(213 days)
a. Endoscopes: The Henke-Sass, Wolf Cystoscopes are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the devices include the visualization and manipulation of the anatomy, as the surgeon deems appropriate. The Henke-Sass, Wolf Cystoscopes are intended to be used in general urological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.
b. Urology Instruments: The Henke-Sass, Wolf Urology Instruments in combination with endoscopes are intended to provide the user with the means for endoscopic visualization during examination, diagnosis and therapy of the lower urinary tract in conjunction with endoscopic accessories, or as the surgeon deems appropriate. The intended for use in urological procedures through the minimally invasive approach, by utilizing natural orifices to access the surgical site.
The Henke-Sass, Wolf Cystoscopes, Hysteroscopes and Accessories are composed of cystoscopes, hysteroscopes and cystoscopic accessories, which provide the user with the means for endoscopic diagnostic and therapeutic procedures. Examples of use of the product include the visualization and manipulation of anatomy, biopsy, and as the surgeon deems appropriate.
The provided text is a 510(k) Summary for the Henke-Sass, Wolf Cystoscopes, Hysteroscopes, and Accessories. It describes the device, its indications for use, and a comparison to a predicate device to establish substantial equivalence. The document is a regulatory submission to the FDA, not a study report that details acceptance criteria and the results of a specific clinical or technical study proving the device meets those criteria.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness studies cannot be fully extracted from this document because it does not contain such a study report.
However, based on the Non-Clinical Performance Data section, we can infer some aspects related to acceptance criteria and the nature of the "study" conducted.
Here's an attempt to answer based only on the provided text, with many fields explicitly stated as "Not applicable" or "Not provided" as the document does not present a detailed scientific evaluation report.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Functional Performance | - Mechanical Performance: (Implicit: Device must function mechanically as intended for endoscopic procedures, including appropriate working length, outer diameter, and deflection capabilities comparable to predicate.) |
- Optical Performance: (Implicit: Clear visualization, light transmission suitable for endoscopic procedures.)
- Illumination Performance: (Implicit: Adequate light output for visualization, comparability to predicate's light source types like Xenon, LED.)
- Sterilization Efficacy: (Achieve Sterility Assurance Level (SAL) of 10^-6 after steam sterilization.) | - Working length: 269mm - 302mm (Meets or is comparable to predicate)
- Outer diameter: 2.7mm - 4.0mm (Meets or is comparable to predicate)
- Deflection: 0° - 70° (Meets or is comparable to predicate)
- Light Source: Xenon, LED (Comparable to predicate)
- Validated for manual and automated cleaning.
- Validated for steam sterilization to provide a sterility assurance of 10^-6. |
| Safety & Risk Management | - Risk Analysis: (Implicit: Risks identified and mitigated in accordance with ISO 14971.) | - Risk analysis carried out in accordance with established in-house acceptance criteria based on ISO 14971. |
| Regulatory Conformance | - Conformance to Recognized Standards and Guidances: (e.g., 510(k) submission guidance for Hysteroscopes and Gynecology Laparoscopes; IEC 60601-2-18, Sec. 201.11.1.2.2; ISO 8600-1, -3, -4, -5, -6.) - Substantial Equivalence: (Implicit: Demonstrate equivalence in indications for use, technological characteristics, safety, and effectiveness to the identified predicate device K040390.) | - Demonstrates conformance with listed recognized standards and guidances.
- Concluded to be substantially equivalent to the predicate device (K040390) based on intended uses, technological characteristics, and non-clinical performance.
- Results show that the subject device has met pre-defined design and performance acceptance criteria. Results of all non-clinical testing support the safety and effectiveness of the subject devices. |
| Cleaning Validation | (Implicit: Cleaning instructions must be effective in preparing the device for sterilization or reuse.) | - The cleaning instructions were validated. |
Explanation of the "Study":
The document refers to "Bench testing" and "Design verification testing" for evaluating mechanical, optical, and illumination performance, and validation for cleaning and sterilization procedures. This is a non-clinical performance study.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not provided. The document states "Bench testing was conducted" but doesn't specify the number of devices or components tested.
- Data Provenance: Not provided, but implicitly generated as part of the device development and validation by Henke-Sass, Wolf GmbH in Germany (company address provided). The testing is proprietary non-clinical data. It is prospective testing designed to validate the new device.
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. This was non-clinical bench testing, not an evaluation requiring expert clinical ground truth assessment for diagnosis. Performance was measured against engineering specifications and validated processes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This was non-clinical bench testing, not an evaluation requiring adjudication of human readings or interpretations.
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 document describes traditional medical devices (endoscopes and accessories), not AI software. Therefore, no MRMC study for AI assistance was performed or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For functional performance (mechanical, optical, illumination): Ground truth was established by engineering specifications, recognized industry standards (e.g., ISO, IEC), and comparison to the characteristics of the legally marketed predicate device.
- For cleaning and sterilization: Ground truth was established by microbiological testing methods to demonstrate a Sterility Assurance Level (SAL) of 10^-6, adhering to relevant standards for reprocessing medical devices.
8. The sample size for the training set
- Not applicable. This is a traditional medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, this is not an AI/ML 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.