Laparoscopic electrodes are surgical instruments with single use or reusable interchangeable tin inserts designed to be introduced through a 5.5mm diameter (or larger) cannula, during laparoscopic surgical procedures. The devices can be used with electrosurgical generators. The interchange ability of the tip inserts allows for three main benefits:

. A removable insert allows for easier cleaning and disinfection of the instrument components.
Versatility of the instrument is greatly increased as one handle can accept many tip configurations,
Semi-disposability allows for multiple uses of one tip insert with cost effective replacement when worn or damaged.
Laparoscopic Electrodes consist of:
I ) Tip Inserts (pre-sterilized single use and non-sterile reusable) that interchangeably fit into a reusable tube.
1. Cartridges (pre-sterilized single use) that fit directly into a reusable handle.
1. Reusable Tubes (non-sterile, rcusable) that fit directly into a reusable handle and accommodates a variety of tip inserts.
  Radiofrequency energy is delivered to the tip through the handle by using a powered lead from an electrosurgical generator to a connector port on the handle. The insulated handle (cleared in 510k # K062337) is the device that will be used by the physician or nurse to attach the tip and control the action of the tip via the grip. A rotary knob allows the tip to be positioned (rotated) while in the cannula.

AI/ML Overview

The device, MEG Laparoscopic Electrodes, is a re-submission of K062337 by Aaron Medical. Unfortunately, the provided document does not contain an acceptance criteria table, detailed performance data from a specific study, nor information regarding sample sizes, data provenance, expert involvement, or adjudication methods for a test set. This type of information is not typically included in a 510(k) summary, as the submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo clinical trial data.

However, based on the provided text, here's what can be gathered regarding the device and its compliance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in a tabular format or detailed performance results in the way a clinical study report would. Instead, the "performance" is implicitly demonstrated through conformance to recognized electrical safety standards and a claim of substantial equivalence to a predicate device.

Acceptance Criteria Category	Specific Criteria (Implicit from document)	Reported Device Performance (Implicit from document)
Electrical Safety Standards Conformance	Adherence to ANSI/AAMI/ISO HF-18: 2001	Stated conformance to ANSI/AAMI/ISO HF-18: 2001
	Adherence to IEC 60601-2-2- 2006	Stated conformance to IEC 60601-2-2- 2006
Functional Equivalence	Ability to grasp, hold, coagulate, and cut tissue	Indicated as capable of grasping, holding, coagulating, and cutting tissue during laparoscopic surgical procedures, similar to predicate.
Material/Design Equivalence	Similar technology to predicate (use of high-frequency radiofrequency energy)	Stated as using technology substantially equivalent to Aaron Modular Monopolar Electrodes (K062337)
Sterilization Efficacy	Single-use components are sterile, reusable components can be sterilized.	Single use provided sterilized by ethylene oxide gas. Reusable provided non-sterile, requiring steam sterilization. (Implicitly, sterilization is effective if performed according to instructions).

2. Sample Size and Data Provenance for Test Set:

The 510(k) summary does not provide information on a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The primary "test" for substantial equivalence often involves comparing technical specifications and intended use with the predicate device, along with adherence to recognized standards. It's unlikely a separate, large-scale test set with patient data was used for this type of submission for this particular device.

3. Number of Experts and Qualifications for Ground Truth:

The document does not mention the use of experts to establish ground truth for a test set. The regulatory review process for a 510(k) relies on the FDA's experts reviewing the provided documentation and comparing it to predicate devices and established standards.

4. Adjudication Method for Test Set:

Since a specific test set with patient data or expert review for ground truth is not described, there is no adjudication method provided.

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

An MRMC study was not conducted or reported for this device. Such studies are typically associated with devices that involve interpretation of medical images or other diagnostic tasks where human reader performance is a key metric. This device is a surgical instrument.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study was not conducted or reported. This device is a manual surgical instrument, not an AI algorithm.

7. Type of Ground Truth Used:

For the purpose of this 510(k) submission, the "ground truth" implicitly refers to:

Established engineering principles and material science: Ensuring the device's construction and materials are suitable for its intended use.
Compliance with recognized electrical safety standards (ANSI/AAMI/ISO HF-18: 2001 and IEC 60601-2-2- 2006): These standards define performance expectations for electrosurgical devices.
The performance and safety profile of the predicate device (Aaron Modular Monopolar Electrodes K062337): The predicate's established safety and effectiveness serve as the benchmark.

8. Sample Size for the Training Set:

The document does not mention a training set or its sample size. This is not an AI/machine learning device that would require such a set.

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

Since there is no training set for this type of device, this question is not applicable.

Summary

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K081431

510(k) SUMMARY (per CFR21 807.92(c))

GENERAL INFORMATION:

JUL 2 4 2008

510k Owner's Name Address

Bovie Medical 7100 30th Avenue North St. Petersburg, Florida 33710-2902

Richard A. Kozloff Vice-President; Quality Assurance/Regulatory Affairs Telephone #: (727) 384-2323 FAX Number: (727) 347-9144

Date Prepared:

Contact Person

May 19, 2008

DEVICE DESCRIPTION:

Trade Name: Common Name: Classification Name:

, ( / . Modular Ergonomic Instrument (MEG)

Laparoscopic Electrodes

Electrosurgical Cutting and Coagulation Devices and Accessories (21CFR 878.4400; Class II; Product Code: GEI)

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510(k) SUMMARY (per CFR21 807.92(c))

DEVICE DESCRIPTION:

Predicate Devices:

Aaron Medical: Modular Monopolar Electrodes

K062337

INTENDED USE:

Laparoscopic Electrodes are used to grasp, hold, coagulate, and cut tissue during laparoscopic surgical procedures.

DEVICE COMPONENTS AND OPERATION:

. A removable insert allows for easier cleaning and disinfection of the instrument components.
Versatility of the instrument is greatly increased as one handle can accept many tip configurations,
Semi-disposability allows for multiple uses of one tip insert with cost effective replacement when worn or damaged.

Laparoscopic Electrodes consist of:

I ) Tip Inserts (pre-sterilized single use and non-sterile reusable) that interchangeably fit into a reusable tube.
1. Cartridges (pre-sterilized single use) that fit directly into a reusable handle.
1. Reusable Tubes (non-sterile, rcusable) that fit directly into a reusable handle and accommodates a variety of tip inserts.

Radiofrequency energy is delivered to the tip through the handle by using a powered lead from an electrosurgical generator to a connector port on the handle. The insulated handle (cleared in 510k # K062337) is the device that will be used by the physician or nurse to attach the tip and control the action of the tip via the grip. A rotary knob allows the tip to be positioned (rotated) while in the cannula.

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510(k) SUMMARY (per CFR21 807.92(c))

These devices use technology that is substantially equivalent to Aaron Modular Monopolar Electrodes (K062337). Both consist of a series of electrodes that are used to cut and coagulate tissue through the utilization of high frequency radiofrequency energy.

Reusable Laparoscopic Electrodes are provided non-sterile and must be sterilized prior to use using steam sterilization.

Single use Laparoscopic Electrodes are provided sterilized using ethylene oxide gas.

Laparoscopic Electrodes conform to particular requirements of electrical safety standards ANSI/AAMI/ISO HF-18: 2001 Electrosurgical Devices and IEC 60601-2-2- 2006, Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment.

There are no significant differences in technology, performance, or intended use between Bovie Laparoscopic Electrodes and the given predicate devices. There are no new questions raised regarding safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect and promote the health and well-being of all Americans. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 2008

Bovie Medical % Mr. Richard A. Kozloff VP, QA/RA 7100 30th Avenue North St. Petersburg, Florida 33710-2902

Re: K081431

Trade/Device Name: MEG Laparoscopic Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 19, 2008 Received: May 21, 2008

Dear Mr. Kozloff:

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.

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Page 2 - Mr. Richard A. Kozloff

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,

Sincerely yours.

Mark N. Millman

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): 1408143 |

Device Name: MEG Laparoscopic Electrodes

Indications for Use:

MEG Laparoscopic Electrodes are used to grasp, hold, coagulate, and cut tissue during laparoscopic surgical procedures.

Prescription Use _ V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number L061431

04-2

Regulation Number and Section

§ 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.