(26 days)
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No
The document describes a system for real-time charting, physiologic monitoring, and data analysis during electrophysiology studies, but there is no mention of AI, ML, or related concepts in the provided text. The modifications are described as creating an additional workstation for charting and monitoring.
No
The device is described as creating an additional workstation for charting and monitoring physiologic data, not for treating a condition.
No
The device is described as an additional workstation for charting and monitoring physiologic data during electrophysiology procedures, rather than performing diagnostic analysis itself. It expands the functionality of a recording system but doesn't state it diagnoses conditions.
No
The device is described as a modification to an existing "Recording System" and is "connected" to it, implying a hardware component or integration beyond just software.
Based on the provided information, the EP-NurseMate™ and EP-NurseMate™ with Physio Module are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- EP-NurseMate Function: The description clearly states that the EP-NurseMate is used for "real-time charting, physiologic monitoring, and data analysis during electrophysiology (EP) studies." This involves monitoring physiological data from the patient during a procedure, not analyzing specimens taken from the patient.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens.
Therefore, the EP-NurseMate™ and EP-NurseMate™ with Physio Module are considered medical devices used for monitoring and data management during clinical procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The EP-NurseMate™ is indicated for use during clinical electrophysiology procedures.
The EP-NurseMate™ with Physio Module is indicated for use during clinical electrophysiology procedures.
The EP-NurseMate™ is intended to be used as an extension of the EP-WorkMate™ Recording System for the viewing and measurements of cardiac electrograms, and electronic data entry of procedural events during a clinical electrophysiology procedure.
The EP-NurseMate™ with Physio Module is intended to be used as an extension of the EP-WorkMate™ Recording System for the viewing and measurements of cardiac electrograms, receiving vital signs measurements from a patient monitoring unit, and electronic data entry of procedural events during a clinical electrophysiology procedure.
Product codes
DQK
Device Description
The EP-NurseMate™ and the EP-NurseMate™ with Physio Module, Version 4.2.0, are modifications to the EP-WorkMate TM Recording System. The EP-NurseMate is connected to the EP-WorkMate Recording System for real-time charting, physiologic monitoring, and data analysis during electrophysiology (EP) studies. Expanding the EP-WorkMate™ Recording System with the optional EP-NurseMate™ or EP-NurseMate™ with Physio Module creates an additional workstation for a member of the EP team to perform charting (e.g., event titles, medications, and comments) and monitor physiologic data from their own display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Clinical simulation testing was performed to confirm that the changes met design requirements and did not adversely affect the safety or efficacy of the devices.
Key Metrics
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Predicate Device(s)
NurseMate™, NurseMate with Physio Module™
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/0 description: The image shows the logo for St. Jude Medical. The logo consists of a 3x3 grid of squares on the left, followed by the text "ST. JUDE MEDICAL" in a bold, sans-serif font. Below the company name, there is a tagline that reads "More control Less risk."
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510(k) SUMMARY
Submitter's Name/Contact Person
Eleanor J. Fox, M.S. Regulatory Affairs Specialist (856) 753-8533
Alternative:
Timothy J. Kappers, MBA, RAC Senior Manager, Regulatory Affairs (651) 756-2904
St. Jude Medical Cooper Run Executive Park 575 Route 73 North, Building D West Berlin, NJ 08091-9293 (USA)
FDA Registration # 2248049
General Information
| Trade Name | EP-NurseMate™ Remote Review and
Charting Station
(also referred to as EP-NurseMate™)
EP-NurseMate™ with Physio Remote
Review and Charting Station with
Physiologic Monitoring Module
(also referred to as EP-NurseMate™ with
Physio Module) |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name | Computer, diagnostic, programmable |
| Classification Name | DQK, Class II, 21 CFR 870.1425 |
| Predicate Device | NurseMate™
NurseMate with Physio Module™ |
Device Description
The EP-NurseMate™ and the EP-NurseMate™ with Physio Module, Version 4.2.0, are modifications to the EP-WorkMate TM Recording System. The EP-NurseMate is connected to the EP-WorkMate Recording System for real-time charting, physiologic monitoring, and data analysis during electrophysiology (EP) studies. Expanding the EP-
DEC 1 5 2009
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Image /page/1/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a 3x3 grid of squares on the left, followed by the text "ST. Jude Medical" in a serif font. Below the text is the tagline "MORE CONTROL. LESS RISK."
WorkMate™ Recording System with the optional EP-NurseMate™ or EP-NurseMate™ with Physio Module creates an additional workstation for a member of the EP team to perform charting (e.g., event titles, medications, and comments) and monitor physiologic data from their own display.
Software Description
The EP-NurseMate™ and the EP-NurseMate™ with Physio Module's functions are controlled by system software. The menu driven software is controlled through a user interface with a touchscreen LCD monitor or keyboard. The EP-NurseMate™ and the EP-NurseMate™ with Physio Module software is a modified version of the EP-WorkMate™ application software. The software was modified using the same Microsoft Visual C++ 6.0 Integrated Development Environment (with Visual Studio Service Pack 6.0A) within which it was originally developed. It is important to note that NurseMate™/EP-NurseMate™ with Physio Module do not control the patient monitor and do not control cardiac stimulation.
Hardware Description
The EP-NurseMate™ hardware consists of a PC, a touchscreen LCD monitor, a keyboard, and a cart.
The EP-NurseMate™ with Physio Module consists of a PC, a touchscreen LCD monitor, a keyboard, a physiologic monitoring device, and a cart.
A graphical presentation of the system interconnections is provided in Figures 1 and 2 of for EP-NurseMate™ and EP-NurseMate™ with Physio, respectively.
Image /page/1/Figure/9 description: The image shows a diagram of a medical system. The system includes components such as a patient, Amp/SCU, EP-WorkMate computer, NurseMate computer, and various monitors. Communication lines connect the Amp/SCU to the EP-WorkMate and NurseMate computers, and the EP-WorkMate and NurseMate computers are connected to their respective monitors.
Figure 1 EP-WorkMate™ with NurseMate™ Block Diagram
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Image /page/2/Figure/1 description: The image shows the logo for St. Jude Medical. The logo consists of a grid of black squares on the left, followed by the text "ST. JUDE MEDICAL" in a bold, serif font. Below the company name, there is a tagline that reads "MORE CONTROL LESS RISK."
Image /page/2/Figure/2 description: The image shows a diagram of a medical monitoring system. The system includes components such as an Amp/SCU unit connected to a patient, EP-WorkMate and NurseMate computers, and various monitors. The diagram also depicts the communication lines between these components, as well as the roles of medical personnel such as doctors and nurses in utilizing the system.
Figure 2: EP-WorkMate® with NurseMate™ with Physio Module Block Diagram
Indications for Use
The EP-NurseMate™ is indicated for use during clinical electrophysiology procedures.
The EP-NurseMate™ with Physio is indicated for use during clinical electrophysiology procedures.
Intended Use
The EP-NurseMate™ is intended to be used as an extension of the EP-WorkMate™ Recording System for the viewing and measurements of cardiac electrograms, and electronic data entry of procedural events during a clinical electrophysiology procedure.
The EP-NurseMate™ with Physio Module is intended to be used as an extension of the EP-WorkMate™ Recording System for the viewing and measurements of cardiac electrograms, receiving vital signs measurements from a patient monitoring unit, and electronic data entry of procedural events during a clinical electrophysiology procedure.
Device Comparison to the Cleared Device
The EP-NurseMate and the EP-NurseMate with Physio Modules have the same indications for use and fundamental scientific technology as the predicate devices. All technological characteristics of the devices are substantially equivalent to the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a grid of nine squares on the left and the words "ST. JUDE MEDICAL" in a stylized font on the right. Below the company name is the tagline "MORE CONTROL LESS RISK."
Summary of Non-Clinical Testing
Clinical simulation testing was performed to confirm that the changes met design requirements and did not adversely affect the safety or efficacy of the devices.
Summary of Design Control Activities
The development of the EP-NurseMate™ and the EP-NurseMate™ with Physio Module were performed in accordance with St. Jude Medical's Quality System requirements, and in compliance with Quality System Regulation design control requirements documented in 21 CFR 820.30. A Declaration of Conformity with Design Controls is provided in Attachment J.
Conclusion
The EP-NurseMate™ and the EP-NurseMate™ with Physio Module have the same indications for use and fundamental scientific technology as the predicate devices. All technological characteristics of the EP-WorkMate are substantially equivalent to the predicate device.
Where operational and performance differences exist between the proposed device and the predicate device, performance testing demonstrated that these differences do not adversely affect the device's safety and effectiveness.
Therefore, St. Jude Medical considers the EP-NurseMate™ and the EP-NurseMate with Physio Module to be substantially equivalent to the predicate devices.
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Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS). The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DEC 1 5 2009
St. Jude Medical, Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo MN 53313
Re: K093583
Trade/Device Name: EP-NurseMate and EP-NurseMate with Physio Module version 4.2 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: December 5, 2009 Received: December 9, 2009
Dear Mr. Job:
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.
5
Page 2 – Mr. Mark Job
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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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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Image /page/6/Picture/0 description: The image shows the logo for St. Jude Medical. The logo consists of a grid of squares on the left and the words "ST. Jude Medical" on the right. Below the company name is the tagline "More control. Less risk."
Indications for Use
510(k) Number (if known)_ K093583
Device Name:
EP-NurseMate™ (EP-NurseMate™ Remote Review and Charting Station) EP-NurseMate™ with Physio Module (EP-NurseMate™ Remote Review and Charting Station with Physiologic Monitoring Module)
Indications for Use:
The EP-NurseMate™ is indicated for use during clinical electrophysiology procedures.
The EP-NurseMate™ with Physio Module 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)
| (Division Sign-Off) |
|---|
| Division of Cardiovascular Devices |
| 510(k) Number | 4093583 |
|---|---|
| --------------- | --------- |
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EP-NurseMate Version 4.2 - St. Jude Medical - November 5, 2009 - Special 510(k) - Page 27 of 2005