PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005

{0}------------------------------------------------ | 2004 | pedi•padz™ Radiolucent Pediatric Multi-Function Electrode<br>510(k) Premarket-Notification Submission | |------|-------------------------------------------------------------------------------------------------------| |------|-------------------------------------------------------------------------------------------------------| | Company: | BIO-DETEK<br>525 Narragansett Park Drive<br>Pawtucket, RI 02861-4323 | |-------------------|-----------------------------------------------------------------------------------------------------------------------------| | Contact: | Robert Morse<br>QA/QC Manager | | Date Prepared: | February 3, 2004 | | Name of Device: | pedi•padz™ Radiolucent Pediatric Multi-<br>Function Electrode | | Predicate Device: | ZOLL Pediatric Multi-Function Electrode<br>K915159A & ZOLL stat•padz™ Radiolucent Adult<br>Multi-Function Electrode K960676 | #### 510(k) Summary; pedi•padz™ Radiolucent Pediatric Multi-Function Electrodes 10.0 ### Device Description and Intended Use: The pedi•padz™ Radiolucent Pediatric Multi-Function Electrodes will connect to ZOLL Pacemakers/Defibrillators, as defined by ZOLL Medical Corporation, for pediatric patients, 0-8 years of age at <551bs/<25kg weight. The electrodes can be used in the radiology department, catheterization laboratory, and electrophysiology laboratory of the Hospital because the image of the electrode on radiographs or fluoroscopic video does not block out anatomical detail. Once the electrodes are connected to the defibrillator they may be used for: - . ECG monitoring - External defibrillation . - Noninvasive pacing . - . Cardio-version The pediepadz™ Radiolucent Pediatric Multi-Function Electrodes consist of a pair of liquid gel electrodes with permanently attached lead wires that join together at a proprietary ZOLL connector. The connector interfaces with ZOLL the Pacemaker/Defibrillator multifunction cable. {1}------------------------------------------------ ## Technological Characteristics The pedi•padz™ Radiolucent Pediatric Multi-Function Electrode is designed to comply with the applicable portions of the following standards: - IEC 60601-2-4 Medical Electrical Equipment . - ANSI/AAMI DF-2: 1996, Cardiac Defibrillator Devices . - ANSI/AAMI/ISO DF39-1993 . - 21 CFR Par 898 Performance Standards for Electrode Lead Wires and Patient . # Basis for Substantial Equivalence: Operation and technological characteristics form the basis for the determination of substantial equivalence of the pedirpadz™ Radiolucent Pediatric Multi-Function Electrode with legally marketed predicate devices. Information supplied in this premarket notification includes descriptive information about the intended use, operation and technological characteristics. This information is provided pursuant to the requirements of the Safe Medical Devices Act of 1990 (SMDA). {2}------------------------------------------------ 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR - 9 2004 Bio-Detek, Inc. c/o Mr. Robert Morse QA/QC Manager 525 Narragansett Park Drive Pawtucket, RI 02861-4323 Re: K040256 Trade Name: pedi.padz" Radiolucent Multi-Function Pediatric Electrodes Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: II (two) Product Code: MLN Dated: February 03, 2004 Received: February 04, 2004 Dear Mr.Morse: 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 {3}------------------------------------------------ ## Page 2 -- Mr. Robert Morse 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. -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 (301) 594-4648. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Duma R. Lo Ames Image /page/3/Picture/5 description: The image shows a signature. The signature is illegible, but it appears to be written in cursive. The signature is on a white background. The signature is likely from a document or form. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### Indications for Use 510(k) Number K040256: Device Name: pedi-padz™ Radiolucent Pediatric Multi-Function Electrodes Intended Use: The pedirpadz™ Radiolucent MFE's are intended to be used on pediatric patients, 0-8 years of age at <55 lbs/25kg weight, for defibrillation, non-invasive pacing, cardioversion, and ecg monitoring in conjunction with ZOLL Pacemaker/Defibrillator equipment. These disposable electrodes will be used with the following devices: - ZOLL PDTM 1200 Pacemaker/Defibrillator ● - ZOLL PDTM 1400 Pacemaker/Defibrillator ● - ZOLL PDTM 2000 Pacemaker/Defibrillator . - ZOLL D900 Defibrillator . - ZOLL D1400 Defibrillator . - ZOLL D2000 Defibrillator � - ZOLL 1600 Pacemaker/Defibrillator . - ZOLL 1700 Pacemaker/Defibrillator . - ZOLL NTP 1000 Noninvasive Temporary Pacemaker . - ZOLL M Series Equipment � - Future ZOLL Devices, as defined by ZOLL Operators Manuals . Prescription Use V _ (Part 21 CFR 801 Subpart D) AND/OR Over-the-Counter Use (Please do not write below this line - Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE) Duna R. Vochner (Division Sic 1-Off) Division J. Cardiovascular Devices 510(k) Number K04 02 56