(133 days)
Not Found
No
The 510(k) summary describes a hardware device (EEG amplifier) for signal acquisition and transmission. There is no mention of any software features that would involve AI or ML for analysis, interpretation, or processing of the acquired signals. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is described as an amplifier to acquire, store, and transmit electrophysiological signals, and is intended only as an adjunct device in patient assessment. It is explicitly stated that "The equipment does not sustain or support life." It does not provide any form of treatment.
No
Explanation: The "Intended Use" states that the device is "intended to be used as a front-end amplifier to acquire, store and transmit electrophysiological signals," and the "Device Description" clarifies that "This equipment is intended only as an adjunct device in patient assessment; it must be used in conjunction with other methods of patient diagnosis." This indicates it's a tool for signal acquisition, not a standalone diagnostic device.
No
The device description explicitly states it is a "compact USB 40-channel amplifier" and details hardware components like channels, inputs, and connectors.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The R-40 EEG Amplifier acquires electrophysiological signals (EEG) directly from the patient's body. This is an in vivo measurement, not an in vitro test of a specimen.
- Intended Use: The intended use is to acquire, store, and transmit electrophysiological signals, which are electrical signals generated by the brain. This is a direct measurement of physiological activity, not a test of a biological sample.
The device is clearly described as an electroencephalograph, which is a type of medical device used for measuring brain activity in vivo.
N/A
Intended Use / Indications for Use
The R-40 EEG Amplifier is intended to be used as a front-end amplifier to acquire, store and transmit electrophysiological signals (wireless or cabled).
Product codes (comma separated list FDA assigned to the subject device)
GWL, GWQ
Device Description
The R-40 EEG Amplifier is a multi-channel electroencephalograph designed for use in routine EEG and lab monitoring applications.
It is a compact USB 40-channel amplifier which incorporates 32 referential channels and 8 polygraphic channels with built-in calibration and electrode impedance measurement. A Nonin pulse oximeter interface is provided, a Patient Event input, 2 Aux DC inputs and an Electrocap connector. Optional wireless communication is available (Bluetooth and WLAN WiFi).
The Amplifier is intended to be connected to a USB port on a PC which is powered from a medically approved power supply.
This equipment is intended only as an adjunct device in patient assessment; it must be used in conjunction with other methods of patient diagnosis. The equipment does not sustain or support life.
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
Not Found
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 performed:
IEC 60601-1: 2005+A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance. Including US AAMI ES 60601-1:2005.
IEC60601-1-2:2007 Medical electrical equipment – Part 1-2: general requirements to basic safety and essential performance- Collateral standard: Electromagnetic compatibility – Requirements and tests.
IEC 60601-2-26:2012 Medical electrical equipment – Part 2: Particular requirements for the safety of electroencephalographs.
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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized representation of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2015
Lifelines Ltd. % Yolanda Smith Consultant Smith Associates 1468 Harwell Ave Crofton, Maryland 21114
Re: K151600
Trade/Device Name: R-40 EEG Amplifier Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological Signal Amplifier Regulatory Class: Class II Product Code: GWL, GWQ Dated: September 11, 2015 Received: September 22, 2015
Dear Ms. 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 (reporting of medical device
1
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 contact the Division of Industry and Consumer Education 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 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.
Carlos L. Pena -S 同公
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) K151600
Device Name R-40 EEG Amplifier
Indications for Use (Describe)
The R-40 EEG Amplifier is intended to be used as a front-end amplifier to acquire, store and transmit electrophysiological signals (wireless or cabled).
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
SPONSOR
Company Name: Company Address: Lifelines, Ltd. 7 Clarendon Court Over Wallop, Hampshire SO20 8HU United Kingdom
| Telephone: | +44 (0)1483 224 245 |
|---|---|
| Contact Person: | Michael Hulin |
Summary Preparation Date: June 2, 2015
DEVICE NAME
| Trade Name: | R-40 EEG amplifier |
|---|---|
| Common/Usual Name: | EEG Amplifier |
| Classification Name: | Amplifier, Physiological Signal |
| Regulation Number: | 21 CFR 882.1835 |
| 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 R-40 EEG Amplifier is a multi-channel electroencephalograph designed for use in routine EEG and lab monitoring applications.
It is a compact USB 40-channel amplifier which incorporates 32 referential channels and 8 polygraphic channels with built-in calibration and electrode impedance measurement. A Nonin pulse oximeter interface is provided, a Patient Event input, 2 Aux DC inputs and an Electrocap connector. Optional wireless communication is available (Bluetooth and WLAN WiFi).
The Amplifier is intended to be connected to a USB port on a PC which is powered from a medically approved power supply.
This equipment is intended only as an adjunct device in patient assessment; it must be used in conjunction with other methods of patient diagnosis. The equipment does not sustain or support life.
DEVICE INDICATIONS FOR USE
The R-40 EEG Amplifier is intended to be used as a front-end amplifier to acquire, store and transmit electrophysiological signals (wireless or cabled).
4
COMPARISON OF TECHNICAL CHARACTERISTICS
The Indications for Use and Intended Use are identical to the predicate device.
The technological characteristics are substantially similar; the new device is based on existing, well established technologies and is intended for use in the established field of EEG. The differences between the new device and the predicate device are:
• The new device has a wider signal input voltage range which includes DC. Most EEG amplifiers are AC coupled which enables high gain to be applied to the small EEG signals. With the improvements to analog-to-digital resolution, the new device captures the DC component of the signal along with the small AC component. This provides useful additional EEG information for the neurophysiologist.
• The new device provides a connector for the attachment of an Electro-cap. This is an added convenience for the user. The Electro-cap has electrodes built in to a head-worn cap and is popular with some users.
• The new device can be powered from a USB port. The device has built-in electrical isolation for patient safety. Data can also been transferred via the USB port.
· The new device offers Bluetooth as an option. This provides short-range wireless communication with the host computer and offers an alternative means of data transfer.
These differences raise no new questions concerning safety or effectiveness. The Lifelines R-40 EEG Amplifier is substantially equivalent to the predicate device.
PERFORMANCE DATA
Safety Testing
IEC 60601-1: 2005+A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance. Including US AAMI ES 60601-1:2005.
IEC60601-1-2:2007 Medical electrical equipment – Part 1-2: general requirements to basic safety and essential performance- Collateral standard: Electromagnetic compatibility – Requirements and tests.
IEC 60601-2-26:2012 Medical electrical equipment – Part 2: Particular requirements for the safety of electroencephalographs.
Clinical testing was not performed with this device.
CONCLUSION
The Lifeline R-40 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.