(165 days)
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.
The Nicolet Wireless Amplifiers are used in a wide variety of EEG applications including: Ambulatory (at home or in transit to home), OR, LTM, EEG, Sleep and ICU. The proposed amplifiers are small portable devices that can run on main electrical A/C power or use a portable battery pack. The proposed device consists of two models designated as the 32 channel and the 64 channel amplifier. These units can acquire from up to 32 or 64 channels, they can be grouped or "cascaded" together for more channels. The amplifiers are capable of acquiring a variety of electrophysiological signals at variable sampling frequencies. These signals include EEG, EKG, EMG, EP, temperature, blood pressure, pulse, and other signals standard to neurological and sleep testing. The amplifiers have wireless capability and a battery pack for mobile data acquisition. Wireless access points collect the wireless data transmissions. The amplifiers can be connected to the Ethernet by a cable and also to AC power. 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 back-up. This amplifier provides storage and subsequent transmission of data that is not transferred live when the amplifier is in out of range situations.
The provided document [K103140](https://510k.innolitics.com/search/K103140) describes the Nicolet Wireless EEG Amplifier, an electroencephalograph device. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance |
|---|---|---|
| Basic safety | IEC 60601-1 | The proposed device passes the applicable tests and standards. |
| Programmable Electrical Medical Systems | IEC 60601-4 | The proposed device passes the applicable tests and standards. |
| Usability | IEC 60601-6 | The proposed device passes the applicable tests and standards. |
| EMC Compatibility | IEC 60601-1-2 | The proposed device passes the applicable tests and standards. |
| Collateral Safety | IEC 60601-1-1 | The proposed device passes the applicable tests and standards. |
| Electroencephalographs | IEC 60601-2-26 | The proposed device passes the applicable tests and standards. |
| Risk Management | ISO 14971 | The proposed device passes the applicable tests and standards. |
| Biocompatibility-non contact device | ISO 10993-1 | The proposed device passes the applicable tests and standards. |
| FCC Specific Absorption Ratio (SAR) | FCC Part 15C; FCC OET Bulletin 65, Supplement C | The proposed device passes the applicable tests and standards. |
| Battery safety | UN/DOT 38.3 Transportation testing for lithium batteries | The proposed device passes the applicable tests and standards. |
| Functional Claims and Intended Use | (Implied: Device meets user needs and design inputs for an EEG amplifier as described in product labeling) | The Nicolet Wireless EEG Amplifiers meet the functional claims and intended use as described in the product labeling. |
| Physical Attributes and Device Performance | (Implied: Meet requirements of standards listed) | Testing also confirmed physical attributes and device performance meet the requirements of the standards listed in the performance testing summary. |
2. Sample Size for the Test Set and Data Provenance
The document explicitly states: "Clinical testing was not performed with this device." Instead, the submission relies on non-clinical performance tests conforming to various international standards. Therefore, an explicit "test set" in the context of clinical data (like patient cases) is not applicable here. The "sample" for these non-clinical tests would refer to the physical device units tested, but this detail is not provided.
- Data Provenance: The tests are non-clinical, meaning they are bench tests conducted in a laboratory setting against engineering standards. The country of origin for the data is not specified beyond the company's address in Middleton, WI, USA, implying testing was likely conducted in the USA or by facilities adhering to these international standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical testing was performed and the evaluation was based on non-clinical performance data against established standards, the concept of "ground truth" derived from expert consensus on medical cases does not directly apply in this submission. The "ground truth" for these tests is defined by the requirements of the referenced international standards (e.g., IEC 60601-1, ISO 14971, etc.). Compliance with these standards is determined by trained engineers and technicians, not medical experts.
4. Adjudication Method for the Test Set
As the evaluation was based on non-clinical performance against engineering standards, an "adjudication method" involving multiple expert interpretations of medical data is not relevant. The pass/fail criteria for each test are typically defined by the specific standard, and results are objectively measured.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "Clinical testing was not performed with this device." Therefore, an MRMC comparative effectiveness study was not conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This device is an Electroencephalograph (EEG) amplifier, which is hardware for acquiring physiological signals. It does not contain an "algorithm only" component in the sense of AI software. The performance tests are for the physical device's electrical, safety, and functional characteristics. Therefore, the concept of "standalone performance" for an algorithm is not applicable.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on engineering standards and normative references. The device's performance was measured against the specified requirements within standards such as:
- IEC 60601-1 (Basic safety)
- IEC 60601-4 (Programmable Electrical Medical Systems)
- IEC 60601-6 (Usability)
- IEC 60601-1-2 (EMC Compatibility)
- IEC 60601-1-1 (Collateral Safety)
- IEC 60601-2-26 (Electroencephalographs)
- ISO 14971 (Risk Management)
- ISO 10993-1 (Biocompatibility)
- FCC Part 15C, FCC OET Bulletin 65, Supplement C (FCC Specific Absorption Ratio)
- UN/DOT 38.3 (Battery safety)
These standards define the acceptable performance parameters.
8. The Sample Size for the Training Set
No training set is mentioned as this is not an AI/machine learning device. The "training" for such a device involves engineering design, development, and adherence to established specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used for an AI/machine learning algorithm. The "ground truth" for the device's design and manufacturing is established by the detailed requirements of the relevant safety and performance standards.
{0}------------------------------------------------
510(k) SUMMARY
ー。
t
APR - 8 2011
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| 1 | Submitter Information | ||||
|---|---|---|---|---|---|
| Name | CareFusion 209, Inc. | ||||
| Address | 1850 Deming Way, Middleton, WI 53562 | ||||
| Phone number | 608-829-8655 | ||||
| Fax number | 608-829-8769 | ||||
| EstablishmentRegistration Number | 3008289288 | ||||
| Name of contactperson | Robert J Burdge | ||||
| Date prepared | 6 April 2011 | ||||
| 2 | Name of Device | ||||
| Trade or proprietaryname | Nicolet Wireless EEG Amplifier | ||||
| Common or usualname | Amplifier, Electroencephalograph | ||||
| Classification name | Electroencephalograph | ||||
| Classification Panel | Neurology | ||||
| Device Class | Class II | ||||
| Regulation | 21 CFR 882.1400 | ||||
| Product Code(s) | GWQ, GWL | ||||
| ਤੇ | Legally marketed device(s) | 510(k) #: | Cleared on: | Name | Code: |
| to which equivalence isclaimed | K061908 | 11/06/2006 | Nicoletone V32 Amplifier with Oximetry | GWQ | |
| K090957 | 05/28/2009 | Blackrock Neuroport Biopotential Signal Processing System | GWL | ||
| K060523 | 03/28/2006 | NeuroPort Instrument | GWQ | ||
| K060803 | 05/02/2006 | gUSBamp | GWL | ||
| K040113K033475 | 02/18/200401/07/2004 | Sandman SD20 AmplifierNihon Kohden WEE-1000 Wireless Amplifier | GWLGWQ | ||
| K003175 | 12/27/2000 | Siesta Compumedics | GWQ | ||
| Reason for 510(k)submission | NicoletOne base systemBattery or Mains power | The changes addressed in this submission include:Addition of wireless communication capability between the amplifier and theIncreased channels and sampling rates | |||
| 4 | Device Description | The Nicolet Wireless Amplifiers are used in a wide variety of EEG applicationsincluding: Ambulatory (at home or in transit to home), OR, LTM, EEG, Sleep andICU. The proposed amplifiers are small portable devices that can run on mainelectrical A/C power or use a portable battery pack. |
{1}------------------------------------------------
| Device Description (cont) | The proposed device consists of two models designated as the 32 channel and the64 channel amplifier.These units can acquire from up to 32 or 64 channels, they can be grouped or"cascaded" together for more channels. The amplifiers are capable of acquiring avariety of electrophysiological signals at variable sampling frequencies. Thesesignals include EEG, EKG, EMG, EP, temperature, blood pressure, pulse, andother signals standard to neurological and sleep testing.The amplifiers have wireless capability and a battery pack for mobile dataacquisition. Wireless access points collect the wireless data transmissions. Theamplifiers can be connected to the Ethernet by a cable and also to AC power. Theamplifiers 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 databack-up.This amplifier provides storage and subsequent transmission of data that is nottransferred live when the amplifier is in out of range situations. | ||
|---|---|---|---|
| 5 | Intended use of the device | The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifierto acquire, store, and transmit electrophysiological signals in a wired or wirelessmode for the Nicolet Neurodiagnostic system. | |
| 6 | Summary of the technological characteristics of the device compared to the predicate device | ||
| Characteristic | New DeviceNicolet Wireless EEG Amplifier | Predicate [Device Name][510(k) number] | |
| Interface to Amplifier | Wired Ethernet (10/100baseT) orWireless Ethernet (802.11b/g) | Wired Ethernet (10/100baseT)or WirelessEthernet (802.11b)Substantially equivalent to the Nihon KohdenWEE-1000 Wireless Amplifier (K033475) | |
| Power | Battery or 110/220VAC | 110 VAC, Battery and USB PortSubstantially equivalent to the Nihon KohdenWEE-1000 Wireless Amplifier (K033475) | |
| System components | Patient Cable, Amplifier, CPU and aDisplay Monitor; Telemetry unit andaccess point | System components comprised of telemetryunit, Electrode junction box and access pointto operate with the current NK commerciallyavailable EEG devicesSubstantially equivalent to the Nihon KohdenWEE-1000 Wireless Amplifier (K033475) | |
| Number of Signal RecordingChannels | Up to 32 or 64 channels | 32 and up to 128 with one device; Up to 256by cascading two devices | |
| PERFORMANCE DATA | |||
| 7 | SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCE | ||
| Performance Test Summary-New Device | |||
| Characteristic | Standard/Test/FDA Guidance | Results Summary | |
| 1. Basic safety | IEC 60601-1 | The proposed device passes the applicable tests and standards. | |
| 2. Programmable ElectricalMedical Systems | IEC 60601-4 | The proposed device passes the applicable tests and standards. | |
| 3. Usability | IEC 60601-6 | The proposed device passes the applicable tests and standards. | |
| 4. EMC Compatibility | IEC60601-1-2 | The proposed device passes the applicable tests and standards. | |
| 5. Collateral Safety | IEC 60601-1-1 | The proposed device passes the applicable tests and standards. | |
| 6. Electroencephalographs | IEC 60601-2-26 | The proposed device passes the applicable tests and standards. | |
| 7. Risk Management | ISO 14971 | The proposed device passes the applicable tests and standards. | |
| 8. Biocompatibility- non contactdevice | ISO 10993-1 | The proposed device passes the applicable tests and standards. | |
| 9. FCC Specific AbsorptionRatio (SAR) | FCC Part 15C; FCC OET Bulletin 65,Supplement C | The proposed device passes the applicable tests and standards. | |
| 10. Battery safety | UN/DOT 38.3 Transportation testingfor lithium batteries | The proposed device passes the applicable tests and standards. | |
| Summary Discussion of Bench Performance Data | |||
| The Nicolet EEG Wireless Amplifier device passed all specified test requirements. | |||
| The validation and verification testing confirmed this device meets user needs and design inputs for an EEG amplifier. | |||
| Testing also confirmed physical attributes and device performance meet the requirements of the standards listed in theperformance testing summary above. These standards address safety, biocompatibility, EMC compatibility, risk,usability, and radiated energy. | |||
| 8 | SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL |
{2}------------------------------------------------
ノ
i
{3}------------------------------------------------
| EQUIVALENCE AND/OR OF CLINICAL INFORMATION | |
|---|---|
| Clinical Performance Data/InformationClinical testing was not performed with this device. | |
| 9 | CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA |
| The Nicolet Wireless EEG Amplifiers meet the functional claims and intended use as described in the product labeling.The safety and effectiveness are substantially equivalent to The K061908- NicoletOne V32 Amplifier with Oximetry, theK090957 Blackrock Neuroport Biopotential Signal Processing System, the K060523 NeuroPort Instrument, theK060803 gUSBamp, the K040113 Sandman SD20 Amplifier, the K033475-Nihon Kohden WEE-1000 WirelessAmplifier and the K003175 Siesta Compumedics described in the submission. |
..
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three overlapping wings or feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Carefusion 209. Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25" Street, NW Buffalo, MN 55313
Re: K103140
APR - 8 2011
Trade/Device Name: Nicolet Wireless EEG Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWL and GWO Dated: January 20, 2011 Received: January 21, 2011
Dear Mr. Job:
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.
{5}------------------------------------------------
Page 2 - Mr. Mark Job
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 (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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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 yours.
signature
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Indications for Use
510(k) Number (if known): _K103140
Device Name: Nicolet Wireless EEG Amplifier
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.
Prescription Use _ XXX_ (Part 21 CFR 801 Subpart D)
.
:
AND/OR
Over-The-Counter use_ (21 CFR Part 801 Subpart C)
(PLEASE DO NO WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Quynh Hoang
(Division S Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K103140
§ 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).