(90 days)
P511
Not Found
No
The summary describes a hardware amplifier system with solid-state switches controlled via a serial port, focusing on electrical safety features. There is no mention of AI, ML, or any data processing that would suggest such technology.
No
The document describes an amplifier system that processes neurodata, but there is no information indicating it is used for treating or diagnosing any medical condition.
No
The "Intended Use / Indications for Use" section states "Neurodata Amplifier System", which suggests it amplifies neurodata rather than interpreting it for diagnostic purposes. There is no mention of diagnostic claims or intended medical diagnosis.
No
The device description explicitly mentions hardware components like "amplifier circuits," "enclosure," "solid-state switches," and "RS-232 serial port." It also describes electrical characteristics like "safety-extra-low-voltage operation (12VDC)" and "isolating the patient applied circuits from the enclosure (earth)." This indicates it is a hardware device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description mentions a "Neurodata Amplifier System" and "patient circuit." This strongly suggests the device is used to amplify physiological signals from a patient, likely for diagnostic or monitoring purposes on the patient.
- Device Description: The description details an amplifier system designed to connect to a patient ("patient applied circuits"). This is characteristic of devices used for direct physiological measurement, not for testing samples in vitro (outside the body).
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
Therefore, the device described is likely a physiological signal amplifier used for clinical purposes, not an IVD.
N/A
Intended Use / Indications for Use
Not Found
Product codes
84GWL
Device Description
The Model 15 combines up to 32 of the P511 amplifier circuits (in banks of 4) in a single enclosure and replaces the P511 manual switches with solid-state switches that are controlled via a standard RS-232 serial port. The Model 15 relies on the essential safely features of the P511 amplifier capacity-coupled patient circuit and safety-extra-low-voltage operation (12VDC) and improves on the safety of the P511 by isolating the patient applied circuits from the enclosure (earth).
Mentions image processing
Not Found
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
Not Found
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
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Key Metrics
Not Found
Predicate Device(s)
Grass ® Model P511
Reference Device(s)
Melville Diagnostics MMC Series
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).
0
K96 3669
EXHIBIT A DEC 1 2 1996
Grass Instrument Division Astro-Med. Inc. Astro-Med Industrial Park West Warwick, Rhode Island 02893 USA Phone: (401) 828-4000 Fax: (401) 822-2430 Contact Person: Steve Johnson September 16, 1996
510(k) Summary of Safety and Effectiveness Grass ® Model 15
1. Identification of the Device
Classification Name: Amplifier, Physiological Signal, 84GWL, Reg. # 882.1835 Neurological Diagnostic Devices
Common/Usual Name: Neurodata Amplifier System
Proprietary-Trade Name: Grass ® Model 15 Neurodata Amplifier System
Equivalent legally marketed devices 2.
This product is similar in design and function to the Grass ® Model P511 and Melville Diagnostics MMC Series amplifier systems
The intended use and essential design, performance, and safety characteristics of the Model 15 are the same as the Grass Model P511 amplifier, a single-channel amplifier with manual control of all settings. The Grass P511 has been in production since 1968 and is still in current production and listed with the FDA. The Model 15 combines up to 32 of the P511 amplifier circuits (in banks of 4) in a single enclosure and replaces the P511 manual switches with solid-state switches that are controlled via a standard RS-232 serial port. The Model 15 relies on the essential safely features of the P511 amplifier capacity-coupled patient circuit and safety-extra-low-voltage operation (12VDC) and improves on the safety of the P511 by isolating the patient applied circuits from the enclosure (earth).