(184 days)
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.
The Spacelabs Healthcare Ltd. (Spacelabs) Sentinel Cardiology Information Management System (Spacelabs) is a stand-alone software product which can capture, store, access and manage electrocardiograph (ECG), ambulatory blood pressure (ABP), stress test, ergospirometry, spirometry, event and plethysmography data with Holter analyses and reports, together with the corresponding patient information. Sentinel can be used as a single stand-alone installation, or as part of a multi-user network. Sentinel may be used for recording and reviewing of ECG of adults and pediatrics in a clinical environment inside and outside of hospitals.
The provided document does not contain detailed acceptance criteria or a study proving the device meets specific performance criteria in the format requested. The document focuses on regulatory submission (510(k)) for the Spacelabs Sentinel Cardiology Information Management System, asserting substantial equivalence to predicate devices, and referencing general quality and safety standards for software and medical electrical equipment.
It states:
- "Test results indicated that Spacelabs Sentinel complies with predetermined specifications and the applicable standard." (Page 6)
- "Verification results indicated that Spacelabs Sentinel complies with the applicable requirements of the standard." (Page 6)
- "Test results indicated that Spacelabs Sentinel complies with predetermined specifications and the applicable standards." (Page 7)
- "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." (Page 7)
However, it does not explicitly list what those "predetermined specifications" or "applicable standards" are in terms of performance metrics (e.g., sensitivity, specificity, accuracy for interpretations), nor does it describe specific studies with sample sizes, ground truth establishment, or expert involvement for these performance metrics.
The "Summary of Performance Testing" section primarily lists compliance with general software development standards (FDA guidance documents, IEC 62304) and electrical safety/usability standards (IEC 60601-1, IEC 60601-1-6, IEC 60601-2-25, IEC 80601-2-30, IEC 62366). While these are important for device safety and functionality, they are not performance criteria related to the diagnostic accuracy of features like "automatic interpretation of 12-lead ECG."
Therefore, based only on the provided text, I cannot complete the table or answer all the requested questions. The document mentions "automatic interpretation of 12-lead ECG" as a feature but does not provide the performance data or details of a study to validate this interpretation.
If more detailed performance study information were available in an accompanying document, it would be needed to answer your request fully.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) |
|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Submission Date: | 25 February 2016 |
|---|---|
| Submitter: | Spacelabs Healthcare Ltd.1 Harforde CourtJohn Tate RoadHertford United KingdomSG13 7NW |
| Submitter Contact: | Mr. Al Van HoudtSpacelabs HealthcarePhone: +1 (425) 363-5970Fax: +1 (425) 363-5762Email: al.vanhoudt@spacelabs.com |
| ApplicationCorrespondent: | Thomas KroenkeSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net303 956 4232 |
| Manufacturing Site: | Spacelabs Healthcare35301 SE Center StreetSnoqualmie, WA 98065 |
| Trade Name: | Sentinel Cardiology Information Management System |
| Common Name: | Programmable Diagnostic Computer |
| Primary ClassificationName: | Programmable Diagnostic Computer |
| Primary ClassificationRegulation: | 21 CFR §870.1425 |
| Primary Product Code: | DQK |
| SecondaryClassification Name: | Transmitters and Receivers, Electrocardiograph, Telephone |
| SecondaryClassificationRegulation: | 21 CFR §870.2920 |
| Secondary ProductCode: | DXH |
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| SubstantiallyEquivalent Devices: | New SpacelabsModel | Predicate510(k) Number | PredicateManufacturer / Model |
|---|---|---|---|
| Sentinel CardiologyInformation ManagementSystem | K062397 | DelMar Reynalds Medical Ltd.(now part of SpacelabsHealthcard Ltd.) / Sentinel | |
| K130155 | GE Medical SystemsInformation Technologies /MUSE Cardiology InformationSystem | ||
| Device Description: | The Spacelabs Healthcare Ltd. (Spacelabs) Sentinel CardiologyInformation Management System (Spacelabs) is a stand-alonesoftware product which can capture, store, access and manageelectrocardiograph (ECG), ambulatory blood pressure (ABP), stresstest, ergospirometry, spirometry, event and plethysmography datawith Holter analyses and reports, together with the correspondingpatient information. Sentinel can be used as a single stand-aloneinstallation, or as part of a multi-user network. Sentinel may be usedfor recording and reviewing of ECG of adults and pediatrics in aclinical environment inside and outside of hospitals. | ||
| Intended Use: | The Sentinel Cardiology Information Management System isintended to connect to supported medical devices and analyzers inorder to download, store, access and manage cardiovascularinformation and to manage patient and facility information. | ||
| The Sentinel Cardiology Information Management System providesdownload and storage of data from supported Holter recorders andfeeds this data to separate and optional Holter analyzers. Thecompleted reports are stored back in Sentinel. | |||
| The Sentinel Cardiology Information Management Systemfacilitates presenting, analyzing, reviewing cardiovascularinformation, including automatic interpretation of 12 lead ECG andstores the finished reports. The automatic interpretation of 12-leadECG is not suitable for neonates. | |||
| Sentinel supports importing reports from external systems andprovides an HL7 interface to external systems. | |||
| The Sentinel Cardiology Information Management System isintended to be used by a trained user and as an aid to a medicalprofessional in hospital or primary care environment. | |||
| The Sentinel Cardiology Information Management System is notintended 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 SystemsMUSE | DelMar ReynaldsMedical Ltd.Sentinel | Proposed Device |
|---|---|---|---|
| Acquisitionand Analysis | All compatibledevices ECGmeasurements View ECGwaveforms Print ECGwaveforms Edit interpretation Serial presentationGE devices ECG interpretation- Marquette 12SL Serial comparison 15 leadadult/pediatric Right ventricularinvolvement ECGinterpretation Third party devicesdifferent than above ECG interpretation- Vendor specific | ABP: TrackerNIBP2,P6, 90207, 90217 Acquire test Edit test Print test View test Holter: Lifecard CF,Aria View ECGwaveforms Print ECGwaveforms Edit interpretation 12 Lead: CD12-Serial, CardioCollect ECG interpretation View ECGwaveforms Print ECGwaveforms Edit interpretation Carts: Voyager, GE-Mac 5000, GE-Mac5500, PhilipsPagewriter,CarioCollect View ECGwaveforms Print ECGwaveforms Edit interpretation | ABP: TrackerNIBP2,90207, 90217,90217A, 90227 Acquire test Edit test Print test Review test Serial presentation Holter, Lifecard CF,Aria. EVO Review ECGwaveforms Print ECGwaveforms Edit interpretation 12-Lead: CD12-Serial, CD12-USB ECG interpretation View ECGwaveforms Print ECGwaveforms Edit interpretation Serial presentation Carts: Voyager, GE-Mac 5000, PhilipsPagewriter Review ECGwaveforms Print ECGwaveforms Edit interpretation Third party devicesdifferent than above ECG interpretation- Vendor specific |
| Modalities | 12 lead restingECG Bedside 12 leadECG Defibrillators | Ambulatory BP 12 lead ECG:Resting Holter Stress | Ambulatory BP 12 lead ECG:Resting andRhythm Holter Stress Event |
| Characteristic | GE Medical SystemsMUSE | DelMar ReynaldsMedical Ltd.Sentinel | Proposed Device |
| ArrhythmiaAnalysis | • Marquette 12SLECG analysis | • Glasgow ECGanalysis for 12 leadECG• HES analysis forstress tests | • Glasgow ECGanalysis for 12 leadECG• HES analysis forstress tests |
Page 3 of 5
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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.
§ 870.1425 Programmable diagnostic computer.
(a)
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.(b)
Classification. Class II (performance standards).