WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM

K963653 · Wallach Surgical Devices, Inc. · HGI · Jun 11, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K963653
• Device Name: WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
• Applicant: Wallach Surgical Devices, Inc.
• Product Code: HGI · Obstetrics/Gynecology
• Decision Date: Jun 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Quantum 2000 System is for in-office 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.

Device Story

Quantum 2000 Electrosurgical System; electrosurgical generator for OB/GYN procedures. Device delivers high-frequency electrical current to surgical electrodes; used for cutting and coagulation of tissue. Operated by physicians in clinical office settings. Provides precise tissue excision and hemostasis during procedures like cervical conization and LLETZ. Benefits include efficient in-office treatment of cervical/vaginal lesions, reducing need for hospital-based surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical generator; high-frequency energy source; standard electrosurgical output for cutting and coagulation; intended for use with compatible surgical electrodes.

Indications for Use

Indicated for in-office electrosurgical OB/GYN procedures, including cervical conization, LLETZ for CIN and dysplasias, external anogenital lesions, and large 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)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 11 1997

Mr. Raymond A. Wiley
Operations Manager
Wallach Surgical Devices, Inc.
235 Edison Road
Orange, Connecticut 06477

Re: K963653
Wallach Quantum 2000 Electrosurgical System
(for Gynecology)
Dated: May 5, 1997
Received: May 8, 1997
Regulatory class: II
21 CFR §884.4120/Product code: 85 HGI

Dear Mr. Wiley:

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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

{1}

Page 1 of 1

510(k) Number (if known): K963653

Device Name: WALLACH QUNATUM 2000 ELECTROSURGICAL SYSTEM

Indications For Use:

The intended use of the Quantum 2000 System is for in-office 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert D. Natting
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K963653

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)