WorkMate Claris System

K210392 · Abbott · DQK · Mar 11, 2021 · Cardiovascular

Device Facts

• Record ID: K210392
• Device Name: WorkMate Claris System
• Applicant: Abbott
• Product Code: DQK · Cardiovascular
• Decision Date: Mar 11, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Indications for Use

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.

Device Story

WorkMate Claris System is a computerized diagnostic tool for clinical electrophysiology (EP) labs. It acquires intracardiac signals from catheters and surface ECG signals via cables. An integrated amplifier conditions these signals before computer processing. During procedures, an automated software waveform detector identifies cardiac activation on preselected leads. The system computes temporal interval measurements (intra-channel and inter-channel) on a beat-by-beat basis, displaying them in real-time. Users can review continuous digitized signals, retrieve past study passages, and interface with external imaging or ablation equipment. The system aids clinicians in monitoring and analyzing cardiac electrical activity to support diagnostic decision-making during EP procedures.

Clinical Evidence

Bench testing only. Software verification testing and design validation studies were performed to ensure the system meets requirements, remains compatible with EP lab equipment, and that the installation process for software/firmware updates is effective. Risk management review confirmed no new hazards were introduced.

Technological Characteristics

Programmable diagnostic computer (Class II, DQK). System components include display workstations (HP z440, Onyx-1723) running Windows 10. Connectivity includes integration with EP catheters, surface ECG leads, and ancillary modules (Scribe, Unity). Software includes McAfee Application Control for security. Sterilization is not applicable as the system is a diagnostic computer.

Indications for Use

Indicated for use during clinical electrophysiology procedures in the EP laboratory for capturing and measuring physiological 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

• Workmate Claris™ System v1.1 (K151911)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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)

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## 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 | |
| Manufacturer<br>Name/Address | Abbott<br>One St. Jude Medical Drive<br>St. Paul, MN 55117 |
| Contact Person | Ed Sandberg<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>[e-mail] |
| 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.<br><br>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.<br><br>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).<br><br>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 |

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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 v1.2<br>WorkMate Claris™ System is indicated for the use during clinical electrophysiology procedures.<br>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.<br>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.<br>The modifications for the subject device are outlined below. | | |
| | Characteristic | Predicate Device (K151911) | Subject Device (K210392) |
| | | H700123, H700124; WorkMate Claris™ System and H700120, H700121<br>WorkMate™ Scribe™ Module | |
| | Trade /<br>Proprietary<br>Name | WorkMate Claris™ System | Same |
| | Device Class | II | Same |
| | Classification<br>Name | Computer, Diagnostic,<br>Programmable | Same |
| | Product Code | DQK | Same |
| | Indications for<br>use | The WorkMate Claris™ System is indicated for use during clinical electrophysiology procedures.<br><br>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<br>(K151911) | Subject Device<br>(K210392) | |
| H700977; WorkMate Claris Display Workstation | | | |
| Software<br>Version | v1.1.1 | v1.2 | |
| Workstation<br>Hardware | HP z620 | HP z440 | |
| H701060, WorkMate™ Scribe™ Display Workstation | | | |
| Software<br>Version | v1.1.1 | v1.2 | |
| Workstation<br>Hardware | HP 8200 | Onyx-1723 | |
| H800007; WorkMate Claris™ System Software Upgrade Kit v1.2 (z440) | | | |
| Operating<br>System | Windows 7 | Windows 10 | |
| Software<br>Version | v1.1.1 | v1.2 | |
| Acrobat Reader | v.11.0.06 | v.20.006.20042 | |
| Bomgar Client<br>(SJMConnect) | v. 14.3.1 | v19.1.7 | |
| McAfee<br>Application<br>Control | v.8.0.0.817 | v.8.2.1.407 | |
| Microsoft Word | v. 15.0.4420.1017 | v. 16.0.10359.20023 | |
| Microsoft<br>Power Point | v. 15.0.4420.1017 | v. v. 16.0.10359.20023 | |
| H800008; WorkMate™ Scribe™ Module Software Version 1.2 | | | |
| Operating<br>System | Windows 7 | Windows 10 | |
| Software<br>Version | v1.1.1 | v1.2 | |
| Acrobat<br>Reader | v.11.0.06 | v.20.006.20042 | |
| Bomgar Client<br>(SJMConnect) | v. 14.3.1 | v19.1.7 | |
| McAfee<br>Application<br>Control | v.8.0.0.817 | v.8.2.1.407 | |
| Microsoft Word | v. 15.0.4420.1017 | v. 16.0.10359.20023…