WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM

• K Number: K963653
• Device Name: WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
• Manufacturer: WALLACH SURGICAL DEVICES, INC.
• Date Cleared: 1997-06-11 ( 272 days)
• Product Code: HGI
• Regulation Number: 884.4120
• Type: Traditional
• Panel: Obstetrics/Gynecology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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 Description

WALLACH QUNATUM 2000 ELECTROSURGICAL SYSTEM

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA to Wallach Surgical Devices, Inc. regarding their Quantum 2000 Electrosurgical System. It states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

The provided text does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory clearance document, not a clinical study report. It indicates that the device is substantially equivalent to devices marketed prior to May 28, 1976, which is the basis for its clearance, not performance against specific acceptance criteria.

Therefore, I cannot answer the questions regarding acceptance criteria and a study that proves the device meets the acceptance criteria from the provided text.

Summary

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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

્રીક 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,

William Yi, Ph.D.

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

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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. "我
  • 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. Ratliff/
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices K46365 1 510(k) Number_

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 884.4120 Gynecologic electrocautery 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).