(101 days)
Not Found
No
The description focuses on signal acquisition, display, automated waveform detection (trigger), and temporal interval measurements based on preselected leads and channels. While this involves automated processing, there is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML. The "automated software waveform detector (trigger)" appears to be a rule-based or algorithmic approach rather than a learned model.
No
The device is described as a system for capturing, measuring, and displaying physiological data, not for providing therapy. It is used for diagnostic purposes during electrophysiology procedures.
Yes
The device captures and measures physiological data (electrical signals from the heart) and performs automated waveform detection and temporal interval measurements, which are then displayed and available for measurement and analysis. This process of acquiring and analyzing physiological data to provide information about a patient's health state is characteristic of a diagnostic device.
No
The device description explicitly states it is a "fully computerized system" that includes digital signal acquisition, display on monitors, connection to catheters and ECG cables, an amplifier, a computer, and potentially other interfaced devices and an optional monitoring station with a PC, monitor, and cart. These are hardware components, not just 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 explicitly states the system is connected to "electrophysiology catheters that are guided into various locations within the heart, and to surface electrocardiogram (ECG) cables." It acquires "Intracardiac and ECG signals" from electrodes. This is a direct interaction with the patient's body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens derived from the human body (such as blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The WorkMate Claris™ System does not process specimens in vitro.
The WorkMate Claris™ System is a physiological monitoring and analysis system used during invasive and non-invasive procedures on a living patient.
N/A
Intended Use / 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.
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.
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 WorkMate Scribe™ Module is an optional integrated monitoring and review station for the WorkMate Claris System that allows a separate user to review and edit current patient study data stored on the WorkMate Claris System and monitor patient data from the WorkMate Claris System during the patient study. The WorkMate Scribe Module consists of a PC, a touch screen LCD monitor and cart connected via Ethernet to a WorkMate Claris System. Vital signs measurements can be imported from an optional external Physiological Module (Smiths Medical Advisor™ Vital Signs Monitor herein referred to as Physio Monitor).
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 software modifications do not affect the safety or effectiveness of the device. All testing performed met the established performance specifications. Performance tests were conducted to test the functionality of the WorkMate Claris™ System. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.
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 K132073
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.
Not Found
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).
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 22, 2015
St. Jude Medical Melissa Frank Senior Regulatory Affairs Specialist One St. Jude Medical Drive St. Paul, MN 55117
Re: K151911
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: September 17, 2015 Received: September 22, 2015
Dear Melissa Frank:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151911
Device Name WorkMate Claris™ System
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CER 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510KSUMMARY
| 510(k) Number | K151911 |
|---|---|
| Date Prepared | 09-July-2015 |
| Submitter Information | St. Jude Medical |
| One St. Jude Medical Drive | |
| St. Paul, MN 551177 | |
| Manufacturer | |
| Name/Address | |
| Contact Person | Melissa Frank |
| Sr. Regulatory Affairs Specialist | |
| Phone (651) 756-2954 | |
| Mfrank02@sjm.com | |
| Device Information | |
| Trade Name | WorkMate Claris™ System |
| Common Name | Programmable Diagnostic Computer |
| Class | II |
| Classification Name | 870.1425, computer, diagnostic, programmable DQK |
| Predicate Device | WorkMate Claris System K132073 |
| 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.
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 WorkMate Scribe™ Module is an optional integrated monitoring and
review station for the WorkMate Claris System that allows a separate user to
review and edit current patient study data stored on the WorkMate Claris
System and monitor patient data from the WorkMate Claris System during the
patient study. The WorkMate Scribe Module consists of a PC, a touch screen
LCD monitor and cart connected via Ethernet to a WorkMate Claris System.
Vital signs measurements can be imported from an optional external
Physiological Module (Smiths Medical Advisor™ Vital Signs Monitor herein
referred to as Physio Monitor). |
| 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. |
| Predicate Comparison | The proposed WorkMate Claris System software upgrade v1.1, which includes
the WorkMate Scribe Module, has the same intended use and fundamental
scientific technology as the predicate device, WorkMate Claris System v1.0.
The WorkMate Claris and WorkMate Scribe software v.1.1 software upgrade
has four main objectives:
- The main objective for the software upgrade is to update the operating
system from Window XP to Windows 7. Microsoft announced that
Windows XP has ended life and Microsoft will not continue to support
Windows XP. - The second objective for the software upgrade is to add a few minor new
customer enhancement software features that have been identified through
voice of customer (VOC). - The third objective of the upgrade is to address software anomalies that
were identified either through in-house testing or product surveillance. - The fourth objective of the upgrade is to update the Software of Unknown
Provenance (SOUP)/ Off-the-Shelf (OTS) programs |
| Non-Clinical Testing
Summary | Design verification activities for functional testing were performed with their
respective acceptance criteria to ensure that the software modifications do not
affect the safety or effectiveness of the device. All testing performed met the
established performance specifications. Performance tests were conducted to
test the functionality of the WorkMate Claris™ System. These tests have been
performed to assess the functionality of the subject device. Results of all
conducted testing were found acceptable in supporting the claim of substantial
equivalence. |
| | The WorkMate Claris System software is developed and tested in accordance
with the following industry guidance documents and standards:
• FDA Reviewers and Compliance on Off-the-Shelf Software used in
Medical Devices and IEC 62304 OTS classification
• Guidance for the Content of Premarket Submissions for Software |
| | Contained in Medical Devices |
| | IEC 62304:2006 Medical Device Software - Software Life Cycle Processes Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff |
| | Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is included as part of this submission. |
| | Software Documentation for OTS software classified as a Minor Level of Concern, Class B according the FDA guidance, FDA Reviewers and Compliance on Off-the-Shelf Software used in Medical Devices and IEC 62304 OTS classification is included as part of this submission. |
| | The changes to the application software and operating system were evaluated through software verification and validation to show that the application software is acceptable for use and meets the requirements. |
| | The WorkMate Claris System conforms to the following standards: IEC 60601-1-2 (2007) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: electromagnetic disturbances - requirements and tests IEC 60601-1 (2005 + CORR.1 (2006) + CORR.2 (2007)) Medical electrical equipment- Part 1: General requirements for basic safety and essential performance ISO 14971 (2012) Medical Devices – Applications of risk management to medical devices IEC 62366 (2007) Medical devices – Application of usability engineering to medical devices |
| | Risk Management
The changes to the application software and operating system were evaluated through review of risk management to ensure no new hazards have been introduced by this change. The risk analysis was completed and risk controls were implemented to mitigate identified hazards. |
| | The WorkMate Claris™ System conforms to the Cybersecurity requirements through the cybersecurity risk management process comprised of a risk assessment, risk control, and maintenance of cybersecurity activities. |
| Statement of Equivalence: | The WorkMate Claris System which includes the WorkMate Scribe Module has the same indications for use as the predicate devices. 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 shown to be substantially equivalent. |
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