(26 days)
ArthroCare System 2000: The ArthroCare System 2000 is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures.
ArthroCare Orthopedic Electrosurgery System: The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in in orthopedic, arthroscopic, and spinal procedures.
ArthroCare Bipolar Loop: The ArthroCare Bipolar Loop is indicated for resection, ablation, and excision, as well as hemostasis of blood vessels in patients requiring endoscopic surgery for general urological procedures including transurethral prostatectomy (TURP), transurethral incisions in the prostate (TUIP), and non-malignant tumors of the bladder wall.
The ArthroCare Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in neurosurgical, spinal, and urological procedures.
The provided 510(k) summary for the ArthroCare System 2000, ArthroCare Orthopedic Electrosurgery System, and ArthroCare Bipolar Loop does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The document is a communication from ArthroCare Corporation to the FDA seeking substantial equivalence for modifications to existing devices (ArthroCare Wands). It primarily focuses on:
- Device Description and Intended Use: Outlining what the devices are and what procedures they are used for.
- Predicate Device: Identifying the previously cleared device (K011634) to which the current submission claims substantial equivalence.
- Modifications: Stating that the proposed modifications are in "materials and labeling" and do not affect the safety or efficacy, or the core technology, principle of operation, performance, or dimensional specifications.
- Substantial Equivalence Claim: Asserting that the modified Wands are substantially equivalent to the predicate devices.
- FDA Response: The FDA letter confirms the substantial equivalence determination based on the provided information.
There is no mention of:
- Acceptance Criteria Table: No such table is presented.
- Reported Device Performance: No specific performance metrics or data derived from testing are included.
- Sample Size/Data Provenance: No information about test sets, sample sizes, or data origin is provided.
- Ground Truth Experts/Qualification: No details about experts, their qualifications, or how ground truth was established.
- Adjudication Method: No adjudication process is described.
- MRMC Comparative Effectiveness Study: No such study is mentioned, nor any effect size.
- Standalone Performance: No algorithm-only performance is discussed, as this is a medical device, not an AI algorithm.
- Type of Ground Truth: No ground truth type is specified because no performance study is detailed.
- Training Set Sample Size: No training set is mentioned as this is not an AI/ML device.
- Training Set Ground Truth Establishment: Not applicable.
This document is a regulatory submission for device modifications based on a claim of substantial equivalence to a predicate device, not a performance study report with acceptance criteria. The claim is that the modifications do not significantly affect the safety or efficacy, implying that the performance assumed for the predicate device still holds without a new performance study being explicitly detailed in this document.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.