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.

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.

AI/ML Overview

The provided text does not contain information about specific acceptance criteria or a study that rigorously proves the device meets those criteria with statistical measures like sensitivity, specificity, or accuracy.

Instead, the document is a 510(k) summary for a medical device (ODONTOSURGE 2) seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that the new device has the same intended use, similar technological characteristics, and performs as safely and effectively as a legally marketed predicate device. It does not typically involve a clinical trial with acceptance criteria for performance metrics in the same way a de novo or PMA submission might.

Here's an analysis based on the provided text, highlighting the absence of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified. This document is a 510(k) showing substantial equivalence, not a performance study with pre-defined criteria.	Not specified. The document concludes the device is "substantially equivalent" to predicate devices based on intended use, general design, materials, and performance, but no quantitative performance metrics are provided.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not applicable. No test set or clinical study demonstrating performance metrics using a sample size is described. The comparison is based on device characteristics.
Data Provenance: Not applicable. The document describes the device and its comparison to a predicate, not data from a test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. No ground truth establishment by experts is described as this is a 510(k) submission for substantial equivalence, not a clinical validation study.

4. Adjudication Method for the Test Set:

Not applicable. No test set or adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document does not describe an MRMC study or any study involving human readers with or without AI assistance. The ODONTOSURGE 2 is an electrosurgery unit and does not appear to involve AI or diagnostic interpretation.

6. Standalone Performance Study (Algorithm Only):

No. The ODONTOSURGE 2 is a hardware electrosurgery unit, and the document explicitly states, "There is no software utilized in the operation of the ODONTOSURGE 2." Therefore, an algorithm-only standalone performance study is not relevant or applicable.

7. Type of Ground Truth Used:

Not applicable. No ground truth is established or used in this 510(k) submission.

8. Sample Size for the Training Set:

Not applicable. There is no software or algorithm that would require a training set.

9. How Ground Truth for the Training Set Was Established:

Not applicable. There is no training set mentioned in the document.

Summary of Device Rationale for Marketing (from the document):

The rationale for marketing the ODONTOSURGE 2 is based on its substantial equivalence to the predicate device, the ArthroCare Dental Electrosurgery System (K962445), and other devices on the market prior to May 28, 1976. The key comparative points are:

Intended Use: The same as the predicate device (cutting and coagulating soft tissue in the oral cavity for various dental procedures).
Sterilization Method: The same.
Mode of Operation: The same.
General Design, Materials of Fabrication, and Performance: Concluded to be the same.
Difference: The only noted difference is the frequency of operation, which PERIOgiene believes offers convenience and safety advantages. However, this difference does not invalidate the conclusion of substantial equivalence for regulatory purposes here.

The FDA's decision to clear the device (K981390) confirms their agreement that it is substantially equivalent to a legally marketed predicate, meaning it is as safe and effective as existing devices, based on a comparison of device characteristics rather than a new performance study with explicit acceptance criteria.

Summary

{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

Intended use

{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

Regulation Number and Section

§ 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.