ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M

{0}------------------------------------------------ 0710860 pg 1 of 1 ## 510(K) Summary E Surgical. LLC 1990 N. California Blvd., Suite 1040 Walnut Creek, CA 94596 925-280-8388 Phone 925-280-1788 Fax Contact: Hans Richter, RA/QA Director AUG 3 1 2007 - I. Trade Name: E Surgical Electrodesurgical Infant Patient Return Electrode, Dual Plate with Cord. - II. Common Name: Electrosurgical Infant Patient Return Electrode - III. Classification: 21 CFR 878.4400, Electrosurgical Cutting and Coagulation Device and Accessories - IV. Product Code: GEI - V. Indications for Use: A Single use, non sterile dispersive electrode with or without a pre-attached cord to adhere to the infant patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient. - VI. Predicate Device: Valleylab, Inc., VL 7510-25 Infant REM Polyhesive II Patient Return Electrode. 510 (K) #K060255 - Device Description: The E Surgical Infant Patient Return Electrode Dual Plate is a VII. single use, non-sterile disposable electrode with and without a pre-attached cord. The use is to complete an electrical circuit during electro surgery between the generator, the active electrode, and an infant patient. - VIII. Summary of Technological Characteristics: The E Surgical Infant Patient Return Dual Electrode is comparable to the Valleylab, Inc.'s VL E7510-25 Dual Pad, REM compatible electrode, a legally marketed device. The E Surgical pad is furnished with a 9'2" cord. The pad has a hydrogel adhesive for conductivity with an acrylic border to prevent invasion of fluids. Both pad designs are compatible with return electrode monitoring generator systems. - IX. Performance Data: The E Surgical Pad complies with the ANSI/AAMI HF-18 standard Electrosurgical Device for Dispersive Electrode Thermal Safety and Contact Impedance. The Pad design is proven safe by compliance to biocompatibility standard ISO 10993. {1}------------------------------------------------ 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 stylized eagle with three lines representing its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 3 1 2007 E Surgical, LLC % Mr. Hans J. Richter RA/QA Director 1910 N. California Boulevard Suite 1040 Walnut Creek, California 94596 Re: K071080 Trade/Device Name: E Surgical Electrosurgical Infant Patient Return Electrode, Dual Plate With Cord Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 17, 2007 Received: August 21, 2007 Dear Mr. Richter: 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 {2}------------------------------------------------ Page 2 - Mr. Hans J. Richter 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. 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, permitts 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N Melkerson Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ K071080 pg 1 of 1 ## INDICATIONS FOR USE 510(k) Number (if known): Device Name: E Surgical Electrosurgical Infant Patient Return Electrode, Dual Plate With Cord. Indications for Use: A Single use, non-sterile dispersive electrode with a pre-attached cord used to adhere to the Infant patient over the entire pad surface to complete the electrosurgical circuit hetween the generator, the active electrode, and the patient. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-the-Counter Use (21 CFR 801 Subpart C) Mark A. Milliken (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number