(152 days)
Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current.
Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications. The general indications include transcervical resection, vaporization, cutting and coagulation of tissue in the uterus in conductive irrigation fluid as part of a resectoscope system. Specific indications: transcervical diagnosis and treatment (resection, vaporization, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis), lysis of intrauterine septa, endometrial ablation.
The Olympus Resection Electrodes with HF cable that are subject to this submission are for application in saline. Depending on the characteristics of electrical current, which is provided by the electrosurgical generator, electrosurgery can be used for coagulation, vaporization and cutting. The subject HF-Resection Electrodes consist of an active tip, PTFE color code identification, an insulator between the electrode and electrode tube, a guiding tube, telescope clip and arm (shaft). The accompanying HF cables consist of two lantern plugs on the instrument side and one generator plug on the generator side. The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, bands, rollers, needles or buttons. The electrodes have a shaft diameter of 24 Fr, range in length from 261.8-336.7mm, and range in tip angle from 12° - 30° tips. The design of the HF cable plugs fits Olympus electrosurgical generators with Universal Socket. All subject Resection Electrodes are single-use electrodes and are delivered sterile. All subject Resection Electrodes are provided with a single-use, sterile cable to connect the electrode to the generator.
This document is a 510(k) Premarket Notification from the FDA regarding Olympus Winter & Ibe GmbH's Resection Electrodes with HF cable. It describes the device, its intended use, and its equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy, as this is a traditional medical device (electrodes) rather than a diagnostic device or AI algorithm with such measures. Instead, the acceptance criteria are based on demonstrating comparable safety and effectiveness to the predicate device through various non-clinical performance and safety tests, and compliance with relevant standards.
Here's a summary of the performed tests as evidence of meeting safety and effectiveness requirements:
| Acceptance Criteria / Test Category | Test Performed | Reported Device Performance/Conclusion |
|---|---|---|
| Mechanical Performance | - Mechanical compatibility | Demonstrated compatibility. |
| - Detaching force of electrode | Not explicitly stated as pass/fail, but implied to be acceptable as part of overall positive conclusion. | |
| - Lifetime connection/disconnection of the electrodes | Not explicitly stated as pass/fail, but implied to be acceptable as part of overall positive conclusion. | |
| - Compression and tension between guiding sheets and contact part | Not explicitly stated as pass/fail, but implied to be acceptable as part of overall positive conclusion. | |
| - Detaching force of the cable from ESG410 | Not explicitly stated as pass/fail, but implied to be acceptable as part of overall positive conclusion. | |
| Resection/Coagulation Performance | - Duration of single activation in combination with a HF generator | Not explicitly stated as pass/fail, but implied to be acceptable as part of overall positive conclusion. |
| Transport Tests | - Communication with a HF generator | Not explicitly stated as pass/fail, but implied to be acceptable as part of overall positive conclusion. |
| - Electrode pull back to proximal stop | Not explicitly stated as pass/fail, but implied to be acceptable as part of overall positive conclusion. | |
| Usability/User Interface | - Manual assembly of the system | Tested and implied to be acceptable. |
| - Visual inspection of the generator display | Tested and implied to be acceptable. | |
| Electrical Safety | - AAMI/ANSI ES 60601-1:2005 + A1:2012, C1:2009 and A2:2010 (General requirements for safety and essential performance) | Devices tested according to listed standards. Implied compliance as part of overall positive conclusion ("The performance data support the safety and effectiveness of the subject device..."). |
| - AAMI/ANSI/IEC 60601-2-2 2017 (Particular requirements for High Frequency Surgical Equipment) | Devices tested according to listed standards. Implied compliance as part of overall positive conclusion. | |
| - IEC 60601-2-18:2009 (Particular requirements for endoscopic equipment) | Devices tested according to listed standards. Implied compliance as part of overall positive conclusion. | |
| Sterilization & Packaging | - Sterilization according to ISO 11135:2014 | EtO sterilization cycle validated. Sterility assurance level (SAL) of 10^-6^ reached. EtO residuals within limits. |
| - Packaging conforms with ISO 11607-1:2019 | Subject device passed simulated shipping distribution and associated packaging integrity testing per ASTM D4169:2016, ASTM F88, ASTM F1929, and ASTM F2096. | |
| Biocompatibility | - Evaluation in accordance with ISO-10993, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010), irritation (ISO 10993-10:2010), acute systemic toxicity (ISO10993-11:2017), and material-mediated pyrogenicity (ISO10993-11:2017). | Successfully tested for biocompatibility. Patient contact materials (stainless steel, elastosil (glue), ceramic, loctite 4303 (glue), PTFE, PtIr, tungsten) have been successfully tested. |
The study concluded that "The performance data support the safety and effectiveness of the subject device and demonstrate that the subject device is substantially equivalent to the predicate device."
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document describes non-clinical performance and safety testing. It does not refer to "test sets" in the context of patient data. The samples for testing would be units of the device itself (electrodes and cables). The specific number of devices tested for each non-clinical test (e.g., how many electrodes were subjected to lifetime connection/disconnection tests) is not explicitly stated in this summary.
The provenance of this data is from regulatory submissions to the FDA, originating from the manufacturer, Olympus Winter & Ibe GmbH, which is located in Hamburg, Germany. The tests are non-clinical (laboratory/bench tests), not clinical studies; therefore, terms like retrospective/prospective or country of origin of patient data are not applicable.
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)
This is not applicable as the document describes non-clinical testing for a traditional medical device (electrosurgical electrodes and cables), not a diagnostic device or AI algorithm requiring expert-established ground truth from patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable for the reasons stated above.
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
This is not applicable for the reasons stated above. The device is an electrosurgical tool, not an AI-assisted diagnostic or interpretative system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable for the reasons stated above. The device is a physical electrosurgical electrode and cable, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests conducted, the "ground truth" or reference for evaluating performance is typically defined by:
- Engineering specifications and design requirements: For mechanical, electrical, and functional performance.
- Applicable national and international standards: For electrical safety (e.g., IEC 60601 series), sterilization (ISO 11135), packaging (ISO 11607-1, ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and biocompatibility (ISO 10993 series).
- Comparison to the predicate device: The goal is to demonstrate that the subject device is substantially equivalent in terms of safety and effectiveness to the legally marketed predicate device.
8. The sample size for the training set
This is not applicable. The device 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
This is not applicable for the reasons stated above.
§ 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).