(28 days)
The BE Plus / AURA-LTM64 Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations.
The BE Plus / AURA-LTM64 Amplifier is a fully programmable system which provides a total of 64 analog input channels each of which can be configured, amplified and converted to digital form (analog to digital conversion). The amplifier receives its power from a dedicated AC/DC adapter, meeting the IEC 60601-1 requirements, which feeds a +15VDC. Internally, the +15VDC is further isolated by a dedicated DC/DC CF type converter. The BE Plus / AURA-LTM64 Amplifier is intended to be used to amplify and filter bioelectric signals captured via a lead or transducer on the surface of the human body. It captures the data, converts it into a digital form and passes it on to a host computer running appropriate amplification software. Typical fields of application will be: Electroencephalograph (EEG), Evoked Potentials (EP), Polysomnography (Sleep Analysis) and General Polygraphy. The BE Plus / AURA-LTM64 Amplifier does not contains a Pulse Oximeter module. The host computer must use one of the following Operating Systems: Microsoft Windows 98, Microsoft Windows NT or Microsoft Windows XP. The BE Plus / AURA-LTM64 Amplifier system consists of three interconnected units: the amplifier box, the PC interface (PCMCIA interface or BE Net) and the AC/DC adapter; optionally the system may be completed by a led visual stimulator.
The provided text is a 510(k) Summary for a medical device (BE Plus / AURA-LTM64 Amplifier) seeking FDA clearance. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. This type of submission document does not typically include detailed information about specific acceptance criteria or a dedicated study proving performance against those criteria in the way a clinical trial or performance study report would.
Therefore, I cannot extract the full scope of requested information from the provided text. However, I can provide what is explicitly mentioned or can be reasonably inferred from the document regarding "acceptance criteria" through a comparison to predicate devices.
Here's an analysis based on the available text:
The "acceptance criteria" for this 510(k) submission are fundamentally based on demonstrating substantial equivalence to legally marketed predicate devices, specifically the EB Neuro MIZAR Amplifier (K003154) and the EB Neuro Nic36 Amplifier (K041198). The study that "proves" the device meets these criteria is the comparison of technological characteristics presented in the 510(k) summary itself. The FDA's acceptance (issuance of a substantial equivalence determination) is the "proof" that these criteria have been met for market clearance.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are not explicitly stated as quantitative thresholds like in a performance study. Instead, they are implicitly defined by the characteristics of the predicate devices. The "reported device performance" is the description of the new device's characteristics.
| Characteristic (Implicit Acceptance Criterion by Predicate) | Predicate Devices (Accepted Performance) | BE Plus / AURA-LTM64 Amplifier (Reported Performance - Must be substantially equivalent) |
|---|---|---|
| Intended Use | Acquisition of EEG, polygraphy and polysomnography signals and transmission of these to a PC during recording of neurophysiology examinations | Acquisition of EEG, polygraphy and polysomnography signals and transmission of these to a PC during recording of neurophysiology examinations |
| EEG/Polygraphic channels | 32/40 (MIZAR), 36 fixed (Nic36) | 64 monopolar (128 with double Amplifier configuration expansion) |
| DC channels | 32/40 (MIZAR), 4 (Nic36) | 4 |
| A/D conversion | 16 bit Sigma-Delta (MIZAR), 16 bit SAR (Nic36) | 16 bit SAR effectively transferred to host |
| Sampling rate | User selectable (up to 32KHz/Channel for MIZAR, up to 8192 Hz/Channel for Nic36) | User selectable (128, 256, 512... up to 4096 Hz/Channel) |
| CMRR (Common Mode Rejection Ratio) | >100dB (Both Predicates) | >100dB |
| Noise |
§ 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).