← Product Code [MKJ](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/MKJ) · K110978 # ONESTEP PEDIATRIC MFE'S (K110978) _ZOLL Medical Corporation · MKJ · May 13, 2011 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/MKJ/K110978 ## Device Facts - **Applicant:** ZOLL Medical Corporation - **Product Code:** [MKJ](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/MKJ.md) - **Decision Date:** May 13, 2011 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 870.5310 - **Device Class:** Class 3 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic, Pediatric ## Indications for Use Defibrillation . Cardioversion Noninvasive Pacing ◆ ECG Monitoring . For use with ZOLL® Defibrillators: ZOLL Defibrillators, such as; . R Series M Series . E Series . By Trained Personnel only, Including: Physicians Nurses ● Paramedics . Emergency Medical Technicians Cardiovascular Laboratory Technicians The OneStep Pediatric Electrodes are indicated for use on a patient less than 8 years of age or weighs less than 55 Lbs. (25Kg). ## Device Story OneStep Pediatric Multi-function Electrode is a single-use, disposable accessory for ZOLL defibrillators (R, M, and E Series). Device consists of conductive hydrogel, metal conductor, and adhesive perimeter. Used in hospital environments by trained clinicians (physicians, nurses, paramedics, EMTs) for ECG monitoring, defibrillation, cardioversion, and noninvasive pacing. Electrodes couple to patient skin to deliver electrical therapy or acquire ECG signals. Output is processed by the host defibrillator to assist clinical decision-making during cardiac rescue or treatment. Benefits include providing therapy and monitoring for pediatric patients. ## Clinical Evidence Bench testing only. Validation project (VPN 0731) confirmed device integration with ZOLL defibrillators and performance consistency with predicate devices per ANSI/AAMI DF80 and EN 60601-2-4 standards. ## Technological Characteristics Single-use disposable electrode; conductive hydrogel; metal conductor; adhesive perimeter. Dimensions/conductive area meet ANSI/AAMI DF80 and EN 60601-2-4 standards. Connects to ZOLL R, M, and E Series defibrillators via standard cable interface. No active software or electronic components within the electrode itself. ## Regulatory Identification An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia. ## Predicate Devices - ZOLL ready-padz OneStep Pediatric Electrodes (K06559) - ZOLL pedipadz solid gel ([K931787](/device/K931787.md)) - pedi-padz II ([K033474](/device/K033474.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K110978 Image /page/0/Picture/1 description: The image shows the logo for BIO-DETEK INCORPORATED. The words "BIO-DETEK" are in large, bold, sans-serif font. Below that, the word "INCORPORATED" is in a smaller, sans-serif font. The logo is black and white. MAY 1 3 2011 # 510(k) Summary: Rev. 2 Submitter's Name and Address: Bio-Detek, Inc. A Division of ZOLL®Medical Corporation 525 Narragansett Park Drive Pawtucket. RI 02861 Tel. (401) 729-1400 Contact Person: Robert Morse Director, Regulatory Affairs Tel. (866) 639-0060 x. 224 Date Summary Prepared: March 29, 2011 Device Name: OneStep™ Pediatric Multi-function Electrode Classification Name: Electrode, Electrocardiograph, Multi-Function; Accessory to an External Defibrillator #### Substantial Equivalence: The OneStep Pediatric Electrode System is substantially equivalent to ZOLL ready-padz OneStep Pediatric Electrodes that were FDA cleared on 510(k), K06559. In addition, the OneStep Pediatric Electrode is substantially equivalent to the originally cleared ZOLL pedipadz solid gel identified on 510(k), K931787 and pedi-padz II cleared on K033474. The intent is to show that the OneStep Pediatric Electrodes will assist in providing therapy for defibrillation. cardioversion, Noninvasive pacing and ECG monitoring comparable to the previously cleared devices, for use with ZOLL Defibrillators. All of the cleared devices are in the Regulatory Class III category. #### Description of Device: The OneStep pediatricElectrode System is intended for use with ZOLL Defibrillators, such as, R Series M Series, and E Series for ECG monitoring, defibrillation, noninvasive pacing and cardioversion of pediatric patients in either the hospital environment. 525 Narragansell Park Drive, Pawtucket, Rhode Island 02861-4323, Tel. (401) 729-1400 or (800) 729-1408 {1}------------------------------------------------ The system is comprised of a single use, disposable electrode made of conductive hydrogel with a metal conductor and adhesive perimeter suitable for coupling to patient skin during rescue and/or treatment. #### Indications for Use: Intended Use: - o Defibrillation - o Cardioversion - o Noninvasive Pacing - o ECG Monitoring For use with ZOLL® Defibrillators: - ZOLL Defibrillators, such as; o - R Series o - M Series o - E Series 0 By Trained Personnel only, Including: - Physicians 0 - Nurses 0 - Paramedics � - Emergency Medical Technicians o - Cardiovascular Laboratory Technicians o The OneStep Pediatric Electrodes are indicated for use on a patient less than 8 years of age or weighs less than 55 Lbs. (25Kg). ## Comparison of Technological Characteristics: The intended use of the OneStep Pediatric Multi-Function Electrodes as described in the indications for use, and labeling, has not changed as a result of this submission. For the ZOLL R Series, M Series and E Series, the connection to the defibrillator cable is identical to the predicate devices. All four products use the same hydrogel, adhesive material and have a conductive area similar in size that meet/exceed National and International Standards ANSI/AAMI DF80 and EN 60601-2-4 respectively. ## Nonclinical Testing: The OneStep Pediatric Electrode System has been subjected to extensive performance testing to ensure the device meets all of its functional requirements and performance specifications as defined in applicable National/International recognized standards. Validation Project Number (VPN) 0731 addresses design validation to ensure the safety and effectiveness considerations have been successful in integrating the OneStep electrode with previously stated ZOLL defibrillators and performs as well and/or better than the legally marketed predicate devices. Applicable standards are defined in Form FDA 3514, VPN 0731 and Section 2, Device Description, within this premarket submission. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Zoll Medical Corporation c/o Mr. Robert Morse Director, Regulatory Affairs Bio-Detek, Inc. 525 Narragansett Park Drive Pawtucket, RI 02861 MAY 1 3 2011 Re: K110978 Trade/Device Name: OneStep Pediatric Multi-function Electrode Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ, DRO, DQA, LDD, LIX Dated: April 6, 2011 Received: April 7, 2011 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {3}------------------------------------------------ Page 2 - Mr. Robert Morse 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, fu- 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 K110978 510(k) number (if known): __ Device Name: OneStep™ Pediatric Multi-Function Electrode Intended Use: - Defibrillation � - . Cardioversion - Noninvasive Pacing ◆ - ECG Monitoring . For use with ZOLL® Defibrillators: - ZOLL Defibrillators, such as; . - R Series � - M Series . - E Series . By Trained Personnel only, Including: - Physicians � - Nurses ● - Paramedics . - Emergency Medical Technicians � - Cardiovascular Laboratory Technicians The OneStep Pediatric Electrodes are indicated for use on a patient less than 8 years of age or weighs less than 55 Lbs. (25Kg). (Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE) Division Sign-Off Division of Cardiovascular Devices 510(k) Number k//0178 Prescription Use న OR Over the Counter Use Rev. 1 OneStep™ Pediatric (Per 21 CFR 801.109) Section 4, pg. 1 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/MKJ/K110978](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/MKJ/K110978) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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