(148 days)
No
The summary describes a hardware device (EEG amplifier) and associated software for signal acquisition and transmission. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as an amplifier to acquire, store, and transmit electrophysiological signals, not to deliver any form of therapy.
Yes
The device is described as an EEG amplifier intended to acquire, store, and transmit electrophysiological signals. EEG (electroencephalography) is a diagnostic tool used to measure brain activity to diagnose neurological conditions.
No
The device description explicitly states that the device consists of hardware components such as an amplifier, headboxes, power supply, and WLAN access point or LAN cable, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to acquire, store, and transmit electrophysiological signals (EEG). This is a measurement of electrical activity within the body, not an analysis of samples taken from the body (like blood, urine, tissue, etc.).
- Device Description: The description focuses on the hardware for acquiring electrical signals from the scalp (EEG electrodes, headcaps). It doesn't mention any components or processes for analyzing biological samples.
- Lack of IVD Characteristics: IVD devices are typically used to diagnose diseases or conditions by analyzing samples in vitro (outside the body). This device is used to measure a physiological signal in vivo (within the body).
Therefore, the Sienna Ultimate EEG amplifier falls under the category of a medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GWL, GWO
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
A healthcare professional who has the training and knowledge to undertake EEG examinations and is familiar with EEG equipment and practice.
For use in research institutions, clinics, hospital, operating room and epilepsy evaluation environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety Testing
- Basic safety test IEC 60601-1:2012 ed. 3.1: This standard applies to Medical electrical equipment and to general requirements for basic safety and essential performance of Medical electrical equipment. Test was performed on the subject device to demonstrate the compliance with the requirements for basic safety and essential performance. Results: There were no deviations from the standard and the proposed device passed the applicable tests and standards.
- EMC compatibility test IEC 60601-1-2 :2014: This standard applies to Medical electrical equipment and to general requirements for basic safety and essential performance. It specifies the Requirements and tests with regard to Electromagnetic disturbances. Test was performed on the subject device to demonstrate the compliance with the EMC standard and to confirm the substantial equivalence to the predicate device. Results: 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: This standard specifies a process for a manufacturer to analyze, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical equipment. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, e.g., normal use. The test was performed on the subject device to demonstrate the compliance with the usability requirements standard. Results: There were no deviations from the standard and the proposed device passed the applicable tests and requirements.
- Electroencephalographs IEC 60601-2-26 Edition 3: This standard applies to basic safety and essential performance of electroencephalographs used in a clinical environment (e.g., hospital, physician's office, etc.). Test was performed on the subject device to demonstrate the compliance with the basic safety and essential performance of electroencephalographs standard and to determine the substantial equivalence. Results: There were no deviations from the standard and the proposed device passed the applicable tests and requirements.
- Risk Management ISO 14971:2012: This standard specifies the requirements with regard to the application of risk management to medical devices. The risk management was conducted on the subject device to demonstrate the compliance with the standard. Results: 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: This standard specifies the requirements to the biological evaluation of medical devices. Test was not applicable - the subject device is non contact device. Results: The proposed device is non contact device, same as the predicate device K103140 - Nicolet Wireless EEG Amplifier.
- FCC Specific Absorption Ratio (SAR) FCC Part 15C: These are federal rules and regulations regarding unlicensed transmissions. The data was leveraged by review of manufacturer's labeling information (datasheet and user manual). Results: 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 Wideband transmission systems; Data transmission equipment operating in the 2.4 GHz ISM band and using wide band modulation techniques - EN 300 328: This harmonized standard covers the essential requirements on data transmission equipment operating in the 2.4 GHz ISM band. The tests were performed on the subject device to demonstrate the compliance with the requirements of the harmonized standard. Results: There were no deviations from the standard and the proposed device passed the applicable tests and requirements.
- EMC tests Electromagnetic compatibility and Radio Spectrum matters (ERM) – EN 301 489-1 and EN 301 489-17: This harmonized standard covers the requirements on electromagnetic compatibility and Radio Spectrum matters. Results: 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 data was leveraged by review of manufacturer´s labeling information. Results: The proposed device passed the UN Transportation tests T1-T8.
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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);
1
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
2
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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3
510(k) Summary
SPONSOR
| Company Name: | EMS Handels Gesellschaft m.b.H |
|---|---|
| Company Address | 1 Jochingergasse |
| Korneuburg | |
| Austria 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
4
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 and
Difference |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| | EMS Biomedical | CareFusion 209 | |
| | Sienna ULTIMATE | Nicolet Wireless EEG
Amplifier | |
| 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 for
Use Statement | The Sienna Ultimate Wireless
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 Nicolet Wireless 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 Nicolet
Neurodiagnostic system. | Same |
COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)
5
| Description of
Device | The Sienna Ultimate EEG Wireless
Amplifier 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 amplifier
has wireless capability and
an optional feature of
pulse oximetry is available. | The Nicolet EEG Wireless
Amplifier 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 amplifier
has wireless capability and
an optional feature of
pulse oximetry is available. | Same |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical
Application
Environment | For use in research
institutions, clinics,
hospital, operating room
and epilepsy evaluation
environments. | For use in research
institutions, clinic,
hospital, operating room
and epilepsy evaluation
environments. | Same. |
| Intended User | A healthcare professional
who has the training and
knowledge to undertake EEG
examinations and is familiar
with EEG
equipment and practice. | A healthcare professional
who has the training and
knowledge to undertake EEG
examinations and is familiar
with EEG
equipment and practice. | Same |
| Channels | 32 EEG (all configurable as
bipolar) + SpO2 + patient
event button. | 32 EEG (8 configurable as
bipolar) + SpO2 + patient
event button. | Same |
| ADC Resolution | 16 bits (16 bits software) | 24 bits (16 bits software) | Different
Sienna Ultimate uses a 16
bits analog digital
convertor in SAR
technology
Nicolet Wireless EEG
amplifier (K103140) uses
24 bit analog digital
convertor, SD technology.
Using the SAR
technology, EMS EEG
amplifier delivers more
precise results.
The difference does not
affect adversely safety
and effectiveness. |
| Full Scale Input | ±5 mV | ± 5 mV | Same |
| Sampling Rate | 256-4000 Hz | 125 - 12000 Hz | Different
Sienna Ultimate uses
ADC's in SAR technology
and the predicate device
uses ADC's in SD
technology
The result is the same
and the difference in
sampling rate range does
not adversely affect
safety and effectiveness. |
| Input Impedance | >100 ΜΩ | > 40 ΜΩ | Different
The quality of the signal is
depending on the input
impedance. The higher
the input impedance, the
more accurate is the
signal quality.
The better signal quality
positively affects the
device effectiveness and
does not adversely affect |
| CMRR | > 110dB at 50-60Hz | > 110dB at 50-60Hz | Same |
| Input Noise |