(76 days)
Not Found
No
The document describes a standard electrosurgical device and makes no mention of AI or ML capabilities.
Yes
The device is used for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in various ENT surgeries, which are therapeutic interventions.
No
The device is described as an electrosurgical device for ablation, resection, and coagulation of tissue, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it is a "bipolar, single use, high frequency electrosurgical device," which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures (ablation, resection, coagulation, hemostasis) directly on soft tissue and blood vessels within the human body during ENT surgery.
- Device Description: The device is described as a "high frequency electrosurgical device" designed for these surgical indications.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The ArthroCare ENT Plasma Wands is 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
Product codes
GEI
Device Description
The ArthroCare ENT Plasma Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in otorhinolaryngology (ENT) surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, blood vessels, otorhinolaryngology (ENT) surgery including: Adenoid, Cysts, Head, Neck, Oral, Sinus, Mastoid, Myringotomy, Nasal Airway, Hypertrophic Nasal Turbinates, Nasopharyngeal/Laryngeal (Tracheal, Laryngeal), Palate, Tonsillectomy (palatine tonsils), Uvula
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Page 1 of (2)
APR 2 5 2007
510(k) Summary ArthroCare Corporation ENT® Plasma Wands™
2951580
Sincerely yours Mark N. Melkerson Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
Device Name: ENT® Plasma Wands™ K070374 510(k) Number:
Indications for Use:
The ArthroCare ENT Plasma Wands is 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
X
Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use
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| and the collection of the contract of the contract of the contribution of the comments of the comments of the comments of the comments of the comments of the comments of the | Concurrence of CORE Office of Dovice Evaluation (ODE) |
OR
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number 1070374
510(k)