(274 days)
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No
The summary describes a standard semi-automatic external defibrillator with an ECG recognition algorithm, which is a common feature in such devices and does not inherently indicate the use of AI/ML. There is no mention of AI, ML, or related terms in the document.
Yes
The device is used to treat sudden cardiac arrest by delivering a defibrillating shock, indicating a therapeutic purpose.
Yes
The device performs an "ECG recognition algorithm" to evaluate "recordings of actual cardiac signals." This signal analysis for diagnosis is integral to determining the need for a defibrillating shock.
No
The device description explicitly states it is a "semi-automatic external defibrillator" and lists hardware components like a battery, electrodes, and carrying cases. While it includes "event review software," the core device is a hardware defibrillator.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat victims of sudden cardiac arrest by delivering a defibrillating shock. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is an external defibrillator that analyzes the patient's ECG and delivers an electrical shock. It does not analyze biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or processes related to in vitro testing, such as reagents, sample collection, or analysis of biological specimens.
Therefore, the ForeRunner external defibrillator is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
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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) x 8"(W) x 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
emergency responders
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies
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. 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.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.5310 Automated external defibrillator system.
(a)
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.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
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Appendix 25 510(k) Summary of Safety and Effe
Heartstream, Inc. ForeRunner External Defibrillator and Accessories
General Information
Classification
Trade Name
Submitter
Class II
ForeRunner External Defibrillator and Accessories
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.
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) x 8"(W) x 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 vielded 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 semiautomatic 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.