(106 days)
Resectoscopes are used for endoscopically controlled ablation of tissue. They are used for examination, diagnosis and/or therapy in conjunction with endoscopic accessories in the various medical disciplines such as Urology and Gynecology.
Resectoscopes are used in transuretheral resection of the prostate (TURP) and in transuretheral resection of bladder tumors (TURB). They consist of:
- · Endoscope
- · Resectoscope sheaths with obturators
- · Working Element
- · Electrodes
The devices are reusable and provided nonsterile. They must be cleaned and sterilized before use.
The body contact materials are surgical grade stainless steel which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
The provided text is a 510(k) summary for the AED Resectoscope, and it does not contain the detailed information typically found in a study proving a device meets acceptance criteria. This document focuses on demonstrating substantial equivalence to predicate devices, rather than independent performance studies with specific acceptance criteria and detailed statistical analysis.
Therefore, many of the requested fields cannot be filled from the given text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Conformance to ISO 8600-4:1997, 8600-1:2005, 8600-3:1997, 8600-5:2005, 8600-6:2005 and IEC 60601-2-2 2006, IEC 60601-2-18 Edition 3.0 2009-08, IEC 60601-2-2 Edition 5.0 2009-02 and IEC 60601-2-2:2009. | The devices conform to these standards. |
| Basic functional characteristics are substantially equivalent to predicate devices. | Design analysis and comparison confirm that basic functional characteristics are substantially equivalent to the predicate devices cited and raise no new issues of safety and effectiveness. |
| Biocompatibility of body contact materials. | Body contact materials (surgical grade stainless steel) have a long history of biocompatibility for human use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document describes a "design analysis and comparison" rather than a clinical or performance test set involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. Ground truth establishment is typically for diagnostic devices or those requiring expert interpretation. This device is a surgical instrument. The evaluation here is against engineering standards and comparison to predicate devices, not against a "ground truth" established by experts in a clinical scenario.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. This relates to clinical studies with expert reviewers, which is not the type of evaluation described.
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 device is a resectoscope, a surgical instrument, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical surgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. For this type of device, the "truth" is typically adherence to engineering specifications, safety standards, and functional equivalence to legally marketed predicate devices, not a clinical "ground truth" derived from patient outcomes or pathology.
8. The sample size for the training set
- Not applicable. This relates to machine learning models, which are not involved here.
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.