(184 days)
Reprocessed endoscopic electrodes are intended to be used for vaporization, ablation, coagulation and/or resection of soft tissue in the prostate and bladder as well as when ablation and coagulation are required in gynecological and urological surgical procedures.
Reprocessed endoscopic electrodes are electrosurgical electrode devices that have a wide variety of tip configurations and sizes. The device is used to cut and cauterize prostate, bladder, gynecological, and urological tissue. They are used in conjunction with an endoscope and are powered by a separate RF generator. The RF generator component is not included in this submission; only the endoscopic electrodes are reprocessed.
This document is a 510(k) summary for reprocessed endoscopic electrodes, not a detailed study report. Therefore, much of the requested information regarding specific acceptance criteria, study methodologies, and performance metrics is not explicitly provided. However, I can extract the available information and highlight what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Functional Characteristics | Representative samples underwent bench testing to demonstrate appropriate functional characteristics. | Specific criteria (e.g., impedance, power output limits, cutting/coagulation effectiveness) are not detailed. Performance results (e.g., pass/fail rates) are also not provided. |
| Cleaning Procedures | Process validation testing was done to validate the cleaning procedures. | Specific criteria for cleanliness (e.g., residual organic materials, bioburden reduction) are not detailed. Performance results are not provided. |
| Sterilization Procedures | Process validation testing was done to validate the sterilization procedures. | Specific criteria for sterility (e.g., Sterility Assurance Level (SAL)) are not detailed. Performance results are not provided. |
| Device Packaging | Process validation testing was done to validate the device's packaging. | Specific criteria for packaging integrity (e.g., seal strength, bacterial barrier) are not detailed. Performance results are not provided. |
| Manufacturing Process Quality | The manufacturing process includes visual and functional testing of all products produced. | This indicates in-process quality control, but specific performance metrics are not given. |
| Substantial Equivalence | Reprocessed endoscopic electrodes are substantially equivalent to the KSEA Vaporization Electrodes (K961702) and the Vaportrode Vaporization Electrodes (K890328B). | This is the overarching "acceptance" by the FDA, based on "similarities in functional design, materials, indications for use and methods of construction." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Representative samples of reprocessed endoscopic electrodes underwent bench testing." It does not specify the number of devices or the number of tests performed.
- Data Provenance: The document is a 510(k) submission from SterilMed, Inc., located in Minneapolis, MN, USA. The data originates from this company's internal testing as part of their regulatory submission. It is retrospective in the sense that the testing was performed, and the results are reported to the FDA after the fact, but it describes the validation of a manufacturing process for future use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the document describes validation testing for medical devices, not a study involving human interpretation of data where "ground truth" would typically be established by expert consensus (e.g., radiology images). The "ground truth" here is adherence to engineering specifications and regulatory requirements for cleaning, sterilization, and functional performance.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as #3. Adjudication methods are typically used in clinical studies or studies involving human assessment of data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No, an MRMC comparative effectiveness study was not done. This type of study is relevant to AI or diagnostic imaging devices where human readers interpret data, often with and without AI assistance. This document describes the re-processing and functional validation of physical medical devices (electrosurgical electrodes).
- Effect size of human reader improvement: Not applicable.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Was it done? This is not applicable in the context of this device. The devices are physical electrodes used in surgical procedures. There is no "algorithm" or standalone AI performance to evaluate. The testing performed evaluates the physical performance and safety of the reprocessed electrodes.
7. Type of Ground Truth Used
The "ground truth" in this context refers to established engineering standards, regulatory requirements, and validated methods for assessing device performance, cleanliness, and sterility.
- Bench Testing: Engineering specifications for functional characteristics (e.g., cutting ability, coagulation, impedance).
- Process Validation (Cleaning & Sterilization): Regulatory standards for sterility (e.g., SAL), residual organic material limits, and packaging integrity.
- Predicate Device Equivalence: The performance of the original, legally marketed predicate devices serves as the benchmark against which the reprocessed devices must demonstrate substantial equivalence.
8. Sample Size for the Training Set
This section is not applicable. This document describes the validation of a re-processing methodology for physical medical devices. There is no machine learning "training set" involved.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).