SIEMENS FIO2 SENSOR

{0}------------------------------------------------ NOV - 3 1999 #### 510(k) SUMMARY as required per 807.92(c) 1. 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 Regulatory Submissions Manager Date submission was prepared: May 25, 1999 Trade Name, Common Name and Classification Name: 2. - A. Trade Name: Siemens FiO2 Sensor #### Common Name, Classification Name, Class and Regulation Number: B. | Common Name | Classification<br>Number | Class | Regulation Number | |--------------------------------------|--------------------------|-------|-------------------| | Analyzer, Gas, Oxygen, Gaseous-Phase | 73CCL | II | 868.1720 | - Predicate Device Identification: 3. Mine Safety Appliances Company MiniOX® 3000 Oxygen Monitor 510(k) K961644 ## 4. Device Description: The FiO2 Sensor is an addition to the Siemens INFINITY patient monitoring series that measures the oxygen concentration of ambient air in non-pressurized environments such as that found in infant incubators and oxygen hoods. In conjunction with the INFINITY NeoMed pod, the FiO2 Sensor permits oxygen concentration monitoring to be displayed on the INFINITY modular bedside monitors, MultiView WorkStations, and PC's via the INFINITY network. # 5. Intended Use: The intended use of Siemens FiO2 Sensor is to monitor the oxygen level of ambient air in non-pressurized environments such as that found in infant incubators and oxygen hoods. ## 1 #### 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}------------------------------------------------ # 6. Table of Device Similarities and differences to predicate device | | Substantial Equivalent Device | Applicant | Explanation of<br>Differences | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | Manufacturer | Mine safety Appliances Company<br>MiniOx® 3000 Oxygen Monitor | Siemens Medical Systems<br>FiO2 Sensor | | | 510(k) Number | K961644 | To be assigned | | | Intended Use | Direct monitoring of oxygen<br>mixtures in a wide variety of<br>medical applications such as<br>anesthesiology (e.g., anesthesia<br>machines), respiratory therapy<br>(e.g., respirators, ventilators,<br>pediatric incubators), and oxygen<br>therapy (e.g., oxygen tents). | Siemens FiO2 sensor is used to<br>monitor the oxygen level of<br>ambient air in non-pressurized<br>environments such as that<br>found in infant incubators and<br>oxygen hoods. | Siemens FiO2 is not<br>intended for use in<br>ventilator breathing<br>circuits. | | Intended | All patient populations | Infant | | | Population | | | | | Intended | Hospital or other clinical setting | In an environment where | | | Environment | and during emergency transport. | healthcare is provided by<br>healthcare professionals. | | | 02 Alarm System | Low/High O2 Alarm | Same | | | Calibration | 21% O2 or 100%O2 | Same | | | Measuring range | 0-100% | 5-100% | Measuring range is<br>appropriate for intended<br>use and intended<br>population. | | Accuracy | $\pm$ 1% FS (at RTP) | <3% FS (at RTP) | Meets the requirements<br>of ISO 7767 | | Nominal Response<br>time | 97% in 30 seconds (2L/min at<br>RTP) | Same | | | Sensor Type | Galvanic fuel sensor | Same | | | OperatingTemperature<br>range | 0°C to 40°C (32°F to 104°F) | 10°C to 40°C (50° to 104°F) | Operating temperature<br>range is consistent with<br>that of the monitor | 2 # 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) {2}------------------------------------------------ 7. Assessment of non-clinical performance data for equivalence: Exhibit T 8. Assessment of clinical performance data for equivalence: Not Applicable 9. Biocompatability: Not applicable 10. Sterilization: Not applicable 11. Standards and Guidances: Exhibit U 3 #### COMPANY CONFIDENTIAL 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 & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to convey the department's mission of protecting and promoting the health and well-being of Americans. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV - 3 1999 Mr. Penelope Greco Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Re: K991884 Siemens Fi02 Sensor Regulatory Class: II (two) Product Code: CCL Dated: August 27, 1999 Received: August 30, 1999 Dear Mr. Greco: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {4}------------------------------------------------ #### Paqe 2 - Mr. Penelope Greco This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, ferrina Aulestras fes. Ceila M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Page 1 of 1 - K991884 510(k) Number (if known): _ Device Name: Siemens FiO2 Sensor Indications for Use: Siemens FiO2 sensor is indicated for use in an environment 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 oxygen level of ambient air in non-pressurized environments such as that found in infant incubators and oxygen hoods. MRI Compatibility Statement: The Siemens FiO2 sensor 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) to A Watshur vascular. Respiratory 510(k) Numbe