(106 days)
The HF-Resection Electrodes are a bipolar instrument series designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation or removal of soft tissue and where hemostatis is required. The specific urological indications include use in the prostate, bladder and bladder neck. The procedures for which the devices can be used are transurethral resection in saline (TURis), transurethral prostatectorny, transurethral resection of the prostate (TURP) for benign prostatic hyperplasia, transurethral incision of the prostate (TUIP) or bladder neck, transurethral resection of bladder tumors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment. These devices are not intended to be used to treating cancer of the prostate.
The HF-Resection Electrode for Plasma Vaporization is a bipolar instrument designed and intended for use in urological surgical procedures involving the vaporization, ablation, cutting, removal of soft tissue and coagulation where hemostatis is required. The specific soft tissue indications include use in the prostate, bladder neck. The specific treatment indications include benign prostate hyperplasia BPH, bladder cancer, tumors, lesions and neoplasms. The specific urological indications include transurethral electrovaporization (TUVP, TVP, TUEVP), also known as transurethral vapor resection of the prostate (TUVRP) or transurethral vaporization in saline (TUVis). These devices are intended to be used in an irrigated environment. These devices are not intended to be used in treating cancer of the prostate.
The HF-Resection Electrodes and HF Resection Button Electrode for Plasma Vaporization consist of an active tip. PTFE color code identification, an insulator between the electrode tube, a quiding 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.
As an accessory the sterile device recognition cable is enclosed. The cable enables the use of the Gyrus ACMI PK Superpulse System (K100816) with the Olympus HF Electrosurgical Resection and Vaporization Electrodes.
This 510(k) summary describes a submission for HF (High-Frequency) Electrosurgical Resection and Vaporization Electrodes. The document asserts substantial equivalence to predicate devices, rather than presenting a study to prove performance against specific acceptance criteria. Therefore, most of the requested information (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not available in the provided text.
Here's what can be inferred or explicitly stated from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as this is a substantial equivalence submission, not a de novo or PMA where specific performance criteria are typically established and tested against. The implicit acceptance criterion is "substantial equivalence" to the predicate devices in terms of intended use, design, and material specifications, implying similar safety and effectiveness.
- Reported Device Performance: Not reported in a quantitative manner. The document states: "The HF Resection Electrodes and the HF Resection Button Electrode for Plasma Vaporization are basically identical to the predicate devices in intended use, design and material specifications." This is a qualitative claim of similarity, not a measurement of performance against specific metrics.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. No "test set" in the context of performance measurement is described, as the submission relies on substantial equivalence to existing predicate devices.
- Data Provenance: Not applicable. No new performance data is presented.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not applicable. Ground truth establishment for device performance is not described.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. No performance test set or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- MRMC Study: No, an MRMC comparative effectiveness study was not done or reported. This document is a 510(k) summary for electrocautery electrodes, not an AI or diagnostic imaging device that would typically involve such studies.
- Effect Size: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
- Standalone Study: No, a standalone performance study (relevant for AI/software devices) was not done or reported. This device is a surgical instrument.
7. The Type of Ground Truth Used:
- Type of Ground Truth: Not applicable. The submission is based on substantial equivalence to predicate devices, not on proving new performance against an independent ground truth. The "ground truth" here is essentially the established safety and efficacy of the predicate devices.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This is not an AI or machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment for Training Set: Not applicable.
Summary of what the document does provide:
- Device Identification: HF Electrosurgical Resection and Vaporization Electrode Series, for use with the Gyrus ACMI PK® PlasmaKinetic Superpulse System.
- Intended Use/Indications for Use: Detailed descriptions for both the HF-Resection Electrodes and the HF-Resection Electrode for Plasma Vaporization, covering endoscopic urological surgical procedures (resection, ablation, removal of soft tissue, hemostasis) in specific locations (prostate, bladder, bladder neck) and specific conditions (BPH, bladder cancer, tumors, lesions, neoplasms). They are intended for use in an irrigated environment and are not for treating cancer of the prostate.
- Predicate Devices:
- Conclusion: The manufacturer concludes that the new devices do not incorporate any significant changes that could affect the safety or effectiveness, thus asserting substantial equivalence to the predicate devices. The FDA agrees with this finding and clears the devices for market.
§ 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).