VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS

K042604 · Valley Forge Scientific Corp. · GEI · Oct 22, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042604
• Device Name: VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS
• Applicant: Valley Forge Scientific Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 22, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Valley Forge Scientific Malis™ Bipolar Disposable Electro-Surgical Pen is indicated for use with the Valley Forge Scientific 300 Bipolar System. Electro-Surgical accessories: Hand-Switching Pen for the removal of tissue and Electro-Surgical accessories: Hand-Switching for coagulating tissue using high frequency (RF) current.

Device Story

Disposable, finger-operated bipolar electrosurgical instruments featuring blade, ball, or loop tips. Device connects to Valley Forge Scientific 300 Bipolar System to deliver RF current for tissue cutting and coagulation. Operated by surgeons in clinical settings. Unlike monopolar instruments, bipolar design confines current between tips, eliminating need for patient grounding pads and reducing risk of current shunting in wet or irrigated fields. Switch mechanisms are liquid-sealed with molded buttons. Output is controlled by the surgeon via hand-switching to facilitate precise tissue interaction.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Plastic disposable bipolar electrosurgical instruments with blade, ball, or loop tips. Energy source: RF current via external electrosurgical generator. Features liquid-sealed switch mechanisms with molded buttons. Bipolar configuration eliminates grounding pad requirement.

Indications for Use

Indicated for the removal and coagulation of tissue using high-frequency (RF) current in surgical procedures. Intended for prescription use.

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

• Valley Forge Scientific Corp. (K910510)
• Conmed Corp. (K896626)
• Valley Forge Scientific Corp. (K955764)
• New Deantronics (K982742)
• Valley Forge Scientific Corp. (K973554)
• New Deantronics (K982884)
• Conmed Corp. (K932345)
• Birtcher Corp. (K850297)

Submission Summary (Full Text)

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## 510(k) Summarv for the Malis Bipolar Disposable Electro-Surgical Pens

OCT 2 2 2004

Valley Forge Scientific Corp. 136 Green Tree Rd., Suite 100, P. O. Box 1179 Oaks, PA 19456

| Contact Person: | Jerry L. Malis, President |
|-----------------|---------------------------|
| Phone Number: | 610-666-7500 |
| Fax Number: | 610-666-7565 |

| Date Prepared: | September 21, 2004 |
|------------------------|-------------------------------------------------------------------------|
| Proprietary Name: | Valley Forge Scientific Malis™ Bipolar Disposable Electro-Surgical Pens |
| Common Name: | Bipolar Disposable Electro-Surgical Pens |
| Classification Name: | Electrosurgical Cutting and Coagulation Accessory |
| Device Classification: | This device is Class II per CFR § 878.4400- |

Electrosurgical Cutting and Coagulation Instruments

Predicate Devices:

| K910510 | Valley Forge Scientific Corp. | K896626 | Conmed Corp. |
|---------|-------------------------------|---------|-----------------|
| K955764 | Valley Forge Scientific Corp. | K982742 | New Deantronics |
| K973554 | Valley Forge Scientific Corp. | K982884 | New Deantronics |
| K932345 | Conmed Corp. | K850297 | Birtcher Corp. |

Intended Use: The Valley Forge Scientific Malis™ Bipolar Disposable Electro-Surgical Pen is indicated for use with the Valley Forge Scientific 300 Bipolar System.

Device Description: Plastic disposable finger operated bipolar electro-surgical instruments with either blade, ball or loop tips.

Performance Standards: Pursuant to Section 514 of the FD&C Act and 21 CFR 888, no performance standards have been established for this device

Substantial Equivalence:

The Valley Forge Scientific Malis bipolar instruments are similar in use to Bovietype mono-polar instruments which have been marketed for the past 25-30 years (prior to May 28, 1976). Both the mono-polar and the bipolar instruments depend on an electro-surgical generator to deliver RF current to the tips of the instruments for cutting and coagulation.

The difference between the two methods can be found in the fact that with the mono-polar systems, the current passes from an active electrode through the patient to a grounding pad. The bipolar method eliminates the electrical current being passed through the patient and the use of grounding pads and their inherent safety hazards. Bipolar technology also permits the surgeon to work in a wet or irrigated surgical field without current shunting.

The physical construction of both the mono-polar and bipolar instruments are essentially identical. The switch mechanisms on both are liquid sealed with buttons molded in place.

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Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2004

Mr. Jerry L. Malis President and CEO Valley Forge Scientific Corporation 136 Green Tree Road, Suite 100 P.O. Box 1179 Oaks, Pennsylvania 19456

Re: K042604

Trade/Device Name: Valley Forge Scientific MALIS™ Bipolar Disposable Hand-Switching Electro-Surgical Pencil, Loops, and Ball Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 21, 2004 Received: September 24, 2004

Dear Mr. 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 to 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 (PMA), 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

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Page 2 - Mr. Jerry L. Malis

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This ictier with anow you to ough maine of substantial equivalence of your device to a legally prematicated predicated. The 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 11 you desire specific acries at [phone]. Also, please note the regulation entitled, Connact the Office of Coach to premarket notification" (21CFR Part 807.97). You may obtain Whisolaining of Yererence to premessionsibilities under the Act from the Division of Small other general mionnation and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

## Device Name

Valley Forge Scientific MALIS ™ Bipolar Disposable Hand-Switching Electro-Surgical Pencils, Loops, and Ball.

## Indications for Use

Electro-Surgical accessories: Hand-Switching Pen for the removal of tissue and Electro-Surgical accessones: Hand Officening vising high frequency (RF) current.

| Prescription Use:<br>(Per 21 CFR 801 Subpart D) | ✓_________________ |
|--------------------------------------------------------|--------------------|
| AND/OR Over-the-Counter Use:<br>(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)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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**510(k) Number** K042604