(56 days)
Not Applicable
No
The device description explicitly states "There is no software utilized in the operation of the ODONTOSURGE 2," and there are no mentions of AI, ML, or related concepts.
No
The device is described as an electrosurgery unit used for cutting and coagulating soft tissue and controlling bleeding during surgical procedures. These functions are primarily surgical and aimed at facilitating procedures rather than directly treating a disease or condition to restore health.
No
Explanation: The device description states its intended use is for "cutting (removing) soft tissue and controlling bleeding" and "to cut and to coagulate soft tissue" during surgical procedures. There is no mention of diagnosing conditions or providing diagnostic information.
No
The device description explicitly states that the ODONTOSURGE 2 is a high frequency electrosurgery unit comprised of hardware components (control box, hand piece and cord, electrodes) and that "There is no software utilized in the operation of the ODONTOSURGE 2."
Based on the provided information, the ODONTOSURGE 2 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "cutting (removing) soft tissue and controlling bleeding in the oral cavity during surgical procedures". This is a direct surgical intervention on a living patient.
- Device Description: The description details an "electrosurgery unit" used to "cut and to coagulate soft tissue". This is a physical action performed on tissue within the body.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue samples) taken from the body to provide information about a person's health. The ODONTOSURGE 2 does not perform this function.
The ODONTOSURGE 2 is a surgical device used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ODONTOSURGE 2 is intended for use in cutting (removing) soft tissue and controlling bleeding in the oral cavity during surgical procedures in all phases of dentistry, including prosthodontics, periodontics, endodontics, pedodontics, orthodontics, oral surgery, and routine restorative dentistry.
Product codes
EKZ
Device Description
The ODONTOSURGE 2 is a high frequency electrosurgery unit that is comprised of the following three principal components: control box, hand piece and cord, and six different electrodes contained in a separate case. The ODONTOSURGE 2 is compact and easily portable. The ODONTOSURGE 2 is a reusable electrosurgical unit that is used to cut and to coagulate soft tissue during procedures in all disciplines of dentistry. There is no software utilized in the operation of the ODONTOSURGE 2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
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
§ 872.4920 Dental electrosurgical unit and accessories.
(a)
Identification. A dental electrosurgical unit and accessories is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. This device is intended to cut or remove soft tissue or to control bleeding during surgical procedures in the oral cavity. An electrical current passes through the tip of the electrode into the tissue and, depending upon the operating mode selected, cuts through soft tissue or coagulates the tissue.(b)
Classification. Class II.
0
K98/390
JUN 11199
Premarket Notification [510(k)] Summary for the ODONTOSURGE 2
Submitter
PERIOgiene 2625 Midpoint Drive Suite A Ft. Collins, Colorado 80525
Date Summary was prepared
April 16, 1998
Name of the device
ODONTOSURGE 2
Identification of predicate device
ArthroCare Dental Electrosurgery System ArthroCare Corporation K962445
Description of the device
The ODONTOSURGE 2 is a high frequency electrosurgery unit that is comprised of the following three principal components: control box, hand piece and cord, and six different electrodes contained in a separate case. The ODONTOSURGE 2 is compact and easily portable. The ODONTOSURGE 2 is a reusable electrosurgical unit that is used to cut and to coagulate soft tissue during procedures in all disciplines of dentistry. There is no software utilized in the operation of the ODONTOSURGE 2.
Intended use
The ODONTOSURGE 2 is intended for use in cutting (removing) soft tissue and controlling bleeding in the oral cavity during surgical procedures in all phases of dentistry, including prosthodontics, periodontics, endodontics, pedodontics, orthodontics, oral surgery, and routine restorative dentistry.
1
Comparison of device characteristics to predicate
The intended use, sterilization method, and mode of operation of the ODONTOSURGE 2 are the same as the ArthroCare Dental Electrosurgery System. The difference between the two devices is the frequency of operation. However, PERIOgiene believes that this operating frequency offers many convenience and safety advantages.
Conclusion
The intended use, general design, materials of fabrication, and performance of the ODONTOSURGE 2 are the same as the predicate device, ArthroCare Dental Electrosurgery System and devices already on the market. Therefore, the ODONTOSURGE 2 that is the subject of this 510(k) is substantially equivalent to dental electrosurgical units in interstate commerce prior to May 28, 1976.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and two lines representing its legs.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 11 1998
PERIOgiene ·C/O David L. West, Ph.D. Senior Technical Advisor Ouintiles Quintiles-Medical Technology Consultants 15825 Shady Grove Road, Suite 90 Rockville, Maryland 20850
Re: K981390 Trade Name: ODONTOSURGE 2 Requlatory Class: II Product Code: EKZ Dated: April 16, 1998 Received: April 16, 1998
Dear Dr. West:
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 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). 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 wo regulations affecting your device can be found in the Code of Federal Requlations, 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
Page 2 - Dr. West
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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) 594-4692. 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"(21CFR 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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/1 description: The image shows the text "K981390" in a bold, sans-serif font. Below the numbers, the word "CONFIDENTIAL" is printed in a smaller, sans-serif font. A horizontal line underlines the word "CONFIDENTIAL", emphasizing its importance.
510(k) Number
None assigned as of this time
Device Name
ODONTOSURGE 2
Indications for Use
The ODONTOSURGE 2 is intended for use in removing soft tissue and controlling the discussion The ODON COUNTOS In interesatures in all phases of dentistry, including prosthodonties, the oral barty carning our mg only dontics, orthodontics, oral surgery, and routine restorative dentistry.
Concurrence of CDRH, Office of Device Evaluation (ODE)
- Prescription Use (per 21 CFR 801.109)
- Over-the Counter Use
Susan Runoes
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
April 16, 1998 PERIOgiene - ODONTOSURGE 2