XHIBIT CENTRAL STATION, MODEL 96102

K122146 · Spacelabs Healthcare · MHX · Apr 22, 2013 · Cardiovascular

Device Facts

• Record ID: K122146
• Device Name: XHIBIT CENTRAL STATION, MODEL 96102
• Applicant: Spacelabs Healthcare
• Product Code: MHX · Cardiovascular
• Decision Date: Apr 22, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Spacelabs Healthcare Xhibit Central Station, Model 96102 intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms. The Spacelabs Healthcare Xhibit Central Station, Model 96102 is a prescription device intended for use under the direct supervision of a licensed healthcare professional.

Device Story

Xhibit Central Station (Model 96102) provides remote surveillance of patient data from networked Spacelabs Ultraview or Ultraview SL bedside monitors and telemetry systems. Device receives physiological waveforms, calculations, cardiac arrhythmia data, ST data, and patient demographics via TCP/IP network. System displays data for up to 48 patients simultaneously; provides prioritized alarms. Used in clinical settings by healthcare professionals to monitor treatment adequacy and exclude symptom causes. Not a primary alarming device. Output allows clinicians to review patient status centrally, facilitating clinical decision-making and patient management.

Clinical Evidence

No clinical data. Performance established via bench testing, including software verification and validation, electromagnetic compatibility (IEC 60601-1-2: 2007), alarm system testing (IEC 60601-1-8: 2006), and usability engineering (IEC 62366: 2007).

Technological Characteristics

Networked central monitoring station; TCP/IP communication; supports up to 48 patients; prioritized alarm system. Software developed per IEC 62304. Hardware compliant with IEC 60601-1-2 (EMC) and IEC 60601-1-8 (alarms).

Indications for Use

Indicated for central monitoring of adult, pediatric, and neonatal patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. Used to monitor physiological waveforms, calculations, cardiac arrhythmia, ST data, and demographics to assess treatment adequacy or exclude symptoms. Prescription use only under licensed professional supervision.

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

• Philips Medical Systems Intellivue M3290A (Release G), M3155 Configuration (K050742)

Submission Summary (Full Text)

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# 510(k) Summary

Submission Date:

Submitter Contact:

## 08 April 2013

Submitter:

Spacelabs Healthcare 5150 220th Avenue SE Issaquah, WA 98029

Spacelabs Healthcare 5150 220th Avenue SE Issaquah, WA 98029

Mr. David J. Geraghty Spacelabs Healthcare Phone: [phone], ext 5889 Fax: [phone] Email: [e-mail]

Application Correspondent: Thomas Kroenke Principal Consultant Speed To Market, Inc. PO Box 3018 Nederland, CO 80466 USA [e-mail] 303 956 4232

Manufacturing Site:

Spacelabs Healthcare 5150 220th Avenue SE Issaquah, WA 98029

Trade Name:

Central Station Remote Monitor Common Name:

Classification Name:

Alarms); 21 CFR §870.1025

Spacelabs Healthcare Xhibit Central Station, Model 96102

Monitor, Physiological, Patient (With Arrhythmia Detection or

Primary Classification Regulation:

Primary Product Code:

## MHX

21 CFR §870.1025; 21 CFR §870.2300 : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

: '

DSI; MLD; MSX

Secondary Classification Regulation:

Secondary Product Code:

· Page I of 4

APR 2 2 2013

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# 510(k) Summarv

#### K122146

Information Center

| Substantially | New Spacelabs Model | Predicate<br>510(k) Number | Predicate<br>Manufacturer / Model |
|---------------------|----------------------------------------------------------------|----------------------------|-------------------------------------------------------------------------------------------------|
| Equivalent Devices: | | | |
| | Spacelabs Healthcare<br>Xhibit Central Station,<br>Model 96102 | K050742 | Philips Medical Systems<br>Intellivue M3290A<br>(Release G), M3155<br>Configuration, Intellivue |

Device Description:

The Spacelabs Healthcare (Spacelabs) Xhibit Central Station, Model 96102 (Xhibit), is a new version of currently marketed Spacelabs product. Xhibit offers remote surveillance of patient data for those patients connected to a Spacelabs Healthcare Ultraview, Ultraview SL bedside monitor, or telemetry system. Xhibit provides for data communication using the TCP/IP network protocol employed in the Spacelabs Patient Care Management network of hardwired and/or telemetry monitored patients.

Xhibit is not the primary alarming device for the Ultraview or Ultraview SL telemetry system.

The Spacelabs Healthcare Xhibit Central Station, Model 96102 intended use is to provide clinicians with central monitoring of adult. pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms.

The Spacelabs Healthcare Xhibit Central Station, Model 96102 is a prescription device intended for use under the direct supervision of a licensed healthcare professional.

Xhibit employs the same technological characteristics as the predicate device.

| Characteristic | Predicate Device | Proposed Device |
|--------------------------------------|------------------|-----------------|
| Number of Patients per Display | 16 | Same |
| Patients per Central Station | Up to 16 | Up to 48 |
| Traces per Display | Up to 32 | Same |
| Dedicated Display for Data<br>Review | Yes | Same |
| Prioritized Alarms | Yes | Same |

Technology Comparison:

Intended Use:

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# 510(k) Summary

# Summary of Performance Testing:

.

| Software Testing | Xhibit contains MAJOR level of concern software. Software was<br>designed and developed according to a robust software development<br>process, and was rigorously verified and validated. Software<br>information is provided in accordance with internal requirements and<br>the following standards and guidance documents:<br>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; FDA guidance: Cybersecurity for networked medical devices containing off-the-shelf (OTS) software, 14 January 2005; and IEC 62304: 2006, Medical device software - Software life cycle processes. Test results indicate that the Xhibit complies with its predetermined specifications and the applicable standards and guidance documents. |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electromagnetic<br>Compatibility<br>Testing | Xhibit hardware was tested for performance in accordance with the following Standard:<br>IEC 60601-1-2: 2007, Medical electrical equipment – Part 1-2:<br>General requirements for basic safety and essential performance -<br>Collateral standard: Electromagnetic compatibility - Requirements and tests. Test results indicated that Xhibit complies with the Standard. |
| Performance Testing | Xhibit was tested for performance in accordance with internal requirements and the following standards:<br>IEC 60601-1-8: 2006, Medical electrical equipment - General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. IEC 62366: 2007, Medical devices - Application of usability engineering to medical devices. Test results indicate that Xhibit complies with its predetermined specifications and the applicable standards. |

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# 510(k) Summary

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### Conclusion

Verification and validation activities were conducted to establish the performance and safety characteristics of Xhibit. The results of these activities demonstrate that Xhibit is safe and effective when used in accordance with its intended use and labeling.

. .

Therefore, Xhibit is considered substantially equivalent to the predicate device. ・

>

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its body or wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

April 22, 2013

Spacelabs Healthcare c/o Mr. Thomas Kroenke P.O. Box 3018 Nederland, CO 80466 US

Re: K122146 Xhibit Central Station, model 96102 Regulation Number: 21 CFR 870.1025 Regulation Name: Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms) Regulatory Class: Class II Product Code: MHX, DSI, MLD, MSX Dated: April 8, 2013 Received: July 19, 2012

Dear Mr. 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.

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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 (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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Owen-PFaris-S

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

| 510(k) Number (if known): | K K122146 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Spacelabs Healthcare Xhibit Central Station, Model 96102 |
| Indications for Use: | The Spacelabs Healthcare Xhibit Central Station, Model 96102 intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms. The Spacelabs Healthcare Xhibit Central Station, Model 96102 is a prescription device intended for use under the direct supervision of a licensed healthcare professional. |

Prescription Use X (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)

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