elance Vital Signs Monitor, Central Monitor Software

K150329 · Spacelabs Healthcare · MHX · Nov 5, 2015 · Cardiovascular

Device Facts

• Record ID: K150329
• Device Name: elance Vital Signs Monitor, Central Monitor Software
• Applicant: Spacelabs Healthcare
• Product Code: MHX · Cardiovascular
• Decision Date: Nov 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Spacelabs élance Vital Signs Monitor and élance Central Station is indicated for use in patient populations for: - Adult - Pediatric (1 year old and above) The Spacelabs élance Vital Signs Monitor and élance Central Station facilitates the monitoring of: - ECG with arrhythmia detection - Respiration - Non-invasive blood pressures - Invasive blood pressures - Body temperature - Functional arterial oxygen saturation, and - End tidal CO2. The Spacelabs élance Vital Signs Monitor and élance Central Station is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

Device Story

Portable patient monitor family (10.2" or 12.1" displays) and central station software; monitors physiological signals including ECG, respiration, blood pressure (invasive/non-invasive), temperature, SpO2, and EtCO2. Used by clinicians in healthcare facilities. Central station software runs on customer-acquired hardware to aggregate data from monitors. Provides real-time monitoring, arrhythmia detection, and ST-segment analysis. Output allows clinicians to assess patient status, adjust care, and respond to alarms. Benefits include continuous physiological surveillance and timely clinical intervention.

Clinical Evidence

Bench testing only. No clinical data presented. Performance verified against standards including ANSI/AAMI EC57 (arrhythmia/ST-segment), ANSI/AAMI SP10 (NIBP), EN 12470-4 (thermometers), ISO 80601-2-55 (gas monitors), and ISO 80601-2-61 (pulse oximeters). Electrical safety and EMC testing performed per IEC 60601 series.

Technological Characteristics

Portable patient monitor with LCD display (10.2"/12.1"). Parameters: ECG, respiration, NIBP, IBP, temperature, SpO2, EtCO2. Connectivity: Central station software for networked monitoring. Software class: Major level of concern. Standards: IEC 60601-1, IEC 60601-1-2, ANSI/AAMI EC57, ANSI/AAMI SP10, EN 12470-4, EN 60601-1-8, EN 62366, IEC 60601-2-27, IEC 60601-2-30, IEC 60601-2-34, IEC 60601-2-49, ISO 80601-2-55, ISO 80601-2-61.

Indications for Use

Indicated for adult and pediatric patients (1 year and older) in healthcare facilities for monitoring ECG (with arrhythmia detection), respiration, non-invasive/invasive blood pressure, body temperature, functional arterial oxygen saturation, and end-tidal CO2.

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 Healthcare élance Vital Signs Monitor and élance Central Station (K093501)
• Masimo Corporation Masimo SET® Rad-5 Pulse Oximeter (K033296)
• Nellcor Puritan Bennett Incorporated OxiMAX Pulse Oximetry System with N-595 Pulse Oximeter and OxiMAX Sensors and Cables (K012891)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 5, 2015

Spacelabs Healthcare % Thomas Kroenke, Principal Consultant Speed To Market, Inc. PO Box 3018 Nederland, Colorado 80466

Re: K150329

Trade/Device Name: élance Vital Signs Monitor and élance Central Station Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX Dated: October 1, 2015 Received: October 6, 2015

Dear Thomas Kroenke:

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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mitchell Stein

for 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

K150329 510(k) Number (if known):

Device Name: élance Vital Signs Monitor and élance Central Station

Indications For Use: The Spacelabs élance Vital Signs Monitor and élance Central Station is indicated for use in patient populations for:

- Adult ।
- -Pediatric (1 year old and above)

The Spacelabs élance Vital Signs Monitor and élance Central Station facilitates the monitoring of:

- ECG with arrhythmia detection -
- -Respiration
- Non-invasive blood pressures -
- -Invasive blood pressures
- -Body temperature
- Functional arterial oxygen saturation, and -
- -End tidal CO2.

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

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 Center for Devices and Radiological Health (CDRH)

Page 1 of 1

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| Submission Date: | 01 October 2015 | | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Spacelabs Healthcare<br>35301 SE Center St<br>Snoqualmie, WA 98065 | | |
| Submitter Contact: | Mr. Al Van Houdt<br>Spacelabs Healthcare<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | | |
| Application<br>Correspondent: | Thomas Kroenke<br>Speed To Market, Inc.<br>PO Box 3018<br>Nederland, CO 80466 USA<br>[e-mail]<br>303 956 4232 | | |
| Manufacturing Site: | Spacelabs Healthcare<br>35301 SE Center St<br>Snoqualmie, WA 98065 | | |
| Trade Name: | élance Vital Signs Monitor and élance Central Station | | |
| Common Name: | Patient Physiological Monitor (with arrhythmia detection or alarms) | | |
| Classification Name: | Patient Physiological Monitor (with arrhythmia detection or alarms) | | |
| Primary<br>Classification<br>Regulation: | 21 CFR §870.1025 | | |
| Primary Product<br>Code: | MHX | | |
| Substantially<br>Equivalent Devices: | New Spacelabs Model | Predicate<br>510(k) Number | Predicate<br>Manufacturer / Model |
| | Spacelabs Healthcare élance<br>Vital Signs Monitor and<br>élance Central Station | K093501 | Spacelabs Healthcare élance<br>Vital Signs Monitor and élance<br>Central Station |
| | | K033296 | Masimo Corporation Masimo<br>SET® Rad-5 Pulse Oximeter |
| | | K012891 | Nellcor Puritan Bennett<br>Incorporated OxiMAX Pulse<br>Oximetry System with N-595 Pulse<br>Oximeter and OxiMAX Sensors<br>and Cables |

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| Device Description: | The Spacelabs Healthcare (Spacelabs) élance Vital Signs Monitor is a<br>family of portable patient monitors intended to be used by clinicians<br>and medical qualified personnel for monitoring ECG with arrhythmia<br>detection, respiration, NIBP, temperature, SPO2, invasive blood<br>pressure and EtCO2. Models within the Spacelabs élance family come<br>in two different sized viewing areas (10.2" and 12.1"), two different<br>housing colors (white and black) and offer selected monitoring<br>features. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Spacelabs élance Central Station software package is available for<br>use with a customer acquired computer based on specifications<br>provided by Spacelabs. This package allows monitoring of the élance<br>Vital Signs Monitor at a central workstation. |
| Intended Use: | The Spacelabs élance Vital Signs Monitor and élance Central Station is<br>indicated for use in patient populations for:<br>- Adult<br>- Pediatric (1 year old and above)<br>The Spacelabs élance Vital Signs Monitor and élance Central Station<br>facilitates the 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 tidal CO2.<br>The Spacelabs élance Vital Signs Monitor and élance Central Station is<br>a prescription device intended to be used by healthcare professionals in<br>all areas of a healthcare facility. |

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### Technology Comparison:

The Spacelabs Spacelabs élance Vital Signs Monitor and élance Central Station employs the same technological characteristics as the predicate device.

| Characteristic | Predicate Device | Proposed Device |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Parameters | ECG with arrhythmia<br>detection<br>Respiration<br>Non-invasive blood pressure<br>Invasive blood pressure<br>Body temperature<br>Functional arterial oxygen<br>saturation, and<br>End tidal CO2. | Same |
| Display Type | LCD | Same |
| Display Sizes | 10.2" and 12.1" | Same |
| VSM Variants | 5, 5i, 5c, 5 elite, 5i elite, 5c<br>elite<br>7, 7i, 7c, 7 elite, 7i elite, 7c<br>elite | Same |
| Additional Options | - | 93300-M, Masimo SpO2<br>93300-N, Nellcor SpO2<br>93300-A: Arrhythmia<br>93300-S: ST Segment Analysis |

#### Summary of Performance Testing:

Software

The élance VSM and élance CS contain MAJOR level of concern software. Software was designed and developed according to a robust software development process, and was rigorously verified and validated. Software information is provided in accordance with

- · FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05;
- · FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99:
- FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02; and
- · FDA guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 14 Jun 13

Test results indicated that the élance VSM and élance CS software comply with predetermined specification.

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| Electrical Safety | The élance VSM was tested for patient safety in accordance with:<br>IEC 60601-1:1988, Am1: 1991, Am2: 1995, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. Test results indicated that the élance VSM complies with the applicable standards. |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electromagnetic Compatibility | The élance VSM was tested for EMC in accordance with:<br>IEC 60601-1-2: 2007, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. Test results indicated that the élance VSM complies with the applicable standards. |
| Performance Testing – Bench | The élance VSM was tested for parameter performance in accordance with:<br>ANSI/AAMI EC57: 1998/(R) 2003, Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms; ANSI/AAMI SP10: 2002, Am1: 2003, Manual, electronic, or automated sphygmomanometers; EN 12470-4: 2009, Clinical thermometers – Part 4: Performance of electrical thermometers for continuous measurement; EN 60601-1-6: 2010, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability; EN 60601-1-8 2007, Am1: 2013, AC: 2014, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems; EN 62366: 2008, Medical devices - Application of usability engineering to medical devices; IEC 60601-2-27: 2005, Medical electrical equipment – Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment; |

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- Performance Testing – Bench (continued)
- · IEC 60601-2-30: 1999, Medical electrical equipment Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment;
- · IEC 60601-2-34: 2000, Medical electrical equipment Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment;
- · IEC 60601-2-49: 2011, Medical electrical equipment Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment;
- ISO 80601-2-55: 2011, Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors; and
- ISO 80601-2-61: 2011, Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.

The élance CS was tested for parameter performance in accordance with:

- EN 60601-1-6: 2010, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability;
- EN 60601-1-8 2007, Am1: 2013, AC: 2014, Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems;
- · EN 62366: 2008, Medical devices Application of usability engineering to medical devices;
- · Test results indicated that the élance VSM and élance CS comply with these Standards. Additionally, the élance VSM and élance CS were tested in accordance with internal requirements and procedures, and test results indicated that the devices comply with the predetermined requirements.

#### Verification and validation activities were conducted to establish the Conclusion performance and safety characteristics of the élance VSM and élance CS. The results of these activities demonstrate that the élance VSM and élance CS are as safe, as effective, and perform as well as or better than the predicate devices. Therefore, the élance VSM and élance CS are considered substantially equivalent to the predicate devices.