The Lifelines iEEG is a software system that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.

The Lifelines iEEG software allows display, archive, review and analysis of . physiological signals.
Lifelines iEEG also includes the display of a quantitative EEG plot, 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.

Device Description

Lifelines iEEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. 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 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 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 two main components of Lifelines iEEG are iEEG Centrum and iEEG Review.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Lifelines iEEG device:

Based on the provided K123665 510(k) Summary, the Lifelines iEEG is a software system for managing and reviewing EEG examinations. It displays physiological signals and provides analysis features like FFT and Artifact Removal. Crucially, the document does not detail specific acceptance criteria or a study proving that the device meets such criteria in terms of clinical performance or accuracy thresholds. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on functional similarities and safety considerations.

The device does not provide any diagnostic conclusion and is intended for use by qualified medical practitioners who will exercise professional judgment. This implies that the software acts as a tool for presentation and analysis, rather than a diagnostic algorithm requiring performance metrics like sensitivity, specificity, or AUC.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (If explicitly stated)	Reported Device Performance
Not explicitly stated as performance metrics. The focus is on demonstrating functional equivalence to predicate devices and safety.	The device performs display, archive, review, and analysis of physiological signals, including quantitative EEG plots (spectrum, band power, spectral edge). It uses conventional signal processing such as re-montaging and band pass filtering, similar to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a specific test set with a defined sample size for evaluating the clinical performance of the Lifelines iEEG in terms of diagnostic accuracy or other performance metrics. The comparison is primarily functional.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since there is no described test set for clinical performance evaluation, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

As there is no described test set requiring a ground truth, there is no adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

An MRMC study was not conducted or described in this 510(k) summary. The device's purpose is not to assist human readers in a diagnostic task that would be directly compared to unassisted reading, as it doesn't provide diagnostic conclusions or AI-driven interpretations beyond basic signal processing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document does not describe any standalone performance study in terms of diagnostic effectiveness for the algorithm itself. The device is a software system intended to be used by a qualified medical practitioner.

7. The Type of Ground Truth Used

Given the lack of a clinical performance study with acceptance criteria, no specific type of ground truth (e.g., expert consensus, pathology, outcomes data) is mentioned as being used for performance evaluation.

8. The Sample Size for the Training Set

The document does not mention a training set or any deep learning/machine learning models that would require one. The functions described (re-montaging, band pass filtering, FFT analysis, Artifact Removal) are conventional signal processing techniques, not typically "trained" on data in the way AI algorithms are.

9. How the Ground Truth for the Training Set Was Established

As no training set is described, this information is not applicable and not provided.

Summary of Device Evaluation Approach:

The K123665 submission for Lifelines iEEG primarily relies on demonstrating substantial equivalence to predicate devices based on functional characteristics and safety considerations stemming from standard signal processing methods. The key argument is that the Lifelines iEEG performs similar functions (display, archive, review, analysis of EEG signals) to the predicate devices, despite lacking the acquisition and specific spike/seizure detection functionalities. The safety and effectiveness are inferred from the use of conventional, industry-standard methods for signal processing, which are assumed to be similar enough to predicate devices such that the device does not raise new questions of safety or effectiveness. No specific clinical performance metrics or studies proving diagnostic accuracy are presented because the device's intended use is as a display and analysis tool, not a diagnostic aid providing conclusions.

Summary

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K123665 revised 3/22/2013

MAR 2 5 2013

510(k) Summary 807.92(c)

SPONSOR

807.92(a)(1)

Company Name: Kvikna ehf Company Address Vatnagardar 18 104 Reykjavik Iceland

Telephone:

+354 578 8400

Contact Person:

Gardar Thorvardsson

Summary Preparation Date: March 22, 2013

DEVICE NAME

807.92(a)(2)

Lifelines iEEG Trade Name: EEG Software Common/Usual Name: Classification Name: ELectroencephalograph 21 CFR 882.1400 Regulation Number: Product Code: OLT Device Class: Class II

PREDICATE DEVICE

807.92(a)(3)

Legally Marketed Equivalent Device

K Number	Product	Company
K090019	Natus Neuroworks, Model 104196	Natus Medical, Inc.
K964280	DG Nervus	Natus Medical, Inc.
K021185	Nervus Monitor	Taugagreining hf

DEVICE DESCRIPTION

807.92(a)(4)

The 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 two main components of Lifelines iEEG are iEEG Centrum and iEEG Review.

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DEVICE INTENDED USE

807.92(a)(5)

The Lifelines iEEG software allows display, archive, review and analysis of physiological signals. .
Lifelines iEEG also includes the display of a quantitative EEG plot, 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 (USA) law restricts this device to sale by or on the order of a physician.

COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)

	Subject Device	Predicate Device	Predicate Device	Predicate Device
Trade Name	Lifelines iEEG	Natus Neuroworks,Model 104196	DG Nervus (nowNicoletOne)	Nervus Monitor
Company	Kvikna ehf	Natus Medical, Inc.	Natus Medical, Inc.	Taugagreining hf
Intended Use	The Lifelines iEEG isa software system thatdisplays physiologicalsignals.	The Neuroworks isEEG software thatdisplays physiologicalsignals	The Nervus DG is amedical device thatrecords and displaysphysiological signals.	The Nervus Monitoris a medical devicethat records anddisplays physiologicalsignals.
Intended User	qualified medicalpractitioner trained inElectroencephalography	qualified medicalpractitioner trained inElectroencephalography	qualified medicalpractitioner trained inElectroencephalography	qualified medicalpractitioner trained inElectroencephalography
Population age	All age groups	All age groups	All age groups	All age groups
RegulationNumber	21 CFR 882.1400	21 CFR 882.1400	21 CFR 882.1400	21 CFR 882.1400
Product Code	OMB	OMB, OMA, OLT	GWQ	OLV
Software allowsacquisition ofphysiologicalsignals	no	yes	yes	yes
Software allowsdisplay,archive, reviewand analysis ofphysiologicalsignals	yes	yes	yes	yes
Identifies spikes	No	yes	yes	yes
Identifiesseizures	No	yes	yes	yes
Displayscalculated EEGmeasures	Yes	yes	yes	yes
Calculated EEGmeasures	Spectrum, bandpower, spectral edge	Spectrum, bandpower, spectral edge	Spectrum,Spectrogram, band	Spectrum,Spectrogram, band

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K123665 revised 3/22/2013

displayed	peak frequency.	power, peakfrequency, spectraledge	power, peakfrequency, spectraledge
User adjustableseizuredetection	no	no	No
Users canadd/deleteevents	yes	yes	yes
Number of EEGchannels	Up to 128	Up to 512
Type of EEGrecordingsupported	EDF, NicoletOne,Lifelines iEEG	NicoletOne, EDF
Type of EEGanalysis	Clinical, ambulatory	Clinical, ambulatory,long term monitoring

PERFORMANCE TESTING

Software Verification and Validation

Safety Testing IEC 60601-2-26, IEC 60601-1-4

CONCLUSION

807.92(b)(3)

The predicate devices are EEG software products that allows for acquisition, review and archive of EEG and digital video picture of the patient as well as spike and seizure detection. They feature digital remontaging and digital bandpass filters to aid the review process. They use an SQL database to keep track of exams and patient demographics and to control access to patient data.

The Lifelines iEEG has all the same functionality except for acquisition of EEG and the spike and seizure detection. The user must import eeg and video data acquired by other systems into the Lifelines iEEG system. Lifelines iEEG uses conventional, industry standard methods to re-montage and filter data in a similar way as the predicate devices. The data looks the same or very similar in all the devices. The only potential cause of the difference is the difference in the design of filters. This should not affect the safety or efficiency of the device provided that sound signal processing methods are applied.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus.

March 25,2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Kvikna Ehf c/o Yolanda Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114

Re: K123665

Trade/Device Name: Lifelines iEEG Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLT Dated: February 25, 2012 Received: February 26, 2013

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

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Page 2 - Ms. Yolanda Smith

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/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 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,

Image /page/4/Picture/7 description: The image shows the name "Joyce M. Whang" in a simple, sans-serif font. The name is written in black ink on a white background. The letters are evenly spaced and easy to read. The "M." in the middle of the name is stylized with a decorative border.

for Victor Krauthamer, Ph.D. Acting 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): K123665

Device Name: Lifelines iEEG

Indications For Use:

The Lifelines iEEG software allows display, archive, review and analysis of . physiological signals.
Lifelines iEEG also includes the display of a quantitative EEG plot, 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joyce M. Whang

(Division Sign Off)
Division of Neurological and Physical Medicine
Devices (DNPMD)
510(k) Number	K123665

510(k) Number

Regulation Number and Section

§ 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).