(29 days)
N/A
No
The summary describes automated waveform detection and interval measurements, but does not mention AI or ML.
No
The device is described as a system for capturing, measuring, and displaying physiological data, not for providing therapy. It is used for diagnostic and monitoring purposes during electrophysiology procedures.
Yes
The device captures and measures physiological data (electrical signals from the heart), displays these signals, performs automated waveform detection, and computes temporal interval measurements. This process of acquiring and analyzing physiological data to assess a medical condition (cardiac activation and intervals) aligns with the definition of a diagnostic device.
No
The device description explicitly mentions hardware components like an amplifier, computer, monitors, and connections to catheters and ECG cables, indicating it is a system with both hardware and software.
Based on the provided information, the WorkMate Claris™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "during clinical electrophysiology procedures" and for "capturing and measuring physiological data in the clinical electrophysiology (EP) laboratory." This describes a system used in vivo (within the living body) to acquire and analyze electrical signals directly from the heart and body surface.
- Device Description: The description details the connection to electrophysiology catheters guided into the heart and surface ECG cables. It describes the acquisition, amplification, conditioning, display, measurement, and storage of these in vivo electrical signals. It also mentions an integrated cardiac stimulator that sends electrical impulses to the heart.
- Lack of In Vitro Activities: There is no mention of analyzing samples of human origin (like blood, urine, tissue, etc.) outside of the body. IVD devices are specifically designed for the examination of such specimens in vitro to provide information for diagnosis, monitoring, or screening.
The WorkMate Claris™ System is clearly designed for use during a medical procedure performed on a patient, acquiring and analyzing signals directly from the patient's body. This falls under the category of a medical device used for physiological monitoring and analysis, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DQK
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 ablation generators.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical electrophysiology (EP) laboratory
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)
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. All testing performed met the established performance specifications.
Testing: The Workmate Claris™ System v1.2 was developed and tested in accordance with the following industry guidance documents and standards: Off-the-Shelf Software Use in Medical Devices Guidance for Industry and Food and Drug Administration Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff EN ISO 14971:2019 Medical Devices – Application of Risk Management to Medical Devices
Types of Testing Performed: Software verification testing to ensure the software continues to meet requirements following the proposed modifications Design validation studies to ensure the installation process for updating the applicable software and firmware components meets requirements and that the system remains compatible with common electrophysiology lab equipment.
Risk Management: The changes to the Workmate Claris™ System v1.2 were evaluated through review of risk management to ensure no new hazards have been introduced by this change.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Workmate Claris™ System v1.1 (K151911)
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.
N/A
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
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)
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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 | |
| Manufacturer | |
| Name/Address | Abbott |
| One St. Jude Medical Drive | |
| St. Paul, MN 55117 | |
| Contact Person | Ed Sandberg |
| Regulatory Affairs Specialist | |
| Phone: 651-245-8398 | |
| ed.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 v1.2 | ||
| WorkMate 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, H700121 | |||
| WorkMate™ Scribe™ Module | |||
| Trade / | |||
| Proprietary | |||
| Name | WorkMate Claris™ System | Same | |
| Device Class | II | Same | |
| Classification | |||
| Name | Computer, Diagnostic, | ||
| Programmable | Same | ||
| Product Code | DQK | Same | |
| Indications for | |||
| use | 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 | | | |
| Software
Version | v1.1.1 | v1.2 | |
| Workstation
Hardware | HP z620 | HP z440 | |
| H701060, WorkMate™ Scribe™ Display Workstation | | | |
| Software
Version | v1.1.1 | v1.2 | |
| Workstation
Hardware | HP 8200 | Onyx-1723 | |
| H800007; WorkMate Claris™ System Software Upgrade Kit v1.2 (z440) | | | |
| Operating
System | Windows 7 | Windows 10 | |
| Software
Version | 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 | |
| McAfee
Application
Control | v.8.0.0.817 | v.8.2.1.407 | |
| Microsoft Word | v. 15.0.4420.1017 | v. 16.0.10359.20023 | |
| Microsoft
Power Point | v. 15.0.4420.1017 | v. v. 16.0.10359.20023 | |
| H800008; WorkMate™ Scribe™ Module Software Version 1.2 | | | |
| Operating
System | Windows 7 | Windows 10 | |
| Software
Version | 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 | |
| McAfee
Application
Control | v.8.0.0.817 | v.8.2.1.407 | |
| Microsoft Word | v. 15.0.4420.1017 | v. 16.0.10359.20023 | |
| Microsoft
Power Point | v. 15.0.4420.1017 | v. v. 16.0.10359.20023 | |
| Characteristic | Predicate Device
(K151911) | Subject Device
(K210392) | |
| Software
License | N/A | Single License Kit to enable
The WorkMate™ Unity™
(H702321) Module
Software. | |
| H800010; WorkMate™ Unity™ Module Software Kit Installation v1.2 (10 License) | N/A | New model numbers created
for Software License Kits
for the v1.2 Unity software
(10 License) | |
| H800011; WorkMate™ Unity™ Module Software Kit Installation v1.2 (Site License) | N/A | Single License Kit to enable
The WorkMate™ Unity™
(H702321) Module
Software. | |
| H800012; WorkMate Claris™ System Software Upgrade Kit v1.2 (z620) | | | |
| Operating
System | Windows 7 | Windows 10 | |
| Software
Version | 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 | |
| McAfee
Application
Control | v.8.0.0.817 | v.8.2.1.407 | |
| Microsoft Word | v. 15.0.4420.1017 | v. 16.0.10359.20023 | |
| Microsoft
Power 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 Testing
Summary | 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. All testing performed met the
established performance specifications.
Testing
The Workmate Claris™ System v1.2 was developed and tested in accordance
with the following industry guidance documents and standards: |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Off-the-Shelf Software Use in Medical Devices Guidance for Industry and
Food and Drug Administration Staff Guidance for the Content of Premarket Submissions for Software
Contained in Medical Devices Content of Premarket Submissions for Management of Cybersecurity in
Medical Devices: Guidance for Industry and Food and Drug
Administration Staff EN ISO 14971:2019 Medical Devices – Application of Risk Management
to Medical Devices |
| | Types of Testing Performed Software verification testing to ensure the software continues to meet
requirements following the proposed modifications Design validation studies to ensure the installation process for updating
the applicable software and firmware components meets requirements and
that the system remains compatible with common electrophysiology lab
equipment. |
| | Risk Management The changes to the Workmate Claris™ System v1.2 were evaluated
through review of risk management to ensure no new hazards have been
introduced by this change. |
| Statement of
Equivalence | The technological characteristics for the devices are the same as the predicate
devices. Based on this and the data provided in this pre-market notification, the
subject devices and predicate devices have been demonstrated to be substantially
equivalent |