(68 days)
Not Found
No
The description mentions "automated software waveform detector" and "temporal interval measurements are computed on multiple channels on a beat-by-beat basis," which are standard signal processing and analysis techniques, not indicative of AI/ML. There is no mention of AI, ML, or related terms like neural networks or deep learning.
No
The device is described as an electrophysiological recording and monitoring system used to capture, display, store, and retrieve electrical signals during electrophysiology studies. It is primarily for diagnostic and monitoring purposes, not for direct therapeutic intervention.
Yes
The device is described as an "electrophysiological recording and monitoring system that is used to capture, display, store, and retrieve surface and intracardiac electrical signals during electrophysiology studies." This process involves acquiring and analyzing signals to gain information about a patient's condition, which aligns with the definition of a diagnostic device. The "Intended Use / Indications for Use" further specifies its use during "clinical electrophysiology procedures," which are diagnostic in nature.
No
The device description explicitly lists multiple hardware components including a computer, monitors, amplifier, signal conditioning unit, catheter input modules, printer, and carts. It also mentions connections to electrophysiology catheters and ECG cables.
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." This describes a procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device acquires and displays electrical signals directly from the heart and surface ECG leads connected to the patient. It processes these signals for real-time monitoring, measurement, and storage. This is a system used for in vivo (within a living organism) measurement and monitoring.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The WorkMate Claris System does not process such specimens.
Therefore, the WorkMate Claris System is a medical device used for in vivo electrophysiological studies, not an IVD device.
N/A
Intended Use / Indications for Use
The WorkMate(TM) Claris(TM) System is indicated for use during clinical electrophysiology procedures.
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
The WorkMate Claris System is a computer-based electrophysiological recording and monitoring system that is used to capture, display, store, and retrieve surface and intracardiac electrical signals during electrophysiology studies. It consists of a computer, two 23" high-resolution monitors, a multi-channel signal amplifier and filtering system (signal conditioning unit), one or two catheter input modules (CIMs), a printer, and carts. The system may also be configured with an integrated EP-4TM Cardiac Stimulator and touch-screen computer monitor (cleared in K092913).
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 multiple channels on a beat-by-beat basis and dynamically displayed on the real-time display. Menu-driven software is utilized for data acquisition and analysis, interval posting, and instant data retrieval with waveform markers and intervals displayed.
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 realtime 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 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(TM) Vital Signs Monitor herein referred to as Physio Monitor). Patient data stored on the WorkMate Claris System can be reviewed, measured and annotated. Real Time signals currently being acquired by the WorkMate Claris System can be viewed. The product is an add-on extension of the WorkMate Claris System that allows a second user to view and annotate a study in parallel with the System user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart (intracardiac)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The WorkMate Claris System has been designed and tested to applicable safety standards and St. Jude Medical SOPs, including design controls and risk analysis. Design verification activities for mechanical and functional testing were performed with their respective acceptance criteria to ensure that the hardware and limited software modifications do not affect the safety or effectiveness of the device. All testing performed met the established performance specifications.
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.
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).
0
St. Jude Medical
| 510(k) Summary | |
|---|---|
| 510(k) Number | To be assigned |
| Submitter Information: | |
| Date Prepared: | July 02, 2013 |
| Submitter Name & Address: | St. Jude Medical |
| One St. Jude Medical Drive | |
| St. Paul, MN 55117 | |
| Contact Person: | Kris Miller |
| Regulatory Affairs Specialist | |
| Phone (651) 756-2954 | |
| Fax (651) 756-3298 | |
| KMiller03@sjm.com | |
| SEP 09 2013 | |
| Device Information: | |
| Trade Name: | WorkMate Claris System |
| Common Name: | Programmable Diagnostic Computer |
| Class | II |
| Classification Name: | 870.1425, computer, diagnostic, programmable DQK |
| Predicate Device: | EP-WorkMate System (K092810) |
| EP-NurseMate and EP-NurseMate with Physio Module (K093583) | |
| Device Description: WorkMate Claris System | The WorkMate Claris System is a computer-based electrophysiological recording and monitoring system that is used to capture, display, store, and retrieve surface and intracardiac electrical signals during electrophysiology studies. It consists of a computer, two 23" high-resolution monitors, a multi-channel signal amplifier and filtering system (signal conditioning unit), one or two catheter input modules (CIMs), a printer, and carts. The system may also be configured with an integrated EP-4TM Cardiac Stimulator and touch-screen computer monitor (cleared in K092913). |
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 |
| 510(k) Summary | |
| | waveform detector (trigger) performs online recognition of cardiac activation on
preselected leads. Temporal interval measurements are computed on multiple
channels on a beat-by-beat basis and dynamically displayed on the real-time
display. Menu-driven software is utilized for data acquisition and analysis,
interval posting, and instant data retrieval with waveform markers and intervals
displayed. |
| | 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 realtime 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. |
| Device
Description:
WorkMate Scribe
Module | 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). Patient data stored on the WorkMate Claris System can be reviewed,
measured and annotated. Real Time signals currently being acquired by the
WorkMate Claris System can be viewed. The product is an add-on extension of
the WorkMate Claris System that allows a second user to view and annotate a
study in parallel with the System user. |
| Indications for
Use | The WorkMate Claris System is indicated for use during clinical
electrophysiology procedures. |
| Predicate
Indications for
Use | The EP-WorkMate System is indicated for use during clinical electrophysiology
procedures.
The EP-NurseMate is indicated for use during clinical electrophysiology
procedures. |
| Comparison to
Predicate Devices | The WorkMate Claris System which includes the WorkMate Scribe Module has
the same intended use and fundamental scientific technology as the predicate
devices. The technological characteristics of the WorkMate Claris System are
substantially equivalent to the predicate devices including packaging and
labeling. Through bench testing, it was demonstrated that the design
modifications do not adversely affect the safety and effectiveness. |
| Summary on
Non-Clinical
Testing | The WorkMate Claris System has been designed and tested to applicable safety
standards and St. Jude Medical SOPs, including design controls and risk analysis.
Design verification activities for mechanical and functional testing were
performed with their respective acceptance criteria to ensure that the hardware
and limited software modifications do not affect the safety or effectiveness of the
device. All testing performed met the established performance specifications. |
| 510(k) Summary | |
| Statement of
Equivalence | The WorkMate Claris System which includes the WorkMate Scribe Module has
the same indications for use as the predicate devices. The trade names have been
changed 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
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September 9, 2013
St. Jude Medical Kris Miller Regulatory Specialist II One St. Jude Medical Drive St. Paul, MN 55117 US
Re: K132073
Trade/Device Name: WorkMate Claris System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: August 21, 2013 Received: August 22, 2013
Dear Ms. Miller:
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. Ilsuing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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.
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Page 2 - Ms. Kris Miller
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-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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers. International and Consumer Assistance 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,
Owen P. Faris -S
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
K132073 510(k) Number (if known): __
Device Name: WorkMate™ Claris™ System
Indications for Use:
The WorkMate™ Claris™ System is indicated for use during clinical electrophysiology procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Digitally signed by Owen P.
Faris -S
Date: 2013.09.09 10:18:56
-04'00'