MEGA POWER ELECTROSURGICAL GENERATOR

K050579 · Megadyne Medical Products, Inc. · GEI · Mar 24, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050579
• Device Name: MEGA POWER ELECTROSURGICAL GENERATOR
• Applicant: Megadyne Medical Products, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

General-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation to be delivered to target tissue through an accessory electrode during open and laparoscopic surgical procedures.

Device Story

MEGA Power Electrosurgical Generator is a microprocessor-controlled, isolated output, high-frequency generator; produces radio frequency (RF) current for cutting and coagulating tissue. Used in open and laparoscopic surgical procedures; operated by surgeons/clinicians. Device delivers RF energy to target tissue via accessory electrodes. Output allows for monopolar cutting/coagulation and bipolar coagulation. Healthcare providers use the device to achieve hemostasis or perform tissue dissection during surgery, benefiting patients by facilitating surgical intervention.

Clinical Evidence

Bench testing only. The device conforms to AAMI HF 18:2001, IEC 60601-1:2003, IEC 60601-2-2:1998, and IEC 60601-1-2:2001 standards.

Technological Characteristics

Microprocessor-controlled, isolated output, high-frequency electrosurgical generator. Conforms to AAMI HF 18:2001, IEC 60601-1:2003, IEC 60601-2-2:1998, and IEC 60601-1-2:2001. Supports monopolar and bipolar modes.

Indications for Use

Indicated for patients undergoing open or laparoscopic surgical procedures requiring tissue cutting or coagulation via radio frequency current delivered through an accessory electrode.

Regulatory Classification

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.

Predicate Devices

• Valleylab Force FXc (K944602)

Submission Summary (Full Text)

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MAR 2 4 2005

050579

# Section XV 510(k) Summary

February 9, 2005

#### A. Submitter's Name / Address

Ronda K. Magneson Manager, Regulatory Affairs and Quality Assurance Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 [phone] [phone] fax

Page 1 of 2

#### B. Contact Person

Primary: Ronda K. Magneson Manager of Regulatory Affairs / Quality Assurance Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 [phone] [phone] fax

Alternate: Ihsan Samara Compliance Engineer Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 [phone] [phone] fax

#### C. Megadyne's Manufacturing Facility

Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 [phone] [phone] fax

Megadyne Medical Products, Inc. 510(k): Mega Power Electrosurgical Generator

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#### D. Device Name

Common Name:

Trade Name: Classification (if known):

Device, electrosurgical, cutting & coagulation & accessories MEGA Power 21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories

### E. Predicate Device

Valleylab Force FXc (K944602).

#### F. Applicant Device Description

The Megadyne MEGA Power Electrosurgical Generator is a microprocessor controlled, isolated output, high frequency generator designed for use in cutting and coagulating of tissue. The Generator has the ability to perform both monopolar cutting and coagulation and bipolar coagulation of tissue in a wide range of surgical applications.

#### G. Applicant Device Intended Use

General-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation to be delivered to target tissue through an accessory electrode during open and laparoscopic surgical procedures.

#### H. Technological Characteristics

The operating principle of the proposed device is identical to the predicate device.

The proposed device conforms to the applicable sections of AAMI HF 18:2001, IEC 60601-1:2003 IEC 60601-2-2:1998 and IEC 60601-1-2:2001.

#### I. Safety information

Questions of safety and effectiveness are the same for this device as they are for the other electrosurgical generators on the market.

The proposed device conforms to the applicable sections of AAMI HF 18:2001, IEC 60601-1:2003 IEC 60601-2-2:1998 and IEC 60601-1-2:2001.

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MAR 2 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Megadyne Medical Products, Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 55313

Re: K050579

Trade/Device Name: MEGA Power™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 3, 2005 Reccived: March 7, 2005

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(t) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cholosale) to regars the Medical Device Amendments, or 10 commerce prior to May 20, 1978, the enaonance with the provisions of the Federal Food. Drug. de rices that have been require approval of a premarket approval application (PMA). alle Cosmetic rearly that do not require and controls provisions of the Act. The I ou may, merciole, manel the act include requirements for annual registration. Iisting of general controll pro receive, 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 If your device is classined (soc aborto) als. Existing major regulations affecting your device can Ifray be subject to suell additions, 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 r lease be advised that i Dri- 3 issuance over device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must or any I edetar statutes and regisments, including, but not limited to: registration and listing (21 Comply with an the Hot 87043FR Part 801); good manufacturing practice requirements as set OF IT att 6077, laboring (21 OFF egulation (21 CFR Part 820); and if applicable, the electronic form in the quality bybions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Mr. Mark Job

This letter will allow you to begin marketing your device as described in your Section 5 10(k) This letter will allow you to begin marketing your avice of your device of your device to a legally
premarket notification. The FDA finding of substantial equir device than premarket notification. The FDA inding of substantal equive and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parl 801), please
r the results of the man 2012 11:54 at has and as a regulation entitled If you desire specific advice for your device at [phone]. Also, please note the regulation entitled. contact the Office of Complanes at (210) 2017 - 12 (21CFR Part 807.97). You may obtain " Misbranding by reference to premance noutitean.org other general information on your responsions and its toll-free number [phone] or and Manufacturers, International and Consumer Assistance arovedrh/industry/support/index.html.

Sincerely yours,

Elaine, M.D. Ph.D.

Miriam C. Provost, Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section IV Indications for Use Statement

510(k) Number (if known):

Device Name:

MEGA Power™

Indications for use:

General-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation to be delivered to target tissue through an accessory electrode during open and laparoscopic surgical procedures.

K050579

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use ___________

Concurrence of CDRH, Office of Device Evaluation (ODE)

Big
ion of G Restorative
rological Sciences

Kosos79

Megadyne Medical Products, Inc. Megadyne Medical Products, Integrosurgical Generator Page 8 of 74