(116 days)
Not Found
No
The device description explicitly states "There is no software utilized in the operation of the Controller." and there are no mentions of AI, DNN, or ML in the summary.
Yes
The device is used for ablation and coagulation of soft tissue, which are therapeutic interventions.
No
The device is an electrosurgery system indicated for ablation and coagulation of soft tissue, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states that the system is comprised of hardware components (Wand, Cable, Controller) and that "There is no software utilized in the operation of the Controller."
Based on the provided information, the AccENT Head and Neck Electrosurgery System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ablation and coagulation of soft tissue in otolaryngological (ENT) surgery". This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a system for delivering electrical energy to tissue for surgical purposes. It involves a wand, cable, and generator. This is consistent with a surgical device, not a diagnostic device that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The AccENT system is a surgical tool used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The AccENT Head and Neck Electrosurgery System is intended for ablation and coagulation of soft tissue in otolaryngological (ENT) surgery including head, neck, oral, and sinus surgery.
Product codes
GEI
Device Description
The AccENT Head and Neck Electrosurgery System is comprised of three components: the AccENT Wand, the AccENT Cable, and an electrosurgical generator called the Controller. The Cable connects the Controller to the Wand. The Wand is provided in a variety of models, ranging in diameters from 1.5 mm to 4.5 mm. The Wand offset and distal tip angles range from 0 to 90 degrees. The AccENT wand shaft is configured as straight or offset to allow for better access to the treatment area. The distal tip is configured with multi-electrodes. The Wand is supplied sterile and intended for single patient use. The Cable is designed for repeat sterilization by either ethylene oxide gas or steam autoclaving methods, as selected by the user. The Controller is a high frequency electronic instrument. There is no software utilized in the operation of the Controller.
The AccENT Head and Neck Electrosurgery System is bipolar, incorporating a return electrode on the shaft of the device. This means that a return pad is not required for operation. The return energy in a bipolar device with an integral return electrode does not penetrate the tissue as in a monopolar device. In a monopolar device, the energy passes through the patient's body to reach the return pad.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head, neck, oral, and sinus
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)
K943450, K963123, K962445, K964849, K952681, K921884, K914136, K933362
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
ArthroCare Corporation Sunnyvale, California Premarket Notification
510(k) Summary X.
JAN - 9 1998
Name of Device A.
| Trade name: | AccENT Head and Neck Electrosurgery System |
|---|---|
| Common name: | Electrosurgical Unit and Accessories |
| Classification name: | Electrosurgical Cutting and Coagulation Device |
| (21 CFR 878.4400) |
Predicate devices B.
| Device | Premarket Notification |
|---|---|
| ArthroCare Arthroscopic Electrosurgery System | K943450, 03/10/95 |
| ArthroCare Arthroscopic Electrosurgery System 980 | |
| (Model 2000) | K963123, 10/08/96 |
| ArthroCare Dental Electrosurgery System | K962445, 07/30/96 |
| ArthroCare General Dermatology Electrosurgery | |
| System | K964849, 04/14/97 |
| Stryker Hummer II MicroDebrider System | K952681, 07/20/95 |
| Valleylab Force 2 Electrosurgical Generator | K921884, 12/92 |
| Coherent Medical Versapulse Laser System | K914136 |
| Sharplan CO2 Surgical Laser | K933362 |
Device description C.
The AccENT Head and Neck Electrosurgery System is comprised of three components: the AccENT Wand, the AccENT Cable, and an electrosurgical generator called the Controller. The Cable connects the Controller to the Wand. The Wand is provided in a variety of models, ranging in diameters from 1.5 mm to 4.5 mm. The Wand offset and distal tip angles range from 0 to 90 degrees. The AccENT wand shaft is configured as straight or offset to allow for better access to the treatment area. The distal tip is configured with multi-electrodes. The Wand is supplied sterile and intended for single patient use. The Cable is designed for
1
repeat sterilization by either ethylene oxide gas or steam autoclaving methods, as selected by the user. The Controller is a high frequency electronic instrument. There is no software utilized in the operation of the Controller.
The AccENT Head and Neck Electrosurgery System is bipolar, incorporating a return electrode on the shaft of the device. This means that a return pad is not required for operation. The return energy in a bipolar device with an integral return electrode does not penetrate the tissue as in a monopolar device. In a monopolar device, the energy passes through the patient's body to reach the return pad.
D. Intended use
The AccENT Head and Neck Electrosurgery System is intended for ablation and coagulation of soft tissue in otolaryngological (ENT) surgery including head, neck, oral, and sinus surgery.
Technological characteristics E.
The technological characteristics of the AccENT Head and Neck Electrosurgery System are the same as those of the ArthroCare Arthroscopic, Dental, and General Dermatology Systems. These devices are equivalent in terms of design, materials, principle of operation, product specifications and sterilization.
F. Summary
By virtue of design, materials, function and intended use, the AccENT Head and Neck Electrosurgery System is substantially equivalent to devices currently marketed in the United States.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 9 1998
Mr. Mark Smutka Director, Regulatory Affairs and Quality Assurance Arthrocare Corporation 595 North Pastoria Avenue Sunnyvale, California 94086
Re: K973478
Trade Name: AccENT Head & Neck Electrosurgery System Regulatory Class: II Product Code: GEI Dated: December 11, 1997 Received: December 15, 1997
Dear Mr. Smutka:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for
3
Page 2 - Mr. Smutka
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ArthroCare Corporation Sunnyvale, California Premarket Notification
Indications Statement
AccENT Head and Neck Electrosurgery System Device Name:
510(k) Number: K973478
Indications for use:
The AccENT Head and Neck Electrosurgery System is indicated for ablation and coagulation of soft tissue in otolaryngological (ENT) surgery including head, neck, oral, and sinus surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ision Sign-Off
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number L973478
X Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use