(29 days)
The ArthroCare® Bipolar Loop Electrosurgery System is a bipolar electrosurgical device intended for use in patients requiring endoscopic surgery for general urological procedures. Urological tissue can be resected using this System, such as the prostate, in procedures including transurethral prostatectomy (TURP) and transurethral incisions in the prostate (TUIP), as well as non-malignant tumors of the bladder wall. The System has been shown to be effective in tissue resection, ablation, and excision, as well as in hemostasis of blood vessels. It is intended for endoscopic procedures using saline solution. Ringer's lactate, or other conductive solutions as irrigants, under direct or video-assisted fiberoptic visualization.
The ArthroCare® Bipolar Loop Electrosurgery System is a bipolar, high frequency electrosurgical system consisting of three components: an electrosurgical generator called the Controller; a family of disposable, bipolar, single use Wands; and a reusable Patient Cable.
This 510(k) submission (K022543) for the ArthroCare® Bipolar Loop Electrosurgery System is a Special 510(k). This type of submission is used to declare modifications to a previously cleared device. Therefore, the focus is on demonstrating that the modifications do not significantly affect the safety or efficacy of the System and that it remains substantially equivalent to its predicate devices (K955531 and K010568).
Crucially, this document does not contain acceptance criteria or detailed study data proving the device meets specific performance metrics in the way a de novo or traditional 510(k) might for a wholly new device or significant design change.
Instead, the "study" demonstrating that the device meets acceptance criteria is implied by the nature of a Special 510(k): the modifications are not substantial enough to require new clinical performance testing or completely redefined acceptance criteria beyond those already established for the predicate devices. The acceptance criteria are, essentially, that the modified device's performance is still within the bounds of what was deemed safe and effective for the predicate devices, and that the changes do not introduce new safety or effectiveness concerns.
Here's an analysis based on the provided text, addressing your questions where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a Special 510(k) focusing on minor modifications to an already cleared device, formal quantitative acceptance criteria and a detailed table of reported device performance values in the context of new testing are not explicitly provided in the document.
Instead, the "acceptance criteria" are broad and qualitative, centered around the concept of substantial equivalence to the predicate devices. The reported "performance" is implicitly stated by asserting that the modifications do not "significantly affect the safety or efficacy of the System."
| Acceptance Criteria (Implied for Special 510(k)) | Reported Device Performance (Summary Statement) |
|---|---|
| Safety: Does not introduce new safety concerns. | "The proposed modifications... do not significantly affect the safety or efficacy of the System." |
| Efficacy: Maintains the effectiveness for its intended uses. | "The proposed modifications... do not significantly affect the safety or efficacy of the System." |
| Substantial Equivalence: Features remain aligned with predicate devices. | "The modified Bipolar Loop Electrosurgery System... is substantially equivalent to the predicate device." |
| Intended Use: Continues to meet the defined indications for use. | "The indications for use... remain the same as in the predicate cleared 510(k)." |
| Technology/Principle of Operation: No fundamental changes. | "The technology, principle of operation... remain the same as in the predicate cleared 510(k)." |
2. Sample Size Used for the Test Set and Data Provenance
This document does not mention a test set, sample size, or data provenance in the context of new clinical or performance testing for the Special 510(k). The basis for the substantial equivalence claim relies on the unchanged aspects of the device and the minor nature of the modifications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that no new test set or clinical study data is presented for this Special 510(k), there is no information regarding experts establishing ground truth. The initial ground truth (safety and effectiveness) would have been established during the original 510(k) clearances (K955531 and K010568) for the predicate devices.
4. Adjudication Method for the Test Set
As no new test set data is presented, no adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this Special 510(k) document. This type of study is more common for diagnostic imaging or AI-assisted diagnostic devices, and not typically for an electrosurgical system modification focused on substantial equivalence.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is an electrosurgical system operated by a human surgeon, not an algorithm, and therefore the concept of "standalone performance" for an algorithm does not apply in this context.
7. The Type of Ground Truth Used
For this Special 510(k), the "ground truth" is based on the previously established safety and efficacy of the predicate devices (ArthroCare® Bipolar Loop Electrosurgery System, K955531 and K010568). The claim is that the modifications do not alter this established ground truth. There is no new "ground truth" derived from expert consensus, pathology, or outcomes data presented in this specific document.
8. The Sample Size for the Training Set
This document does not involve a training set as it's not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for an electrosurgical device.
Summary of the "Study" Proving Acceptance Criteria for this Special 510(k):
The "study" or justification for meeting acceptance criteria in this Special 510(k) is a comparative analysis against its predicate devices. The submitter states that:
- The indications for use, technology, principle of operation, materials, packaging, and sterilization parameters of the modified device remain the same as the predicate cleared 510(k).
- The modifications are specifically described as changes in performance specifications, dimensional specifications, and labeling, which are considered minor.
- The conclusion is that these proposed modifications are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System.
Therefore, the "proof" is declarative: the changes are minor, and because the original device was safe and effective, the modified one remains safe and effective due to the non-substantial nature of the alterations. This type of submission typically relies on engineering analysis, bench testing demonstrating equivalence of the modified components to the original, and a strong argument for the non-impact of the changes, rather than new clinical trials with patient sample sizes.
§ 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).