(68 days)
The WorkMate(TM) Claris(TM) System is indicated for use during clinical electrophysiology procedures.
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™ 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.
The provided text describes the St. Jude Medical WorkMate Claris System, a computer-based electrophysiological recording and monitoring system, and its associated Scribe Module. However, it does not explicitly detail a study conducted to demonstrate the device's fulfillment of specific acceptance criteria in the manner requested.
Instead, the document focuses on the regulatory submission process (510(k)) and demonstrates substantial equivalence to predicate devices. The "Summary on Non-Clinical Testing" section mentions that the device was designed and tested to applicable safety standards and St. Jude Medical SOPs, including design controls and risk analysis. It states that "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." This indicates that internal testing was conducted against performance specifications, which serve as acceptance criteria, but no specific study details are provided.
Therefore, many of the requested details cannot be extracted from this document, as a formal clinical or comparative effectiveness study with specified sample sizes, ground truth establishment, or expert adjudication, as commonly seen for AI/ML device evaluations, is not described.
Here's a breakdown of what can be gleaned and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The document mentions "established performance specifications" and implies that "design verification activities for mechanical and functional testing were performed with their respective acceptance criteria." However, the specific, quantitative acceptance criteria themselves are not listed.
- Reported Device Performance: Similarly, the document states "All testing performed met the established performance specifications," but the specific performance results that demonstrate this achievement are not provided.
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Design verification activities for mechanical and functional testing performed to ensure hardware and software modifications do not affect safety or effectiveness. | All testing performed met the established performance specifications. |
| Adherence to applicable safety standards and St. Jude Medical SOPs (design controls, risk analysis). | Designed and tested to applicable safety standards and St. Jude Medical SOPs. |
2. Sample size used for the test set and the data provenance
Not explicitly stated in the document. The document refers to "design verification activities" and "bench testing," which implies internal testing rather than a clinical study with a "test set" in the context of data-driven performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/mentioned. The document does not describe a process of establishing ground truth using experts, as might be done for AI/ML performance evaluation. The testing appears to be primarily focused on meeting hardware and software functional specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/mentioned. An adjudication method is typically used to establish ground truth in studies involving human interpretation or performance assessment, which is not detailed here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study is described. The device is a "Programmable Diagnostic Computer" for recording and monitoring, not an AI-assisted diagnostic tool that would typically be evaluated with an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This document describes a medical device system, not a standalone algorithm. The "automated software waveform detector (trigger)" performs online recognition, which is an algorithmic function. The document states that "design verification activities... for... limited software modifications do not affect the safety or effectiveness," implying standalone software testing was part of the internal verification, but no detailed study or results focusing solely on this algorithmic performance are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not explicitly mentioned for any "test set." The "ground truth" for the device's functional performance would have been defined by its established engineering specifications and expected operational parameters, as opposed to clinical "ground truth" in the diagnostic sense.
8. The sample size for the training set
Not applicable/mentioned. The device is not described as an AI/ML device that undergoes a training phase using a specific dataset.
9. How the ground truth for the training set was established
Not applicable/mentioned. (Refer to point 8).
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St. Jude Medical
| 510(k) Summary | |
|---|---|
| 510(k) Number | To be assigned |
| Submitter Information: | |
| Date Prepared: | July 02, 2013 |
| Submitter Name & Address: | St. Jude MedicalOne St. Jude Medical DriveSt. Paul, MN 55117 |
| Contact Person: | Kris MillerRegulatory Affairs SpecialistPhone (651) 756-2954Fax (651) 756-3298KMiller03@sjm.comSEP 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 onpreselected leads. Temporal interval measurements are computed on multiplechannels on a beat-by-beat basis and dynamically displayed on the real-timedisplay. Menu-driven software is utilized for data acquisition and analysis,interval posting, and instant data retrieval with waveform markers and intervalsdisplayed. | |
| 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 alsoretrieve and display earlier passages of the current study without interruption ofthe realtime display. The system can also acquire, display and record data fromother interfaced devices in use during the procedure, such as imaging devices andablation generators. | |
| DeviceDescription:WorkMate ScribeModule | The WorkMate Scribe Module consists of a PC, a touch screen LCD monitor andcart connected via Ethernet to a WorkMate Claris System. Vital signsmeasurements can be imported from an optional external Physiological Module(Smiths Medical Advisor™ Vital Signs Monitor herein referred to as PhysioMonitor). Patient data stored on the WorkMate Claris System can be reviewed,measured and annotated. Real Time signals currently being acquired by theWorkMate Claris System can be viewed. The product is an add-on extension ofthe WorkMate Claris System that allows a second user to view and annotate astudy in parallel with the System user. |
| Indications forUse | The WorkMate Claris System is indicated for use during clinicalelectrophysiology procedures. |
| PredicateIndications forUse | The EP-WorkMate System is indicated for use during clinical electrophysiologyprocedures.The EP-NurseMate is indicated for use during clinical electrophysiologyprocedures. |
| Comparison toPredicate Devices | The WorkMate Claris System which includes the WorkMate Scribe Module hasthe same intended use and fundamental scientific technology as the predicatedevices. The technological characteristics of the WorkMate Claris System aresubstantially equivalent to the predicate devices including packaging andlabeling. Through bench testing, it was demonstrated that the designmodifications do not adversely affect the safety and effectiveness. |
| Summary onNon-ClinicalTesting | The WorkMate Claris System has been designed and tested to applicable safetystandards and St. Jude Medical SOPs, including design controls and risk analysis.Design verification activities for mechanical and functional testing wereperformed with their respective acceptance criteria to ensure that the hardwareand limited software modifications do not affect the safety or effectiveness of thedevice. All testing performed met the established performance specifications. |
| 510(k) Summary | |
| Statement ofEquivalence | The WorkMate Claris System which includes the WorkMate Scribe Module hasthe same indications for use as the predicate devices. The trade names have beenchanged The technological characteristics for the devices are the same as thepredicate devices. Based on this and the data provided in this pre-marketnotification, the subject devices and predicate devices have been shown to besubstantially 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'
§ 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).