(259 days)
No
The document describes a software product for analyzing ECG recordings and detecting arrhythmias using "algorithms," but it does not explicitly mention or provide details about the use of AI or ML techniques. The focus is on traditional signal processing and rule-based detection.
No
The device is described as an "Analyzer" and "software product" used to analyze ECG recordings and assist in detecting arrhythmias. It is explicitly stated that a physician must review the report before initiating or changing patient treatment, indicating it is a diagnostic tool, not a therapeutic one.
Yes
The device analyzes recorded ambulatory electrocardiograms to detect certain arrhythmias and allows the user to view and edit analysis results, correlating symptomatic patient events and constructing a report for use by Physicians/Cardiologists. It is also explicitly stated as a "triage tool for assessment of ambulatory ECG." These functions directly align with the purpose of a diagnostic device.
Yes
The device description explicitly states that the Spacelabs Lifescreen PRO Analyzer is a "rapid analysis software product" and details its function in analyzing ECG recordings imported from a separate system. While it interacts with ECG recorders and a management system, the device itself is described solely as software performing analysis.
Based on the provided information, the Spacelabs Lifescreen PRO Analyzer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lifescreen PRO's Function: The Lifescreen PRO analyzes electrocardiograms (ECG), which are recordings of the electrical activity of the heart. This is a physiological measurement taken directly from the body, not a test performed on a sample in vitro (in glass/outside the body).
- Intended Use: The intended use clearly states it analyzes recordings of ambulatory electrocardiograms.
- Device Description: The description reinforces that it analyzes ECG recordings.
Therefore, the Spacelabs Lifescreen PRO Analyzer falls under the category of a medical device that analyzes physiological signals, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DOK
Device Description
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.
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
Not Found
Intended User / Care Setting
Physicians / Cardiologists
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: 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.
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.
Conclusion: Verification and validation activities were conducted to establish the 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
No automated algorithm for arrhythmia detection offers 100% sensitivity and accuracy for the detection of arrhythmia events.
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.
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
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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
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)
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3
| Submission Date: | 02 July 2020 | |||
|---|---|---|---|---|
| Submitter: | Spacelabs Healthcare Ltd. | |||
| Unit B, Foxholes Centre | ||||
| John Tate Road | ||||
| Hertford | ||||
| Hertfordshire | ||||
| SG13 7DT | ||||
| United Kingdom | ||||
| Submitter | ||||
| Correspondent | Mr. Roger Moldon | |||
| Phone: +011 44-1992-507730 | ||||
| Email: roger.moldon@spacelabs.com | ||||
| Application | ||||
| Correspondent: | Thomas Kroenke | |||
| Principal Consultant | ||||
| Speed To Market, Inc. | ||||
| PO Box 3018 | ||||
| Nederland, CO 80466 USA | ||||
| tkroenke@speedtomarket.net | ||||
| +1 (303) 956 4232 | ||||
| Manufacturing Site: | Spacelabs Healthcare Ltd. | |||
| Unit B, Foxholes Centre | ||||
| John Tate Road | ||||
| Hertford | ||||
| Hertfordshire | ||||
| SG13 7DT | ||||
| United Kingdom | ||||
| Trade Name: | Spacelabs Lifescreen PRO Analyzer | |||
| Common and | ||||
| Classification | ||||
| Name: | Computer, Diagnostic, Programmable | |||
| Classification | ||||
| Regulation: | 21 CFR §870.1425 | |||
| Product Code: | DQK | |||
| Substantially | ||||
| Equivalent Devices: | New Spacelabs | |||
| Model | Predicate | |||
| 510(k) Number | Predicate | |||
| Manufacturer / Model | ||||
| Spacelabs Lifescreen | ||||
| PRO Analyzer | K110001 | Spacelabs Pathfinder SL |
4
| Device Description: | 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. |
| --------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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 Holter
Analyzer is intended to be used to
analyze recordings of ambulatory
electrocardiograms made on
compatible Holter recorders. It is
capable of detecting certain
abnormal arrhythmias, and allows
the operator to view and edit the
ECG and the analysis results, and
construct a report for physician 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. |
| Operating
Principle | The general operating principle is
that the analyzer displays the ECG
waveform associated with an ECG
recording.
The analyzer can be setup to identify
and highlight certain types of beats,
events or arrhythmias.
The operator can review or revised
the classifications, make
measurements on the ECG
waveforms and then collate
associated information to generate a
report which is intended for review
by a physician to aid diagnosis. | Same. |
6
| Technology
Comparison (cont): | Characteristic | Spacelabs Healthcare Ltd.
Pathfinder SL
(K110001) | Spacelabs Healthcare Ltd.
Lifescreen PRO Analyzer |
|----------------------------------|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| | Compatibility
with ECG
Recorders | Compatible with the following
Spacelabs devices:
● Aria;
● Lifecard CF;
● Lifecard 12; and
● Evo. | Compatible with the following
Spacelabs devices:
● Lifecard CF; and
● Evo. |
| | Compatibility
with Databases | Pathfinder SL must be used in
conjunction with Spacelabs Sentinel
CIMS database which can be one of
many SQL Server variants. | Same. |
| | Reports | User customization of report
formats. | Same. |
| | Analysis of
ECG
recordings | Supports analysis and reporting of
ECG recordings up to 7 days. | Supports analysis and reporting of
ECG recordings up to 30 days. |
| | Sleep Apnea | Integrated the detection and
highlighting of possible periods of
sleep 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.