(90 days)
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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).
This K96 3669 document is a 510(k) summary for the Grass® Model 15 Neurodata Amplifier System. It focuses on demonstrating substantial equivalence to pre-existing devices rather than presenting a study proving the device meets specific performance acceptance criteria.
Therefore, the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert adjudication cannot be extracted from the provided text. The document primarily describes the device, its classification, and its equivalence to older Grass models (P511) and the Melville Diagnostics MMC Series, highlighting design and safety similarities.
There is no mention of a clinical or performance study with defined acceptance criteria, test sets, training sets, or expert evaluations. The closest relevant information is the assertion that the Model 15 shares essential design, performance, and safety characteristics with the older, FDA-listed Grass P511 amplifier.
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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).
§ 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).