LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPOSABLE PEDIATRIC DISPERSIVE ELECTRODES; WITH AND WITHOUT CORD

{0}------------------------------------------------ OCT 21 1997 Two Ludlow Park Drive P.O. Box 297 Chicopee, MA 01021-0297 413-593-6400 ## Ludlow Technical Products ## 510 (k) SUMMARY Electrosurgical Dispersive Electrodes Pediatric Dual and Single Element Pads Ludlow Technical Products Two Ludlow Park Drive Chicopee, MA 01022 K973110 Ludlow Technical Products considers their pediatric dual and single element ESD electrodes to be safe and effective for use in monopolar electro-surgery when used according to the intended procedures as related in the instructions accompanying the product. The function of the Ludlow Technical Products pediatric ESD electrodes is to complete the electrosurgical circuit between the patient, the active electrode, and the generator. The instruction for use insert as well as the pouch labeling contain the necessary warnings per the AAMI standard section 4.1.4.2 "Electrodes intended for use on Infants". The safety issues of the device were evaluated to the ANSI/AAMI specification HF 18-1993 whereby this standard was issued to "help insure safe and effective use of electrosurgical devices". The ANSI/AAMI standard HF 18-1993 covers all facets of electrosurgical devices. The Ludlow Technical Products Pediatric ESD electrodes were tested according to section 4.2.3 "Dispersive Electrodes", which covers Maximum Safe Temperature Rise, Electrode Contact Impedance, Electrode Adherence, and Packaging/Shelf life; also, section 4.2.5 which covers "Operating Conditions". In each of the test areas listed, the Ludlow Technical Products Pediatric dispersive electrode met the requirements of the ANSI/AAMI HF 18-1993 standard. These results are on file at Ludlow Technical Products. The Ludlow Technical Products Pediatric electrode was also tested successfully to the ISO - 10993, Biological Evaluation of Medical Devices Part I : Evaluation & Testing. The Ludlow Technical Products Pediatric ESD electrode is substantially equivalent to products existing the marketplace. The Valleylab E7510 Infant REM Polyhesive II is a Disposable Patient Return Electrode to which we have drawn the comparison. The Ludlow Technical Products pediatric electrode functions the same as the Valleylab E7510 Infant pad. The products are the same in their construction using conductive adhesive hydrogel along with a foil/polyester conductor plate and a foam insulation backing. This summary of 510 (k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. M. Bean Rice ---- M. Beth Rice A CLICO INTERNATIONAL LTD. COMPANY 8/5/97 Date Date {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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856 1997 OCT 2 1 1997 Mr. Patrick A. Malia Manager of Quality Assurance Ludlow Technical Products Two Ludlow Park Drive, PO Box 297 Chicopee, Massachusetts 01021-0297 Re: K973110 Trade Name: Disposable Dispersive Electrode, Pediatric, Dual and Single Element, Corded and Non-Corded Regulatory Class: II Product Code: GEI Dated: August 5, 1997 Received: August 20, 1997 Dear Mr. Malia: 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 requirements , 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 {2}------------------------------------------------ Page 1 - Mr. Patrick A. Malia devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. 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 vour 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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for ProCam Medical. The logo consists of a black square with a design inside, followed by the word "ProCam" in large, bold letters. Below "ProCam" is the word "MEDICAL" in smaller, bold letters. The logo appears to be printed in black ink on a white background. ## INDICATIONS FOR USE STATEMENT 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Indications For Use: The ProCam Medical Pediatric Dispersive Electrode is indicated for use in monopolar electrosurgical applications as a non-sterile, disposable device, for single patient use, only. It is intended to disperse the current as it is removed from the patient during the electrosurgical process. By connecting to the electrosurgical generator, via the pre-attached cable or re-useable cable, the circuit is completed causing successful cutting or coagulation in the patient. This electrode is intended for use in electrosurgery on pediatric patients weighing 25 lbs. or less and with the generator power settings less than 150 watts. The Pediatric Dispersive Electrode is not indicated for use for high-powered procedures such as transurethral resection (TUR). The device will work with any standard generator. (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 | K973110 | | Prescription Use | <span style="text-decoration: overline;">X</span> | OR | Over-The-Counter Use | |------------------|---------------------------------------------------|----|----------------------| |------------------|---------------------------------------------------|----|----------------------| (Per 21 CFR 801.109) Two Ludlow Park Drive • Chicopee, MA 01022 • 413-593-6100 • 113-593-8391 FAX A *tyco* INTERNATIONAL LTD COMPANY