(184 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or methodologies that are characteristic of AI/ML, such as training data, test data, or specific algorithms like deep learning or neural networks. While it performs "automatic interpretation of 12 lead ECG", this can be achieved through rule-based systems or traditional signal processing techniques, not necessarily AI/ML.
No
The device is a Cardiology Information Management System used to download, store, access, and manage cardiovascular information, acting as an aid for medical professionals to present, analyze, and review data. It does not directly provide therapy.
Yes
Explanation: The device is intended to facilitate "presenting, analyzing, reviewing cardiovascular information, including automatic interpretation of 12 lead ECG" and is used "as an aid to a medical professional," which aligns with the function of a diagnostic device.
Yes
The device description explicitly states that the Sentinel Cardiology Information Management System is a "stand-alone software product". The performance studies also reinforce this by stating it is a "software product only".
Based on the provided information, the Sentinel Cardiology Information Management System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Sentinel system's intended use and device description clearly state that it connects to medical devices and analyzers to download, store, access, and manage cardiovascular information (ECG, ABP, stress test data, etc.). It processes data from these devices, not from human specimens directly.
- The system's function is focused on managing and presenting data related to the electrical and mechanical activity of the heart and related physiological measurements. This is distinct from analyzing biological samples.
- There is no mention of analyzing biological specimens or providing diagnostic information based on such analysis.
The Sentinel system is a Cardiology Information Management System, which is a type of medical device software used to handle and process data generated by other medical devices.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DQK, DXH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults and pediatrics. The automatic interpretation of 12-lead ECG is not suitable for neonates.
Intended User / Care Setting
Trained user and as an aid to a medical professional in hospital or primary care environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software: Software was designed and developed according to a robust software development process, and was rigorously verified and validated. 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.
Bench Testing: Spacelabs Sentinel was tested in accordance with: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
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
1
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
2
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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3
| Submission Date: | 25 February 2016 |
|---|---|
| Submitter: | Spacelabs Healthcare Ltd. |
| 1 Harforde Court | |
| John Tate Road | |
| Hertford United Kingdom | |
| SG13 7NW | |
| Submitter Contact: | Mr. Al Van Houdt |
| Spacelabs Healthcare | |
| Phone: +1 (425) 363-5970 | |
| Fax: +1 (425) 363-5762 | |
| Email: al.vanhoudt@spacelabs.com | |
| Application | |
| Correspondent: | Thomas Kroenke |
| Speed To Market, Inc. | |
| PO Box 3018 | |
| Nederland, CO 80466 USA | |
| tkroenke@speedtomarket.net | |
| 303 956 4232 | |
| Manufacturing Site: | Spacelabs Healthcare |
| 35301 SE Center Street | |
| Snoqualmie, WA 98065 | |
| Trade Name: | Sentinel Cardiology Information Management System |
| Common Name: | Programmable Diagnostic Computer |
| Primary Classification | |
| Name: | Programmable Diagnostic Computer |
| Primary Classification | |
| Regulation: | 21 CFR §870.1425 |
| Primary Product Code: | DQK |
| Secondary | |
| Classification Name: | Transmitters and Receivers, Electrocardiograph, Telephone |
| Secondary | |
| Classification | |
| Regulation: | 21 CFR §870.2920 |
| Secondary Product | |
| Code: | DXH |
4
| Substantially
Equivalent Devices: | New Spacelabs
Model | Predicate
510(k) Number | Predicate
Manufacturer / Model |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-------------------------------------------------------------------------------------------|
| | Sentinel Cardiology
Information Management
System | K062397 | DelMar Reynalds Medical Ltd.
(now part of Spacelabs
Healthcard Ltd.) / Sentinel |
| | | K130155 | GE Medical Systems
Information Technologies /
MUSE Cardiology Information
System |
| Device Description: | 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. | | |
| Intended 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 to manage patient 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. | | |
5
Technology Comparison:
The Spacelabs Sentinel Cardiology Information Management System employs the same technological characteristics as the predicate device.
| Characteristic | GE Medical Systems
MUSE | DelMar Reynalds
Medical Ltd.
Sentinel | Proposed Device |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Acquisition
and Analysis | All compatible
devices ECG
measurements View ECG
waveforms Print ECG
waveforms Edit interpretation Serial presentation
GE devices ECG interpretation
- Marquette 12SL Serial comparison 15 lead
adult/pediatric Right ventricular
involvement ECG
interpretation Third party devices
different than above ECG interpretation - Vendor specific | ABP: TrackerNIBP2,
P6, 90207, 90217 Acquire test Edit test Print test View test Holter: Lifecard CF,
Aria View ECG
waveforms Print ECG
waveforms Edit interpretation 12 Lead: CD12-
Serial, CardioCollect ECG interpretation View ECG
waveforms Print ECG
waveforms Edit interpretation Carts: Voyager, GE-
Mac 5000, GE-Mac
5500, Philips
Pagewriter,
CarioCollect View ECG
waveforms Print ECG
waveforms Edit interpretation | ABP: TrackerNIBP2,
90207, 90217,
90217A, 90227 Acquire test Edit test Print test Review test Serial presentation Holter, Lifecard CF,
Aria. EVO Review ECG
waveforms Print ECG
waveforms Edit interpretation 12-Lead: CD12-
Serial, CD12-USB ECG interpretation View ECG
waveforms Print ECG
waveforms Edit interpretation Serial presentation Carts: Voyager, GE-
Mac 5000, Philips
Pagewriter Review ECG
waveforms Print ECG
waveforms Edit interpretation Third party devices
different than above ECG interpretation - Vendor specific |
| Modalities | 12 lead resting
ECG Bedside 12 lead
ECG Defibrillators | Ambulatory BP 12 lead ECG:
Resting Holter Stress | Ambulatory BP 12 lead ECG:
Resting and
Rhythm Holter Stress Event |
| Characteristic | GE Medical Systems
MUSE | DelMar Reynalds
Medical Ltd.
Sentinel | Proposed Device |
| Arrhythmia
Analysis | • Marquette 12SL
ECG analysis | • Glasgow ECG
analysis for 12 lead
ECG
• HES analysis for
stress tests | • Glasgow ECG
analysis for 12 lead
ECG
• HES analysis for
stress tests |
Page 3 of 5
6
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. |
7
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.