MALIS IRRIGATION MODULE 1000

K033499 · Valley Forge Scientific Corp. · GEI · Nov 28, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K033499
• Device Name: MALIS IRRIGATION MODULE 1000
• Applicant: Valley Forge Scientific Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 28, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The MALIS™ Irrigation Module 1000 is indicated for use with irrigating bipolar forceps with the CODMAN® / MALIS™ generators.

Device Story

The MALIS™ Irrigation Module 1000 is an irrigation control system designed for use with MALIS™ CMC-III Bipolar Electrosurgical Systems and Synergy MALIS™ Precision Systems. The device provides controlled flow of irrigating fluid across the tips of bipolar irrigating forceps during electrosurgical procedures. It functions as an accessory to electrosurgical generators to facilitate irrigation, which helps maintain a clear surgical field and prevents tissue adhesion to the forceps tips. The system is intended for use by clinicians in surgical settings. It operates by regulating fluid delivery to the forceps, supporting the primary electrosurgical function of cutting and coagulation.

Clinical Evidence

Bench testing only. Verification and validation tests were conducted on the system and its software. Electrical safety testing was performed. All testing passed.

Technological Characteristics

Irrigation control system for bipolar electrosurgical forceps. Provides controlled fluid flow. Compatible with MALIS™ CMC-III and Synergy MALIS™ Precision Systems. Includes software-controlled irrigation management. Subject to electrical safety standards.

Indications for Use

Indicated for use with irrigating bipolar forceps in conjunction with CODMAN® / MALIS™ electrosurgical generators for surgical procedures requiring bipolar coagulation and cutting.

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

• MALIS™ Irrigation System (K854413)

Submission Summary (Full Text)

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NOV 2 8 2003

## 510(k) Summary for the MALIS™ Irrigation Module 1000

K 0 33 4 99
Valley Forge Scientific Corp. 136 Green Tree Rd., Suite 100, P.O. Box 1179 Oaks, PA. 19456

| Contact Person: | Jerry L. Malis, President<br>Phone Number: 610-666-7500<br>Fax Number: 610-666-7565 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | 10/30/03 |
| Proprietary Name: | MALISTM Irrigation Module 1000 |
| Common Name: | Irrigation Device for Bipolar Coagulation and Cutting |
| Classification Name: | Electrosurgical Cutting and Coagulation Accessory |
| Device Classification: | This device is Class II per Class II per 21 CFR § 878.4400 -<br>Electrosurgical Cutting and Coagulation Device and<br>Accessories |
| Predicate Device: | MALISTM Irrigation System (K854413) |
| Intended Use: | The MALISTM Irrigation Module 1000 is indicated for use with<br>irrigating bipolar forceps with the CODMAN® / MALISTM<br>generators. |
| Device Description: | The MALISTM Irrigation Module 1000 is an irrigation control<br>system for use with the MALISTM CMC-III Bipolar<br>Electrosurgical Systems and the Synergy MALISTM Precision<br>System. This system provides controlled flow of irrigating fluid<br>across the tips of bipolar irrigating forceps. |
| Performance Data: | Verification and validation tests were conducted on the on both<br>the system and its software. Electrical safety testing was also<br>conducted. All testing passed. |
| Substantial Equivalence: | The modified system, the MALIS™ Irrigation Module 1000, is<br>substantially equivalent to the predicate MALISTM Irrigation<br>System (K854413) in terms of intended use, function, technical<br>specifications, and operating principles. The safety and efficacy<br>of the MALIS™ Irrigation Module 1000 is therefore<br>substantiated by its similarity to the original device, MALISTM<br>Irrigation System (K854413). |

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NOV 2 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K033499

Trade/Device Name: MALIS™ Irrigation Module 1000 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 3, 2003 Received: November 6, 2003

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

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Page 2 - Mr. Jerry L. Malis

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [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 Manufacturers, International 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.

Sincerely yours,

Mark N. Milken

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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K033499 510(k) Number (if known):

Device Name MALISTM Irrigation Module 1000

Indications for Use

The MALIS™ Irrigation Module 1000 is indicated for use with irrigating bipolar forceps with the CODMAN® / MALIS™ generators.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: \checkmark OR Over-The-Counter Use: **__**
(Per 21 CFR 801.109)

for Mark n Melken
Division Sign-Off!
Division of General, Restorative
Neurological Devices
:) Number **__** K033499