← Product Code [MKJ](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/MKJ) · K955628 # FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS (K955628) _Heartstream, Inc. · MKJ · Sep 10, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/MKJ/K955628 ## Device Facts - **Applicant:** Heartstream, Inc. - **Product Code:** [MKJ](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/MKJ.md) - **Decision Date:** Sep 10, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.5310 - **Device Class:** Class 3 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Indications for Use The ForeRunner external defibrillator, is indicated for use on victims of sudden cardiac arrest on whom an apparent lack of circulation is indicated by unconsciousness, absence of breathing and absence of detectable pulse. ## Device Story Portable, battery-powered semi-automatic external defibrillator (AED) for emergency responders treating cardiac arrest. Device monitors patient ECG via disposable electrodes; internal algorithm analyzes rhythm to determine shock necessity. Provides voice and visual prompts to guide operator through defibrillation process. Output is a low-energy DC defibrillation shock. Used in field/emergency settings. Benefits include rapid, automated treatment of cardiac arrest by emergency personnel. ## Clinical Evidence Extensive clinical trial conducted to evaluate defibrillation effectiveness and safety of the waveform compared to predicate devices. Bench testing included environmental and performance testing per industry standards, ECG recognition algorithm validation using actual cardiac signal recordings, and software validation. Biocompatibility testing performed on electrode patient-contact materials per international standards. All testing yielded acceptable results. ## Technological Characteristics Portable, battery-powered, semi-automatic low-energy DC defibrillator. Dimensions: 2.5" x 8" x 8.8"; weight: ~4 lbs. Includes disposable battery, single-use electrodes, and optional event recording data cards. ECG recognition algorithm used for rhythm analysis. Biocompatibility of patient-contact materials verified per international standards. ## 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 Medical Corporation Semi-Automatic External Defibrillator - SurVivaLink Corporation VivaLink Semi-Automatic External Defibrillator - Laerdal Medical Corporation Heartstart Semi-automatic External Defibrillator - Hewlett Packard Corporation Codemaster XL Defibrillator/Monitor - PhysioControl Corporation LifePak 100 External Defibrillator ## Reference Devices - W. Kouwenhoven, M.D. Biphasic External Defibrillator - Mine Safety Appliance Company Biphasic External Defibrillator - Katecho, Inc. External Pacing and Defibrillation electrodes - Zoll Medical Corporation Multi-function electrodes - SurVivaLink Corporation Defibrillation electrodes ## 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} K955628 Sept. 10, 1996 # Appendix 25 ## 510(k) Summary of Safety and Effectiveness Heartstream, Inc. ForeRunner External Defibrillator and Accessories ### General Information | Classification | Class II | | --- | --- | | Trade Name | ForeRunner External Defibrillator and Accessories | | Submitter | Heartstream, Inc. 2401 Fourth Avenue Suite 300 Seattle, Washington, USA 98121 | | Contact | Lori Glastetter Director, Regulatory Affairs | ### Substantially Equivalent and Preamendment Devices | Manufacturer | Product | | --- | --- | | Zoll Medical Corporation | Semi-Automatic External Defibrillator | | SurVivaLink Corporation | VivaLink Semi-Automatic External Defibrillator | | Laerdal Medical Corporation | Heartstart Semi-automatic External Defibrillator | | Hewlett Packard Corporation | Codemaster XL Defibrillator/Monitor | | PhysioControl Corporation | LifePak 100 External Defibrillator | | W. Kouwenhoven, M.D. (Johns Hopkins Hospital) | Biphasic External Defibrillator | | Mine Safety Appliance Company | Biphasic External Defibrillator | | Katecho, Inc. | External Pacing and Defibrillation electrodes | | Zoll Medical Corporation | Multi-function electrodes | | SurVivaLink Corporation | Defibrillation electrodes | ### Intended use The ForeRunner external defibrillator, is indicated for use on victims of sudden cardiac arrest on whom an apparent lack of circulation is indicated by unconsciousness, absence of breathing and absence of detectable pulse. 510(k) Notification HEARTSTREAM, INC. Appendix 25, page 1 of 2 CONFIDENTIAL {1} # Device Description The ForeRunner external defibrillator is a semi-automatic external defibrillator incorporating voice prompts to advise the operator of the need to deliver a defibrillating shock. The device is designed to be used by emergency responders in the treatment of cardiac arrest. The device is portable, weighing approximately 4 pounds and measuring approximately $2.5"(H) \times 8"(W) \times 8.8"(D)$. The ForeRunner product line consists of the defibrillator, a disposable battery, a pack of disposable single use electrodes, carrying cases and other optional accessories, such as event recording data cards and event review software. # Testing Extensive environmental and performance tests are conducted on the ForeRunner external defibrillator. These tests included performance tests in accordance to established industry standards. The electrocardiogram (ECG) recognition algorithm is evaluated using recordings of actual cardiac signals in accordance to established industry standards. Further, the software for the product is validated per recognized validation techniques. Biocompatibility testing is performed on patient contact materials of defibrillation electrodes in accordance to international standards. All testing of the products yielded acceptable results prior to commercial distribution. # Summary of Substantial Equivalence The ForeRunner external defibrillator is intended for emergency treatment of cardiac arrest. The ForeRunner external defibrillator is a portable, battery powered semi-automatic low energy DC defibrillator. Portable low power DC defibrillators are commonly used by emergency personnel to defibrillate unconscious patients. The ForeRunner functions in the same manner as the predicate devices in that it is a portable, low power, battery operated defibrillator. The ForeRunner external defibrillator is semi-automatic and has visual and voice prompts for ease of operations. The design features and materials used in the manufacture of the ForeRunner external defibrillator are substantially equivalent to the predicate products. Additionally, the ForeRunner external defibrillator is of similar shape and functionality to predicate devices. The defibrillation waveform has been shown to be substantially equivalent to predicate product waveform with respect to defibrillation effectiveness and safety in an extensive clinical trial. Therefore, due to the similarity of design features, materials, test results, clinical results and the similarity of the indicated use to other predicate devices, Heartstream, Inc. believes this product does not raise any new safety or effectiveness issues. 510(k) Notification HEARTSTREAM, INC. Appendix 25, page 2 of 2 CONFIDENTIAL --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/MKJ/K955628](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/MKJ/K955628) **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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