SPACELABS MEDICAL MULTIPARAMETER MODULE 91496

{0}------------------------------------------------ K 05/17) ## Spacelabs Medical, Inc. Special 510(k) Multiparameter Module 91496 with Option N 510(k) Summary This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 1992. | Date: | January, 2005 | |---------------------------------|--------------------------------------------------------------------------------------------------| | Submitter: | Spacelabs Medical, Inc.<br>5150 220th Avenue SE<br>Issaquah, WA 98029 | | | Mr. Al Van Houdt<br>1 425 657 7200, x5970<br>1 425 657 7210 (FAX)<br>Al.VanHoudt@slmd.com | | Proprietary Name: | Spacelabs Medical Multiparameter Module 91496 (Option N) | | Common Name and Classification: | Arrhythmia Detector and Alarm<br>74DSI, §870.1025, Class II | | | Noninvasive Blood Pressure Measurement System<br>74DXN, §870.1130, Class II | | | Oximeter<br>74DQA, §870.2700, Class II | | | Blood Pressure Computer<br>74DSK, §870.1110, Class II | | | Clinical Electronic Thermometer<br>80BWX, §880.2910, Class II | | | Thermal Cardiac Output Monitor<br>74KFN, §870.1435, Class II | | Predicate Devices: | K972502: Spacelabs Medical Integrated Multiparameter Module 90496 | | | K012891: OxiMAX Pulse Oximetry System with N-595 Pulse Oximeter and<br>OxiMAX Sensors and Cables | 000021 {1}------------------------------------------------ ## Spacelabs Medical, Inc. Special 510(k) Multiparameter Module 91496 with Option N 510(k) Summary The Spacelabs Medical Multiparameter Module 91496 with Option N is a slim, Device lightweight singular modular unit that, when used in conjunction with a Description: ilght Care Medical Patient Care Management System (PCMS), provides the capability to acquire various common physiologic data in a clinical setting. The Module 91496 is the primary interface to the patient being monitored. The Module 91496 is capable of acquiring and processing ECG, respiration, invasive and noninvasive blood pressure, temperature, cardiac output and SpO2 parameters for a single patient. The Module 91496 accumulates the patient physiological data of interest and provides both waveform and digital data to a Spacelabs Medical PCMS monitor via SDLC communications. The PCMS monitor will provide the display capabilities for the care provider. Option N utilizes Nellcor Puritan Bennett OxiMax oximetry and sensors and OxiMax-compatible adapter cables. The Spacelabs Medical Multiparameter Module 91496 is intended for use with Intended Use: the PCMS to acquire, monitor and process various clinical parameters from adult or neonatal/infant populations in any type of clinical environment other than home use. Physiologic parameters that may be monitored include cardiac activity, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2), and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis. The Spacelabs Medical Multiparameter Module 91496 with Option N is Comparison of substantially equivalent to the Spacelabs Medical Multiparameter Module Technological Characteristics: 90496 in design concepts, technologies, materials and intended use, and to the Nellcor N-595 Pulse Oximeter with regard to SpO2 analysis. Test The Module 91496 was validated through rigorous testing that, in part, support the compliance of the Module 91496 to applicable standards. Additionally, the Discussion: software for the Module 91496 was developed following a robust software development process and was fully specified and validated. Safety testing has been performed by third party agencies to ensure the device complies with applicable industry and safety standards. The Module 91496 is substantially equivalent to its predicate devices in design Testing Conclusion: concepts, technologies, materials and intended use. ## 000022 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S.A." are arranged in a circular pattern around the bird symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 4 - 2005 Mr. Al Van Houdt Director, Regulatory Affairs and Quality Spacelabs Medical, Incorporated 51 50 220th Avenue SE Issaquah, Washington 98027 Re: K050175 KUSUI 75 Trade/Device Name: Spacelabs Medical Multiparameter Module 91496 with Option N Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Regulatery Class DQA, DSI, LOS, DXN, DSK, DXG, FLL Dated: February 24, 2005 Received: February 25, 2005 Dear Mr. Houdt: We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becater wined the device is substantially equivalent (for the relerenced above and nave decemblics re) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Annehuments, of to devroes that the tic Act (Act) that do not require approval of a premarket the I cuclar I vou, Drug, and Cooumay, therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the ristration, 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 II your device is chasified (ob acontrols. Existing major regulations affecting (FMA), it may be subject to sach adam form and Regulations, Title 21, Parts 800 to 898. In your device can be found in the announcements concerning your device in the Federal Register. {3}------------------------------------------------ Page 2 - Mr. Houdt Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s Issualice of a substanterines with other requirements mean that FDA has made a determination that your device the Federal accepted mean that FDA has made a decermination that your mistered by other Federal agencies. of the Act or any Federal statutes and regulations administered by patistration of the Act of ally rederal statutes and regulations, but not limited to: registration You must comply with an the Fee S required (21 CFR Part 801); good manufacturing practice and listing (21 CFR Fall 807), labeling (21 CFR (21 (21 (21 Park 820); and if requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality by sense (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) ITIIs letter with anow yourse organ mailing of substantial equivalence of your device to a premiarket notification. The FDF initial a 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), II you desire specific ua noo fer your as at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Inay obtain other general mireters, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Sygitte Michaux Cnd. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use , : | 510(k) Number (if<br>known): | K050175 | |------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Spacelabs Medical Multiparameter Module 91496 with Option N | | Indications for<br>Use: | Conditions to be screened, monitored, treated or diagnosed.<br>Patient conditions indicated by abnormalities in various physiologic parameters,<br>including ECG waveform, respiratory effort, invasive and noninvasive blood<br>pressure measurements, temperature, cardiac output, and pulse oximeter (SpO₂)<br>readings.<br>Prescription use only.<br>Yes. Caution statement is provided in the introductory page of the Patient Care<br>Management System which includes the operating instructions for this Module.<br>Parts of body applied to.<br>Specific to the physiologic parameter being monitored, accessories may be applied<br>externally to the chest and limbs or invasively into the blood stream.<br>Frequency of use.<br>Frequency as directed by physician.<br>Physiological purpose.<br>In conjunction with clinical findings, a screening and diagnostic tool for use in:<br>assessing electrical activity of the heart in order to detect abnormal cardiac rhythms, including life threatening events such as high and low heart rates, asystole and ventricular fibrillation as well as, in adults, the detection of rhythms such as ventricular runs, tachycardia, and ST segment deviations; monitoring respiratory effort to detect abnormal respiration events such as high and low respiration rates and episodes of apnea; continuous monitoring of invasive pressure signals to detect abnormal events such as high and low pressure; episodic monitoring of noninvasive pressure signals to detect abnormal events such as high and low pressure; continuous monitoring of temperature signals to detect abnormal events such as high and low body temperature; monitoring of the patient's pumping ability of the heart and various hemodynamic values to detect abnormal flow volumes; and noninvasive, continuous monitoring of pulse oxygen saturation signals in order to detect desaturation due to abnormal pulmonary/circulatory functions. | | Prescription Use<br>X<br>(Part 21 CFR 801 Subpart D) | AND/OR<br>Over-The-Counter Use<br>(21 CFR 807 Subpart C) | | | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)<br>(Division Sign-Off)<br>(Division of Anesthesiology, General Hospital,)<br>Concurrence of CDRH, Office of Device Evaluation (ODE) | (x) Number_K 050175 :