LIFELINES IEEG

{0}------------------------------------------------ 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) 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. {1}------------------------------------------------ #### DEVICE INTENDED USE #### 807.92(a)(5) 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. 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,<br>Model 104196 | DG Nervus (now<br>NicoletOne) | Nervus Monitor | | Company | Kvikna ehf | Natus Medical, Inc. | Natus Medical, Inc. | Taugagreining hf | | Intended Use | The Lifelines iEEG is<br>a software system that<br>displays physiological<br>signals. | The Neuroworks is<br>EEG software that<br>displays physiological<br>signals | The Nervus DG is a<br>medical device that<br>records and displays<br>physiological signals. | The Nervus Monitor<br>is a medical device<br>that records and<br>displays physiological<br>signals. | | Intended User | qualified medical<br>practitioner trained in<br>Electroencephalograp<br>hy | qualified medical<br>practitioner trained in<br>Electroencephalograp<br>hy | qualified medical<br>practitioner trained in<br>Electroencephalograp<br>hy | qualified medical<br>practitioner trained in<br>Electroencephalograp<br>hy | | Population age | All age groups | All age groups | All age groups | All age groups | | Regulation<br>Number | 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 allows<br>acquisition of<br>physiological<br>signals | no | yes | yes | yes | | Software allows<br>display,<br>archive, review<br>and analysis of<br>physiological<br>signals | yes | yes | yes | yes | | Identifies spikes | No | yes | yes | yes | | Identifies<br>seizures | No | yes | yes | yes | | Displays<br>calculated EEG<br>measures | Yes | yes | yes | yes | | Calculated EEG<br>measures | Spectrum, band<br>power, spectral edge | Spectrum, band<br>power, spectral edge | Spectrum,<br>Spectrogram, band | Spectrum,<br>Spectrogram, band | {2}------------------------------------------------ #### K123665 revised 3/22/2013 | displayed | peak frequency. | peak frequency. | power, peak<br>frequency, spectral<br>edge | power, peak<br>frequency, spectral<br>edge | |-----------------------------------------|------------------------------------|-----------------|-----------------------------------------------|--------------------------------------------| | User adjustable<br>seizure<br>detection | no | | no | No | | Users can<br>add/delete<br>events | yes | | yes | yes | | Number of EEG<br>channels | Up to 128 | | Up to 512 | | | Type of EEG<br>recording<br>supported | EDF, NicoletOne,<br>Lifelines iEEG | | NicoletOne, EDF | | | Type of EEG<br>analysis | Clinical, ambulatory | | Clinical, ambulatory,<br>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. {3}------------------------------------------------ ### 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): K123665 Device Name: Lifelines iEEG Indications For Use: 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. 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