(148 days)
The Sienna Ultimate EEG amplifier is intended to be used as a front end amplifier to acquire, store and transmit electrophysiological signals in a wired or wireless mode for the EMS Neurodiagnostic system.
The Sienna Ultimate is a small portable device which is capable of acquiring a variety of electrophysiological signals at variable sampling frequencies and can be used in a wide variety of EEG applications. The proposed device consists of two models designated as the 32 channel and the 64 channel amplifier in a wireless or wired mode, passive headboxes, medical grade power supply, WLAN access point (for wireless models) or medical grade isolated LAN cable (for wired models), Sienna EEG software. The following accessories can be connected to the passive headboxes: EEG electrodes, EEG headcaps and pulse oximeter sensors.
The provided text describes the safety and performance testing for the "Sienna Ultimate Wireless Amplifier" (EEG Amplifier), but it does not present acceptance criteria in a quantitative table or a study proving that the device meets those criteria with performance metrics. The information focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized standards.
Therefore, many of the requested details about acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth are not explicitly available in the provided text.
Here's an analysis based on the information that is available:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a table of quantitative acceptance criteria with corresponding device performance metrics. Instead, it relies on demonstrating compliance with recognized safety and performance standards. The "Results" column in the "Safety Testing" table primarily states "There were no deviations from the standard and the proposed device passed the applicable tests and requirements."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample size used for any of the tests. It refers to "the subject device" or "the sample of the proposed device" passing tests, implying at least one device was tested. There is no information about data provenance (e.g., country of origin, retrospective/prospective).
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 applicable and not provided. The testing described is primarily engineering and regulatory compliance testing against defined standards, not a clinical study requiring expert ground truth for interpretation of observational data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as there's no diagnostic or interpretive task described that would require an adjudication method.
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:
This is not applicable. The device is a physiological signal amplifier (EEG amplifier), not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is hardware (an EEG amplifier), not software or an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This is not applicable directly in the way it's usually considered for diagnostic devices. The "ground truth" for the tests performed was compliance with the technical specifications and requirements outlined in the referenced international standards (e.g., IEC 60601-1, IEC 60601-2-26).
8. The sample size for the training set:
This is not applicable as the device is a hardware amplifier and not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as above.
Summary of available information regarding compliance with standards:
The study proving the device meets its requirements is a series of engineering and regulatory compliance tests against recognized international standards.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance (Results from "Safety Testing" table) |
|---|---|
| Basic Safety (IEC 60601-1:2012 ed. 3.1): Compliance with general requirements for basic safety and essential performance (e.g., power input, humidity, marking legibility/durability, leakage currents, dielectric strength, surfaces, temperatures, overflow/spillage, abnormal operation, mechanical strength). | "There were no deviations from the standard and the proposed device passed the applicable tests and standards." |
| EMC Compatibility (IEC 60601-1-2 :2014): Compliance with requirements and tests regarding electromagnetic disturbances (emissions and immunity). | "There were no deviations from the standard and the sample of the proposed device passed the acceptance criteria of the applicable tests and requirements." |
| Usability (IEC 60601-1-6, Edition 3.1): Compliance with ISO standards for analyzing, specifying, designing, verifying, and validating usability to mitigate risks caused by usability problems. | "There were no deviations from the standard and the proposed device passed the applicable tests and requirements." |
| Electroencephalographs (IEC 60601-2-26 Edition 3): Compliance with particular requirements for the basic safety and essential performance of electroencephalographs. | "There were no deviations from the standard and the proposed device passed the applicable tests and requirements." |
| Risk Management (ISO 14971:2012): Application of risk management to medical devices. | "The applied risk management and the evaluation of the risks connected with the use of the proposed device demonstrate, that the device complies with the requirements of risk management to medical devices." |
| Biological Evaluation (ISO10993-1): Biological evaluation of medical devices. | "Test was not applicable – the subject device is non contact device." (Confirmed to be non-contact, similar to predicate). |
| FCC Specific Absorption Ratio (SAR) (FCC Part 15C): Compliance with federal rules and regulations regarding unlicensed transmissions. | "The proposed device passes the applicable rules and regulations. The compliance with these regulations is substantially equivalent to the predicate device K103140 - Nicolet Wireless EEG Amplifier." |
| Radio Spectrum Tests (EN 300 328): Compliance with essential requirements on data transmission equipment operating in the 2.4 GHz ISM band (e.g., RF output power, power spectral density, duty cycle, unwanted emissions). | "There were no deviations from the standard and the proposed device passed the applicable tests and requirements." |
| EMC Tests (EN 301 489-1 and EN 301 489-17): Compliance with requirements on electromagnetic compatibility and radio spectrum matters (emissions and immunity). | "There were no deviations from the standard and the proposed device passed the applicable tests and requirements." |
| Battery Safety Tests (UN/DOT 38.3): Transportation testing for lithium batteries. | "The proposed device passed the UN Transportation tests T1-T8." |
Conclusion from the document: "The Sienna Ultimate EEG amplifier meets the functional claims and intended use as described in the product labeling. The safety and effectiveness are substantially equivalent to the predicate device, Nicolet Wireless EEG Amplifier."
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
October 6, 2017
EMS Handels Gesellschaft m.b.H. % Ms. Yolanda Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114
Re: K171397
Trade/Device Name: Sienna Ultimate Wireless Amplifier Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological Signal Amplifier Regulatory Class: Class II Product Code: GWL, GWO Dated: September 6, 2017 Received: September 8, 2017
Dear Ms. Yolanda Smith:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
William J. Heetderks -S 2017.10.06 17:00:34 -04'00'
for Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171397
Device Name Sienna Ultimate EEG Amplifier
Indications for Use (Describe)
The Sienna Ultimate EEG amplifier is intended to be used as a front end amplifier to acquire, store and transmit electrophysiological signals in a wired or wireless mode for the EMS Neurodiagnostic system.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
SPONSOR
| Company Name: | EMS Handels Gesellschaft m.b.H |
|---|---|
| Company Address | 1 JochingergasseKorneuburgAustria A-2100 |
| Telephone: | +43 2262 61655-0 |
| Fax: | +43 2262 61655-3 |
| Contact Person: | Ruzena Ortnerova |
Summary Preparation Date: April 10, 2017
DEVICE NAME
| Trade Name: | Sienna Ultimate |
|---|---|
| Common/Usual Name: | EEG Amplifier |
| Classification Name: | Amplifier, Physiological Signal |
| Regulation Number: | 21 CFR 882.1400 |
| Product Code: | GWL, GWQ |
| Device Class: | Class II |
PREDICATE DEVICE
| Legally Marketed Equivalent Device | ||
|---|---|---|
| Company | Product | 510(k) # |
| Carefusion 209, In. | Nicolet Wireless EEG Amplifier | K103140 |
DEVICE DESCRIPTION
The Sienna Ultimate is a small portable device which is capable of acquiring a variety of electrophysiological signals at variable sampling frequencies and can be used in a wide variety of EEG applications.
The proposed device consists of two models designated as the 32 channel and the 64 channel amplifier in a wireless or wired mode, passive headboxes, medical grade power supply, WLAN access point (for wireless models) or medical grade isolated LAN cable (for wired models), Sienna EEG software. The following accessories can be connected to the passive headboxes: EEG electrodes, EEG headcaps and pulse oximeter sensors. The accessories are not supplied by EMS. EMS recommends the use of FDA cleared EEG electrodes and EEG headcaps from local US suppliers. For use as a pulse oximeter
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sensor, the FDA cleared reusable and disposable sensors (K092101, Nonin USA) from the 8000 and 7000 series are recommended.
In wireless models: WLAN access points collect the wireless data transmissions. The amplifiers are IP addressable and can be connected directly to a network device. In all situations the amplifiers store a copy of the data locally to allow for data backup. The amplifiers provide storage and subsequent transmission of data that is not transferred live when the amplifier is in out of range situations.
In wired models: Amplifiers can be connected via medical grade isolated LAN cable to the network. The amplifiers are IP addressable. The amplifiers store a copy of the data locally to allow for data backup. The amplifiers provide storage and subsequent transmission of data that is not transferred live when the amplifier is disconnected from the LAN interface.
The use of 2 pcs. of 64 channel amplifier models (wireless or wired mode) enables EEG acquisition of up to 128 channels.
DEVICE INDICATIONS FOR USE
The Sienna Ultimate EEG amplifier is intended to be used as a front end amplifier to acquire, store and transmit electrophysiological signals in a wired or wireless mode for the EMS Neurodiagnostic system.
| Parameters | Subject Device | Predicate Device | Similarities andDifference |
|---|---|---|---|
| EMS Biomedical | CareFusion 209 | ||
| Sienna ULTIMATE | Nicolet Wireless EEGAmplifier | ||
| 510(k) Number | K103140 | ||
| Product Code | GWL, GWQ | GWL, GWQ | Same |
| Regulation No. | 21 CFR 882.1400 | 21 CFR 882.1400 | Same |
| Regulation Name | Amplifier, Physiological | Amplifier, Physiological | Same |
| Indications forUse Statement | The Sienna Ultimate WirelessEEG amplifier is intended tobe used as a front endamplifier to acquire, storeand transmitelectrophysiological signals ina wired or wireless modefor the EMS Neurodiagnosticsystem. | The Nicolet Wireless EEGAmplifier is intended to beused as a front end amplifierto acquire, store, andtransmit electrophysiologicalsignals in a wired or wirelessmode for the NicoletNeurodiagnostic system. | Same |
COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)
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| Description ofDevice | The Sienna Ultimate EEG WirelessAmplifier is a smallportable device which iscapable of acquiring avariety ofelectrophysiologicalsignals at variablesampling frequencies andcan be used in a widevariety of EEGapplications. The amplifierhas wireless capability andan optional feature ofpulse oximetry is available. | The Nicolet EEG WirelessAmplifier is a smallportable device which iscapable of acquiring avariety ofelectrophysiologicalsignals at variablesampling frequencies andcan be used in a widevariety of EEGapplications. The amplifierhas wireless capability andan optional feature ofpulse oximetry is available. | Same |
|---|---|---|---|
| ClinicalApplicationEnvironment | For use in researchinstitutions, clinics,hospital, operating roomand epilepsy evaluationenvironments. | For use in researchinstitutions, clinic,hospital, operating roomand epilepsy evaluationenvironments. | Same. |
| Intended User | A healthcare professionalwho has the training andknowledge to undertake EEGexaminations and is familiarwith EEGequipment and practice. | A healthcare professionalwho has the training andknowledge to undertake EEGexaminations and is familiarwith EEGequipment and practice. | Same |
| Channels | 32 EEG (all configurable asbipolar) + SpO2 + patientevent button. | 32 EEG (8 configurable asbipolar) + SpO2 + patientevent button. | Same |
| ADC Resolution | 16 bits (16 bits software) | 24 bits (16 bits software) | DifferentSienna Ultimate uses a 16bits analog digitalconvertor in SARtechnologyNicolet Wireless EEGamplifier (K103140) uses24 bit analog digitalconvertor, SD technology.Using the SARtechnology, EMS EEGamplifier delivers moreprecise results.The difference does notaffect adversely safetyand effectiveness. |
| Full Scale Input | ±5 mV | ± 5 mV | Same |
| Sampling Rate | 256-4000 Hz | 125 - 12000 Hz | DifferentSienna Ultimate usesADC's in SAR technologyand the predicate deviceuses ADC's in SDtechnologyThe result is the sameand the difference insampling rate range doesnot adversely affectsafety and effectiveness. |
| Input Impedance | >100 ΜΩ | > 40 ΜΩ | DifferentThe quality of the signal isdepending on the inputimpedance. The higherthe input impedance, themore accurate is thesignal quality.The better signal qualitypositively affects thedevice effectiveness anddoes not adversely affect |
| CMRR | > 110dB at 50-60Hz | > 110dB at 50-60Hz | Same |
| Input Noise | < 2.0 µV pk-pk | < 2.0 µV pk-pk | Same |
| Bandwidth (-3dB) | 0,1-1500 Hz max. | 0.048 to 5856 Hz max. | DifferentRange is sufficient for EEGexaminations, does notadversely affect safetyand effectiveness. |
| Input Bias Current | < 200 pA | < 200 pA | Same |
| Calibration | 100 µV at 1 sec period | 10, 50, 100, 1000 µV at 1, 5,10, 20 sec period | DifferentEMS uses 100 µV squarewave 1Hz calibrationsignal, because this signalis commonly used in EEGacquisition.Using this commonlyused 100 µV at 1 secsignal, the experienceduser quickly can identifythe filter characteristics. |
| ImpedancePass/Fail Levels | 1-50 kΩLinear measurement on allchannels, user definablesteps from the above range. | 2, 5, 10, 20, 50 kΩ | Substantially equivalentto Nicolet Wireless EEGamplifier (K103140),more flexible — userdefinable steps from therange |
| Host PC | Wired (Ethernet) or | Wired (Ethernet) or | Same |
| Communication | Wireless (802.11b/g) | Wireless (802.11b/g) | Same |
| Power | Battery or medical gradepower supply | Battery or medical gradepower supply | Same |
| Internal Storage | 32 GB flash card | 32 GB flash card | Same |
| Internal Battery | Li-ion rechargeable | Li-ion rechargeable | Same |
| Patient Event | Yes | Yes | Same |
| Patient Contact | Device does not directlycontact the patient | Device does not directlycontact the patient | Same |
| Size | 13 x 7,2 x 4 cm | 13 x 16 x 7 cm | Smaller size, morecomfortable for patient,does not adversely affectsafety and effectiveness. |
| Weight | 230 gm | 725 gm | Smaller weight, morecomfortable for patient,does not adversely affectsafety and effectiveness. |
| Compliance/regulatory | EN60601-1EN60601-2-26EN60601-1-2CE Mark | IEC 60601-1 + ANSI + CANIEC 60601-2-26IEC 60601-1-2CE Mark | Substantially equivalentto the Nicolet WirelessEEG amplifier (K103140). |
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The Sienna Ultimate EEG amplifier has the same indication for use, clinical application environment, same intended users and substantially same features as the predicate device Nicolet Wireless EEG amplifier (K103140). The differences between the subject device and the predicate device are:
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- ADC resolution. Sienna Ultimate uses a 16 bits analog digital convertor in SAR . technology, which causes no delay between input and output. Sienna Ultimate uses the full 16 bit of the ADC by software. Nicolet Wireless EEG amplifier (K103140) uses 24 bit analog digital convertor, SD technology, which causes delay between input and output. When using this technology, high oversampling is needed to minimize the delay. Nicolet Wireless EEG amplifier uses only the first 16 bit from the analog digital convertor by the software - same resolution to Sienna Ultimate. Using the SAR technology, EMS EEG amplifier delivers more precise results. The subject and predicate devices both finally transfer and store the data in software with 16 bits. The safety is not adversely affected by this feature. The efficacy is positively influenced in the new device.
- . Sampling rate - The difference in sampling rate between the subject device and the predicate device is caused by the different ADC technologies which are used. The predicate device uses the ADC (analog digital convertor) SD (sigma delta) technology which requires a very high oversampling to minimize the delay of final output sampling rate. The subject device, Sienna Ultimate uses the ADC´s in SAR technology which does not require oversampling up to 12000 Hz. Therefore, the sampling rate from 256-4000Hz is fully sufficient.
- Input impedance - The quality of the signal is depending on the input impedance. The higher the input impedance, the more accurate is the signal quality. The Sienna Ultimate uses higher input impedance. The safety is not adversely affected by higher impedance values.
- . Bandwidth - The range from 0,1 up to 1500 Hz is sufficient for EEG examinations. Typical EEG spectrum ranges from 0.1 Hz up to 100 Hz. Therefore, the difference in bandwidth up to 1500 Hz and up to 5856 Hz does not influence the product effectiveness and the safety.
PERFORMANCE DATA
Safety Testing
| Test | Test description | Purpose | Results |
|---|---|---|---|
| Basic safety testIEC 60601-1:2012 ed.3.1 | Medical electrical equipment - Part1: General requirements for basicsafety and essential performance.Following tests were performed:4.11 power input5.7 humidity preconditioning5.9.2 determination of accessibleparts7.1.2 legibility of marking7.1.3 durability of marking8.7 leakage currents8.8.3 dielectric strength test9.3 surfaces, corners and edges | This standard applies toMedical electricalequipment and to generalrequirements for basicsafety and essentialperformance of Medicalelectrical equipment.Test was performed on thesubject device todemonstrate the compliancewith the requirements forbasic safety and essentialperformance. | There were no deviationsfrom the standard and theproposed device passedthe applicable tests andstandards. |
| 11.1 excessive temperatures inME equipment11.6.1 overflow, spillage, leakage,ingress of water13.2 abnormal operation15.3 mechanical strength tests | |||
| EMC compatibility testIEC 60601-1-2 :2014 | Medical electrical equipment - Part1-2: general requirements for basicsafety and essential performance –Collateral Standard:Electromagnetic disturbances –Requirements and tests.Tests of EMC emission andimmunity were performed on thesubject device including theaccessories (see 2.2 of the testreport). | This standard applies toMedical electricalequipment and to generalrequirements for basicsafety and essentialperformance. It specifies theRequirements and tests withregard to Electromagneticdisturbances.Test was performed on thesubject device todemonstrate the compliancewith the EMC standard andto confirm the substantialequivalence to the predicatedevice. | There were no deviationsfrom the standard andthe sample of theproposed device passedthe acceptance criteria ofthe applicable tests andrequirements. |
| UsabilityIEC 60601-1-6,Edition 3.1 | Medical electrical equipment - Part1-6: General requirements for basicsafety and essential performance -Collateral standard: Usability | This standard specifies aprocess for a manufacturer toanalyze, specify, design,verify and validate usability,as it relates to basic safetyand essential performance ofmedical electricalequipment. This usabilityengineering process assessesand mitigates risks caused byusability problemsassociated with correct useand use errors, e.g., normaluse.The test was performed onthe subject device todemonstrate the compliancewith the usabilityrequirements standard. | There were no deviationsfrom the standard andthe proposed devicepassed the applicabletests and requirements. |
| ElectroencephalographsIEC 60601-2-26Edition 3 | Medical electrical equipment - Part2-26: Particular requirements for thebasic safety and essentialperformance ofelectroencephalographs | This standard applies tobasic safety and essentialperformance ofelectroencephalographs usedin a clinical environment(e.g., hospital, physician'soffice, etc.).Test was performed on thesubject device todemonstrate the compliancewith the basic safety andessential performance ofelectroencephalographsstandard and to determinethe substantial equivalence | There were no deviationsfrom the standard andthe proposed devicepassed the applicabletests and requirements. |
| Risk ManagementISO 14971:2012 | Medical devices. Application ofrisk management to medicaldevices | This standard specifies therequirements with regard tothe application of riskmanagement to medicaldevices.The risk management wasconducted on the subjectdevice to demonstrate thecompliance with the standard. | The applied riskmanagement and theevaluation of the risksconnected with the use ofthe proposed devicedemonstrate, that thedevice complies with therequirements of riskmanagement to medicaldevices. |
| BiologicalevaluationISO10993-1 | Biological evaluation of medicaldevices – evaluation and testingwithin the risk managementprocess | This standard specifies therequirements to the biologicalevaluation of medical devices.Test was not applicable - thesubject device is non contactdevice. | The proposed device is noncontact device, same as thepredicate device K103140 -Nicolet Wireless EEGAmplifier. |
| FCC SpecificAbsorption Ratio(SAR)FCC Part 15C | FCC Specific Absorption Ratio(SAR) | These are federal rules andregulations regardingunlicensed transmissions.The data was leveraged byreview of manufacturer'slabeling information (datasheetand user manual). | The proposed device passesthe applicable rules andregulations. The compliancewith these regulations issubstantially equivalent tothe predicate deviceK103140 - Nicolet WirelessEEG Amplifier. |
| Radio SpectrumtestsWidebandtransmissionsystems; Datatransmissionequipmentoperating in the 2.4GHz ISM band andusing wide bandmodulationtechniques - EN300 328 | Following tests were performed:RF output power, Power spectraldensity, Duty Cycle, Mediumutilization factor, Occupiedchannel bandwidth, Transmitterunwanted emissions in the out-of-band domain, transmitterunwanted emissions in thespurious domain, Receiverspurious emission, Receiverblocking | This harmonized standardcovers the essentialrequirements on datatransmission equipmentoperating in the 2.4 GHz ISMband.The tests were performed onthe subject device todemonstrate the compliancewith the requirements of theharmonized standard. | There were no deviationsfrom the standard and theproposed device passed theapplicable tests andrequirements. |
| EMC testsElectromagneticcompatibility andRadio Spectrummatters (ERM) – EN301 489-1 and EN301 489-17 | Electromagnetic compatibilitytests, tests of EMC emission andimmunity, conducted emission,radiated emission, limits andrequirements | This harmonized standard coversthe requirements onelectromagnetic compatibility andRadio Spectrum matters | There were nodeviations from thestandard and theproposed devicepassed theapplicable tests andrequirements. |
| Battery safety testsUN/DOT 38.3 | Transportation testing for lithiumbatteries | The data was leveraged by reviewof manufacturer´s labelinginformation. | The proposeddevice passed theUN Transportationtests T1-T8. |
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Summary Discussion of Bench Performance Data
The Sienna Ultimate amplifier passed all specified test requirements.
Testing confirmed that the device design and device performance meet the requirements of the standards listed in the above performance testing summary.
The a.m. standards address safety, particular safety for Electroencephalographs, biocompatibility, EMC compatibility, risks, usability, battery safety and radiated energy.
The safety, performance and effectiveness are substantially equivalent to the predicate device K103140 – Nicolet Wireless EEG Amplifier.
Clinical testing was not performed with this device.
CONCLUSION
The Sienna Ultimate EEG amplifier meets the functional claims and intended use as described in the product labeling. The safety and effectiveness are substantially equivalent to the predicate device, Nicolet Wireless EEG Amplifier.
§ 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).