, Transurethral Prostatic Resection, and Treatment of Vesical Neck Constriction. |
| Principles of Operation | Remains the same as the predicate device. Designed to work with currently marketed Electrosurgery Systems (controller, disposable Bipolar Loop, reusable/disposable Loop Cable/Cord). |
| Packaging Materials | Remains the same as the predicate device. |
| Sterilization Parameters | Remains the same as the predicate device. |
| Performance Specifications (as modified) | The modifications to performance specifications are considered not substantial and do not significantly affect safety or efficacy. (Specific values for performance are not provided in this summary, but would have been part of the full submission to justify equivalence.) |
| Dimensional Specifications (as modified) | The modifications to dimensional specifications are considered not substantial and do not significantly affect safety or efficacy. (Specific values for dimensions are not provided in this summary, but would have been part of the full submission to justify equivalence.) |
| Materials (as modified) | The modifications to materials are considered not substantial and do not significantly affect safety or efficacy. (Specific new materials are not detailed, but would have been part of the full submission to justify equivalence, e.g., biocompatibility testing data if new patient-contacting materials were introduced.) |
| Labeling (as modified) | The modifications to labeling are considered not substantial and do not significantly affect safety or efficacy. (Details of labeling changes are not provided, but they would be consistent with the modified specifications and maintain clarity regarding safe and effective use.) |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable / Not Provided. This 510(k) is for a modification to a mechanical/electrical surgical instrument, not an AI/software device that typically uses "test sets" of data. The "test" here refers to demonstrating safety and performance equivalence through engineering verification and validation, rather than data-driven clinical prediction on a patient cohort. The document emphasizes that the modifications do not significantly affect safety or efficacy, implying internal company testing (e.g., bench testing, biocompatibility for material changes) rather than clinical studies on patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable / Not Provided. See point 2. Ground truth in this context would likely refer to engineering specifications or validated performance characteristics rather than expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided. See point 2 and 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is not an AI/software device; it's a surgical instrument. An MRMC study is not relevant here.
6. If a Standalone (algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a physical medical device, not a standalone algorithm.
7. The Type of Ground Truth Used
- Not Applicable (in the context of clinical data/AI). For this device, "ground truth" generally refers to:
- Engineering Specifications: Design tolerances, material properties, electrical output specifications, etc.
- Performance Benchmarks: Comparison against the predicate device's known performance characteristics (e.g., cutting efficacy, coagulation properties, structural integrity, electrical safety).
- Regulatory Standards: Adherence to relevant national and international standards for medical devices.
The document states the modifications are "not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices," implying that internal testing (bench, possibly animal) was performed to show that the modified device performs comparably to the predicate.
8. The Sample Size for the Training Set
- Not Applicable / Not Provided. This is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. There is no training set mentioned or implied for this type of 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.