Spacelabs Lifescreen PRO Analyzer

K201921 · Spacelabs Healthcare, Ltd. · DQK · Mar 26, 2021 · Cardiovascular

Device Facts

• Record ID: K201921
• Device Name: Spacelabs Lifescreen PRO Analyzer
• Applicant: Spacelabs Healthcare, Ltd.
• Product Code: DQK · Cardiovascular
• Decision Date: Mar 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Spacelabs Lifescreen PRO Analyzer (Model 98800 Analyzer) is intended to be used to analyze recordings of ambulatory electrocardiograms made on compatible ECG recorders. Lifescreen PRO is capable of analyzing the ECG, detecting certain arrhythmias, allowing the user to view and edit analysis results, correlating symptomatic patient events and construct a report for use by Physicians / Cardiologists. Lifescreen PRO can be used as a triage tool for assessment of ambulatory ECG from supported devices; supporting selection and export of ECG segments for more detailed analysis in the Spacelabs Pathfinder SL Analyzer.

Device Story

Software-based analyzer for ambulatory ECG recordings (up to 30 days); inputs ECG data from Spacelabs recorders via Sentinel Cardiology Information Management System. Algorithm performs automated detection of major arrhythmic events (AF, Pause, VT, V-Run, Trigeminy, Bigeminy, SVT, SV-Run, Bradycardia) and calculates beat burdens. Monitors signal quality; inhibits analysis during noise. User interface allows full disclosure review, manual editing of events/beats, and artifact marking. Output is a clinical report for physician/cardiologist review to aid diagnosis. Supports export of segments to Pathfinder SL for detailed analysis. Used in clinical settings by trained users; intended to assist, not replace, physician interpretation.

Clinical Evidence

Bench testing only. Verification and validation activities conducted per internal requirements, IEC 62304, IEC 82304-1, IEC 60601-2-47, and IEC 62366-1. Testing confirmed compliance with predetermined specifications and performance standards. No clinical trial data presented.

Technological Characteristics

Software-only diagnostic analyzer. Operates on Windows-based hardware via Sentinel CIMS database (SQL Server). Connectivity: Networked/Database-integrated. Analysis: Automated arrhythmia detection and beat classification. Standards: IEC 62304 (software lifecycle), IEC 60601-2-47 (ambulatory ECG safety/performance), IEC 62366-1 (usability).

Indications for Use

Indicated for analysis of ambulatory ECG recordings from compatible Spacelabs recorders (Lifecard CF, Evo) to detect arrhythmias, correlate symptomatic events, and generate reports for physician review. Used as a triage tool for assessment of ECG data.

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

• Spacelabs Pathfinder SL (K110001)

Reference Devices

• Sentinel Cardiology Information Management System (K152881)

Submission Summary (Full Text)

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March 26, 2021

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

Re: K201921

Trade/Device Name: Spacelabs Lifescreen PRO Analyzer Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: February 19, 2021 Received: February 23, 2021

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K201921

Device Name Spacelabs Lifescreen PRO Analyzer

#### Indications for Use (Describe)

The Spacelabs Lifescreen PRO Analyzer (Model 98800 Analyzer) is intended to be used to analyze recordings of ambulatory electrocardiograms made on compatible ECG recorders. Lifescreen PRO is capable of analyzing the ECG, detecting certain arrhythmias, allowing the user to view and edit analysis results, correlating symptomatic patient events and construct a report for use by Physicians / Cardiologists.

Lifescreen PRO can be used as a triage tool for assessment of ambulatory ECG from supported devices; supporting selection and export of ECG segments for more detailed analysis in the Spacelabs Pathfinder SL Analyzer.

Type of Use (Select *one* or *both*, as applicable)

| <div> <span style="text-decoration: underline;"></span>Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|---------------------------------------------------------------------------------------------------------------|
| <div> Over-The-Counter Use (21 CFR 807) </div> |

|| | Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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| Submission Date: | 02 July 2020 | | | |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-----------------------------------|--|
| Submitter: | Spacelabs Healthcare Ltd.<br>Unit B, Foxholes Centre<br>John Tate Road<br>Hertford<br>Hertfordshire<br>SG13 7DT<br>United Kingdom | | | |
| Submitter<br>Correspondent | Mr. Roger Moldon<br>Phone: [phone]<br>Email: [e-mail] | | | |
| Application<br>Correspondent: | Thomas Kroenke<br>Principal Consultant<br>Speed To Market, Inc.<br>PO Box 3018<br>Nederland, CO 80466 USA<br>[e-mail]<br>[phone] | | | |
| Manufacturing Site: | Spacelabs Healthcare Ltd.<br>Unit B, Foxholes Centre<br>John Tate Road<br>Hertford<br>Hertfordshire<br>SG13 7DT<br>United Kingdom | | | |
| Trade Name: | Spacelabs Lifescreen PRO Analyzer | | | |
| Common and<br>Classification<br>Name: | Computer, Diagnostic, Programmable | | | |
| Classification<br>Regulation: | 21 CFR §870.1425 | | | |
| Product Code: | DQK | | | |
| Substantially<br>Equivalent Devices: | New Spacelabs<br>Model | Predicate<br>510(k) Number | Predicate<br>Manufacturer / Model | |
| | Spacelabs Lifescreen<br>PRO Analyzer | K110001 | Spacelabs Pathfinder SL | |

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| Device Description: | The Spacelabs Lifescreen PRO Analyzer is a rapid analysis software<br>product that can be used to analyze electrocardiology (ECG) recordings<br>of up to 30 days in duration from Spacelabs Healthcare's range of<br>Ambulatory ECG recorders. The ECG recordings are downloaded into<br>the Sentinel Cardiology Information Management System (Sentinel),<br>cleared by FDA in 510(k) submission K152881, imported into<br>Lifescreen PRO, and then analyzed.<br><br>Lifescreen PRO is designed to provide a rapid analysis of the detection<br>and reporting of major arrhythmic events and patient reported<br>symptomatic events including AF, Pause, VT, V-Run (>3 beats),<br>Trigeminy and Bigeminy, SVT, SV-Run, and Bradycardia.<br><br>Individual normal, ventricular, and supraventricular beat burdens are<br>presented as a percentage of the total beat counts.<br><br>No automated algorithm for arrhythmia detection offers 100% sensitivity<br>and accuracy for the detection of arrhythmia events. Laboratory testing<br>and clinical studies have shown that scanning and a review of analyzed<br>results by a trained user provides the highest degree of report accuracy.<br>Following analysis, the report should be reviewed by a physician prior to<br>initiating or changing patient treatment.<br><br>ECG data with a lot of noise, which can result from poor hook-up and/or<br>poor-quality electrodes, can result in beat misclassification. The<br>algorithm monitors the ECG quality throughout and will inhibit analysis<br>during periods of noise; the inhibited analysis is clearly shown in grey.<br>This allows the user to review the inhibited areas to ensure that<br>significant events have not been missed.<br><br>Various tools are provided in Lifescreen PRO to allow the trained user to<br>quickly view the full disclosure ECG, add, delete, or reclassify events<br>and beats, or artefact periods of noisy ECG. Where more detailed<br>analysis is required, Lifescreen PRO also has the ability to export<br>sections of a recording up to 7 days in duration into the Sentinel<br>Cardiology Information Management System for further analysis using<br>the Pathfinder SL analysis system. |
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Intended Use: The Spacelabs Lifescreen PRO Analyzer (Model 98800 Analyzer) is intended to be used to analyze recordings of ambulatory electrocardiograms made on compatible ECG recorders. Lifescreen PRO is capable of analyzing the ECG, detecting certain arrhythmias, allowing the user to view and edit analysis results, correlating symptomatic patient events and construct a report for use by Physicians / Cardiologists. Lifescreen PRO can be used as a triage tool for assessment of ambulatory ECG from supported devices; supporting selection and export of ECG segments for more detailed analysis in the Spacelabs Pathfinder SL Analyzer.

Technology Comparison: The Lifescreen PRO employs the same technological characteristics as the predicate device.

| Characteristic | Spacelabs Healthcare Ltd.<br>Pathfinder SL<br>(K110001) | Spacelabs Healthcare Ltd.<br>Lifescreen PRO Analyzer |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Spacelabs Pathfinder SL Holter<br>Analyzer is intended to be used to<br>analyze recordings of ambulatory<br>electrocardiograms made on<br>compatible Holter recorders. It is<br>capable of detecting certain<br>abnormal arrhythmias, and allows<br>the operator to view and edit the<br>ECG and the analysis results, and<br>construct a report for physician use. | The Spacelabs Lifescreen PRO<br>Analyzer (Model 98800 Analyzer) is<br>intended to be used to analyze<br>recordings of ambulatory<br>electrocardiograms made on<br>compatible ECG recorders. Lifescreen<br>PRO is capable of analyzing the ECG,<br>detecting certain arrhythmias, allowing<br>the user to view and edit analysis<br>results, correlating symptomatic<br>patient events and construct a report<br>for use by Physicians / Cardiologists.<br>Lifescreen PRO can be used as a triage<br>tool for assessment of ambulatory<br>ECG from supported devices;<br>supporting selection and export of<br>ECG segments for more detailed<br>analysis in the Spacelabs Pathfinder<br>SL Analyzer. |
| Operating<br>Principle | The general operating principle is<br>that the analyzer displays the ECG<br>waveform associated with an ECG<br>recording.<br>The analyzer can be setup to identify<br>and highlight certain types of beats,<br>events or arrhythmias.<br>The operator can review or revised<br>the classifications, make<br>measurements on the ECG<br>waveforms and then collate<br>associated information to generate a<br>report which is intended for review<br>by a physician to aid diagnosis. | Same. |

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| Technology<br>Comparison (cont): | Characteristic | Spacelabs Healthcare Ltd.<br>Pathfinder SL<br>(K110001) | Spacelabs Healthcare Ltd.<br>Lifescreen PRO Analyzer |
|----------------------------------|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| | Compatibility<br>with ECG<br>Recorders | Compatible with the following<br>Spacelabs devices:<br>● Aria;<br>● Lifecard CF;<br>● Lifecard 12; and<br>● Evo. | Compatible with the following<br>Spacelabs devices:<br>● Lifecard CF; and<br>● Evo. |
| | Compatibility<br>with Databases | Pathfinder SL must be used in<br>conjunction with Spacelabs Sentinel<br>CIMS database which can be one of<br>many SQL Server variants. | Same. |
| | Reports | User customization of report<br>formats. | Same. |
| | Analysis of<br>ECG<br>recordings | Supports analysis and reporting of<br>ECG recordings up to 7 days. | Supports analysis and reporting of<br>ECG recordings up to 30 days. |
| | Sleep Apnea | Integrated the detection and<br>highlighting of possible periods of<br>sleep apnea within the recording. | Not applicable. |

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#### Summary of Performance Testing:

Software The Lifescreen PRO was designed and developed according to a robust software development process and was rigorously verified and validated. Software information is provided in accordance with internal requirements and the following guidance documents and Standards: 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, 27 Sep 19. FDA guidance: General principles of software validation; Final . guidance for industry and FDA staff, 11 Jan 02. ● Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 02 Oct 14. Design Considerations and Premarket Submission . Recommendations for Interoperable Medical Devices, 06 Sep 17. . IEC 62304: 2006, Am1:2015, Medical device software - Software life-cycle processes. IEC 82304-1: 2016, Health Software – Part 1: General . requirements for product safety Test results indicate that the Lifescreen PRO complies with its predetermined specifications, guidance documents and Standards. Summary of Performance Testing (continued): Performance Testing The Lifescreen PRO was tested for performance in accordance with – Bench internal requirements, applicable Standards, and guidance document. . IEC 60601-2-47: 2012, Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems IEC 62366-1: 2015. Medical devices – Application of usabilitv . engineering to medical devices. . Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices, 06 Sep 17. Test results indicated that the Lifescreen PRO complies with internal requirements, applicable Standards, and the guidance document.

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Verification and validation activities were conducted to establish the Conclusion performance and safety characteristics of the Lifescreen PRO. The results of these activities demonstrate that the Lifescreen PRO is as safe, as effective, and performs as well as the predicate device when used in accordance with its intended use and labeling. Therefore, the Lifescreen PRO is considered substantially equivalent to the predicate device.