(7 days)
No
The summary describes a traditional electrosurgical device and contains no mention of AI, ML, or related concepts like image processing or training/test sets.
Yes
The device is indicated for surgical procedures like ablation, resection, and coagulation of soft tissue, as well as hemostasis of blood vessels, which are therapeutic interventions.
No.
The device is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in ENT surgery, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states that the ArthroCare ENT Plasma Wands are "bipolar, single use, high frequency electrosurgical devices," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for surgical procedures (ablation, resection, coagulation, hemostasis) on soft tissue and blood vessels within the patient's body during ENT surgery.
- Device Description: The device is described as a high-frequency electrosurgical device used for these surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside the body to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples taken from the human body. This device is used directly on the patient during surgery.
N/A
Intended Use / Indications for Use
The ArthroCare ENT Plasma Wands 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
- 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 and blood vessels in otorhinolaryngology (ENT) surgery including: Adenoid, Cysts, Head, Neck, Oral, Sinus, Mastoid, Myringotomy, Nasal Airway, Hypertrophic Nasal Turbinates, Nasopharyngeal, Laryngeal, Tracheal, Laryngeal Polypectomy, Laryngeal Lesion, Neck, Papilloma Keloids, Palatal, Uvula/Soft Palate, Tonsil.
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
Artl ArthroCare ENT Plasma Wauds
DEC - 1 2006
Page 1 of 2
General Information
Submitter Name/Address:
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936
Establishment Registration Number:
Contact Person:
Director, Regulatory Affairs
Valerie Defiesta-Ng
November 21, 2006
2951580
Date Prepared:
Device Description
Trade Name:
Generic/Common Name:
Classification Name:
ArthroCare® ENT Plasma Wands
Electrosurgical Device and Accessories
Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)
Predicate Devices ArthroCare® ENT Plasma Wands
K033257, cleared 10/30/03
Product Description
The ArthroCare ENT Plasma Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in otorhinolaryngology (ENT) surgery.
1
Page 2 of 2
Intended Use
The ArthroCare ENT Plasma Wands are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:
- Adenoidectomy
- 이 Cysts
- ' Head, Neck, Oral, and Sinus Surgery
- . Mastoidectomy
- 프 Myringotomy with Effective Hemorrhage Control
- 해 Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
- 트 Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
- . Neck Mass
- 트 Papilloma Keloids
- 미 Submucosal Palatal Shrinkage
- Submucosal Tissue Shrinkage 트
- . Tonsillectomy
- . Traditional Uvulopalatoplasty (RAUP)
- Tumors
- Tissue in the Uvula/Soft Palate for the Treatment of Snoring
Substantial Equivalence
This Special 510(k) proposes a material modification in for the ArthroCare ENT Plasma Wands, which were previously cleared under K033257 on October 30, 2003. The indications for use, technology, principle of operation, dimensional specifications, performance specifications, labeling and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k).
Summary of Safety and Effectiveness
The modified ArthroCare ENT Plasma Wands, as described in this submission, are substantially equivalent to the predicate Wands. The proposed material modification is not a substantial change or modification, and does not significantly affect the safety or efficacy of the devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC = 1 2006
ArthroCare Corporation % Ms. Valerie Defiesta-Ng Director, Regulatory Affairs 680Vaqueros Avenue Sunnyvalc, California 94085
Re: K063538
Trade/Device Name: ArthroCare® ENT Plasma Wands Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 21, 2006 Received: November 24, 2006
Dear Ms. Defiesta-Ng:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA mav publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Valerie Defiesta-Ng
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Foe
Mark N. Malkerson
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: ArthroCarc® ENT Plasma Wands
кобз538 510(k) Number:
Indications for use:
The ArthroCare ENT Plasma Wands are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:
- " Adenoidectomy
- 1 Cysts
- 트 Head, Neck, Oral, and Sinus Surgery
- 트 Mastoidectomy
- Myringotomy with Effective Hemorrhage Control
- Nasal Airway Obstruction by Reduction of Hypertrophic 비 Nasal Turbinates
- t Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
- 트 Neck Mass
- 트 Papilloma Keloids
- . Submucosal Palatal Shrinkage
- . Submucosal Tissue Shrinkage
- Tonsillectomy
- 해 Traditional Uvulopalatoplasty (RAUP)
- 포 Tumors
- Tissue in the Uvula/Soft Palate for the Treatment of 미 Snoring
| Prescription Use | X | OR | Over-the-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | L063538 |
|---|---|
| --------------- | --------- |