(220 days)
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No
The summary describes a simple pager device for alarm annunciation and provides no indication of AI/ML technology.
No
The device is described as a pager for annunciation of events and alerts, which aids in communication and information dissemination. It explicitly states that "Primary care ... remains unchanged by the addition of a pager," indicating it supports, rather than provides, therapeutic interventions. Therapeutic devices are directly involved in treating or mitigating a disease or condition.
No
Explanation: The device, a pager, is described as intended for the annunciation of events and providing zone information to alert individuals to a patient condition. It explicitly states that "Primary care via the central station, telemetry system, or patient bedside monitor remains unchanged by the addition of a pager," indicating it does not diagnose or interpret patient data itself. Its function is to communicate information, not to diagnose.
No
The description explicitly states the device is a "pager and an alarm display unit," which are typically hardware components, and there is no mention of it being solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the pager is for the "annunciation of events to provide zone information" and "alerts or draws an identified individual's attention to a defined patient condition." This describes a device used for communication and alerting within a healthcare setting, not for performing tests on samples taken from the human body.
- Device Description: It's described as a "pager and an alarm display unit," which aligns with its communication and alerting function.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on laboratory tests
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This pager's function is to relay information and alerts, not to perform such analyses.
N/A
Intended Use / Indications for Use
The pager is intended for the annunciation of events to provide zone information that is secondary to the primary care provided. It provides specific information within a zone and alerts or draws an identified individual's attention to a defined patient condition in a timely manner. Primary care via the central station, telemetry system, or patient bedside monitor remains unchanged by the addition of a pager.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Marquette Electronics. Inc. name for this device is the ADU/ Pager-LAN System. This device is commonly known as a pager and an alarm display unit. The pager is intended for the annunciation of events to provide zone information that is secondary to the primary care provided. It provides specific information within a zone and alerts or draws an identified individual's attention to a defined patient condition in a timely manner. Primary care via the central station, telemetry system, or patient bedside monitor remains unchanged by the addition of a pager.
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
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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)
Validation test results indicate that the pager meets the requirements of its intended use. This information is secondary to the primary care provided. Primary care remains unchanged by the addition of a pager
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.
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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).
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
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510(k) Summary of Safety and Effectiveness
Date: June 11th, 1996
Submitter/ Manufacturing Information The sponsor of this 510(k) Premarket Notification is
Marquette Electronics, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 USA
Establishment registration number is 2124823.
The Pagers and Pcople Finder Series are manufactured by:
Motorola Inc. Paging Terminal Products Division 1500 NW 22nd Avenue Boynton Beach, CA 33426-8292 USA
Any questions regarding the contents of this submission may be directed to:
Dianne Schmitz Corporate Regulatory Affairs Marquette Electronics Inc.
Phone: (414)362-3230 Fax: (414)355-3790
General Information
Trade/ Proprietary Name Marquette Electronics. Inc. name for this device is the ADU/ Pager-LAN System.
Common/ Usual Name This device is commonly known as a pager and an alarm display unit.
Device Classification
Unclassified according to a review performed of the CDRH Manual - FDA 91-4246 Classification Names for Medical Devices and In Vitro Diagnostic Products , as well as the Diogenes 510/k) Register and database.
Performance Standards
Performance standards (Section 514 of the Act) have not vet been established for the device that is the subject of this premarket notification submission
Device Description and Intended Use
The pager is intended for the annunciation of events to provide zone information that is secondary to the primary care provided. It provides specific information within a zone and alerts or draws an identified individual's attention to a defined patient condition in a timely manner. Primary care via the central station, telemetry system, or patient bedside monitor remains unchanged by the addition of a pager.
Conclusion
Validation test results indicate that the pager meets the requirements of its intended use. This information is secondary to the primary care provided. Primary care remains unchanged by the addition of a pager
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