(21 days)
Not Found
No
The summary describes a standard electrosurgical device and does not mention any AI or ML components or functionalities.
Yes
The device is an electrosurgical tool used for ablation, resection, and coagulation of soft tissue, and hemostasis of blood vessels during various ENT surgeries, which are therapeutic interventions.
No
The device is designed for surgical procedures involving ablation, resection, coagulation, and hemostasis of tissue, which are therapeutic actions, 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 body during ENT surgery.
- Device Description: The device is described as a high-frequency electrosurgical device, which is a tool used directly on tissue during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside the body to provide information about a patient's health status, which is the defining characteristic of an IVD.
IVDs are used to perform tests on samples taken from the body, while this device is used to perform procedures directly on the body.
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, blood vessels, head, neck, oral, sinus, mastoid, nasal, nasopharyngeal, laryngeal, uvula, soft palate.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 3 0 2003
Image /page/0/Picture/1 description: The image shows the logo for ArthroCare Corporation. The logo features a stylized, cursive letter "A" followed by the text "rthroCare" in a serif font. Below "rthroCare" is the word "CORPORATION" in a smaller, sans-serif font.
Page ①
510(k) Summary
ArthroCare Corporation ArthroCare ENT Plasma Wands KO33257
General Information
Submitter Name/Address:
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936
Director, Regulatory Affairs
Establishment Registration Number:
2951580
Contact Person:
Date Prepared:
Device Description
Trade Name:
Generic/Common Name:
Classification Name:
October 8, 2003
Valerie Defiesta-Ng
ArthroCare® ENT Plasma Wands
Electrosurgical Device and Accessories
Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)
Predicate Devices
ArthroCare ArthroWands
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
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
- 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
- 에 Submucosal Palatal Shrinkage
- 발 Submucosal Tissue Shrinkage
- Tonsillectomy
- Traditional Uvulopalatoplasty (RAUP) 프
- 8 Tumors
- Tissue in the Uvula/Soft Palate for the Treatment of Snoring
Substantial Equivalence
This Special 510(k) proposes modifications in dimensional specifications, materials, and labeling for the ArthroCare ENT Plasma Wands, which were previously cleared under K030108 on February 3, 2003. The indications for use, technology, principle of opcration, performance specifications, materials, and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k).
Summarv of Safety and Effectiveness
The modified ArthroCare ENT Plasma Wands, as described in this submission, are substantially equivalent to the predicate Wands. The proposed modification in dimensional specifications, materials, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 0 2003
Ms. Valerie Defiesta-Ng Director, Regulatory Affairs ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, California 94085-2936
Re: K033257
Trade/Device Name: ArthroCare® 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: October 8, 2003 Received: October 10, 2003
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.
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. 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: | ArthroCare ENT Plasma Wands |
|---|---|
| -------------- | ----------------------------- |
KO33257 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 ■
- 트 Cysts
- Head, Neck, Oral, and Sinus Surgery 지
- 트 Mastoidectomy
- Myringotomy with Effective Hemorrhage Control 모
- Nasal Airway Obstruction by Reduction of Hypertrophic 보 Nasal Turbinates
- Nasopharyngeal/Laryngeal indications including Tracheal ■ Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
- 피 Neck Mass
- Papilloma Keloids
- Submucosal Palatal Shrinkage ■
- Submucosal Tissue Shrinkage ■
- Tonsillectomy 트
- Traditional Uvulopalatoplasty (RAUP) ■
- Tumors
- Tissue in the Uvula/Soft Palate for the Treatment of 트 Snoring
X
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
Over-the-Counter Use
(Per 21 CFR 801.109)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K033257
İ X