SPACELABS MEDICAL MULTIPARAMETER MODULE 91496

K050605 · Spacelabs Medical, Inc. · DSI · May 3, 2005 · Cardiovascular

Device Facts

• Record ID: K050605
• Device Name: SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
• Applicant: Spacelabs Medical, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: May 3, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Spacelabs Medical Multiparameter Module 91496 is intended for use with 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.

Device Story

Module 91496 is a slim, modular unit interfacing with Spacelabs Patient Care Management System (PCMS). It acquires and processes ECG, respiration, invasive/noninvasive blood pressure, temperature, cardiac output, and SpO2 (via Masimo SET technology) signals. Data is transmitted to PCMS via SDLC for display, recording, and analysis by clinicians in clinical settings. The device acts as a primary patient interface; output allows providers to detect abnormal rhythms, hemodynamic instability, or desaturation, facilitating clinical decision-making and patient monitoring.

Clinical Evidence

No clinical data. Device validation relied on bench testing, software verification/validation, and compliance testing to applicable industry and safety standards.

Technological Characteristics

Modular unit for physiologic data acquisition. Integrates Masimo SET oximetry technology. Connectivity via SDLC to Spacelabs PCMS. Software-based processing for ECG, pressure, temperature, and SpO2. Designed for clinical environment use (non-home).

Indications for Use

Indicated for adult and neonatal/infant patients requiring monitoring of physiologic parameters including ECG, respiration, invasive/noninvasive blood pressure, temperature, cardiac output, and SpO2. Used for screening and diagnostic assessment of cardiac rhythms (e.g., tachycardia, asystole, ventricular fibrillation), respiratory effort (e.g., apnea), hemodynamic values, and oxygen desaturation. Prescription use only.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• Spacelabs Medical Integrated Multiparameter Module 91496 with Option N (K051175)
• Spacelabs Medical Integrated Multiparameter Module 90496 (K972502)
• Masimo Corp. SET Rad-5 Pulse Oximeter (K033296)

Submission Summary (Full Text)

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KO50605

### Spacelabs Medical, Inc. Special 510(k) Multiparameter Module 91496 with SpO₂ Option M 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: | March 10, 2005 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------|
| Submitter: | Spacelabs Medical, Inc.<br>5150 220 ^th Avenue SE<br>Issaquah, WA 98029 |
| | Mr. Al Van Houdt<br>1 425 657 7200, x5970<br>1 425 657 7210 (FAX)<br>[e-mail] |
| Proprietary<br>Name: | Spacelabs Medical Multiparameter Module 91496 (with SpO2 Option M) |
| Common Name<br>and<br>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<br>Devices: | K051175: Spacelabs Medical Integrated Multiparameter Module 91496 with Option N<br>(Nellcor SpO2 oximetry) |
| | K972502: Spacelabs Medical Integrated Multiparameter Module 90496 |
| | K033296: Masimo Corp. SET Rad-5 Pulse Oximeter |

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# Spacelabs Medical, Inc. Special 510(k) Multiparameter Module 91496 with SpO₂ Option M 510(k) Summary

| Device<br>Description: | The Spacelabs Medical Multiparameter Module 91496 with Option M is a slim,<br>lightweight singular modular unit that, when used in conjunction with a Spacelabs<br>Medical Patient Care Management System (PCMS), provides the capability to acquire<br>various common physiologic data in a clinical setting. |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Module 91496 is the primary interface to the patient being monitored. The Module<br>91496 is capable of acquiring and processing ECG, respiration, invasive and<br>noninvasive blood pressure, temperature, cardiac output and SpO2 parameters for a<br>single patient. The Module 91496 accumulates the patient physiological data of<br>interest and provides both waveform and digital data to a Spacelabs Medical PCMS<br>monitor via SDLC communications. The PCMS monitor will provide the display<br>capabilities for the care provider. |
| | Option M utilizes Masimo SET oximetry and sensors and SET-compatible adapter<br>cables. |
| Intended Use: | The Spacelabs Medical Multiparameter Module 91496 is intended for use with the<br>PCMS to acquire, monitor and process various clinical parameters from adult or<br>neonatal/infant populations in any type of clinical environment other than home use.<br>Physiologic parameters that may be monitored include cardiac activity, respiration,<br>invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2), and<br>cardiac output. Acquired data may then be communicated to an information network<br>for display, recording, editing and analysis. |
| Comparison of<br>Technological<br>Characteristics: | The Spacelabs Medical Multiparameter Module 91496 with Option M is substantially<br>equivalent to the Spacelabs Medical Multiparameter Module 90496 (with Option U)<br>and Module 91496 (with Option N) in design concepts, technologies, materials and<br>intended use, and to the Masimo SET Rad-5 Oximeter with regard to SpO2 analysis. |
| Test Discussion: | The Module 91496 was validated through rigorous testing that, in part, supports the<br>compliance of the Module 91496 to applicable standards. Additionally, the software for<br>the Module 91496 was developed following a robust software development process<br>and was fully specified and validated. Safety testing has been performed by third<br>party agencies to ensure the device complies with applicable industry and safety<br>standards. |
| Testing<br>Conclusion: | The Module 91496 is substantially equivalent to its predicate devices in design<br>concepts, technologies, materials and intended use. |

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird with three stylized wing-like shapes.

MAY - 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Al Van Houdt Director, Regulatory Affairs and Quality Spacelabs Medical, Incorporated 5150 220th Avenue Street P.O. Box 7018 Issaquah, Washington 98027-7018

Re: K050605

Trade/Device Name: Spacelabs Medical Multiparameter Module 91496 with Option M Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, DPZ, DSI, LOS, DXN, DSK, DXG and FLL Dated: April 14, 2005 Received: April 15, 2005

Dear Mr. Houdt:

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 mendments, 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 approvisions of the Act. The general controls provisions of the Act include controls 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Writ), it may of basyse 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.

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#### Page 2 - Mr. Houdt

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sylvie H. McMain Omd.

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

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# Spacelabs Medical, Inc. Special 510(k) Multiparameter Module 91496, SpO2 Option M

#### 1.4 Indications for Use

K 050605 510(k) Number (if known): Spacelabs Medical Multiparameter Module 91496 with Option M Device Name: Conditions to be screened, monitored, treated or diagnosed. Indications for Use: Patient conditions indicated by abnormalities in various physiologic parameters, including ECG waveform, respiratory effort, invasive and noninvasive blood pressure measurements, temperature, cardiac output, and pulse oximeter (SpO2) readings. Prescription use only. Yes. Caution statement is provided in the introductory page of the Patient Care Management System which includes the operating instructions for this Module. Parts of body applied to. Specific to the physiologic parameter being monitored, accessories may be applied externally to the chest and limbs or invasively into the blood stream. Frequency of use. Frequency as directed by physician. Physiological purpose. In conjunction with clinical findings, a screening and diagnostic tool for use in: 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.

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Spacelabs Medical, Inc. Special 510(k) Multiparameter Module 91496, SpO2 Option M

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ruuysion

(Division Sign-Off) (Division Sign-Om)
Division of Anesthesiology, General Hospital, Infaction Control. Dental

510(k) Number. K0506

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