LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS)

K040699 · Megadyne Medical Products, Inc. · GEI · Jun 4, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040699
• Device Name: LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS)
• Applicant: Megadyne Medical Products, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Reusable Uncoated Laparoscopic Electrodes are intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation. The electrodes are reusable; they are intended to be cleaned, sterilized, and reused.

Device Story

Reusable Uncoated Laparoscopic Electrodes consist of stainless steel electrosurgical tips and insulated shafts; designed for use in general laparoscopic surgery. Device connects to industry-standard electrosurgical pencils or foot cables. Insulation features a patented yellow indicator layer that becomes visible when primary insulation reaches end-of-life, signaling the need for replacement to prevent unwanted current paths. Operated by surgeons in clinical settings; device is reusable and requires cleaning and sterilization between uses. Output is electrosurgical energy for tissue cutting and coagulation. Benefits include improved safety through visual wear-indication, reducing risk of accidental burns from compromised insulation.

Clinical Evidence

Bench testing only. Conformance to ANSI/AAMI HF 18-2001 demonstrated through dielectric withstand testing, mechanical strength testing, environmental cycling, and sterilization validation. No clinical data provided.

Technological Characteristics

Stainless steel electrosurgical electrodes with insulated shafts. Features patented yellow indicator layer for insulation wear detection. Compatible with standard electrosurgical pencils/cables. Conforms to ANSI/AAMI HF 18-2001. Reusable; requires sterilization.

Indications for Use

Indicated for patients undergoing general laparoscopic surgical procedures requiring electrosurgical cutting and/or coagulation.

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

• E-Z Clean Laparoscopic Electrode (K913281)
• Electrosurgical Cutting and Coagulation Device (K943055)

Submission Summary (Full Text)

{0}------------------------------------------------

Page 1 of 3

# 040699

| Decision-Making Process<br>Flowchart step | Answer | Remarks |
|----------------------------------------------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance data<br>demonstrate equivalence? | Yes | Performance data demonstrate substantial<br>equivalence. The changes do not affect the<br>safety and effectiveness of the device. Ref.<br>Section VIII Performance Data and Standards<br>Conformance. |
| "Substantially Equivalent"<br>Determination | | The device is substantially equivalent to the<br>predicate devices. |

# Section XIV 510(k) Summary

### March 12, 2004

- 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
# B. Contact Person

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

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

Page 22 of 24 Megadyne Medical Products, Inc. 510(k): Reusable Uncoated Laparoscopic Electrodes

{1}------------------------------------------------

Page 2 of 3

#### C. Device Name

| Common Name: | Device, electrosurgical, cutting & coagulation & accessories |
|----------------------------|---------------------------------------------------------------------------------|
| Trade Name: | Laparoscopic Electrode, Reusable Indicator Shaft (LERIS) |
| Classification (if known): | 21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories |

### D. Predicate Devices

Megadyne's E-Z Clean Laparoscopic Electrode, cleared for marketing via 510(k) #(K913281) and, Electrosurgical Cutting and Coagulation Device, cleared for marketing via 510(k) #K943055.

## E. Applicant Device Description

The Reusable Uncoated Laparoscopic Electrodes are stainless steel electrosurgical electrodes insulated over the majority of their length to protect against unwanted current paths. The insulation has a patented indication layer that aids in determining the electrode's end-of-life. The reusable uncoated laparoscopic electrode tip has the intended geometry for cutting and coagulation and is offered in several configurations. The electrodes are intended for general laparoscopic electrosurgical use, and designed to fit into industry standard electrosurgical pencils and/or foot cables distributed by various manufacturers.

#### F. Applicant Device Intended Use

Reusable Uncoated Laparoscopic Electrodes are intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation.

and of cought are reusable; they are intended to be cleaned, sterilized, and reused.

#### G. Technological Characteristics

The Reusable Uncoated Laparoscopic Electrode shares the same technological characteristic found in the predicate devices. It is an electrode provided with various uncoated tip configurations and a shaft that includes the patented indicator shaft technology. The indicator shaft provides a safe method to utilize the electrode without compromising safety. This is accomplished by exposing a visible yellow layer indicating that the primary insulation has reached the end of its life.

{2}------------------------------------------------

Page 3 of (3)

#### H. Safety information

Questions of safety and effectiveness are the same for this device as for other laparoscopic electrodes on the market. There are no new technologies incorporated into the proposed electrode.

Prior to release of the device for distribution, Megadyne conducted extensive testing of the device to assure its conformance to the voluntary standard ANSI / AAMI HF 18-2001, Electrosurgical Devices (Ref. Appendix). The clauses of the standard which apply to accessories are:

Sterilization of reusable accessories:

Conformance with the sterilization of reusable accessories requirement was demonstrated using the methods specified by the standard. The device is well within the requirements of the standard.

Dielectric withstand of accessories:

Conformance with the dielectric withstand of accessories requirement was demonstrated using the method specified by the standard. The device is well within the requirements of the standard.

Shipping temperature:

Conformance with the shipping temperature requirement for accessories was demonstrated using the method specified by the standard. The device is well within the requirements of the standard.

Mechanical shock:

Conformance with the sterilization of reusable accessories requirement was demonstrated using the method specified by the standard. The device is well within the requirements of the standard.

#### Megadyne's Manufacturing Facility I.

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

#### Appendix Section XV

The following test reports are available upon request: Document Number Document Title LERIS Dielectric Withstand Test X1150198-01 X1150209-01 LERIS Functionality Testing Memo to Design History File LERIS Electrode Environmental Cycling X1150197-01 LERIS Mechanical Strength Test

Megadyne Medical Products, Inc. Page 24 of 24 510(k): Reusable Uncoated Laparoscopic Electrodes

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "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.

Public Health Service

JUN - 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ronda K. Magneson Manager, Regulatory Affairs and Quality Assurance Megadyne Medical Products, Inc. 11506 South State Street Draper, Utah 84020

Re: K040699

Trade/Device Name: Laparoscopic Electrode, Reusable Indicator Shaft (LERIS) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 12, 2004 Received: March 17, 2004

Dear Ms. Magneson:

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 issuançe 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.

{4}------------------------------------------------

Page 2 - Ms. Ronda K. Magneson

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and the FDA finding of substantial equivalence of your device to a legally prematicated predicated 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Wilkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

#### Indications for Use Statement Section IV

| 510(k) Number (if known): | K040699 |
|---------------------------|----------------------------------------------------------|
| Device Name: | Laparoscopic Electrode, Reusable Indicator Shaft (LERIS) |

Indications for use:

Device Name:

The Reusable Laparoscopic Electrodes are intended to be used in general laparoscopic The Reusable Laparoscopic Electrodes and intensurgical cutting and/or coagulation.
surgical procedures requiring the use of electrosurgical cutting and/or sterlized, and reus surgical procedures requiring the use of clectrosargious commy
The electrodes are reusable; they are intended to be cleaned, sterilized, and reused.

| Prescription Use | <div> <img alt="Checkmark" src="checkmark.png"/> </div> |
|-----------------------------|---------------------------------------------------------|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device E

Division of General, Restorative, and Neurological Devices

| Megadyne Medical Products, Inc. | |
|---------------------------------------------------|---------|
| 510(k): Reusable Uncoated Laparoscopic Electrodes | |
| Page 9 of 24 | |
| 510(k) Number | K040699 |