(76 days)
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
The ArthroCare ENT Plasma Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in otorhinolaryngology (ENT) surgery.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the ArthroCare ENT® Plasma Wands™. The document is a 510(k) summary and FDA clearance letter, which primarily focuses on establishing substantial equivalence to predicate devices and listing the intended uses of the device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given input.
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Page 1 of (2)
APR 2 5 2007
510(k) Summary ArthroCare Corporation ENT® Plasma Wands™
2951580
< 070374
General Information
Manufacturer:
ArthroCare, Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936
Establishment Registration Number:
Contact Person:
Valerie Defiesta-Ng Director, Regulatory Affairs (408) 736-0224
Date Prepared:
Device Description
Trade Name:
Generic/Common Name:
ENT® Plasma Wands™
February 7, 2007
Electrosurgical Device and Accessories Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)
Predicate Devices ArthroCare ENT Plasma Wands
K014290, cleared March 28, 2002 K063538, cleared December 1, 2006
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K 070374
Page 2 of (2)
Intended Use
The proposed indications statement for 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 Description
The ArthroCare ENT Plasma Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in otorhinolaryngology (ENT) surgery.
Substantial Equivalence
In establishing substantial equivalence to the predicate devices, ArthroCare evaluated the indications for use, materials incorporated, product specifications, and energy requirements of those systems. The expansion of the indications to include specific ENT procedures does not raise any new issues of safety or efficacy.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 5 2007
Arthrocare Corporation % Ms. Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523
Re: K070374
Trade/Device Name: ENT® Plasma Wands™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 7, 2007 Received: February 8, 2007
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 may 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.
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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 Mark N. Melkerson Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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)
§ 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.