SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE

K090556 · Spacelabs Healthcare Medical Equipment (Suzhou) CO · MHX · Apr 30, 2009 · Cardiovascular

Device Facts

• Record ID: K090556
• Device Name: SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE
• Applicant: Spacelabs Healthcare Medical Equipment (Suzhou) CO
• Product Code: MHX · Cardiovascular
• Decision Date: Apr 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Spacelabs élance Vital Signs Monitor is indicated for use in patient populations for: - Adult - Pediatric The Spacelabs élance Vital Signs Monitor facilitates the monitoring of: - ECG with arrhythmia detection - Respiration - Non-invasive blood pressures - Invasive blood pressures - Body temperature - Functional arterial oxygen saturation, and - Expired and/or inspired CO2. The Spacelabs élance Vital Signs Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

Device Story

Portable patient monitoring system; monitors ECG, respiration, NIBP, IBP, temperature, SpO2, and EtCO2. Available in 10.2" and 12.1" display sizes. Used by clinicians in healthcare facilities. Includes optional central station software (93900) for remote monitoring via customer-provided computer. Provides real-time physiological data and arrhythmia detection to assist clinical decision-making. Benefits include continuous patient status tracking and alarm notification.

Clinical Evidence

No clinical data. Bench testing only, including performance, functional, environmental, and shipping/transportation testing. Software, electrical safety, and EMC testing performed per applicable standards.

Technological Characteristics

Portable patient monitor; 10.2" or 12.1" display. Parameters: ECG, respiration, NIBP, IBP, temperature, SpO2, EtCO2. Connectivity: Central station software package (93900) for networked monitoring. Non-sterile device. No patient contact materials.

Indications for Use

Indicated for adult and pediatric patient populations for monitoring ECG (with arrhythmia detection), respiration, non-invasive blood pressure, invasive blood pressure, body temperature, functional arterial oxygen saturation, and expired/inspired CO2. Prescription use only by healthcare professionals in healthcare facilities.

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

• Zoe Medical Nightingale Monitoring System (K001775)
• Oridion Capnostream 20 (K060065)
• Masimo Corporation SET Rad 5 MS-11 board (K033296)
• Invivo Escort M8 Vital Signs Patient Monitor Model 3810 (K062144)
• Nellcor Oximax N-595 pulse oximeter (K012891)

Submission Summary (Full Text)

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# K090556

"

## 510(k) Summary

### APR 3 0 2009

| Submission Date: | 23 February 2009 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Spacelabs Healthcare Medical Equipment (Suzhou) Co., Ltd.<br>Building 30, West Wing<br>Chuang Tou Industrial Square, Yang Xian Road |
| Submitter Contact: | Jennifer Cui<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Official Contact: | Thomas Kroenke<br>Principal Consultant<br>Speed To Market, Inc.<br>PO Box 3018<br>Nederland, CO 80466 USA<br>[e-mail]<br>303 956 4232 |
| Trade Name: | Spacelabs élance Vital Signs Monitoring System |
| Common Name: | Patient Physiological Monitor (with arrhythmia detection or alarms) |
| Classification Name: | Monitor, physiological, patient (with arrhythmia detection or alarms) |
| Classification<br>Regulation: | 21 CFR §870.1025 |
| Product Code: | MHX |

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| Substantially<br>Equivalent Devices: | Spacelabs élance Vital Signs<br>Monitoring System | Predicate 510(k)<br>Number | Predicate<br>Manufacturer / Model |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---------------------------------------------------------------|
| | ECG component | K001775 | Zoe Medical Nightingale<br>Monitoring System |
| | Respiration component | | |
| | Non-invasive blood pressures<br>component | | |
| | Invasive blood pressures<br>component | | |
| | Temperature component | | |
| | Expired and/or inspired CO2<br>component | K060065 | Oridion Capnostream 20 |
| | Functional arterial oxygen<br>saturation component | K033296 | Masimo Corporation SET<br>Rad 5 MS-11 board |
| | Arrhythmia detection and<br>invasive pressure monitoring<br>(IBP) | K062144 | Invivo Escort M8 Vital<br>Signs Patient Monitor<br>Model 3810 |
| | Functional arterial oxygen<br>saturation component | K012891 | Nellcor Oximax N-595<br>pulse oximeter |
| Device Description: | The Spacelabs Healthcare Medical Equipment (Suzhou) Co., Ltd.<br>(Spacelabs) élance Vital Signs Monitoring System (élance) is a family<br>of portable patient monitors intended to be used by clinicians and<br>medical qualified personnel for monitoring ECG, Respiration, NIBP,<br>Temperature, SPO2, Invasive Blood Pressure and EtCO2. Models<br>within the Spacelabs élance family come in two different sized viewing<br>areas (10.2" and 12.1"), two different housing colors (white and black)<br>and offer selected monitoring features. See the following Product<br>Configuration List for the identified models and Spacelabs defined<br>monitoring features. | | |
| Central Station: | A software package (93900) is available for use with customer acquired<br>computer based on specifications provided by Spacelabs Medical. This<br>package allows monitoring of the élance at a central workstation. | | |
| Technology<br>Comparison: | The élance utilizes the same or similar technology for each parameter<br>as utilized by the predicate devices. | | |

. . .

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#### Intended Use:

The Spacelabs élance Vital Signs Monitor is indicated for use in patient populations for:

- Adult
- Pediatric

The Spacelabs élance Vital Signs Monitor facilitates the monitoring of:

- ECG with arrhythmia detection
- Respiration
- Non-invasive blood pressures
- Invasive blood pressures
- Body temperature
- Functional arterial oxygen saturation, and
- Expired and/or inspired CO2.

The Spacelabs élance Vital Signs Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

#### Performance Testing:

| Sterilization<br>Validation | The Spacelabs élance is not sterilized or sterilizable, and therefore this<br>section does not apply to the monitor itself. |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Shelf Life Testing | The Spacelabs élance is not sterilized or sterilizable, and therefore this<br>section does not apply to the monitor itself. |
| Biocompatibility<br>Testing | The Spacelabs élance has no patient contact materials, and therefore<br>this section does not apply to the monitor itself. |
| Software Testing | Software for the Spacelabs élance was designed and developed according<br>to a robust software development process, and was rigorously verified<br>and validated. Test results indicated that the Spacelabs élance complies<br>with its predetermined specification. |
| Electrical Safety | The Spacelabs élance was tested for patient safety in accordance with<br>applicable Standards. Test results indicated that the Spacelabs élance<br>complies with its predetermined specification. |
| Electromagnetic<br>Compatibility Testing | The Spacelabs élance was tested for EMC in accordance with<br>applicable Standards. Test results indicated that the Spacelabs élance<br>complies with its predetermined specification. |
| Performance Testing<br>– Bench | The Spacelabs élance was tested in accordance with internal requirements<br>and procedures, and test results indicated that the device complies with<br>the predetermined requirements. This testing includes performance and<br>functional, environmental, and shipping and transportation testing. |
| Performance Testing<br>— Animal: | Animal performance testing was not performed and is not necessary to<br>demonstrate safety and effectiveness of the Spacelabs élance. |

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| Performance Testing | Clinical performance testing was not performed and is not necessary to |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| – Clinical: | demonstrate safety and effectiveness of the Spacelabs élance. |
| Conclusion | Based upon a comparison of devices and performance testing results,<br>the Spacelabs élance is substantially equivalent to the predicate devices. |

. . . .

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Public Health Service

Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design, resembling an eagle or a bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the design.

MAY 19 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spacelabs Healthcare Medical Equipment (Suzhou) Co., Ltd. c/o Mr. Thomas Kroenke Speed To Market, Inc. P.O. Box 3018 Nederland, CO 80466

Re: K090556

Trade/Device Name: élance Vital Signs Monitoring System; and, élance Central Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (including ST-segment measurement and alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: February 23, 2009 Received: March 2, 2009

Dear Mr. Kroenke:

This letter corrects our substantially equivalent letter of April 30, 2009.

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 (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.

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.

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Page 2 - Mr. Thomas Kroenke

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 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

signature

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

| 510(k) Number (if known): | K |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Spacelabs Healthcare, Inc. (Spacelabs) élance Vital Signs<br>Monitoring System |
| Indications for Use: | The Spacelabs élance Vital Signs Monitor is indicated for use in<br>patient populations for:<br>- Adult<br>- Pediatric |
| | The Spacelabs élance Vital Signs Monitor facilitates the<br>monitoring of:<br>- ECG with arrhythmia detection<br>- Respiration<br>- Non-invasive blood pressures<br>- Invasive blood pressures<br>- Body temperature<br>- Functional arterial oxygen saturation, and<br>- End title CO2. |
| | The Spacelabs élance Vital Signs Monitor is a prescription<br>device intended to be used by healthcare professionals in all<br>areas of a healthcare facility. |

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

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(Division Sign-Off) Division of Cardiovascular Devices Division of Caraloversealar Bo
510(k) Number_Ko G0 53 G

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