SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM

K152881 · Spacelabs Healthcare, Ltd. · DQK · Apr 1, 2016 · Cardiovascular

Device Facts

• Record ID: K152881
• Device Name: SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM
• Applicant: Spacelabs Healthcare, Ltd.
• Product Code: DQK · Cardiovascular
• Decision Date: Apr 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Indications for Use

The Sentinel Cardiology Information Management System is intended to connect to supported medical devices and analyzers in order to download, store, access and manage cardiovascular information and facility information. The Sentinel Cardiology Information Management System provides download and storage of data from supported Holter recorders and feeds this data to separate and optional Holter analyzers. The completed reports are stored back in Sentinel. The Sentinel Cardiology Information Management System facilitates presenting, analyzing, reviewing cardiovascular information, including automatic interpretation of 12 lead ECG and stores the finished reports. The automatic interpretation of 12-lead ECG is not suitable for neonates. Sentinel supports importing reports from external systems and provides an HL7 interface to external systems. The Sentinel Cardiology Information Management System is intended to be used by a trained user and as an aid to a medical professional in hospital or primary care environment. The Sentinel Cardiology Information Management System is not intended for patient monitoring.

Device Story

Sentinel Cardiology Information Management System is a standalone software platform for capturing, storing, and managing cardiovascular data; inputs include ECG, ambulatory blood pressure (ABP), stress test, ergospirometry, spirometry, event, and plethysmography data from supported medical devices. System operates as a single installation or multi-user network; used by trained clinicians in hospitals or primary care. It integrates Glasgow ECG analysis for 12-lead ECG and HES analysis for stress tests to provide automated interpretations. Outputs include finished reports and reviewed waveforms; clinicians use these to aid in diagnosis and clinical decision-making. System supports HL7 interfaces for external system integration. Benefits include centralized data management, standardized reporting, and automated diagnostic support, improving clinical workflow efficiency.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation activities included software life cycle processes (IEC 62304), electrical safety (IEC 60601-1), usability (IEC 62366), and performance testing against specific standards for electrocardiographs (IEC 60601-2-25) and automated non-invasive sphygmomanometers (IEC 80601-2-30).

Technological Characteristics

Standalone software for cardiology data management. Connectivity via network; supports HL7 interface. Implements Glasgow ECG analysis and HES stress test analysis algorithms. Designed to comply with IEC 62304 (software life cycle), IEC 60601-1 (safety), and IEC 62366 (usability).

Indications for Use

Indicated for use by trained medical professionals in hospital or primary care environments to manage cardiovascular data (ECG, ABP, stress, ergospirometry, spirometry, event, plethysmography) for adult and pediatric patients. Automatic 12-lead ECG interpretation is contraindicated for neonates. Not for patient monitoring.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• Sentinel (K062397)
• MUSE Cardiology Information System (K130155)

Submission Summary (Full Text)

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Public Health Service

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

April 1, 2016

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

Re: K152881

Trade/Device Name: Sentinel Cardiology Information Management System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DXH Dated: February 26, 2016 Received: February 29, 2016

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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,

FDA

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) K152881 Page 1 of 1

Device Name

Spacelabs Healthcare Ltd. Sentinel Cardiology Information Management System

Indications for Use (Describe)

The Sentinel Cardiology Information Management System is intended to connect to supported medical devices and analyzers in order to download, store, access and manage cardiovascular information and facility information.

The Sentinel Cardiology Information Management System provides download and storage of data from supported Holter recorders and feeds this data to separate and optional Holter analyzers. The completed reports are stored back in Sentinel.

The Sentinel Cardiology Information Management System facilitates presenting, analyzing, reviewing cardiovascular information, including automatic interpretation of 12 lead ECG and stores the finished reports. The automatic interpretation of 12-lead ECG is not suitable for neonates.

Sentinel supports importing reports from external systems and provides an HL7 interface to external systems. The Sentinel Cardiology Information Management System is intended to be used by a trained user and as an aid to a medical professional in hospital or primary care environment.

The Sentinel Cardiology Information Management System is not intended for patient monitoring.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:10px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span> <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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| Submission Date: | 25 February 2016 |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Spacelabs Healthcare Ltd.<br>1 Harforde Court<br>John Tate Road<br>Hertford United Kingdom<br>SG13 7NW |
| 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 Street<br>Snoqualmie, WA 98065 |
| Trade Name: | Sentinel Cardiology Information Management System |
| Common Name: | Programmable Diagnostic Computer |
| Primary Classification<br>Name: | Programmable Diagnostic Computer |
| Primary Classification<br>Regulation: | 21 CFR §870.1425 |
| Primary Product Code: | DQK |
| Secondary<br>Classification Name: | Transmitters and Receivers, Electrocardiograph, Telephone |
| Secondary<br>Classification<br>Regulation: | 21 CFR §870.2920 |
| Secondary Product<br>Code: | DXH |

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| Substantially<br>Equivalent Devices: | New Spacelabs<br>Model | Predicate<br>510(k) Number | Predicate<br>Manufacturer / Model |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-------------------------------------------------------------------------------------------|
| | Sentinel Cardiology<br>Information Management<br>System | K062397 | DelMar Reynalds Medical Ltd.<br>(now part of Spacelabs<br>Healthcard Ltd.) / Sentinel |
| | | K130155 | GE Medical Systems<br>Information Technologies /<br>MUSE Cardiology Information<br>System |
| Device Description: | The Spacelabs Healthcare Ltd. (Spacelabs) Sentinel Cardiology<br>Information Management System (Spacelabs) is a stand-alone<br>software product which can capture, store, access and manage<br>electrocardiograph (ECG), ambulatory blood pressure (ABP), stress<br>test, ergospirometry, spirometry, event and plethysmography data<br>with Holter analyses and reports, together with the corresponding<br>patient information. Sentinel can be used as a single stand-alone<br>installation, or as part of a multi-user network. Sentinel may be used<br>for recording and reviewing of ECG of adults and pediatrics in a<br>clinical environment inside and outside of hospitals. | | |
| Intended Use: | The Sentinel Cardiology Information Management System is<br>intended to connect to supported medical devices and analyzers in<br>order to download, store, access and manage cardiovascular<br>information and to manage patient and facility information. | | |
| | The Sentinel Cardiology Information Management System provides<br>download and storage of data from supported Holter recorders and<br>feeds this data to separate and optional Holter analyzers. The<br>completed reports are stored back in Sentinel. | | |
| | The Sentinel Cardiology Information Management System<br>facilitates presenting, analyzing, reviewing cardiovascular<br>information, including automatic interpretation of 12 lead ECG and<br>stores the finished reports. The automatic interpretation of 12-lead<br>ECG is not suitable for neonates. | | |
| | Sentinel supports importing reports from external systems and<br>provides an HL7 interface to external systems. | | |
| | The Sentinel Cardiology Information Management System is<br>intended to be used by a trained user and as an aid to a medical<br>professional in hospital or primary care environment. | | |
| | The Sentinel Cardiology Information Management System is not<br>intended for patient monitoring. | | |

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#### Technology Comparison:

The Spacelabs Sentinel Cardiology Information Management System employs the same technological characteristics as the predicate device.

| Characteristic | GE Medical Systems<br>MUSE | DelMar Reynalds<br>Medical Ltd.<br>Sentinel | Proposed Device |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Acquisition<br>and Analysis | All compatible<br>devices ECG<br>measurements View ECG<br>waveforms Print ECG<br>waveforms Edit interpretation Serial presentation<br>GE devices ECG interpretation<br>- Marquette 12SL Serial comparison 15 lead<br>adult/pediatric Right ventricular<br>involvement ECG<br>interpretation Third party devices<br>different than above ECG interpretation<br>- Vendor specific | ABP: TrackerNIBP2,<br>P6, 90207, 90217 Acquire test Edit test Print test View test Holter: Lifecard CF,<br>Aria View ECG<br>waveforms Print ECG<br>waveforms Edit interpretation 12 Lead: CD12-<br>Serial, CardioCollect ECG interpretation View ECG<br>waveforms Print ECG<br>waveforms Edit interpretation Carts: Voyager, GE-<br>Mac 5000, GE-Mac<br>5500, Philips<br>Pagewriter,<br>CarioCollect View ECG<br>waveforms Print ECG<br>waveforms Edit interpretation | ABP: TrackerNIBP2,<br>90207, 90217,<br>90217A, 90227 Acquire test Edit test Print test Review test Serial presentation Holter, Lifecard CF,<br>Aria. EVO Review ECG<br>waveforms Print ECG<br>waveforms Edit interpretation 12-Lead: CD12-<br>Serial, CD12-USB ECG interpretation View ECG<br>waveforms Print ECG<br>waveforms Edit interpretation Serial presentation Carts: Voyager, GE-<br>Mac 5000, Philips<br>Pagewriter Review ECG<br>waveforms Print ECG<br>waveforms Edit interpretation Third party devices<br>different than above ECG interpretation<br>- Vendor specific |
| Modalities | 12 lead resting<br>ECG Bedside 12 lead<br>ECG Defibrillators | Ambulatory BP 12 lead ECG:<br>Resting Holter Stress | Ambulatory BP 12 lead ECG:<br>Resting and<br>Rhythm Holter Stress Event |
| Characteristic | GE Medical Systems<br>MUSE | DelMar Reynalds<br>Medical Ltd.<br>Sentinel | Proposed Device |
| Arrhythmia<br>Analysis | • Marquette 12SL<br>ECG analysis | • Glasgow ECG<br>analysis for 12 lead<br>ECG<br><br>• HES analysis for<br>stress tests | • Glasgow ECG<br>analysis for 12 lead<br>ECG<br><br>• HES analysis for<br>stress tests |

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### Summary of Performance Testing:

| 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; |
| | • FDA guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 02 Oct 14; and |
| | • IEC 62304: 2006, Medical device software – Software life cycle processes. |
| | Test results indicated that Spacelabs Sentinel complies with predetermined specifications and the applicable standard. |
| Electrical Safety | Spacelabs Sentinel is a software product only, and designed to comply with the applicable requirements of: |
| | • IEC 60601-1: 2005, Am1: 2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance |
| | Verification results indicated that Spacelabs Sentinel complies with the applicable requirements of the standard. |

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Performance Testing -Spacelabs Sentinel was tested in accordance with: Bench • IEC 60601-1-6: 2010, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance --Collateral standard: Usability; · IEC 60601-2-25: 2011, Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs; • IEC 80601-2-30: 2013, Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers; and · IEC 62366: 2006, Am1: 2014, Medical devices - Application of usability engineering to medical devices. · Test results indicated that Spacelabs Sentinel complies with predetermined specifications and the applicable standards. Conclusion Verification and validation activities were conducted to establish the performance and safety characteristics of Spacelabs Sentinel. The results of these activities demonstrate that Spacelabs Sentinel is as safe, as effective, and performs as well as or better than the predicate device. Therefore, Spacelabs Sentinel is considered substantially equivalent

to the predicate device.