WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR

K983208 · Wallach Surgical Devices, Inc. · GEI · Feb 22, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K983208
• Device Name: WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
• Applicant: Wallach Surgical Devices, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Quantum 500 Electrosurgical Generator is for all General & Plastic Surgery related in-office high frequency, electrosurgical procedures. Some indications for applications include: - 1) Cutting skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, nevi, keratosis, oculoplastic procedures, blepharoplasty, aponeurotic repair, and levator resection. - 2) Blended Cutting and Coagulation skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, skin tags, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, development of skin flaps, and oculoplastic procedures. - 3) Hemostasis control of bleeding, epilation, and telangiectasia. - 4) Fulguration basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, and hemostasis. - 5) Bipolar pinpoint, precise coagulation. Pinpoint hemostasis in any field; wet or dry.

Device Story

Wallach Quantum 500 is an electrosurgical generator for in-office general and plastic surgery. Device delivers high-frequency electrical current to surgical instruments for cutting, coagulation, and fulguration of tissue. Operated by physicians in clinical settings. Provides precise tissue management for procedures like skin incisions, biopsies, tumor destruction, and hemostasis. Output affects clinical decision-making by enabling controlled tissue resection and bleeding management. Benefits include improved surgical precision and efficiency in office-based procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical generator; high-frequency energy source; supports monopolar and bipolar modes; designed for in-office surgical applications.

Indications for Use

Indicated for general and plastic surgery patients requiring high-frequency electrosurgical procedures, including skin incisions, biopsies, tumor/cyst/abscess management, cosmetic repairs, oculoplastic procedures, and hemostasis. Prescription use only.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 1999

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

Re: K983208

> Trade Name: Wallach Quantum 500 Electrosurgical Generator Regulatory Class: II Product Code: GEI Dated: December 4, 1998 Received: December 10, 1998

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 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 current Good Manufacturing Practice requirement, 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Michael Malis

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,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification Submittal for Wallach Quantum 500

SECTION 8 - Page 1 of 1

Page

12/2/98

pñ.

510(k) Number (if known) K983208

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Indications for use: The intended use of the Quantum 500 Electrosurgical Generator is for all General & Plastic Surgery related in-office high frequency, electrosurgical procedures. Some indications for applications include:

- 1) Cutting skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, nevi, keratosis, oculoplastic procedures, blepharoplasty, aponeurotic repair, and levator resection.
- 2) Blended Cutting and Coagulation skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, skin tags, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, development of skin flaps, and oculoplastic procedures.
- 3) Hemostasis control of bleeding, epilation, and telangiectasia.
- 4) Fulguration basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, and hemostasis.
- 5) Bipolar pinpoint, precise coagulation. Pinpoint hemostasis in any field; wet or dry.

510kform\quantum5\IndicForUse2.doc, Dec. 1998

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983208

Prescription Ser (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96).