(261 days)
The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological procedures.
The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic electrosurgical procedures.
The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological and hysteroscopic electrosurgical procedures.
Indications for Use in UROLOGY: The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological procedures.
Indications for Use in GYNECOLOGY: The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic hysteroscopic electrosurgical procedures
Indications for Use in UROLOGY and GYNECOLOGY: The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological and hysteroscopic electrosurgical procedures.
Resectoscopes are used for endoscopically controlled ablation of tissue. They are used for examination, diagnosis and/or therapy in conjunction with endoscopic accessories in medical disciplines such as Urology and Gynecology. A resectoscope is a combined cystoscope (urology) or hysteroscope (gynecology) and electrosurgical instruments and consists of a sheath, obturator, working element and HF electrode.
This document describes the KARL STORZ Bipolar Resectoscopes with HF cable (K221893). It is important to note that this device is not an AI/ML powered device, therefore, many of the typical acceptance criteria and study details related to AI performance, such as sample sizes for test and training sets, expert qualifications, and adjudication methods, are not applicable.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a traditional medical device and not an AI/ML powered device, the "acceptance criteria" are based on compliance with recognized standards and design specifications, rather than quantitative performance metrics like sensitivity or specificity.
| Acceptance Criterion (Non-Clinical) | Reported Device Performance |
|---|---|
| Electrical Safety and EMC | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18 |
| Biocompatibility | Complies with ISO 10993 (specific parts not detailed, but generally covers biocompatibility) |
| Performance Testing | |
| - Attachment/Detachment force of the electrode | Verified (Met design specifications) |
| - System Interlocking Test | Verified (Met design specifications) |
| - Flow Test (comparative) | Verified (Met design specifications) |
| - Bending Force Test | Verified (Met design specifications) |
| - HF Tissue and HF Durability Test | Verified (Met design specifications) |
| Design Specifications | All design specifications were met through additional bench testing. (Specific quantitative specifications are not provided in this summary, but are internally verified by the manufacturer). |
| Substantial Equivalence to Predicate Device | The conclusions drawn from the nonclinical tests demonstrate that the subject device performs as well as or better than devices currently marketed for the same intended use. (This is the overarching acceptance criterion for 510(k) clearance). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for a non-AI/ML medical device. Testing was primarily bench testing to verify engineering specifications and compliance with standards. There is no "test set" in the context of image or data analysis.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth, in the context of AI, refers to expert-labeled data. For this device, "ground truth" would be established by engineering specifications and objective measurements against those specifications.
4. Adjudication Method
Not applicable. This is relevant for studies involving human interpretation or labeling of data, which is not the case here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This a traditional medical device, not an AI-assisted device, therefore, no such study was conducted to evaluate human reader improvement with AI.
6. Standalone Performance Study
Yes, in a sense. The non-clinical performance data (electrical safety, biocompatibility, and various performance tests) represent the "standalone" performance of the device without human interaction being a variable in the performance assessment itself (though human surgeons use the device). The tests verify the device's inherent functional characteristics and safety.
7. Type of Ground Truth Used
For non-clinical testing of a traditional medical device, the "ground truth" used would be:
- Engineering Specifications: Pre-defined technical requirements for the device's dimensions, material properties, electrical characteristics, mechanical strength, and functional performance.
- Recognized Standards: International (e.g., IEC, ISO) and national standards that set minimum safety and performance requirements for medical devices of this type.
- Comparative Performance to Predicate Device: The performance of the legally marketed predicate device (K210651), which serves as a benchmark for substantial equivalence.
8. Sample Size for the Training Set
Not applicable. This device does not involve machine learning; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a machine learning model, establishing ground truth for such a set is irrelevant.
§ 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.