(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 | <1.5μVpp (0.5μVrms) (MIZAR), <0.5μVrms (AC) / <7μVrms (DC) (Nic36) | <0.5μVrms (AC) / <7μVrms (DC) |
| Power Supply | External IEC 60601-1 Mains (Both) | External IEC 60601-1 Mains |
| Internal storage | N/A (Both) | Auxiliary FLASH memory to accumulate data when optical link is temporary unconnected. Real time clock on board. Precision of hundreds of seconds. Coin battery auxiliary supply. (This is a new feature that does not detract from substantial equivalence, as it is an enhancement). |
| Amplifier - PC Interface | PCMCIA or BE Net (Both) | PCMCIA or BE Net |
| Other Interfaces | 128x64 graph LCD, 5 push buttons (MIZAR); Power On LED / LED matrix Ohm Meter (Nic36) | Power On LED (bicolor) / LED matrix Ohm Meter |
| Use standard sensors and electrodes | Yes (Both) | Yes |
| Dimensions | 250 (L) x 170 (W) x 65 (H) (MIZAR); 203 (L) x 135 (W) x 38 (H) (Nic36) | 194 (L) x 125 (W) x 37 (H) |
| Case material | Polycarbonate plastic (Both) | Polycarbonate plastic |
| Total weight | 1.5 Kg (MIZAR), 0.55 Kg (Nic36) | 0.48 Kg |
| Isolation | Fiber optic link; Patient isolation BF type (MIZAR); Patient isolation CF type (Nic36) | Fiber optic link; Patient isolation CF type |
| Safety Standard | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, IEC 60601-1-4 (MIZAR); + IEC 60601-2-40 (Nic36) | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, IEC 60601-2-40, IEC 60601-1-4 |
| Firmware | Resident and Runtime downloadable (Both) | Resident and Runtime downloadable |
| Patient connection and inputs | Various configurations of Monopolar, Bipolar, Reference, ISO GROUND inputs. (Both) | 64 Monopolar inputs - 64 plugs; 2 References inputs - 2 plugs; 2 ISO GROUND inputs - 2 plugs |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. 510(k) submissions demonstrating substantial equivalence, especially for devices like physiological signal amplifiers, typically rely on engineering testing to confirm specifications, not patient data in the sense of a clinical trial. The "test set" here refers to the device itself being tested against its specifications and then compared to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided and is not applicable to a 510(k) submission for a physiological signal amplifier based on substantial equivalence. There is no "ground truth" in the clinical sense established by experts as would be for an AI diagnostic device. The performance specifications are engineering parameters.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable for this type of submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This device is a physiological signal amplifier, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is hardware and associated firmware/software for signal acquisition, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance, in the context of a 510(k) submission for substantial equivalence, is essentially the engineering specifications and demonstrated performance of the predicate devices. The new device's performance characteristics (e.g., CMRR, noise, sampling rate) are measured and then compared to those of the predicates to show it is as safe and effective. It does not involve clinical "ground truth" from patient data.
8. The sample size for the training set
This information is not provided and is not applicable. This device is not an AI/ML model that requires a training set of data.
9. How the ground truth for the training set was established
This information is not provided and is not applicable.
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510(k) Summary EB Neuro. S.p.A. BE Plus / AURA-LTM64 Amplifier
JAN 2 4 2006
053606
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR¶807.92(a).
807.92(a)(1)
Submitter Information
Carri Graham
Official Correspondent
The Anson Group
11460 N. Meridian St.
Suite 150
Carmel, IN 46032
| Phone: | (317) 569-9500 x 103 |
|---|---|
| Facsimile: | (317) 569-9520 |
| Contact Person: | Carri Graham |
| Date: | December 22, 2005 |
807.92(a)(2)
| Trade Name: | BE Plus / AURA-LTM64 Amplifier |
|---|---|
| Common Name: | Physiological Signal Amplifier |
| Classification Name(s): | Physiological Signal Amplifier |
| Classification Number: | 84GWL |
807.92(a)(3)
Predicate Device(s)
| EB Neuro, S.p.A. | MIZAR Amplifier | K003154 |
|---|---|---|
| EB Neuro, S.p.A. | NIC36 Amplifier | K041198 |
Additional Substantial Equivalence Information is provided in the following Substantial Equivalence Comparison Table.
f. 1 of 5
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510(k) Summary EB Neuro, S.p.A. BE Plus / AURA-LTM64 Amplifier
807.92 (a)(4)
Device Description
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.
807.92(a)(5)
Intended Use(s)
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.
5 2015 11
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807.92(a)(6)
Technological Characteristics
| Item | EB NeuroMIZAR AmplifierK003154 | EB NeuroNic36 AmplifierK041198 | EB NeuroBE Plus / AURA-LTM64 AmplifierThis Submission |
|---|---|---|---|
| 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 | Acquisition of EEG, polygraphy and polysomnography signals and transmission of these to a PC during recording of neurophysiology examinations |
| EEG/Polygraphic channel | 32/40 (64/96/128 with expansion boards) | 36 monopolar fixed – (no expansion boards) | 64 monopolar (128 with the double Amplifier configuration expansion) |
| DC channel | 32/40 | 4 | 4 |
| A/D conversion | 16 bit Sigma-Delta A/D effectively transferred to host | 16 bit SAR effectively transferred to host | 16 bit SAR effectively transferred to host |
| Sampling rate | User selectable (128, 256, 512 ... up to 32KHz/Channel) | User selectable (128, 256, 512... up to 8192 Hz/Channel) | User selectable (128, 256, 512... up to 4096 Hz/Channel) |
| CMRR | >100dB | >100dB | >100dB |
| Noise | <1.5μVpp (0.5μVrms) | <0.5μVrms (AC)<7μVrms (DC) | <0.5μVrms (AC)<7μVrms (DC) |
| Power Supply | External IEC 60601-1 MainsInternal batteries (optional) | External IEC 60601-1 Mains | External IEC 60601-1 Mains |
| Internal storage | N/A | N/A | Auxiliary FLASH memory to accumulate data when optical link is temporary unconnected.Real time clock on board. Precision of hundreds of seconds. Coin battery auxiliary supply. |
| Time marker of data acquisition flow | N/A | N/A | |
| Amplifier - PC Interface | PCMCIA or BE Net | PCMCIA (NicPCMCIA) or BE Net (NicNet) | PCMCIA or BE Net |
| Item | EB NeuroMIZAR AmplifierK003154 | EB NeuroNic36 AmplifierK041198 | EB NeuroBE Plus / AURA-LTM64 AmplifierThis Submission |
| Other Interfaces | 128x64 graph LCDdisplay 5 push buttons | Power On LED / LEDmatrix Ohm Meter | Power On LED (bicolor) /LED matrix Ohm Meter |
| Use standardsensors andelectrodes | Yes (electrodes andsensors are not includedwith the Amplifier) | Yes (electrodes andsensors are not includedwith the Amplifier) | Yes (electrodes andsensors are not includedwith the Amplifier) |
| Dimension | 250 (L) x 170 (W) x 65(H) (mm) | 203 (L) x 135 (W) x 38(H) (mm) | 194 (L) x 125 (W) x 37(H) (mm) |
| Case material | Polycarbonate plastic | Polycarbonate plastic | Polycarbonate plastic |
| Total weight | 1.5 Kg | 0.55 Kg | 0.48 Kg |
| Isolation | Fiber optic linkPatient isolation BF typeAuxiliary I/Ocomponents ports:N°2 BF typeN°1 B type | Fiber optic linkPatient isolation CF typeAuxiliary I/Ocomponents ports:N°2 B type | Fiber optic linkPatient isolation CF typeAuxiliary I/O componentsports:N°2 B type |
| Safety Standard | IEC 60601-1IEC 60601-1-2IEC 60601-2-26IEC 60601-1-4 | IEC 60601-1IEC 60601-1-2IEC 60601-2-26IEC 60601-2-40IEC 60601-1-4 | IEC 60601-1IEC 60601-1-2IEC 60601-2-26IEC 60601-2-40IEC 60601-1-4 |
| SystemComponents | AmplifierHead boxAC/DC AdapterPCMCIA or BE NetInterfacesDC Input box (optional)LED Flash stimulator(optional) | AmplifierAC/DC AdapterPCMCIA(NicPCMCIA) or BENet (NicNet) InterfacesDC Input box(NicDCIN) (optional)LED Flash stimulator(NicLED PhoticStimulator) (optional) | AmplifierAC/DC AdapterPCMCIA or BE NetInterfacesDC Input box (optional)LED Flash stimulator(optional) |
| Firmware | Resident and Runtimedownloadable | Resident and Runtimedownloadable | Resident and Runtimedownloadable |
| Patient connectionand inputs | 32 Monopolar inputs -32 plugs8 Bipolar inputs - 16plugs1 Thermistor - 2 plugs2 Reference inputs - 2plugs14 ISO GROUNDinputs — 14 plugs | 36 Monopolar inputs -36 plugs2 Reference inputs - 2plugs2 ISO GROUND inputs- 2 plugs | 64 Monopolar inputs - 64plugs2 References inputs - 2plugs2 ISO GROUND inputs -2 plugs |
| Item | EB NeuroMIZAR AmplifierK003154 | EB NeuroNic36 AmplifierK041198 | EB NeuroBE Plus / AURA-LTM64 AmplifierThis Submission |
| I/O connections | 1 Fiber optic port1 AC/DC Adapter port3 Auxiliary componentsport: generic TX/RXserial I/O, LED Flashstimulator, pressionbutton connector | 1 Fiber optic port2 Auxiliary componentsport: AC/DC Adapter,generic TX/RX serialI/O, DC Input box(NicDCIN), LED Flashstimulator (NicLEDPhotic Stimulator) | 1 Fiber optic port1 Auxiliary componentsport: AC/DC Adapter,generic TX/RX serial I/O,DC Input box, LED Flashstimulator1 Amplifier Linkexpansion port: AC/DCAdapter, BE Plus/AURA-LTM64 Amplifier |
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510(k) Summary
EB Neuro, S.p.A.
BE Plus / AURA-LTM64 Amplifier
.
{4}------------------------------------------------
510(k) Summary
EB Neuro, S.p.A. BE Plus / AURA-LTM64 Amplifier
:
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing the body and wings.
Public Health Service
JAN 2 4 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EB Neuro. S.P.A. c/o Ms. Carri Graham Anson Group 11460 N. Meridian Street, Suite 150 Carmel, Indiana 46032
Re: K053606
Trade/Device Name: BE Plus / AURA-LTM64 Amplifier Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological signal amplifier Regulatory Class: II Product Code: GWL Dated: December 21, 2005 Received: December 27, 2005
Dear Ms. Graham:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Ms. Graham
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.ida.gov/cdrh/industry/support/index.html.
Sincerely vours.
Kaibaichnichum
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: BE Plus / AURA-LTM64 Amplifier
Indications For Use:
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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Charbare Buchupdomxr
Division of General. Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K053606
§ 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).