(174 days)
Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and / or therapy in various medical disciplines, such as urology and gynecology
The resectoscopes consist of working elements, standard and continuous-irrigation resectoscope sheaths, coagulation and cutting electrodes, standard, timerlake (deflecting) and visual obturators, and endoscopes. The working element is the carrier of the endoscope and guide element to the electrodes. The standard resectoscope sheath is inserted together with obturators in to the body opening to enable an atraumatic passage. After removal of the obturators, the shaft provides a guidance for the working element and rinsing charge, while the distal sheath simultaneously serves as a cutting-edge. The obturator fills the hollow sheaths. The visual obturator in combination with the endoscope is used to insert the sheath under vision. The standard electrodes are used for combined cutting and coagulation of soft tissue, e.g. prostate or myoma. The inside of the patient is visualized when the endoscope is inserted into the body through natural or surgically generated access.
This document describes the 510(k) premarket notification for Richard Wolf Medical Instruments Corporation's Resectoscopes E-Line. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria through a detailed study with specific acceptance criteria and outcome measures.
Therefore, many of the requested sections (1-9) which typically apply to studies designed to prove a device meets specific performance criteria are not directly applicable or are not explicitly stated in this type of submission.
Here's an analysis based on the provided text, addressing the points where information is available or inferable:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or a direct performance table are provided in the 510(k) summary. The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices by asserting that "The new technological characteristics have not diminished safety or effectiveness."
Instead of performance criteria, the summary mentions:
- Improved Design: "The resectoscopes improved design and material achieves a more efficient operation."
- Reduced Spring Force: "The new E-Line working elements have a spring forced reduced by 55% from the earlier generation, while the sliding ability is improved. The resulting operation shows less signs of fatigue."
- Higher Wear Resistance: "The material used for the new E-Line resectoscope sheath insulation at the cut-off edge is ceramic rather than GFK which results in higher wear resistance."
- Lighter Housing: Sheaths made from Titan rather than brass/new silver, resulting in a housing "approximately 20% lighter than its predecessor."
- Improved Sealing: E-Line electrode insulation made from Hytrel instead of Teflon, which "produces size accuracy and improves sealing."
- Improved Temperature Resistance and Processing: By replacing Maranyl with Radel.
These are design improvements and material changes, not quantifiable performance metrics with pre-defined acceptance thresholds in the context of a clinical or standalone 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 applicable/not specified. The submission does not detail a study involving a specific test set of cases or data.
- Data Provenance: Not applicable/not specified.
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. No "ground truth" establishment for a test set is described, as no clinical study or performance evaluation requiring expert consensus for diagnostic accuracy is reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication is mentioned.
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 medical instrument (resectoscope), not an AI/imaging diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No "ground truth" was established as there was no study requiring it for performance evaluation.
8. The sample size for the training set
Not applicable. This device is a medical instrument, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Information that is provided in the document regarding the "study" (performance data):
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"Performance Data 5.0" Section:
- "No performance standards are known." This explicitly states that there were no pre-existing, recognized performance standards the device aimed to meet through a specific study.
- Conformity to European Device Directive: "The devices conform to the relevant provisions of European Device Directive 93/42/EEC." This indicates compliance with regulatory requirements, which often include safety and effectiveness principles.
- Testing Performed: "Endurance tests and steam sterilization tests were performed to guarantee that the devices are safe and effective." This is the primary "study" mentioned for non-clinical performance verification.
- Standard Compliance (for HF devices): "The HF devices were tested for conformity with the specified standards ANSI/AAMI HF 18, IEC 601-2-2 / IEC 601-2-18." This refers to electrical safety and electromagnetic compatibility standards, not clinical performance.
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"Clinical Tests 6.0" Section:
- "No clinical tests were performed." This is a critical piece of information, confirming that no human subject studies were conducted to assess clinical effectiveness or safety directly for this 510(k) submission. The safety and effectiveness claims are based on substantial equivalence to predicate devices and non-clinical testing.
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"Conclusions Drawn 7.0" Section:
- "The devices were designed and tested to guarantee the safety and effectiveness when used according to the instruction manuals." This summarizes the overall approach: design controls and non-clinical testing for safety and effectiveness, leveraging the substantial equivalence pathway for market clearance.
In summary, this 510(k) submission for the Resectoscopes E-Line relies on demonstrating substantial equivalence to existing, legally marketed predicate devices, coupled with non-clinical endurance and sterilization testing and compliance with electrical safety standards. It does not present a de novo clinical study with defined acceptance criteria for a new performance claim, a test set, or a ground truth as would be typical for a diagnostic or AI device.
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.