(21 days)
Not Found
No
The description details a standard electrosurgical system (generator, wands, cable) and its intended uses, with no mention of AI, ML, or any features that would suggest their use.
Yes
This device is a surgical system indicated for ablation, resection, coagulation of soft tissue, and hemostasis in various ENT procedures, which are all therapeutic interventions targeting specific medical conditions.
No
The device is indicated for surgical procedures involving ablation, resection, coagulation, and hemostasis of soft tissue and blood vessels, not for diagnosing medical conditions.
No
The device description explicitly states it consists of a generator, disposable wands, and a reusable patient cable, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The ArthroCare ENT Coblator Surgery System is an electrosurgical system used for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels directly within the patient's body during surgery. It is a surgical tool, not a device that analyzes samples outside the body.
- Intended Use: The intended use clearly describes surgical procedures performed on the patient, not the analysis of patient samples.
Therefore, the device's function and intended use fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ArthroCare ENT Coblator Surgery System is 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 Coblator Surgery System is a bipolar, high frequency electrosurgical system consisting of three components: an electrosurgical generator called the Controller; a family of disposable, bipolar, single use Wands; and a reusable Patient Cable.
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, specifically: Adenoid, Cysts (Head, Neck, Oral, Sinus), Mastoid, Myringotomy area, Nasal Airway (Hypertrophic Nasal Turbinates), Nasopharyngeal, Laryngeal (Tracheal, Laryngeal Polypectomy, Laryngeal Lesion), Neck, 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
This Special 510(k) proposes a modification in the performance specifications. dimensional specifications, and labeling for the ArthroCare ENT Coblator Plasma Surgery System, which was previously cleared in K021364 on May 30, 2002. The indications for use, technology, principle of operation, materials, packaging, and sterilization parameters of the ArthroCare ENT Coblator Surgery System remain the same as in the predicate cleared 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.
0
Image /page/0/Picture/0 description: The image shows the logo for ArthroCare Corporation. The logo features a stylized "A" with a swooping line underneath, followed by the text "rthroCare" in a clean, sans-serif font. Below "rthroCare" is the word "CORPORATION" in smaller, all-caps letters.
FEB 0 3 2003
510(k) Summary 030108 ArthroCare Corporation ArthroCare ENT Coblator Surgery System
General Information
Submitter Name/Address: ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936 (408) 736-0224 Phone Number: Valerie Defiesta-Ng Contact Person: Director, Regulatory Affairs Date Prepared: January 10, 2003 Device Description Trade Name: ArthroCare ENT Coblator Surgery System Generic/Common Name: Electrosurgical Device and Accessories Electrosurgical Cutting and Coagulation Classification Name: Device and Accessories (21 CFR 878.4400) Predicate Devices ENTec® Plasma Wands K021364
Product Description
The ArthroCare ENT Coblator Surgery System is a bipolar, high frequency electrosurgical system consisting of three components: an electrosurgical generator called the Controller; a family of disposable, bipolar, single use Wands; and a reusable Patient Cable.
1
Intended Uses
The ArthroCare ENT Coblator Surgery System is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:
- 파 Adenoidectomy
- Cysts
- Head, Neck, Oral, and Sinus Surgery
- 트 Mastoidectomy
- Myringotomy with Effective Hemorrhage Control
- 파 Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
- 트 Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
- 트 Neck Mass
- Papilloma Keloids
- 트 Submucosal Palatal Shrinkage
- 트 Submucosal Tissue Shrinkage
- Tonsillectomy
- l Traditional Uvulopalatoplasty (RAUP)
- I Tumors
- Tissue in the Uvula/Soft Palate for the Treatment of Snoring
Substantial Equivalence
This Special 510(k) proposes a modification in the performance specifications. dimensional specifications, and labeling for the ArthroCare ENT Coblator Plasma Surgery System, which was previously cleared in K021364 on May 30, 2002. The indications for use, technology, principle of operation, materials, packaging, and sterilization parameters of the ArthroCare ENT Coblator Surgery System remain the same as in the predicate cleared 510(k).
Summary of Safety and Effectiveness
The modified ArthroCare ENT Coblator Surgery System, as described in this Special 510(k), is substantially equivalent to the predicate device. The proposed modifications in performance specifications, dimensional specifications, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 3 2003
Arthocare Corporation Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-2936
Re: K030108
Trade/Device Name: Arthrocare ENT Coblator Surgery System Regulation Number: 878:4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: January 10, 2003 Received: January 13, 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. Iisting 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). Other general information on your responsibilities under the Act may be obtained 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
ForCelia 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
ArthroCare ENT Coblator Surgery System Device Name:
KO30108 510(k) Number:
Indications for Use:
The ArthroCare ENT Coblator Surgery System is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:
- Adenoidectomy l
- 트 Cysts
- Head, Neck, Oral, and Sinus Surgery .
- 트 Mastoidectomy
- Myringotomy with Effective Hemorrhage Control 트
- I Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
- 트 Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
- 트 Neck Mass
- 트 Papilloma Keloids
- 트 Submucosal Palatal Shrinkage
- 발 Submucosal Tissue Shrinkage
- 이 Tonsillectomy
- 이 Traditional Uvulopalatoplasty (RAUP)
- 해 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
Ivision Sign-Off) Ivision of General, Restorative and Neurological Devices
Number K630/08