(29 days)
The WorkMate Claris™ System is indicated for the use during clinical electrophysiology procedures.
The WorkMate Claris™ System is a fully computerized system for capturing and measuring physiological data in the clinical electrophysiology (EP) laboratory. It provides digital signal acquisition and display of those electrical signals on high resolution monitors.
The WorkMate Claris™ System is connected to electrophysiology catheters that are guided into various locations within the heart, and to surface electrocardiogram (ECG) cables. Intracardiac and ECG signals are then acquired from electrodes on the indwelling catheters and ECG leads connected to the amplifier, which amplifies and conditions the signals before they are received by the WorkMate Claris System computer for display, measurement and storage. The cardiac stimulator integrated with the parent recording system, sends electrical impulses to indwelling catheters through the Amplifier.
During the procedure, cardiac signals are acquired and an automated software waveform detector (trigger) performs online recognition of cardiac activation on preselected leads. Temporal interval measurements are computed on a beat-by-beat basis on multiple channels and dynamically posted on the Real Time display. Intervals are calculated between waveforms from the same source on a specific channel (intra- channel measurements) and from multi-source signals across two or more channels (inter-channel measurements).
Signals are also presented on a review monitor for measurement and analysis. Continuous capture of the digitized signals can be invoked, and the user can also retrieve and display earlier passages of the current study without interruption of the real-time display. The system can also acquire, display and record data from other interfaced devices in use during the procedure, such as imaging devices and ablation generators.
The provided text describes regulatory information for the Abbott WorkMate Claris™ System (K210392), which is a Special 510(k) submission. This type of submission is used when a modification to a legally marketed device does not alter its fundamental scientific technology, intended use, or indications for use, and does not raise new questions of safety and effectiveness.
Such submissions typically rely on design verification and validation testing to demonstrate that the changes have not adversely affected the device's performance or safety, rather than extensive clinical studies that prove efficacy or comparative effectiveness with human readers. The document explicitly states: "The changes are limited to the modification of system software to support an operating system update to Windows® 10, to manage end of life components, security updates/enhancements, and address software bug fixes." It also notes: "There are no new or increased risks that result from the modifications and the changes do not raise any new questions of safety and effectiveness in regards to the subject device."
Therefore, the study proving the device meets acceptance criteria primarily involves non-clinical functional and design validation testing, rather than clinical trials involving human subjects or AI-assisted performance studies as might be seen for novel AI/ML devices.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of quantitative acceptance criteria or detailed numerical performance metrics for the WorkMate Claris System (v1.2) itself. Instead, it indicates that:
- Acceptance Criteria: "Design verification activities for functional testing were performed with their respective acceptance criteria to ensure that the proposed modifications do not affect the safety or effectiveness of the device."
- Reported Device Performance: "All testing performed met the established performance specifications."
Given the nature of a Special 510(k) for a software and hardware update, the acceptance criteria would be focused on maintaining the existing established performance specifications of the predicate device (WorkMate Claris™ System v1.1). These would generally involve:
| Acceptance Criteria Category | General Acceptance Criteria (Inferred) | Reported Device Performance (as stated) |
|---|---|---|
| Functional Performance | Continuous and accurate acquisition, display, measurement, and storage of physiological (EP) data. | "All testing performed met the established performance specifications." |
| System Compatibility | Compatibility with existing EP lab equipment and indwelling catheters. | "that the system remains compatible with common electrophysiology lab equipment." |
| Software Integrity | Software functions as intended, free from critical bugs introduced by updates. | "Software verification testing to ensure the software continues to meet requirements..." |
| Installation Process | Successful update installation without errors or system degradation. | "Design validation studies to ensure the installation process... meets requirements." |
| Security | Maintenance or improvement of security posture with new OS and software versions. | "security updates/enhancements" |
| Risk Assessment | No new or increased risks identified due to modifications. | "review of risk management to ensure no new hazards have been introduced by this change." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of patient data or clinical cases. The testing described is primarily non-clinical design verification and validation. This would involve testing the system with various simulated inputs, hardware configurations, and software functionalities.
- Data Provenance: Not applicable as the testing is non-clinical system performance validation, not studies on patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts/Qualifications: This is not applicable in the context of this Special 510(k) submission. The review of the device's performance against its specifications would be done by engineers, quality assurance personnel, and potentially clinical subject matter experts for functional validation, but not typically in a formal "ground truth" establishment sense for a test set of medical cases.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no mention of a human-in-the-loop performance study or a test set requiring adjudication in the medical context (e.g., image interpretation).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission is for software and hardware updates to an existing device, not for a new AI/ML diagnostic algorithm that assists human readers. The document highlights that the device "uses the same fundamental scientific technology, intended use, and indications as the predicate device."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: Not applicable in the context of AI/ML algorithm performance. The device is a physiological data acquisition and display system; its "performance" is based on the accuracy and reliability of its data capture and presentation capabilities, not on a diagnostic algorithm's output. The document describes "functional testing" and "software verification testing" which are forms of standalone performance validation for the system as a whole.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical testing, the "ground truth" would be established by the device's functional specifications and requirements. For example, if the system is designed to measure a specific temporal interval within ±X milliseconds, then the "ground truth" for testing would be the known, precisely controlled input signal, and the device's output would be compared against that known value.
- This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense, but rather engineering-level validation against known performance standards.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is not an AI/ML model that undergoes a "training" phase with a dataset. It's a deterministic system for acquiring and displaying physiological signals.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth Establishment: Not applicable, as there is no training set for an AI/ML model.
In summary, the K210392 submission for the WorkMate Claris™ System v1.2 is a "Special 510(k)" based on modifications to an existing device. The acceptance criteria and supporting studies are focused on non-clinical design verification and validation to ensure that the updated device maintains its safety and effectiveness and performs according to its established specifications, without introducing new risks. It does not involve clinical studies, multi-reader studies, or AI algorithm training/testing.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 11, 2021
Abbott Ed Sandberg Senior Regulatory Affairs Specialist One St. Jude Medical Drive St. Paul, Minnesota 55117
Re: K210392
Trade/Device Name: WorkMate Claris System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: February 9, 2021 Received: February 10, 2021
Dear Ed Sandberg:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
{1}------------------------------------------------
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 (OS) 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,
Aneesh Deoras Assistant Director (Acting) 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) K210392
Device Name WorkMate Claris™ System
Indications for Use (Describe)
The WorkMate Claris™ System is indicated for the use during clinical electrophysiology procedures.
The WorkMate Claris System is a fully computerized system for capturing and measuring physiological data in the clinical electrophysiology (EP) laboratory. It provides digital signal acquisition and display of those electrical signals on high resolution monitors.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X 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}------------------------------------------------
510(k) Summary K210392, WorkMate Claris™ System
Image /page/3/Picture/1 description: The image shows the Abbott logo. The logo consists of a blue, stylized letter "A" on the left and the word "Abbott" in black, bold font on the right. The blue "A" is made up of three horizontal lines that are connected by a vertical line on the left side.
| 510(k) Information | |
|---|---|
| 510(k) Number | K210392 |
| 510(k) Type | Special 510(k) |
| Date Prepared | February 9th, 2021 |
| Submitter Information | |
| ManufacturerName/Address | AbbottOne St. Jude Medical DriveSt. Paul, MN 55117 |
| Contact Person | Ed SandbergRegulatory Affairs SpecialistPhone: 651-245-8398ed.sandberg@abbott.com |
| Device Information | |
| Trade Name | Workmate Claris™ System v1.2 |
| Common Name | Programmable Diagnostic Computer |
| Class | II |
| Classification Name | 870.1425, computer, diagnostic, programmable |
| Product Code | DQK |
| Predicate Device | Workmate Claris™ System v1.1 (K151911) |
| Reference Applications | N/A |
| Device Description | The WorkMate Claris™ System is a fully computerized system for capturing and measuring physiological data in the clinical electrophysiology (EP) laboratory. It provides digital signal acquisition and display of those electrical signals on high resolution monitors.The WorkMate Claris™ System is connected to electrophysiology catheters that are guided into various locations within the heart, and to surface electrocardiogram (ECG) cables. Intracardiac and ECG signals are then acquired from electrodes on the indwelling catheters and ECG leads connected to the amplifier, which amplifies and conditions the signals before they are received by the WorkMate Claris System computer for display, measurement and storage. The cardiac stimulator integrated with the parent recording system, sends electrical impulses to indwelling catheters through the Amplifier.During the procedure, cardiac signals are acquired and an automated software waveform detector (trigger) performs online recognition of cardiac activation on preselected leads. Temporal interval measurements are computed on a beat-by-beat basis on multiple channels and dynamically posted on the Real Time display. Intervals are calculated between waveforms from the same source on a specific channel (intra- channel measurements) and from multi-source signals across two or more channels (inter-channel measurements).Signals are also presented on a review monitor for measurement and analysis. Continuous capture of the digitized signals can be invoked, and the user can also retrieve and display earlier passages of the current study without interruption of the real-time display. The system can also acquire, display and record data from other interfaced devices in use during the procedure, such as imaging devices and |
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the Abbott logo. The logo consists of a blue symbol on the left and the word "Abbott" in black on the right. The blue symbol is a stylized letter "a" made up of three horizontal lines and a curved line. The word "Abbott" is in a bold, sans-serif font.
| ablation generators. | |||
|---|---|---|---|
| Indications for Use | Workmate Claris™ System v1.2WorkMate Claris™ System is indicated for the use during clinical electrophysiology procedures.WorkMate Claris™ System is a fully computerized system for capturing and measuring physiological data in the clinical electrophysiology (EP) laboratory. It provides digital signal acquisition and display of those electrical signals on high resolution monitors. | ||
| Submission History | No prior submissions have been made to FDA for the device that is the subject of this submission. | ||
| Predicate Comparison | |||
| Comparison | The WorkMate Claris™ System v.1.2, subsystems, and optional ancillary modules, WorkMate™ Scribe™ Module and WorkMate™ Unity™ Review Module, use the same fundamental scientific technology, intended use, and indications as the predicate device. The changes are limited to the modification of system software to support an operating system update to Windows® 10, to manage end of life components, security updates/enhancements, and address software bug fixes.There are no new or increased risks that result from the modifications and the changes do not raise any new questions of safety and effectiveness in regards to the subject device.The modifications for the subject device are outlined below. | ||
| Characteristic | Predicate Device (K151911) | Subject Device (K210392) | |
| H700123, H700124; WorkMate Claris™ System and H700120, H700121WorkMate™ Scribe™ Module | |||
| Trade /ProprietaryName | WorkMate Claris™ System | Same | |
| Device Class | II | Same | |
| ClassificationName | Computer, Diagnostic,Programmable | Same | |
| Product Code | DQK | Same | |
| Indications foruse | The WorkMate Claris™ System is indicated for use during clinical electrophysiology procedures.The WorkMate Claris™ System is a fully computerized system for capturing and measuring physiological data in the clinical electrophysiology (EP) laboratory. It provides digital signal acquisition and display of those electrical signals on high resolution monitors. | Same | |
| Characteristic | Predicate Device(K151911) | Subject Device(K210392) | |
| H700977; WorkMate Claris Display Workstation | |||
| SoftwareVersion | v1.1.1 | v1.2 | |
| WorkstationHardware | HP z620 | HP z440 | |
| H701060, WorkMate™ Scribe™ Display Workstation | |||
| SoftwareVersion | v1.1.1 | v1.2 | |
| WorkstationHardware | HP 8200 | Onyx-1723 | |
| H800007; WorkMate Claris™ System Software Upgrade Kit v1.2 (z440) | |||
| OperatingSystem | Windows 7 | Windows 10 | |
| SoftwareVersion | v1.1.1 | v1.2 | |
| Acrobat Reader | v.11.0.06 | v.20.006.20042 | |
| Bomgar Client(SJMConnect) | v. 14.3.1 | v19.1.7 | |
| McAfeeApplicationControl | v.8.0.0.817 | v.8.2.1.407 | |
| Microsoft Word | v. 15.0.4420.1017 | v. 16.0.10359.20023 | |
| MicrosoftPower Point | v. 15.0.4420.1017 | v. v. 16.0.10359.20023 | |
| H800008; WorkMate™ Scribe™ Module Software Version 1.2 | |||
| OperatingSystem | Windows 7 | Windows 10 | |
| SoftwareVersion | v1.1.1 | v1.2 | |
| AcrobatReader | v.11.0.06 | v.20.006.20042 | |
| Bomgar Client(SJMConnect) | v. 14.3.1 | v19.1.7 | |
| McAfeeApplicationControl | v.8.0.0.817 | v.8.2.1.407 | |
| Microsoft Word | v. 15.0.4420.1017 | v. 16.0.10359.20023 | |
| MicrosoftPower Point | v. 15.0.4420.1017 | v. v. 16.0.10359.20023 | |
| Characteristic | Predicate Device(K151911) | Subject Device(K210392) | |
| SoftwareLicense | N/A | Single License Kit to enableThe WorkMate™ Unity™(H702321) ModuleSoftware. | |
| H800010; WorkMate™ Unity™ Module Software Kit Installation v1.2 (10 License) | N/A | New model numbers createdfor Software License Kitsfor the v1.2 Unity software(10 License) | |
| H800011; WorkMate™ Unity™ Module Software Kit Installation v1.2 (Site License) | N/A | Single License Kit to enableThe WorkMate™ Unity™(H702321) ModuleSoftware. | |
| H800012; WorkMate Claris™ System Software Upgrade Kit v1.2 (z620) | |||
| OperatingSystem | Windows 7 | Windows 10 | |
| SoftwareVersion | v1.1.1 | v1.2 | |
| Acrobat Reader | v.11.0.06 | v.20.006.20042 | |
| Bomgar Client(SJMConnect) | v. 14.3.1 | v.19.1.7 | |
| McAfeeApplicationControl | v.8.0.0.817 | v.8.2.1.407 | |
| Microsoft Word | v. 15.0.4420.1017 | v. 16.0.10359.20023 | |
| MicrosoftPower Point | v. 15.0.4420.1017 | v. 16.0.10359.20023 |
{5}------------------------------------------------
510(k) Summary K210392, WorkMate Claris™ System
Image /page/5/Picture/1 description: The image shows the logo for Abbott. The logo consists of a blue square with a white "A" inside of it, followed by the word "Abbott" in black, bold font. The logo is simple and modern, and the colors are eye-catching.
{6}------------------------------------------------
510(k) Summary K210392, WorkMate Claris™ System
Image /page/6/Picture/1 description: The image shows the Abbott logo. The logo consists of a blue, stylized letter "a" on the left and the word "Abbott" in black, bold font on the right. The blue "a" is made up of three horizontal lines that are connected by a vertical line on the left side.
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image shows the Abbott logo. The logo consists of a blue abstract shape on the left and the word "Abbott" in black bold font on the right. The blue shape is a stylized letter "A".
| Non-Clinical TestingSummary | Design verification activities for functional testing were performed with theirrespective acceptance criteria to ensure that the proposed modifications do notaffect the safety or effectiveness of the device. All testing performed met theestablished performance specifications.TestingThe Workmate Claris™ System v1.2 was developed and tested in accordancewith the following industry guidance documents and standards: |
|---|---|
| Off-the-Shelf Software Use in Medical Devices Guidance for Industry andFood and Drug Administration Staff Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices Content of Premarket Submissions for Management of Cybersecurity inMedical Devices: Guidance for Industry and Food and DrugAdministration Staff EN ISO 14971:2019 Medical Devices – Application of Risk Managementto Medical Devices | |
| Types of Testing Performed Software verification testing to ensure the software continues to meetrequirements following the proposed modifications Design validation studies to ensure the installation process for updatingthe applicable software and firmware components meets requirements andthat the system remains compatible with common electrophysiology labequipment. | |
| Risk Management The changes to the Workmate Claris™ System v1.2 were evaluatedthrough review of risk management to ensure no new hazards have beenintroduced by this change. | |
| Statement ofEquivalence | The technological characteristics for the devices are the same as the predicatedevices. Based on this and the data provided in this pre-market notification, thesubject devices and predicate devices have been demonstrated to be substantiallyequivalent |
§ 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).