(256 days)
No
The description mentions conventional signal processing and advanced analysis methods like FFT and Artifact Removal, but does not mention AI or ML.
No
The device is described as an EEG system for acquisition, display, archive, storage, and analysis of physiological signals (EEG), and it explicitly states, "This device does not provide any diagnostic conclusion about the patient's condition to the user." It is used for monitoring and analysis, not for treatment.
No
The 'Intended Use / Indications for Use' section explicitly states: "This device does not provide any diagnostic conclusion about the patient's condition to the user." It facilitates the acquisition and analysis of physiological signals, which a qualified practitioner then uses to make a judgment, but the device itself does not offer a diagnosis.
No
The device description explicitly lists hardware components such as "Lifelines Trackit", "Lifelines Photic Stimulator", "Off the shelf PC and medical grade power supply", and "Off the shelf IP Video Camera" as part of the system, indicating it is not solely software.
Based on the provided information, the Lifelines iEEG is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Lifelines iEEG Function: The Lifelines iEEG system acquires, displays, archives, stores, and analyzes physiological signals (EEG) directly from the patient's brain. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for acquiring and analyzing physiological signals (EEG) and aiding a qualified medical practitioner in monitoring and analyzing the EEG. It explicitly states it "does not provide any diagnostic conclusion about the patient's condition to the user."
Therefore, the Lifelines iEEG falls under the category of a medical device that directly interacts with the patient to acquire physiological data, rather than an IVD device that analyzes specimens.
N/A
Intended Use / Indications for Use
The Lifelines iEEG is an EEG system that allows acquisition, display, archive, storage and analysis of physiological signals. The intended user of this product is a qualified medical practitioner trained in electroencephalography who will exercise professional judgment in using the information. The Lifelines iEEG system also includes the display of a quantitative EEG plots, power spectrum, which is intended to help the user to monitor and analyze the EEG. This device does not provide any diagnostic conclusion about the patient's condition to the user.
Product codes (comma separated list FDA assigned to the subject device)
OLT, GWQ
Device Description
Lifelines iEEG is medical device used to acquire, display, archive, store and analyze EEG examinations. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of acquiring and presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The system software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
The components of Lifelines iEEG are:
- Lifelines iEEG software:
- . iEEG Centrum
- . iEEG Review
- iEEG Acquisition .
- Lifelines Trackit, Lifelines Ltd, 510(k)#K010460
- Lifelines Photic Stimulator, Lifelines Ltd, 510(k)# K101691 ●
- Off the shelf PC and medical grade power supply ●
- Off the shelf IP Video Camera ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain (electroencephalographic signals from the brain)
Indicated Patient Age Range
All age groups
Intended User / Care Setting
Qualified medical practitioner trained in Electroencephalography.
Hospital, clinics, patients home.
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)
Software Verification and Validation.
Immunity Verification.
Third party testing for conformance with IEC 60601-1:2005 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
Third party testing for conformance with IEC 60601-1-2:2007 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
Checklist testing for IEC 62304:2006 - Medical Device Software - Software - Software Life Cycle Processes
Checklist testing for IEC 62366:2007 - Medical Devices - Application Of Usability Engineering To Medical Devices
Third party testing for conformance with IEC 60601-2-26:2002 - Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs
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
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three faces in profile, representing the department's focus on health and human well-being. The logo is simple, using only black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Auqust 21, 2015
Kvikna ehf c/o Yolanda Smith Smith Associates 1468 Harwell Ave Crofton, MD 21114
Re: K143487
Trade/Device Name: Lifelines iEEG 2.0 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLT, GWQ Dated: July 22, 2015 Received: July 23, 2014
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
1
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 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/Resourcesfor You/Industry/default.htm. 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/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
Carlos 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) K143487
Device Name Lifelines iEEG 2.0
Indications for Use (Describe)
The Lifelines iEEG is an EEG system that allows acquisition, display, archive, storage and analysis of physiological signals. The intended user of this product is a qualified medical practitioner trained in electroencephalography who will exercise professional judgment in using the information. The Lifelines iEEG system also includes the display of a quantitative EEG plots, power spectrum, which is intended to help the user to monitor and analyze the EEG. This device does not provide any diagnostic conclusion about the patient's condition to the user.
Type of Use (Select one or both, as applicable)
| ☑ 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: | Kvikna Medical ehf |
| Company Address | Stórhöfði 21 |
| 110 Reykjavik | |
| Iceland | |
| Telephone: | +354 578 8400 |
| Contact Person: | Gardar Thorvardsson |
| Summary Preparation Date: | November 14, 2014 |
| DEVICE NAME | |
| Trade Name: | Lifelines iEEG 2.0 |
| Common/Usual Name: | EEG System |
| Classification Name: | Electroencephalograph |
| Regulation Number: | 21 CFR 882.1400 GWQ, |
| Product Code: | GWQ, OLT |
| Device Class: | Class II |
| PREDICATE DEVICE | |
| Company | Product |
| Natus Medical, Inc | DG Nervus |
DEVICE DESCRIPTION
●
Lifelines iEEG is medical device used to acquire, display, archive, store and analyze EEG examinations. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of acquiring and presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The system software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
510(k) # K964280
The components of Lifelines iEEG are:
- Lifelines iEEG software:
- . iEEG Centrum
- . iEEG Review
- iEEG Acquisition .
- Lifelines Trackit, Lifelines Ltd, 510(k)#K010460
- Lifelines Photic Stimulator, Lifelines Ltd, 510(k)# K101691 ●
- Off the shelf PC and medical grade power supply ●
- Off the shelf IP Video Camera ●
4
INDICATIONS FOR USE
The Lifelines iEEG is an EEG system that allows acquisition, display, archive, storage and analysis of physiological signals. The intended user of this product is a qualified medical practitioner trained in electroencephalography who will exercise professional judgment in using the information. The Lifelines iEEG system also includes the display of a quantitative EEG plots, power spectrum, which is intended to help the user to monitor and analyze the EEG. This device does not provide any diagnostic conclusion about the patient's condition to the user.
Caution: Federal law restricts this device to sale by or on the order of a physician licensed by the law of the State in which he practices to use or order the use of the device.""
| Subject Device | Predicate Device | Similarities and Differences | |
|---|---|---|---|
| Trade Name | Lifelines iEEG | DG Nervus | |
| (now NicoletOne) | |||
| Company | Kvikna Medical ehf | Natus Medical, Inc. | |
| K Number | K964280 | ||
| Intended Use | The Lifelines iEEG is an EEG | ||
| system that allows acquisition, | |||
| display, archive, storage and | |||
| analysis of physiological signals. | |||
| The intended user of this product | |||
| is a qualified medical practitioner | |||
| trained in | |||
| electroencephalography who will | |||
| exercise professional judgment in | |||
| using the information. The | |||
| Lifelines iEEG system also | |||
| includes the display of a | |||
| quantitative EEG plots, power | |||
| spectrum, which is intended to | |||
| help the user to monitor and | |||
| analyze the EEG. This device does | |||
| not provide any diagnostic | |||
| conclusion about the patient's | |||
| condition to the user. | The Nervus DG is intended to | ||
| be used as an | |||
| Electroencephalograph: to | |||
| acquire, display, store and | |||
| archive | |||
| electroencephalographic | |||
| signals from the brain using a | |||
| full montage array (i.e. 16 or | |||
| more electrodes) and user | |||
| specified locations. | The Lifelines iEEG system | ||
| (Subject Device) and the DG | |||
| Nervus have equivalent | |||
| intended use. | |||
| Intended User | Qualified medical practitioner | ||
| trained in | |||
| Electroencephalography | Qualified medical | ||
| practitioner trained in | |||
| Electroencephalography | No difference. | ||
| Population age | All age groups | All age groups | No difference. |
| Use environment | Hospital, clinics, patients home | Hospital, clinic, patients | |
| home | No difference. | ||
| Regulation Number | 21 CFR 882.1400 | 21 CFR 882.1400 | No difference. |
| Product Code | GWQ, OLT | GWQ | Lifelines iEEG includes OLT |
| product code as it offers | |||
| quantitative EEG in the form | |||
| of power spectrum and | |||
| related parameters. | |||
| Device allows acquisition | |||
| of physiological signals | Yes | Yes | No difference. |
| Subject Device | Predicate Device | Similarities and Differences | |
| Trade Name | Lifelines iEEG | DG Nervus | |
| (now NicoletOne) | |||
| Device allows display, | |||
| archive, review and | |||
| analysis of physiological | |||
| signals | Yes | Yes | No difference. |
| Identifies spikes | No | Yes | Lifelines iEEG does not offer |
| automated spike detection | |||
| Identifies seizures | No | Yes | Lifelines iEEG does not offer |
| automated seizure detection | |||
| Displays calculated EEG | |||
| measures | Yes | Yes | No difference. |
| Calculated EEG measures | |||
| displayed | Spectrum, Power Spectrum | ||
| Density, band power, spectral | |||
| edge, peak frequency | Spectrum, Spectrogram, | ||
| band power, peak frequency, | |||
| spectral edge | No difference. The algorithm | ||
| used to calculate Spectrogram | |||
| in DG Nervus and Power | |||
| spectrum density in iEEG is | |||
| the same. | |||
| Users can add/delete | |||
| events | Yes | Yes | No difference. |
| Number of EEG channels | Software: up to 128 | ||
| Hardware: up to 32 | Up to 512 | Lifelines system and Lifelines | |
| iEEG software system support | |||
| up to 128 channels, the DG | |||
| Nervus supports up to 512 | |||
| channels. | |||
| Type of EEG recording | |||
| supported | EDF, NicoletOne, Lifelines iEEG | EDF, NicoletOne | The Lifelines iEEG system and |
| the Lifelines iEEG software | |||
| system support the Lifelines | |||
| iEEG (.ieeg) recording type | |||
| which DG Nervus does not | |||
| Type of EEG analysis | Clinical, ambulatory, long term | ||
| monitoring | Clinical, ambulatory, long | ||
| term monitoring | No difference. | ||
| Photic activation of the | |||
| EEG | Yes | Yes | No difference. |
| Differential input | |||
| impedance | >20 Mohms | > 20MΩ | No difference. |
| Common mode input | |||
| impedance | >100 Mohms | > 100MΩ | No difference. |
| Channel equivalent input | |||
| noise |