GYNEX ELECTRODES

K982739 · Gynex Corp. · HGI · Mar 12, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K982739
• Device Name: GYNEX ELECTRODES
• Applicant: Gynex Corp.
• Product Code: HGI · Obstetrics/Gynecology
• Decision Date: Mar 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Soft tissue cutting & coagulation Intraepithelial neoplasia Condylomata acuminata Misc. lesions; polyps, molluscum contagiosum, nevi, seborrheic keratosis, achricordon, etc.

Device Story

Gynex Electrodes are sterile, single-use electrosurgical accessories designed for gynecologic procedures. The device consists of an insulated metallic shaft (2.5mm diameter) terminating in a tungsten wire loop (curved or square) for excisional procedures or a brass ball tip for fulguration and coagulation. Operated by a physician in a clinical setting, the electrode connects to an electrosurgical generator. High-frequency current passes through the tungsten wire or ball tip to destroy tissue via high temperatures under direct visual observation. The device facilitates tissue excision, biopsy, or treatment of chronic cervicitis. Benefits include precise tissue removal and coagulation, reducing the need for traditional scalpel surgery in specific gynecologic applications.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and intended use comparisons to the predicate device.

Technological Characteristics

Materials: Tungsten wire (0.18mm), stainless steel, brass, Teflon. Design: Insulated 2.5mm diameter shaft with curved/square wire loops or ball tips. Energy: Electrosurgical (high-frequency current). Sterilization: EtO gas (ANSI/AAMI/ISO 11135-1994). Standards: ISO 10993-7.2, ISO 9000 series, Quality Systems Regulations.

Indications for Use

Indicated for soft tissue cutting and coagulation in gynecologic procedures, including treatment of intraepithelial neoplasia, condylomata acuminata, and miscellaneous lesions such as polyps, molluscum contagiosum, nevi, seborrheic keratosis, and achricordon. Prescription use only.

Regulatory Classification

Identification

A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.

Predicate Devices

• Cooper Surgical; Single-Use Tungsten Wire LEEP Electrodes, Sterile (K952483)

Submission Summary (Full Text)

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K982739

3/12/99

# Summary of Safety and

Effectiveness Information Premarket Notification, Section 510(k) Gynex Electrodes

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

#### Device Name: 1.

Trade Name: Gynex Electrodes Common Name: cutting & coagulation electrodes Classification Name: electrocautery, Gynecologic and accessories

#### Establishment Name & Registration Number: 2.

GYNEX Corporation Name: Number: 3032109

#### 3. Classification:

& 878.4120 Electrocautery, Gynecologic and accessories. (a) Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables. (b) Classification. Class II (performance standards).

Device Class: Class II

Classification Panel: OB/GYN

Product Code: HGI

#### 4. Preamendments Device:

1. Cooper Surgical; Single-Use Tungsten Wire LEEP Electrodes, Sterile, K952483

## Gynex Corporation Device

Curved electrode: 12cm x 1cm x 0.7cm Curved electrode: 12cm x 1cm x 1cm Curved electrode: 12cm x 1.5cm x 0.5cm Curved electrode: 12cm x 1.5cm x 0.7cm Curved electrode: 12cm x 2cm x 0.8cm Curved electrode: 12cm x 2cm x 1cm Square electrode: 12cm x 1cm x 1cm Square electrode: 5.5cm x 1cm x .64cm Ball electrode: 12cm x 5mm Ball electrode: 5.5cm x 5mm

## Equivalent Cooper Surgical Device

ltem #R1007 ZL: 12cm x 1cm x 0.7cm ltem #R1010 ZL: 12cm x 1cm x 1cm ltem #R1505 ZL: 12cm x 1.5cm x 0.5cm ltem #R1507 ZL: 12cm x 1.5cm x 0.7cm Item #R2008 ZL: 12cm x 2cm x 0.8cm item #R2010 ZL: 12cm x 2cm x 1cm ltem #S1010 ZL: 12cm x 1cm x 1cm ltem #S1007 ZL: 5.5cm x 1cm x 7.0mm ltem #B0512 ZL: 12cm x 5mm Item #B0555 ZL: 5.5cm x 5mm

#### 5. Device Description:

The Gynex Electrodes are made of thin 0.18mm hard tungsten wire with a high melting temperature and excellent conductiveness of electric current. The electrodes are available in three different styles intended for use in two different types of electrosurgical procedure. The three styles are curved wire loop electrodes, square wire loop electrodes and ball-type

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electrodes. The two intended uses are excisional procedures (wire loop) and fulguration or coagulation procedures (ball electrode).

All electrode styles consist of an insulated conductive metallic shaft of varing length terminating in a bare metalic "ball" a "square wire loop" or a "curved wire loop". The wire loop electrodes vary in both width and depth of the loop. Electrode shaft diameter is constant at 2,5mm.

#### 6. Applicant Name & Address:

GYNEX Corporation 16700 NE 79th St., Suite 204 Redmond, WA 98052

#### 7. Company Contact:

Mr. Steve Angelo, President GYNEX Corporation 16700 NE 79th St., Suite 204 Redmond, WA 98052 425.882.1179 * 425.895.0115 - fax

#### 8. Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax

#### 9. Voluntary Standards:

United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include ASTM, GYNEX Corporation. Standard Operating Procedures (SOP), vendor certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality requiations.

#### 10. Storage, Packaging & Sterilization Information:

Gynex brand Electrodes are supplied "STERILE". The sterilization method is EtO gas sterilization and the exposure cycle has been validated to achieve a sterility assurance level of 10°. The sterilization process, the validation procedure and the nature of the gas residuals are conducted and characterized in accordance with ANSI/AAMI/ISO 11135 -1994; EN550: 1994; AAMI method designation EOR; ISO/DIS 10993-7.2; FDA Proposed "Maximum Residue Limits and Maximum Exposure" and the Pharmacopeia of the United States.

Packaging materials are typical medical grade peel-type pouches of the generic mylar/nonwoven sandwich variety. All packaging should be inspected on arrival for evidence of shipping damage. Damaged packaging may indicate the presence of unsafe product and it should not be used until carefully inspected. Any shipping damaged product should be returned promptly. Sterile product must be handled, opened and placed into use following accepted sterile technique.

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### Comparison Table: 11.

| FEATURE | Gynex Disposable Electrodes | Cooper Surgical Single-Use Wire<br>Electrodes | SE? |
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Intended Use: | Soft tissue cutting & coagulation<br>Intraepithelial neoplasia<br>Condylomata acuminata<br>Misc. lesions; polyps, molluscum<br>contagiosum, nevi, seborrheic keratosis,<br>achricordon | Same | YES |
| Design: | Tugnsten wire<br>Curved loop<br>Square loop<br>Brass ball electrode | Tugnsten wire<br>Curved loop<br>Square loop<br>Brass ball electrode | YES |
| Sterile: | Yes | Yes | YES |
| Sizes: | Curved electrode: 12cm x 1cm x 0.7cm<br>Curved electrode: 12cm x 1cm x 1cm<br>Curved electrode: 12cm x 1.5cm x 0.5cm<br>Curved electrode: 12cm x 1.5cm x 0.7cm<br>Curved electrode: 12cm x 2cm x 0.8cm<br>Curved electrode: 12cm x 2cm x 1cm<br>Square electrode: 12cm x 1cm x 1cm<br>Square electrode: 5.5cm x 1cm x 6.4mm<br>Ball electrode: 12cm x 5mm<br>Ball electrode: 5.5cm x 5mm<br>Shaft diameter 2.5mm | Curved electrode: 12cm x 1cm x 0.7cm<br>Curved electrode: 12cm x 1cm x 1cm<br>Curved electrode: 12cm x 1.5cm x 0.5cm<br>Curved electrode: 12cm x 1.5cm x 0.7cm<br>Curved electrode: 12cm x 2cm x 0.8cm<br>Curved electrode: 12cm x 2cm x 1cm<br>Square electrode: 12cm x 1cm x 1cm<br>Square electrode: 5.5cm x 1cm x .7cm<br>Ball electrode: 12cm x 5mm<br>Ball electrode: 5.5cm x 5mm<br>plus additional size square, ball and needle-<br>type electrodes<br>Shaft diameter 2.5mm | YES |
| Material: | Tungsten wire<br>Stainless steel<br>Brass<br>Teflon | Tungsten wire<br>Stainless steel<br>Brass<br>Teflon | YES |
| Origin: | Europe | Europe | YES |
| Manufacturer: | Gynex Corporation | Cooper Surgical | YES |
| Product Code: | HGI | HGI | YES |
| K - Number: | Pending | K952483 | YES |

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract design featuring three stylized human profiles facing to the right, with three parallel lines above them, possibly representing wings or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 1999

Gynex Corporation c/o Mr. David W. Schlerf Official Correspondent BUCKMAN Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 Re: K982739

GYNEX Electrodes Dated: November 20, 1998 Received: February 24, 1999 Regulatory Class: II 21 CFR 878.4120/Procode: 85 HGI

Dear Mr. Schlerf:

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 regulations affecting your device can be found in the Code of Federal Regulations, 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _1 __ of __ 1

**510(k) Number**: K982739

Device Name(s):

GYNEX Electrodes

# Intended Use of the Device:

- 1. Soft tissue cutting & coagulation
- 2. Intraepithelial neoplasia
- 3. Condylomata acuminata
- 4. Misc. Iesions; polyps, molluscum contagiosum, nevi, seborrheic keratosis, achricordon, etc.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Segerson
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_

Prescription Use X
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional format 1-2-96)

GYNEX-ELECTRODES.doc