LOOP ELECTRODE, BALL ELECTRODE

K993527 · Palm Medical USA, Inc. · HGI · Jul 6, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K993527
• Device Name: LOOP ELECTRODE, BALL ELECTRODE
• Applicant: Palm Medical USA, Inc.
• Product Code: HGI · Obstetrics/Gynecology
• Decision Date: Jul 6, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indication for the LLETZ procedure include: A cytological and coposcopic suspicion of CIN; A transformation zone which is fully visible and fully confined to the cervix; LLETZ in indicated for those patients who have had abnormal pap smear report with cytologic evidence of CIN, colposcopic examination of the cervix unsatisfactory finding and who, in the physician's opinion are suitable candidates for the procedure.

Device Story

Ball and Loop electrodes used for Loop Electrosurgical Excision Procedure (LLETZ) and LOOP procedures. Device functions as an electrosurgical accessory to excise cervical tissue. Operated by physicians in clinical settings. Provides tissue excision or coagulation via electrical current. Benefits include diagnostic and therapeutic management of cervical intraepithelial neoplasia (CIN).

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Electrosurgical electrodes (ball and loop configurations) for use with electrosurgical generators. Class II device (21 CFR 884.4120).

Indications for Use

Indicated for patients with abnormal Pap smear (cytologic evidence of CIN) and unsatisfactory colposcopic examination of the cervix, where the transformation zone is fully visible and confined to the cervix, and the physician deems the patient a suitable candidate for LLETZ/LOOP procedures.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 6 2000

Mr. Mark J. Kahn Palm Medical USA, Inc. 6322 N.W. 18th Drive Suite 170 Gainesville, FL 32653

Re: K993527 Ball and Loop Electrodes for LOOP and LLETZ procedures Dated: April 4, 2000 Received: April 7, 2000 Regulatory Class: II 21 CFR §884.4120/Procode: 85 HGI

Dear Mr. Kahn:

We have reviewed your Section 510(k) notification of intent to market the device 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 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 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 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.

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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510(k) Number (if known): K993527

Device Name: Loop ELECTRODE/BALL ELECTREDE

Indications For Use:

## Indication for the LLETZ procedure include:

A cytological and coposcopic suspicion of CIN;

A transformation zone which is fully visible and fully confined to the cervix;

LLETZ in indicated for those patients who have had abnormal pap smear report with cytologic evidence of CIN, colposcopic examination of the cervix unsatisfactory finding and who, in the physician's opinion are suitable candidates for the procedure.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <table border="0"><tr><td>(Division Sign-Off)</td></tr><tr><td>Division of Reproductive, Abdominal, ENT, and Radiological Devices</td></tr><tr><td>510(k) Number</td><td>K993527</td></tr></table> | (Division Sign-Off) | Division of Reproductive, Abdominal, ENT, and Radiological Devices | 510(k) Number | K993527 |
|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|--------------------------------------------------------------------|---------------|---------|
| (Division Sign-Off) | | | | | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | | | | | |
| 510(k) Number | K993527 | | | | |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use | | | |

(Optional Format 1-2-96)