SIEMENS INFINITY EEG POD

{0}------------------------------------------------ K991012 ### 510(k) SUMMARY as required per 807.92(c) 2. Submitters Name, Address: Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: David Simard, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Date submission was prepared: March 19, 1999 Trade Name, Common Name and Classification Name: 3. A. Trade Name: Siemens INFINITY EEG Pod ### Common Name, Classification Name, Class and Regulation Number: B | Common Name | Classification<br>Number | Class | Regulation Number | |-----------------------|--------------------------|-------|-------------------| | Electroencephalograph | OLT, ORT | II | 882.1400 | | | OMC | | | - Predicate Device Identification: 2. Aspect Medical Systems, Inc. Model A-1000 EEG Monitor 510(k) K963644 ### 3. Device Description: The INFINITY EEG pod is an addition to Siemens SC9000/SC8000/SC7000/SC9000XL INFINITY patient monitoring series. When connected to an INFINITY EEG pod, an INFINITY Modular Bedside Monitor is capable of measuring up to four channels of EEG waveforms. Each waveform has its own parameter box, and each parameter box displays up to three parameters that can be trended, printed, and displayed on a central station. 1 ### 4. Intended Use: To monitor the state of the brain by data acquisition of EEG signals. # COMPANY CONFIDENTIAL Siemens Medical Systems, Inc. Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923 USA Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD) {1}------------------------------------------------ | | Substantial Equivalent Device | Applicant | Explanation of Difference | |-------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------| | Manufacturer | Aspect Medical Systems, Inc.<br>A-1000 EEG Monitor and A-<br>1050 EEG Monitor | Siemens Medical Systems<br>Infinity EEG Pod | | | 510(k) Number | K963644 | To be assigned | | | Intended Use | To monitor the state of the<br>brain by data acquisition of<br>EEG signals | Same | | | Intended<br>Population | All patient populations | Same | | | Intended<br>Environment | The intensive care unit,<br>operating room and clinical<br>research | An environment where patient care<br>is provided by Healthcare<br>Professionals | | | Computed<br>Parameters | Total Power | Same | | | | Delta, Theta, Alpha, Beta<br>Power | Same | | | | Spectral Edge Frequency | Same | | | | Median Frequency | Same | | | | Burst Suppression ratio | Same | | | | Power of user defined Band 1 | No | Parameter not supported | | | Power of user defined Band 2 | No | | | | Asymmetry | No | | | | Bispectral Index | No | | | | EMG Power Band 1 | No | | | | EMG Power Band 2 | No | | 2 # COMPANY CONFIDENTIAL Siemens Medical Systems, Inc. Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923 USA {2}------------------------------------------------ 6. Assessment of non-clinical performance data for equivalence: Exhibit U 7. Assessment of clinical performance data for equivalence: Exhibit V - 8. Biocompatability: Not applicable - 9. Sterilization: Not applicable FDA Electroencephalograph Devices Guidance for 510(k) 10. Standards and Guidances: Content, Draft Document Version 1.0, November 3, 1997 > IEC 601-2-26: 1994, Medical Electrical Equipment: Part 2: Particular Requirements for the Safety of Electroencephalographs > > 3 ### COMPANY CONFIDENTIAL Siemens Medical Systems, Inc. Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923 USA Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD) {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing and leg. The eagle is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Ms. Penelope H. Greco Regulatory Submissions Manager Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, Massachusetts 01923 APR - 9 2012 Re: K991012 Trade/Device Name: Siemens INFINITY EEG Pod Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLT, ORT, OMC Dated (Date on orig SE ltr): March 19, 1999 Received (Date on orig SE ltr): March 26, 1999 Dear Ms. Greco: This letter corrects our substantially equivalent letter of June 24, 1999. 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. {4}------------------------------------------------ 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/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/Resourcesfor You/Industry/default.htm. Sincerely yours. Kesia Alexander Image /page/4/Picture/8 description: The image shows the name and title of Malvina B. Eydelman, M.D. She is the Director of the Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices. The division is part of the Office of Device Evaluation. The office is part of the Center for Devices and Radiological Health. Enclosure {5}------------------------------------------------ Page_1_of_1 510(k) Number (if known): K 991012 Device Name: Siemens INFINITY EEG Pod ## Indications for Use: Siemens INFINITY EEG Pod is indicated for use in the adult, pediatric and neonatal populations, in an Stement where patient care is provided by healthcare professionals, i.e. Physicians, Nurses, Technicians, when the professional determines that the device is required to monitor the state of the brain by data acquisition of EEG signals. MRI Compatibility Statement: The Siemens INFINITY EEG Pod is not intended for use in a MRI magnetic field. # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use_ (Optional Format 1-2-96) coiledo Divisio 510iki Nu