(200 days)
Marquette Series 900, Marquette Series 1500 Responder
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No
The summary describes a standard cardiac monitor/defibrillator with pacing capabilities and does not mention any AI or ML terms or functionalities.
Yes
The device is described as a "cardiac monitor/defibrillator with an external pacing option" used for "evaluating and treating life-threatening arrhythmias." Defibrillation and pacing are therapeutic interventions.
Yes
The device is described as a "cardiac monitor" and "capable of monitoring the heart rate," which indicates its ability to gather physiological data for evaluation. Its intended use in "evaluating and treating life-threatening arrhythmias" further supports its diagnostic role.
No
The device description explicitly states it is an "emergency cardiac monitor/defibrillator with an external pacing option," which are hardware components. The performance studies also mention "animal studies on the defibrillation and pacing functions," further indicating hardware functionality.
Based on the provided information, the Responder 2500 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "evaluating and treating life-threatening arrhythmias" and involves "external and internal defibrillation (including cardioversion)," "monitoring the heart rate," and "external pacing." These are all direct interventions and monitoring of physiological signals within the patient's body.
- Device Description: The description confirms it's a "cardiac monitor/defibrillator with an external pacing option."
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Responder 2500 does not perform any such analysis of specimens.
The Responder 2500 is a therapeutic and monitoring device used directly on the patient.
N/A
Intended Use / Indications for Use
Responder 2500 is intended to be used in a hospital environment by emergency personnel in evaluating and treating life-threatening arrhythmias.
♦ Responder 2500 is intended to be used by trained operators
♦ Responder 2500 is designed for external and internal defibrillation (including cardioversion)
♦ Responder 2500 is capable of monitoring the heart rate with adjustable alarm limits.
♦ Responder 2500 is designed for external pacing with adjustable current and rate.
Product codes
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Device Description
Responder 2500 and Cardiac Care System is an emergency cardiac monitor/defibrillator with an external pacing option.
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
hospital environment by emergency personnel
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Quality assurance measures applied to the development of Responder 2500 included: Requirements specification reviews, code inspections, software and hardware testing, safety testing, environmental testing, field tests on the monitor function and animal studies on the defibrillation and pacing functions, and final validation. The results demonstrated that Responder 2500 is as safe, as effective, and performs as well as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Marquette Series 900, Marquette Series 1500 Responder
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 870.5550 External transcutaneous cardiac pacemaker (noninvasive).
(a)
Identification. An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles.(b)
Classification. Class II. The special controls for this device are:(1) “American National Standards Institute/American Association for Medical Instrumentation's DF-21 ‘Cardiac Defibrillator Devices’ ” 2d ed., 1996, and
(2) “The maximum pulse amplitude should not exceed 200 milliamperes. The maximum pulse duration should not exceed 50 milliseconds.”
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FEB 2 8 1997
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SECTION 2 - SUMMARY AND CERTIFICATION
2.1 510(k) Summary of Safety and Effectiveness
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.
| Submitter: | Marquette Electronics, Inc.
8200 W. Tower Avenue
Milwaukee, WI 53223
Telephone: (414) 355-5000
FAX: (414) 362-3553 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kristin Pabst |
| Device: | Trade Name: Responder 2500 Defibrillator and Cardiac Care System |
| | Classification Name: DC-Defibrillator, low energy (including paddles) |
| | Pacemaker, Cardiac, External Transcutaneous (Non-invasive) |
| Predicate Devices: | Marquette Series 900
Marquette Series 1500 Responder |
| Device Description: | Responder 2500 and Cardiac Care System is an emergency cardiac monitor/defibrillator with an external pacing option. |
| Intended Use: | Responder 2500 is intended to be used in a hospital environment by emergency personnel in evaluating and treating life-threatening arrhythmias. |
| | ♦ Responder 2500 is intended to be used by trained operators |
| | ♦ Responder 2500 is designed for external and internal defibrillation (including cardioversion) |
| | ♦ Responder 2500 is capable of monitoring the heart rate with adjustable alarm limits. |
| | ♦ Responder 2500 is designed for external pacing with adjustable current and rate. |
510(k) Notification "Responder 2500" - August 9, 1996
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The intended use of Responder 2500 is identical to the intended use of the predicate devices.
Responder 2500 employs the same technology as the predicate devices. Technology:
Performance:
Responder 2500 complies with the voluntary standards ANSI/AAMI DF2-1996, ANSI/AAMI ES1 1993, ANSVAAMI EC13 1992, IEC 601-1, IEC 601-1-2, IEC 601-2-4, IEC 601-2-27, UL 2601-1.
The following quality assurance measures were applied to the development of Responder 2500.
Requirements specification reviews, code inspections, software and hardware testing, safety testing, environmental testing, field tests on the monitor function and animal studies on the defibrillation and pacing functions, and final validation.
The results of these measurements demonstrated that Responder 2500 is as safe, as effective, and performs as well as the predicate devices Marquette Series 900 and Marquette Series 1500 Responder.