(173 days)
The Reprocessed ArthroCare ENT Coblators are indicated for ablation, resection, and coagulation 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 Procedures,
- Laryngeal 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
Reprocessed ENT Coblators are radiofrequency (RF) surgical devices which are powered by an RF generator. The device is designed for the hemostasis of blood vessels, dissection, and removal of tissue during otorhinolaryngology ( ENT) surgical procedures.
ENT probes vary in their configuration depending on intended usage in their diameter, length, electrode shape, and saline delivery/suction capabilities. The materials of constructions are generally polycarbonate handles, stainless steel shafts, Polyester or Tygon insulation material, tungsten electrodes, alumina ceramic tips and PVC saline delivery/suction tubing lines
The provided text describes the 510(k) summary for the device "Reprocessed ArthroCare ENT Coblator." This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving a totally new device meets acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, performance against those criteria, and the specifics of a study proving device performance (like sample size for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance) is not applicable in the context of this 510(k) submission.
The core of this submission is to show that the reprocessed device performs as safely and effectively as the original (OEM) device, with specific testing around the reprocessing procedure and material changes.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a quantitative table of acceptance criteria with specific thresholds and device performance metrics in the way one would expect for a novel device's clinical trial. Instead, it outlines the types of performance tests conducted to demonstrate equivalence to the predicate devices. The acceptance criterion for these tests is that the reprocessed device performs equivalently to the OEM device.
| Test Category | Specific Tests Conducted | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|---|
| Cleaning | Residual Protein & Carbohydrates, Visual Inspection, Cleaning Performance Qualification | No significant residuals; visually clean. | Devices passed these tests, demonstrating effective cleaning. |
| Functional | Thermal Effects Performance Testing, Probe Drop Performance Testing | Thermal performance equivalent to OEM; withstands drops without functional degradation. | Devices passed these tests, demonstrating equivalent functional performance. |
| Sterilization & Packaging | EtO Sterilization Testing, EtO Residuals Testing, Simulated Shipment Testing | Sterilized effectively; EtO residuals within limits; packaging integrity maintained. | Devices passed these tests, demonstrating effective sterilization and packaging integrity. |
| Product Stability | Shelf Life Testing (1-year Accelerated Aging) | Device maintains performance after aging. | Devices passed, indicating performance for 1 year. |
| Biocompatibility | Cytotoxicity, Irritation, Acute Systemic, Material Mediated Pyrogenicity, Sensitization | Biocompatible (especially for new FEP insulation). | Devices passed all biocompatibility tests. |
| Reprocessing/Cleaning Residuals | Detergent Residuals Testing | No significant detergent residuals. | Devices passed, demonstrating no significant detergent residuals. |
| Electrical Safety & EMC | IEC 60601-1-2 EMC Testing, IEC 60601-2-2 Electrical Safety Testing | Meets relevant safety and electromagnetic compatibility standards. | Devices passed all electrical safety and EMC tests. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document does not specify the exact sample sizes (number of units) used for each type of benchtop performance testing. It generally refers to "the subject devices" and "the reprocessed devices" in comparison to "an identical new OEM device," implying a comparative study design.
- Data Provenance: The document does not explicitly state the country of origin of the data. Given the submission is to the FDA (USA), it's highly probable the testing was conducted in the US or at a facility recognized by US standards. The testing described is prospective in nature, as it involves newly reprocessed devices undergoing specific tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This type of information (number and qualification of experts for ground truth) is relevant for clinical studies involving human interpretation (e.g., radiology AI). For a reprocessed electrosurgical device, "ground truth" is established by direct physical, chemical, and electrical measurements against established engineering and safety standards, or direct comparison to the OEM device. Experts involved would be engineers, chemists, and microbiologists in the respective testing fields, but their roles are not for "establishing ground truth" in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where multiple human readers interpret medical images or data and a consensus is needed. In benchtop testing of a reprocessed medical device, the results are typically quantitative measurements or pass/fail criteria based on objective standards, not subjective interpretations requiring adjudication.
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. An MRMC study is relevant for diagnostic devices, particularly those involving AI or image interpretation by human readers. This device is an electrosurgical cutting and coagulation device, not a diagnostic imaging device. Its performance is assessed through benchtop and lab testing, not through human reader interpretation of images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device does not contain an algorithm or software. The document explicitly states under "Software Verification and Validation Testing": "Software Testing is not applicable, because the device does not contain software."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, the "ground truth" (or more accurately, the reference standard) is the performance of the new, original equipment manufacturer (OEM) device and adherence to established international and national standards for medical device safety and performance (e.g., IEC 60601 for electrical safety, biocompatibility standards, and internal specifications for functional performance like thermal effects). The goal is to demonstrate that the reprocessed device is "as good as" the original and meets all relevant safety requirements.
8. The sample size for the training set:
- Not Applicable. This refers to machine learning models. The Reprocessed ArthroCare ENT Coblator is a physical medical device, not an AI/ML algorithm, so there is no training set.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant to the device described.
In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence of a reprocessed physical medical device to its predicate. The type of testing and "acceptance criteria" presented are geared towards proving that the reprocessing does not compromise the device's safety and effectiveness compared to the original, rather than establishing efficacy for a novel diagnostic or AI-driven device.
§ 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.