MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM

K050364 · Valley Forge Scientific Corp. · GEI · Mar 9, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050364
• Device Name: MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM
• Applicant: Valley Forge Scientific Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 9, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Malis 2000 Electrosurgical Generator is indicated for use in micro, macro and endoscopic bipolar cutting and coagulation of tissue and sealing of blood vessels in all areas of surgery.

Device Story

Malis 2000 Bipolar Electrosurgical System; generator delivers RF power for tissue cutting and coagulation. System includes generator, bipedal footswitch, and connecting cable for irrigation. Surgeon operates via footswitch or finger-operated instruments. Rotary switches control power output; LED screen displays settings. Used in micro, macro, and endoscopic surgery. Provides precise tissue management and vessel sealing; benefits include improved surgical control and visualization via digital interface.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Electrosurgical generator; RF energy source; digital control circuitry; rotary power controls; LED display; non-sterile; supports bipolar cutting and coagulation; compatible with irrigation systems.

Indications for Use

Indicated for micro, macro, and endoscopic bipolar tissue cutting, coagulation, and blood vessel sealing in all surgical procedures.

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.

Predicate Devices

• VFS 300 (K955346)

Submission Summary (Full Text)

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MAR 9 2005

# K 050364

## Summary of Safety & Effectiveness

This 510 K Summary is being submitted in accordance with the requirements of 1990 and 21CFR807.92.

## General Information

| Date Prepared: | March 7, 2005 |
|----------------|-------------------------------------------------------------------|
| Submittor: | Valley Forge Scientific Corp.<br>P. O. Box 1179<br>Oaks, PA 19456 |
| Contact: | Jerry Malis, M.D.<br>[phone]<br>Fax [phone] |

General Provisions

| Trade name | Malis Bipolar 2000 Electrosurgical System |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification: | Electro Surgical Device |
| Predicate Device: | K955346, VFS 300 |
| Classification: | Class II |
| Performance Standard: | Pursuant to Section 1990 CFR 870.92, no<br>performance standards have been<br>established for this device. |
| Intended Use: | The Malis 2000 Electrosurgical Generator is<br>indicated for use in micro, macro and endoscopic<br>bipolar cutting and coagulation of tissue and<br>sealing of blood vessels in all areas of surgery. |

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Device Description:

The Malis 2000 Bipolar Electrosurgical System includes the generator, a Bipedal footswitch for operating the cutting and coagulation functions, a connecting cable to allow the use of a MALIS irrigator with the MALIS 2000 generator. The unit incorporates the use of a LCD panel to make it easier for the surgeon to see the setting.

Substantial Equivalence: _

| Item | Existing Device<br>K 955346 | Modified Device |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | VFS 300 Bipolar Electro-<br>surgical Generator | Malis 2000 Bipolar Electro-<br>surgical Generator |
| Intended Use | The Valley Forge Scientific<br>Malis Bipolar Generator is<br>indicated for use in surgical<br>procedures for cutting<br>tissue and coagulating<br>blood vessels. | The Valley Forge Scientific<br>Malis Bipolar Generator is<br>indicated for use in surgical<br>procedures for cutting<br>tissue and coagulating<br>blood vessels. |
| Control Circuitry | Digital | Digital |
| Method of Operation | Delivery of RF power for<br>cutting and coagulating. | Delivery of RF power for<br>cutting and coagulating. |
| RF Output Range | 5 watts to 300 watts | 5 watts to 300 watts |
| Blend Cut/Coag | Three (3) levels | Three (3) levels |
| Activation | By Footpedal | By footpedal and finger<br>operated instruments. |
| Output power controls | Up/down rocker switches | Rotary Switches |
| Power Display for Outputs | Segmental digital indicators | LED Display Screen |
| Sterilization | Non sterile | Non sterile |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, with three wavy lines below the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 9 - 2005

Jerry L. Malis, M.D. President Valley Forge Scientific Corporation P.O. Box 1179 Oaks, Pennsylvania 19456

Re: K050364

Trade/Device Name: Malis Bipolar 2000 Electrosurgical System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 8, 2005 Received: February 14, 2005

Dear Dr. Malis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 10 devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (IPMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Jerry L. Malis, M.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse Fig. finding of substantial equivalence of your device to a legally premative notificated. " 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), please If you desire specific auries 10. 90% [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sinccrely yours,

for Miriam C. Provost, Ph.D.

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices ()ffice of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Malis 2000 Bipolar Electrosurgical System

# INDICATIONS FOR USE

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

### Device Name

Valley Forge Scientific MALIS ™ 2000 Bipolar Electrosurgical Generator.

#### Indications for Use

The MALIS 2000 Bipolar Electrosurgical system is indicated for use in micro, macro and endoscopic bipolar cutting and coagulation of tissue and sealing of blood vessels in all types of surgery.

| Prescription Use: | X | AND/OR | Over-the-Counter Use: |
|----------------------------|---|--------|------------------------|
| (Per 21 CFR 801 Subpart D) | | | (21 CFR 807 Subpart C) |

(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,

and Neurological Devices

| 510(k) Number | K050364 |
|---------------|---------|
|---------------|---------|