(259 days)
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.
The Spacelabs Lifescreen PRO Analyzer is a rapid analysis software product that can be used to analyze electrocardiology (ECG) recordings of up to 30 days in duration from Spacelabs Healthcare's range of Ambulatory ECG recorders. The ECG recordings are downloaded into the Sentinel Cardiology Information Management System (Sentinel), cleared by FDA in 510(k) submission K152881, imported into Lifescreen PRO, and then analyzed.
Lifescreen PRO is designed to provide a rapid analysis of the detection and reporting of major arrhythmic events and patient reported symptomatic events including AF, Pause, VT, V-Run (>3 beats), Trigeminy and Bigeminy, SVT, SV-Run, and Bradycardia.
Individual normal, ventricular, and supraventricular beat burdens are presented as a percentage of the total beat counts.
No automated algorithm for arrhythmia detection offers 100% sensitivity and accuracy for the detection of arrhythmia events. Laboratory testing and clinical studies have shown that scanning and a review of analyzed results by a trained user provides the highest degree of report accuracy. Following analysis, the report should be reviewed by a physician prior to initiating or changing patient treatment.
ECG data with a lot of noise, which can result from poor hook-up and/or poor-quality electrodes, can result in beat misclassification. The algorithm monitors the ECG quality throughout and will inhibit analysis during periods of noise; the inhibited analysis is clearly shown in grey. This allows the user to review the inhibited areas to ensure that significant events have not been missed.
Various tools are provided in Lifescreen PRO to allow the trained user to quickly view the full disclosure ECG, add, delete, or reclassify events and beats, or artefact periods of noisy ECG. Where more detailed analysis is required, Lifescreen PRO also has the ability to export sections of a recording up to 7 days in duration into the Sentinel Cardiology Information Management System for further analysis using the Pathfinder SL analysis system.
The provided text does not contain detailed information about specific acceptance criteria or a dedicated study with performance metrics in the format requested. While it mentions that "Test results indicated that the Lifescreen PRO complies with internal requirements, applicable Standards, and the guidance document," it does not provide the quantitative acceptance criteria, the reported device performance against those criteria, or the methodology of such a study.
However, based on the general information provided about the device's capabilities and regulatory compliance, I can infer some aspects and construct a table to illustrate the type of information that would be present if it were fully detailed.
Here's a breakdown of what can be extracted and what is missing:
The Spacelabs Lifescreen PRO Analyzer is designed for:
- Analyzing ambulatory ECG recordings.
- Detecting certain arrhythmias (AF, Pause, VT, V-Run (>3 beats), Trigeminy, Bigeminy, SVT, SV-Run, and Bradycardia).
- Allowing user review and editing of analysis results.
- Correlating symptomatic patient events.
- Constructing a report for physicians/cardiologists.
- Serving as a triage tool for assessment and export of ECG segments for more detailed analysis.
The document indicates that the device undergoes "performance testing" in accordance with internal requirements and standards like IEC 60601-2-47: 2012 (Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems). This standard would typically define performance requirements for arrhythmia detection and accuracy.
Missing Information:
- Specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets for each arrhythmia).
- Reported device performance (actual values) for these criteria.
- Details of the study that generated these performance numbers (sample size, data provenance, ground truth establishment, expert qualifications, adjudication method, standalone vs. MRMC).
- Training set details.
Inferred Table of Acceptance Criteria and Reported Device Performance (Illustrative - actual values not provided in the text):
| Performance Metric (Arrhythmia Type) | Acceptance Criteria (Illustrative) | Reported Device Performance (Illustrative - Not provided in text) |
|---|---|---|
| Atrial Fibrillation (AFib) Detection | Sensitivity ≥ 90%, Specificity ≥ 90% | No specific values provided in text |
| VT/V-Run Detection (≥3 beats) | Sensitivity ≥ 95%, Specificity ≥ 90% | No specific values provided in text |
| Pause Detection | Sensitivity ≥ 85%, Specificity ≥ 85% | No specific values provided in text |
| Bradycardia Detection | Sensitivity ≥ 90%, Specificity ≥ 90% | No specific values provided in text |
| Beat Classification Accuracy (Overall) | Overall Accuracy ≥ 90% | No specific values provided in text |
| QRS Detection | Accuracy ≥ 99% | No specific values provided in text |
Study Details (Based on what can be inferred or what is explicitly missing):
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text mentions "Laboratory testing and clinical studies," but no details on the datasets used.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications: "scanning and a review of analyzed results by a trained user provides the highest degree of report accuracy." It also mentions "reviewed by a physician prior to initiating or changing patient treatment." However, the exact qualifications of those establishing the ground truth for a test set are not detailed.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- The text describes the device as providing "rapid analysis" and assisting "selection and export of ECG segments for more detailed analysis." It also states, "No automated algorithm for arrhythmia detection offers 100% sensitivity and accuracy for the detection of arrhythmia events. Laboratory testing and clinical studies have shown that scanning and a review of analyzed results by a trained user provides the highest degree of report accuracy." This implies that the device is intended to be used with human review, but it doesn't explicitly describe an MRMC comparative effectiveness study or quantify improvement with AI assistance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that standalone performance was evaluated, as it refers to the algorithm's detection capabilities. However, it strongly emphasizes the need for human review to achieve the "highest degree of report accuracy." It does not provide specific standalone performance metrics distinct from a human-in-the-loop context.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Implicitly, the ground truth for ECG analysis and arrhythmia detection would be established by expert consensus based on manual review of ECG recordings, likely by cardiologists or trained technicians. This is suggested by phrases like "scanning and a review of analyzed results by a trained user provides the highest degree of report accuracy" and "reviewed by a physician."
-
The sample size for the training set:
- Not specified.
-
How the ground truth for the training set was established:
- Not specified, but likely similar to the test set, involving expert review and annotation of ECG recordings.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
{2}------------------------------------------------
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 807) |
|| | Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
| Submission Date: | 02 July 2020 | |||
|---|---|---|---|---|
| Submitter: | Spacelabs Healthcare Ltd.Unit B, Foxholes CentreJohn Tate RoadHertfordHertfordshireSG13 7DTUnited Kingdom | |||
| SubmitterCorrespondent | Mr. Roger MoldonPhone: +011 44-1992-507730Email: roger.moldon@spacelabs.com | |||
| ApplicationCorrespondent: | Thomas KroenkePrincipal ConsultantSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net+1 (303) 956 4232 | |||
| Manufacturing Site: | Spacelabs Healthcare Ltd.Unit B, Foxholes CentreJohn Tate RoadHertfordHertfordshireSG13 7DTUnited Kingdom | |||
| Trade Name: | Spacelabs Lifescreen PRO Analyzer | |||
| Common andClassificationName: | Computer, Diagnostic, Programmable | |||
| ClassificationRegulation: | 21 CFR §870.1425 | |||
| Product Code: | DQK | |||
| SubstantiallyEquivalent Devices: | New SpacelabsModel | Predicate510(k) Number | PredicateManufacturer / Model | |
| Spacelabs LifescreenPRO Analyzer | K110001 | Spacelabs Pathfinder SL |
{4}------------------------------------------------
| Device Description: | The Spacelabs Lifescreen PRO Analyzer is a rapid analysis softwareproduct that can be used to analyze electrocardiology (ECG) recordingsof up to 30 days in duration from Spacelabs Healthcare's range ofAmbulatory ECG recorders. The ECG recordings are downloaded intothe Sentinel Cardiology Information Management System (Sentinel),cleared by FDA in 510(k) submission K152881, imported intoLifescreen PRO, and then analyzed.Lifescreen PRO is designed to provide a rapid analysis of the detectionand reporting of major arrhythmic events and patient reportedsymptomatic events including AF, Pause, VT, V-Run (>3 beats),Trigeminy and Bigeminy, SVT, SV-Run, and Bradycardia.Individual normal, ventricular, and supraventricular beat burdens arepresented as a percentage of the total beat counts.No automated algorithm for arrhythmia detection offers 100% sensitivityand accuracy for the detection of arrhythmia events. Laboratory testingand clinical studies have shown that scanning and a review of analyzedresults by a trained user provides the highest degree of report accuracy.Following analysis, the report should be reviewed by a physician prior toinitiating or changing patient treatment.ECG data with a lot of noise, which can result from poor hook-up and/orpoor-quality electrodes, can result in beat misclassification. Thealgorithm monitors the ECG quality throughout and will inhibit analysisduring periods of noise; the inhibited analysis is clearly shown in grey.This allows the user to review the inhibited areas to ensure thatsignificant events have not been missed.Various tools are provided in Lifescreen PRO to allow the trained user toquickly view the full disclosure ECG, add, delete, or reclassify eventsand beats, or artefact periods of noisy ECG. Where more detailedanalysis is required, Lifescreen PRO also has the ability to exportsections of a recording up to 7 days in duration into the SentinelCardiology Information Management System for further analysis usingthe Pathfinder SL analysis system. |
|---|---|
| --------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
{5}------------------------------------------------
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.Pathfinder SL(K110001) | Spacelabs Healthcare Ltd.Lifescreen PRO Analyzer |
|---|---|---|
| Intended Use | The Spacelabs Pathfinder SL HolterAnalyzer is intended to be used toanalyze recordings of ambulatoryelectrocardiograms made oncompatible Holter recorders. It iscapable of detecting certainabnormal arrhythmias, and allowsthe operator to view and edit theECG and the analysis results, andconstruct a report for physician use. | The Spacelabs Lifescreen PROAnalyzer (Model 98800 Analyzer) isintended to be used to analyzerecordings of ambulatoryelectrocardiograms made oncompatible ECG recorders. LifescreenPRO is capable of analyzing the ECG,detecting certain arrhythmias, allowingthe user to view and edit analysisresults, correlating symptomaticpatient events and construct a reportfor use by Physicians / Cardiologists.Lifescreen PRO can be used as a triagetool for assessment of ambulatoryECG from supported devices;supporting selection and export ofECG segments for more detailedanalysis in the Spacelabs PathfinderSL Analyzer. |
| OperatingPrinciple | The general operating principle isthat the analyzer displays the ECGwaveform associated with an ECGrecording.The analyzer can be setup to identifyand highlight certain types of beats,events or arrhythmias.The operator can review or revisedthe classifications, makemeasurements on the ECGwaveforms and then collateassociated information to generate areport which is intended for reviewby a physician to aid diagnosis. | Same. |
{6}------------------------------------------------
| TechnologyComparison (cont): | Characteristic | Spacelabs Healthcare Ltd.Pathfinder SL(K110001) | Spacelabs Healthcare Ltd.Lifescreen PRO Analyzer |
|---|---|---|---|
| Compatibilitywith ECGRecorders | Compatible with the followingSpacelabs devices:● Aria;● Lifecard CF;● Lifecard 12; and● Evo. | Compatible with the followingSpacelabs devices:● Lifecard CF; and● Evo. | |
| Compatibilitywith Databases | Pathfinder SL must be used inconjunction with Spacelabs SentinelCIMS database which can be one ofmany SQL Server variants. | Same. | |
| Reports | User customization of reportformats. | Same. | |
| Analysis ofECGrecordings | Supports analysis and reporting ofECG recordings up to 7 days. | Supports analysis and reporting ofECG recordings up to 30 days. | |
| Sleep Apnea | Integrated the detection andhighlighting of possible periods ofsleep apnea within the recording. | Not applicable. |
{7}------------------------------------------------
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.
{8}------------------------------------------------
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.
§ 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).