(33 days)
The ArthroCare ENT Plasma Wands are indicated for ablation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:
- · Adenoidectomy
- Cysts
- · Head, Neck, Oral, and Sinus Surgery
- Mastoidectomy
- · Myringotomy with Effective Hemorrhage Control
- · Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
- Nasopharyngeal/Laryngeal Indications including Tracheal Polypectomy, and Laryngeal Lesion Debulking
- Neck Mass
- · Papilloma Keloids
- · Submucosal Palatal Shrinkage
- Submucosal Tissue Shrinkage
- · Tonsillectomy (including palatine tonsils)
- · Traditional Uvulopalatoplasty (RAUP)
- Tumors
- · Tissue in the Uvula/Soft Palate for the Treatment Of Snoring
The ArthroCare ENT Plasma Wands are bipolar, high frequency electrosurgical devices designed for use in otorhinolaryngology (ENT) surgery. The Wands consists of a single or multiple active electrode(s) located on the distal end of the shaft, a suction line, a saline line, and an injection molded, medical grade plastic handle with integrated cable at the proximal end of the wand. A cable connector is attached to the end of the cable, which connects the wand directly to the ArthroCare Coblator II Controller (CII Controller). The EVac 70 Xtra and PROcise XP Wands with Integrated Cable (EVac 70 Xtra and PROcise XP Wands) are a part of the ENT Plasma Wand family previously cleared under 510(k) K070374 for a change in indications; the integrated cable design was first cleared under 510(k) K033257.
Consistent with the predicate cleared under 510(k) K070374, the ENT Plasma Wands are only compatible with the CII Controller. The controller is designed to deliver radiofrequency energy to the active electrode(s) at the distal end of the wand. Each Wand is designed for soft tissue procedures where tissue resection, ablation, coagulation, and hemostasis are desired. The Wands are provided sterile, and are intended for single use.
This 510(k) seeks clearance for the following changes:
- 트 Addition of an Electronic Use-Limiting (EUL) feature to the integrated cable which will limit the re-use of these single-use disposable Wands.
- 트 A change in the design of the cable connector which mates with the Controller.
- 트 Implementation of Ethylene Oxide (EO) sterilization in lieu of e-Beam sterilization.
This document does not contain the detailed acceptance criteria or a study that precisely defines performance metrics with specific numerical targets. Instead, it is a 510(k) premarket notification summary for a medical device (ArthroCare ENT Plasma Wands) that seeks to establish substantial equivalence to a predicate device.
The core of this submission is to demonstrate that the modified device (EVac 70 Xtra and PROcise XP Wands with Integrated Cable) is as safe and effective as the previously cleared predicate device (ENT Plasma Wands, K070374), despite some minor changes.
Here's an attempt to extract and infer the information based on the provided text, while acknowledging that many specific details requested are not present in this type of FDA submission summary:
Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide specific numerical acceptance criteria. Instead, it states that various tests "met the required specifications" or "perform as intended" or are "substantially equivalent."
| Acceptance Criteria Category | Specific Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Functional Performance | Device operates as intended. | Met required specifications. |
| Ablation Life | Meets specified lifespan for ablation. | Met required specifications. |
| Coagulation | Achieves effective coagulation. | Met required specifications. |
| Software Testing | Software functions correctly. | Met required specifications. |
| Biocompatibility | Biocompatible with human tissue. | Met required specifications. |
| Electrical Safety | IEC 60601-2-2 compliant. | Met required specifications. |
| Tissue Effects (Ablation/Coagulation) | Comparable to predicate device. | Comparable to predicate devices in animal tissue. |
| Mechanical Properties | Acceptable for intended use. | Acceptable. |
| Safety and Efficacy | Equivalent to predicate device. | Not affected by modifications; substantially equivalent. |
| Sterilization | Effective sterilization using EO. | EO sterilization implemented. |
| Use-Limit Feature | Limits re-use of single-use wands. | Feature added to limit re-use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific tests. The performance data section vaguely mentions "animal tissue" for ablation and coagulation testing.
- Data Provenance: "Animal tissue" is mentioned, implying in vivo or ex vivo animal studies. The country of origin is not specified but is implicitly within the scope of ArthroCare Corporation's operations (Austin, TX, USA). The studies are prospective in the sense that they were conducted for this 510(k) submission to demonstrate the equivalence of the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This document describes bench testing and animal tissue testing (likely performed by engineers/scientists), not studies requiring human expert adjudication of clinical outcomes or images for ground truth.
4. Adjudication Method for the Test Set
Not applicable. This was primarily bench and animal tissue testing, not a study requiring human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study is not mentioned as it is not typically required for a 510(k) submission seeking substantial equivalence for minor device modifications, especially when clinical data is explicitly stated as "not required."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical instrument (electrosurgical wand), not an AI algorithm. Its performance is inherent in its physical and functional characteristics.
7. The Type of Ground Truth Used
For the ablation and coagulation testing (the closest thing to a performance evaluation of its intended effect), the "ground truth" seems to be the observable tissue effects in animal tissue, which were then compared to the effects produced by the predicate device. The fundamental assumption is that if the new device produces similar tissue effects, it is equivalent.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is a physical medical device and not an AI/machine learning system.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 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.