WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)

K983840 · Wallach Surgical Devices, Inc. · HGI · May 20, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K983840
• Device Name: WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
• Applicant: Wallach Surgical Devices, Inc.
• Product Code: HGI · Obstetrics/Gynecology
• Decision Date: May 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Quantum 500 Electrosurgical Generator is for in-office high frequency, electrosurgical OB/GYN procedures. Some OB/GYN indications for applications include: 1) Cervical Conization. 2) Large Loop Excision of the Transformation Zone (LLETZ) in the diagnosis and treatment of some Cervical Intraepithelial Neoplasias (CIN) and Dysplasias. 3) External Anogenital Lesions. 4) Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions. 5) Bipolar pinpoint, precise coagulation. Pinpoint hemostasis in any field, wet or dry.

Device Story

Quantum 500 Electrosurgical Generator provides high-frequency electrical energy for OB/GYN surgical procedures. Device operates as electrosurgical unit (ESU) for cutting and coagulation. Used in clinical office settings by physicians. Input is electrical power; output is high-frequency current delivered via electrodes to target tissue. Enables precise tissue excision (e.g., LLETZ, conization) and hemostasis. Benefits include controlled tissue removal and bleeding management during gynecological interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical generator providing high-frequency energy for cutting and coagulation. Designed for in-office OB/GYN use. Supports bipolar coagulation. Device is a standalone electrical unit.

Indications for Use

Indicated for patients undergoing in-office high frequency electrosurgical OB/GYN procedures, including cervical conization, LLETZ for CIN and dysplasias, treatment of external anogenital lesions, large VAIN lesions, and bipolar coagulation/hemostasis.

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 20 1999

Mr. Michael Malis General Manager Wallach Surgical Devices, Inc. 235 Edison Road Orange, Connecticut 06477

K983840 Re: Wallach Quantum 500 Electrosurgical Generator - for Gynecologic Indications Dated: February 17, 1999 Received: February 22, 1999 Requiatory Class: II 21 CFR 881.4120/ Procode: 85 HGI

Dear Mr. Malis:

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). 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 Requlation (QS) for Medical Devices: General requiation (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 regult 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 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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oSECTION 4 - Page 1 of 1 Page

## K983840

510(k) Number (if known):

Device Name:

## WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR FOR OB/GYN

Indications For Use:

Indications for use: The intended use of the Quantum 500 Electrosurgical Generator is for in-office high frequency, electrosurgical OB/GYN procedures. Some OB/GYN indications for applications include:

- 1) Cervical Conization.
- 2) Large Loop Excision of the Transformation Zone (LLETZ) in the diagnosis and treatment of some Cervical Intraepithelial Neoplasias (CIN) and Dysplasias.
- 3) External Anogenital Lesions.
- 4) Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions.
- 5) Bipolar pinpoint, precise coagulation. Pinpoint hemostasis in any field, wet or dry.

510kform\g5obgyn\intnduseob#2.doc, February 17, 1999

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.105)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K983840/S⁰⁰¹