DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES

K993777 · R-Group Intl. · HGI · May 25, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K993777
• Device Name: DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES
• Applicant: R-Group Intl.
• Product Code: HGI · Obstetrics/Gynecology
• Decision Date: May 25, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The loop electrodes are designed for the LEEP or LLETZ procedure, which is performed to remove a lesion of abnormal cells from the cervix. The loop electrode is attached to an electrosurgical generator that mits an electrical current used to cut away the affected tiscues following the removal of the cells in the affected area the ball electrode is used to seal the area and stop any bleeding that may have occurred. Some indications for use are: a. Cervical conizations b. Large Loop Excision of the Transformation Zone (LLETZ) in the Diagnosis and Treatment of some Cervical Intraepithelial Neoplasias (CIN) and Dysplasias. c. External Anogenital Lesions d. Large Vaginal Intraepithelial Neoplasic (VAIN) Lesions.

Device Story

Disposable electrosurgical electrodes (ball and loop types) used in LEEP/LLETZ procedures; intended for excision of cervical/vaginal lesions and hemostasis. Device connects to an electrosurgical generator; loop electrode cuts tissue via electrical current; ball electrode provides coagulation to stop bleeding. Used in clinical settings by physicians. Benefits include precise tissue removal and effective hemorrhage control during gynecological procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable electrosurgical electrodes consisting of ball and loop configurations. Operates via connection to an external electrosurgical generator. Materials and sterilization methods are consistent with standard electrosurgical instrumentation for gynecological use.

Indications for Use

Indicated for patients requiring removal of cervical lesions, including cervical conizations, LLETZ for CIN and dysplasias, external anogenital lesions, and large vaginal intraepithelial neoplasic (VAIN) lesions.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2000

Ms. Kerry Anne Kahn Regulatory Affairs Coordinator R-Group International, Inc. 2321 N.W. 66th Ct., Suite W-4 Gainesville, FL 32653

Re: K993777 Disposable Ball and Loop Electrodes Dated: February 25, 2000 Received: February 25, 2000 Requiatory Class: II 21 CFR §884.4120/Procode: 85 HGI

Dear Ms. Kahn:

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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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 requlation may result in requlatory 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 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 question 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" (21CFR 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/dsmaldsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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## Statement of Intended Use

K993777 510(k) Number (if known): Disposable Ball and Loop Electrode Device Name: Indications for Use:

The loop electrodes are designed for the LEEP or LLETZ procedure, which is performed to remove a lesion of abnormal cells from the cervix. The loop electrode is attached to an electrosurgical generator that mits an electrical current used to cut away the affected tiscues following the removal of the cells in the affected area the ball electrode is used to seal the area and stop any bleeding that may have occurred.

Some indications for use are:

- a. Cervical conizations
- b. Large Loop Excision of the Transformation Zone (LLETZ) in the Diagnosis and Treatment of some Cervical Intraepithelial Neoplasias (CIN) and Dysplasias.
- c. External Anogenital Lesions
- d. Large Vaginal Intraepithelial Neoplasic (VAIN) Lesions.

(Please do not write below this line-continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

OR

Over-the-Counter Use: (Optional Format 1-2)

David A. Seyson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number