SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496

K972502 · Spacelabs Medical, Inc. · DSI · May 28, 1998 · Cardiovascular

Device Facts

• Record ID: K972502
• Device Name: SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496
• Applicant: Spacelabs Medical, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: May 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Spacelabs Medical Integrated Multiparameter Module 90496 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

The Spacelabs Medical Integrated Multiparameter Module 90496 is a modular unit that interfaces with a Patient Care Management System (PCMS) to acquire and process physiologic data. It collects ECG, respiration, invasive/noninvasive blood pressure, temperature, cardiac output, and SpO2 signals from adult or neonatal patients. The module processes these inputs and transmits waveform and digital data via SDLC communications to a bedside or central monitor. Clinicians use the displayed data to detect abnormal physiologic events and inform clinical decision-making. The device is intended for clinical environments, excluding home use. It consolidates multiple monitoring capabilities into a single unit compatible with existing Spacelabs PCMS infrastructure.

Clinical Evidence

Bench testing only. The device underwent extensive safety and performance testing to ensure compliance with functional requirements and industry standards, including IEC 601.1, ANSI/AAMI EC11, EC13, AAMI ECAR-1987, and ANSI/AAMI SP-10 for accuracy. No clinical trial data was required or provided.

Technological Characteristics

Modular unit for PCMS integration. Parameters: ECG, respiration, invasive/noninvasive blood pressure, temperature, cardiac output, SpO2. Connectivity: SDLC communications to PCMS. Standards: IEC 601.1, ANSI/AAMI EC11, EC13, AAMI ECAR-1987, ANSI/AAMI SP-10. Energy source: Standard medical monitor power. Packaging: Lightweight singular modular unit.

Indications for Use

Indicated for adult or neonatal/infant patients requiring monitoring of ECG, respiratory effort, invasive/noninvasive blood pressure, temperature, cardiac output, and SpO2. Used to detect abnormal cardiac rhythms (e.g., asystole, ventricular fibrillation, tachycardia, ST segment deviations), abnormal respiration (e.g., apnea), abnormal pressure, abnormal body temperature, and abnormal hemodynamic flow/oxygen saturation. 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 90470 (K952912)
• Spacelabs Medical Integrated Multiparameter Expansion Housing Module 90352 (K945429)
• Spacelabs Medical 12-Lead ECG and ST Segment Module 90492 (K962970)
• Baxter Edwards Critical Care Division Explorer Cardiac Output Computer (K896930)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows a sequence of handwritten alphanumeric characters, specifically 'K972502'. The characters are written in a simple, slightly irregular style, suggesting they were written quickly or without strict adherence to a particular font. The numbers are easily readable, and the 'K' is distinct.

Image /page/0/Picture/3 description: The image shows the date "MAY 2 8 1998" at the top. Below the date is the logo for "Spacelabs medical". The logo is in black and white and features a stylized graphic element above the text.

15220 N.E. 40th Succes 10 13x 97013 Kedruond, Washington 98073-9713 475-382-3700

# 510(k) SAFETY AND EFFECTIVENESS SUMMARY

# Spacelabs Medical Integrated Multiparameter Module 90496

| 1. | Submitter's Name | Russ Garrison<br>Director of Regulatory Affairs |
|----|------------------|-----------------------------------------------------------------------|
| | Company | Spacelabs Medical Inc.<br>15220 N.E. 40th Street<br>Redmond. WA 98073 |
| | Telephone: | [phone] |
| | Facsimile: | [phone] |

- Spacelabs Medical Integrated Multiparameter Module 90496 2. Name of Device
Classification:

Arrhythmia Detector and Alarm 74DSI: 21 CFR 870.1025 Class III

Noninvasive Blood Pressure Measurement System 74DXN, 21 CFR 870.1130 Class II

Oximeter 74DQA; 21 CFR 870.2700 Class II

Blood Pressure Computer 74DSK: 21 CFR 870.1110 Class II

Clinical Electronic Thermometer 80BWX: 21 CFR 880.2910 Class II

Monitor. Cardiac Output. Thermal 74KFN: 21 CFR 870.1435 Class II

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We consider the Spacelabs Medical Integrated Multiparameter Predicate Device(s) গে Module 90496 to be substantially equivalent to a combination of features offered by predicate devices, with identical intended uses for each of the seven (7) physiological parameters that may be monitored by the Model 90496.

> Spacelabs Medical believes that the Integrated Multiparameter Module 90496 is substantially equivalent to a combination of the Spacelabs Medical Integrated Multiparameter Module 90470 (510[k] reference K952912) for monitoring of electrocardiographic signals, respiration, noninvasive pressure measurement and pulse oximetry oxygen saturation (SpO2); Spacelabs Medical Integrated Multiparameler Expansion Housing Module 90352 (510[k] K945429) for monitoring of invasive blood pressure measurement, temperature and electrocardiographic activity and respiration: Spacelabs Medical 12-Lead ECG and ST Segment Module 90492 (510[k]s 12-lead electrocardingram and K962970) for K942058 monitoring; and the Baxter Edwards Critical Care Division Explorer Cardiac Output Computer (510[k] K896930) for monitoring cardiac output.

The Integrated Multiparameter Module 90496 is a slim, র্বা Device Description lightweight singular modular unit that. when used in conjunction with a Spacelabs Medical Palient Care Management System (PCMS), provides the capability to acquire various common physiologic data in a clinical setting.

> The Module is the primary interface to the patient being monitored. The Module 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 accumulates the patient physiological data of interest and provides both waveform and digital data to a Spacelabs Medical monitor via SDLC communications. The monitor will provide the display capabilities for the care provider.

The Spacelabs Medical Integrated Multiparameter Module ഗ് Intended Use 90496 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.

- 6. Comparison of We consider the Integrated Multiparameter Module 90496 to be Technological substantially equivalent to a combination of systems currently Characteristics marketed by Spacelabs Medical and, for the cardiac output feature, to the Edwards Critical Care Division of Baxter Healthcare Corporation.

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The design, components, storage technology and energy source are similar to its predicate devices. All systems provide a means for interfacing with a patient, collecting parameter specific physiologic data, and processing the data for alarm generation and display of numeric values and waveforms on a bedside or central monitoring system.

The only significant differences between the Spacelabs Medical Integrated Multiparameter Module 90496 and the comparable systems are in the physiologic feature sets offered by each the systems and in the hardware packaging of the feature sets of the Integrated Multiparameter Module 90496 into one modular unit designed to be compatible with the existing Patient Care Monitoring System (PCMS) currently offered by Spacelabs Medical.

The Spacelabs Medical Integrated Multiparameter Module 7. Testing 90496 has been subject to extensive safety and performance Final testing for the system included various testing. performance tests designed to ensure that the device meets all functional requirements and performance specifications. Safety testing has been performed by third party agencies to ensure the device complies to applicable industry and safety standards. The Integrated Multiparameter Module 90496 has also been tested to assure compliance to the requirements of various standards, including IEC 601.1. ANSI/AAMI EC11 and EC13, AAMI ECAR-1987, and ANSI/AAMI SP-10 for accuracy testing.

In conclusion, the Spacelabs Medical Integrated Multiparameter Module 90496 is as safe and effective as the predicate devices and raises no new issues.

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DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 1998

Mr. Russ Garrison SpaceLabs Medical, Inc. 15220 N.E. 40th Street P.O. Box 97013 Redmond, WA 98073-9713

Re: K972502 SpaceLabs Medical Integrated Multiparameter Module 90496 Regulatory Class: III (three) Product Code: 74 DSI February 25, 1998 Dated: Received: February 27, 1998

Dear Mr. Garrison:

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 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 aqainst 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 would 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 requlatory 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.

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#### Page 2 - Mr. Russ Garrison

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours
Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

Page 1 of 2

510(k) Number (if known): Not Known (New Submission) K972502

Device Name: Spacelabs Medical Integrated Multiparameter Module 90496

Indications for Use:

### Condition to be screened, monitored, treated or diagnosed.

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:

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- 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.

(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)

Mr. Rufs
Division Sign-Off

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number _