(90 days)
Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications. Cutting, ablation, resection, vaporization and coagulation with HF current.
Gynecology: Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications. The general indications include transcervical resection, vaporization, ablation, cutting and coagulation of tissue in the uterus in nonconducting irrigation fluid.
Specific intended use Gynecology:
- -Transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium
- -Lysis of intrauterine septa
- -Endometrial ablation
The Olympus Resection Electrodes that are subject to this submission are either monopolar or for application in saline. The main difference between monopolar electrosurgery and electrosurgery in saline is that while in monopolar electrosurgery a neutral electrode is required, whereas in electrosurgery in saline the (neutral) return electrode is part of the surgical device.
Depending on the characteristics of electrical current, which is provided by the electrosurgical generator, electrosurgery can be used for coagulation, vaporisation 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 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.
All subject Resection Electrodes are single-use electrodes and are delivered sterile.
This document is a 510(k) Premarket Notification from the FDA for Olympus Winter & Ibe Gmbh's electrodes. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove a device meets specific acceptance criteria in the typical sense of algorithm performance metrics.
Therefore, many of the requested sections about acceptance criteria and study design for performance metrics, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission. The document primarily details the device's technical specifications, indications for use, and a comparison to predicate devices based on safety and effectiveness, rather than a clinical performance study with numerical acceptance criteria.
However, I can extract information related to the safety and material performance testing mentioned in the document.
1. Table of acceptance criteria and the reported device performance
The document does not provide specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) or quantitative performance metrics for the device's clinical efficacy in the way an AI or diagnostic device submission might. Instead, the "acceptance criteria" are implied by adherence to recognized international standards for various non-clinical tests. The reported "performance" is that these tests were conducted and the device complied with the requirements of these standards, supporting its safety and effectiveness.
| Category | Acceptance Criteria (Implied by Standards Adherence) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 and FDA guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'' for tests including: Cytotoxicity, Irritation, Sensitization, Chemical Analysis, and Biological-toxicological evaluation. The implied acceptance is that the device materials are biocompatible and do not pose unacceptable biological risks to the patient. | All biocompatibility testing has been conducted according to the specified standards and guidance. The different technological characteristics (patient contacting materials) were tested and "do not affect the safety and effectiveness of the subject devices." |
| Electrical Safety | Compliance with: |
- AAMI/ANSI ES 60601-1:2005 + A1:2012, C1:2009 and A2:2010 (Medical Electrical Equipment - Part 1.1 General requirements for safety and essential performance).
- AAMI/ANSI/IEC 60601-2-2 2009 (Medical Electrical Equipment - Part 2-2: Particular Requirements for the Basic Safety And Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories).
- IEC 60601-2-18:2009 (Medical Electrical Equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment). The implied acceptance is that the device is electrically safe for its intended use. | Electrical Safety was tested according to the listed standards. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 and IEC 60601-2-2 for the resectoscope system. The implied acceptance is that the device, as part of the system, operates without causing or being unduly affected by electromagnetic disturbances. | EMC testing was conducted for the resectoscope system (not standalone electrodes). It was demonstrated that "the compatible resectoscope system complies with all requirements of IEC 60601-1-2 and IEC 60601-2-2." It is assumed that since electrodes are made of similar conductive materials and contain no electrical components, they will not affect the electrical properties of the system. |
| Thermal Safety | Compliance with AAMI/ANSVIEC 60601-2-2 2009 (Medical Electrical Equipment - Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories). The implied acceptance is that the device does not reach unsafe temperatures during operation. | Tested according to AAMI/ANSVIEC 60601-2-2 2009. |
| Sterilization | Compliance with ISO 11135 for the EtO sterilization cycle and conformity with AAMI ANSI ISO 11607-1:2006 for packaging. A Sterility Assurance Level (SAL) of 10-6 must be reached. EtO residuals must be within limits. | Sterilization is performed according to ISO 11135 and packaging conforms with AAMI ANSI ISO 11607-1:2006. The EtO sterilization cycle has been validated, and an SAL of 10-6 was reached. EtO residuals are within limits. |
| Shelf Life | Adequate performance and package integrity over the declared shelf life. | Shelf life testing was conducted, including performance testing and package integrity testing, to support a shelf life of 5 years. |
| Performance Testing Bench | Mechanical and electrical performance, resection/coagulation effectiveness, durability, and transport/packaging integrity. Implied acceptance is that the devices perform their intended functional tasks reliably and safely. | Conducted tests include mechanical and electrical performance testing, resection/coagulation testing, durability testing, and transport/packaging testing. (No specific numerical results or thresholds provided, but the statement indicates compliance was achieved to support substantial equivalence). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document describes non-clinical performance and safety testing. It does not refer to a "test set" in the context of diagnostic performance or AI model evaluation. The tests mentioned (biocompatibility, electrical safety, thermal safety, sterilization, shelf life, bench testing) were conducted on device samples to ensure compliance with standards. The sample sizes for these engineering and materials tests are not specified in the summary but would be determined by the specific test protocols for each standard. Data provenance is not applicable as it is laboratory testing for device characteristics, not 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)
This is not applicable to the type of testing described. "Ground truth" in the context of expert consensus on medical images or diagnoses is not a component of this submission for an electrosurgical device. The ground truth for the performance tests would be the established scientific and engineering principles and the requirements defined within the referenced international standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept applies to human reader studies or similar diagnostic performance evaluations, which were not part of this 510(k) submission.
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 is a premarket notification for electrosurgical electrodes, not an AI-assisted diagnostic device. No MRMC study or AI component is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is based on adherence to recognized international standards and engineering principles. For example:
- Biocompatibility: Defined by ISO 10993-1.
- Electrical Safety: Defined by AAMI/ANSI ES 60601-1, AAMI/ANSI/IEC 60601-2-2, IEC 60601-2-18.
- EMC: Defined by IEC 60601-1-2 and IEC 60601-2-2.
- Sterilization: Defined by ISO 11135 and AAMI ANSI ISO 11607-1:2006.
- Thermal Safety: Defined by AAMI/ANSVIEC 60601-2-2.
- Functional Performance: Evaluated against design specifications and predicate device performance.
There is also a "Clinical Evaluation" mentioned, which was a "comprehensive literature review" rather than new clinical data or expert consensus on cases.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. It's a medical device, and the testing outlined is for manufacturing, material properties, and safety.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this device.
§ 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).