The Laparoscopic Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an electrosurgical generator for the laparoscopic delivery of radiofrequency ("RF") current and sterile saline for cutting and coagulating soft tissue. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Device Description

The Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an electrosurgical generator for the laparoscopic delivery of radiofrequency ("RF") current and sterile saline for cutting and coagulating soft tissue.
Device Components and Operation:

Insulated Handle: The Insulated Handle encases the controlling mechanism for the flow of saline, and activation of the RF current for the device. The activation of RF current is accomplished by a single push button on the top of the handle. The Handle has a flow control mechanism so the flow of saline can be regulated by the user within the sterile field. The tubing length is approximately ten (10) feet in length and incorporates an I.V. spike on the end to attach directly to a hanging IV (saline) bag. The Handle power cord is approximately ten (10) feet in length and incorporates a 3-prong electrical plug. The insulation of the Insulated Handle and Power Cord meets the requirements for Dielectric Withstands of Accessories.
Shaft and Electrode Tip: The electrode tip delivers RF energy for cutting and coagulation and delivers saline which is gravity-fed from an Intravenous bag to the tip. The electrode shaft measures 32 centimeters (12.6 inches) in length and is intended to be placed through a cannula with a minimum diameter of 10 millimeters.

AI/ML Overview

This document is a 510(k) summary for the Bovie Medical Laparoscopic Saline Enhanced Electrosurgical Resection (SEER) Device. It does not contain a study demonstrating device performance against acceptance criteria.

The purpose of a 510(k) summary is to demonstrate substantial equivalence to a predicate device, not necessarily to present a de novo study with acceptance criteria and performance data. In this case, the manufacturer is relying on the established safety and effectiveness of their previously cleared device (Bovie Medical Resection Device, K-082568) and highlighting the technological similarity, with the primary difference being the laparoscopic application.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment because this information is not present in the provided text.

Specifically:

A table of acceptance criteria and the reported device performance: Not provided. The document states "The Laparoscopic Resection Device conforms to the requirements of safety standard IEC 60601-2-2," but it does not detail specific performance criteria or how the device met them.
Sample sizes used for the test set and the data provenance: Not provided. No specific test set or associated data is discussed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. No test set requiring ground truth establishment is mentioned.
Adjudication method for the test set: Not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device used by human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a surgical device, not an algorithm.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable. This is a hardware device, not a machine learning algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

The document primarily focuses on establishing substantial equivalence to a predicate device by comparing:

Intended Use: Both devices are for cutting and coagulating soft tissue using RF current. The new device specifies "laparoscopic delivery" and "sterile saline."
Technology: Both use a "sintered stainless steel electrode tip" for RF energy delivery.
Differences: The primary difference is the laparoscopic application versus open surgical procedures.
Safety Standards: The laparoscopic device conforms to IEC 60601-2-2.

The conclusion is that "There are no significant differences in technology, intended use, or performance between the Laparoscopic Resection Device and the given predicate device. There are no new questions raised regarding safety or effectiveness." This statement is the basis for the 510(k) clearance, rather than a detailed performance study with acceptance criteria.

Summary

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KOSIYUO

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

GENERAL INFORMATION:

OCT - 9 2009

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 12, 2009

DEVICE DESCRIPTION:

Trade Name:

Common Name:

Classification Name:

Laparoscopic Saline Enhanced Electrosurgical Resection (SEER) Device

Resection (Cutting and Coagulation) Device

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

Predicate Device:

Bovie Medical Resection Device (K-082568)

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

INTENDED USE:

DEVICE COMPONENTS AND OPERATION:

1. Insulated Handle:
  The Insulated Handle encases the controlling mechanism for the flow of saline, and activation of the RF current for the device.

The activation of RF current is accomplished by a single push button on the top of the handle.

The Handle has a flow control mechanism so the flow of saline can be regulated by the user within the sterile field. The tubing length is approximately ten (10) feet in length and incorporates an I.V. spike on the end to attach directly to a hanging IV (saline) bag.

The Handle power cord is approximately ten (10) feet in length and incorporates a 3-prong electrical plug.

The insulation of the Insulated Handle and Power Cord meets the requirements for Dielectric Withstands of Accessories.

Shaft and Electrode Tip:

The electrode tip delivers RF energy for cutting and coagulation and delivers saline which is gravity-fed from an Intravenous bag to the tip.

The electrode shaft measures 32 centimeters (12.6 inches) in length and is intended to be placed through a cannula with a minimum diameter of 10 millimeters..

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

This device use technology substantially equivalent to the Bovie Medical Resection Device (K-082568). Both consist of a sintered stainless steel electrode tip that is used to cut and coagulate tissue through the utilization of high frequency radiofrequency energy. The difference between the two devices is that the predicate device is used for open surgical procedures and the Laparoscopic Resection Device is used for laparoscopic procedures.

Laparoscopic Resection Devices are provided sterilized using ethylene oxide gas, and are for single use only.

The Laparoscopic Resection Device conforms to the requirements of safety standard IEC 60601-2-2.

There are no significant differences in technology, intended use, or performance between the Laparoscopic Resection Device and the given predicate device. 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 stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Bovie Medica Inc. % Mr. Richard Kozloff 7100 30th Avenue North Saint Petersburg, Florida 33710

OCT - 9 2009

Re: K091440

Trade/Device Name: Laparoscopic Resection Device, model sr326L Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 21, 2009 Received: August 25, 2009

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 Kozloff

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Laparoscopic Resection Device Device Name:

Indications for Use:

Prescription Use (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 Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091440

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.