(24 days)
The EP-4 Cardiac Stimulator is indicated for use during clinical cardiac electrophysiology procedures. The EP-4 Cardiac Stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachyarrhythmias, and measurements of electrical conduction.
The EP-4 Cardiac Stimulator consists of a touch-screen computer, an AC-powered stimulation module, which provides electrical stimulation to the heart during electrophysiology case studies. The EP-4 consists of a touch-screen computer that controls a two- or four-channel AC-powered stimulation module, and a keyboard. The stimulator is capable of performing single channel, simultaneous, or sequential stimulation at programmed output settings using existing/predicate programmed protocols. The device is independent and self-contained, with the exception of marker outputs and an external sync input connector. It can be configured as a stand-alone system or in conjunction with the EP-WorkMate™ Recording System. It may also be used with other EP recording systems.
The provided document is a 510(k) premarket notification for the EP-4™ Cardiac Stimulator, which is an external programmable pacemaker pulse generator. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, the EP-4™ Clinical Stimulator (K040207).
The document does not contain acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, or specific physiological parameters with defined thresholds) or a formal study designed to "prove" the device meets such criteria through a statistical analysis against a ground truth.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device. This is a regulatory pathway where a new device is shown to be as safe and effective as a legally marketed device that is not subject to premarket approval (PMA). The "study" described is primarily bench testing to confirm that design changes did not adversely affect safety or efficacy.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:
-
A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with numerical performance metrics. The "acceptance criteria" in the context of this 510(k) submission are implicitly tied to demonstrating that the EP-4 Cardiac Stimulator is "substantially equivalent" to its predicate device (EP-4 Clinical Stimulator).
The reported "performance" is described qualitatively:
- "Bench testing was performed to confirm that the changes met design requirements and did not adversely affect the safety or efficacy of the product."
- "Where design 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."
- The device has the "same intended use and fundamental scientific technology" and "all technological characteristics... are substantially equivalent" to the predicate.
No specific numerical performance values (e.g., stimulation accuracy within a certain mV or ms, battery life, etc.) that would typically be associated with explicit acceptance criteria are provided in this regulatory summary.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes "bench testing," which refers to laboratory testing of the device itself, not a clinical study involving patients or a dataset of patient data. Therefore, there is no "test set" in the context of patient data, nor is there information on data provenance.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As this was bench testing for substantial equivalence, clinical ground truth establishment in the traditional sense (e.g., by medical experts for diagnostic accuracy) was not the focus. The "ground truth" for bench testing would be engineering specifications and predicate device performance, verified by engineers and quality control personnel. No information on specific expert qualifications for this type of verification is provided.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no specific "test set" of patient data requiring clinical adjudication.
-
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. The EP-4 Cardiac Stimulator is a medical device for electrical stimulation, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related effectiveness are not relevant to this submission.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware system with embedded software for cardiac stimulation, not an algorithm being tested in isolation. The device's functionality is inherently "standalone" in operation once programmed, but this is distinct from testing an AI algorithm's performance without human interaction.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For bench testing, the "ground truth" would be established against the design requirements, engineering specifications, and performance characteristics of the predicate device. The goal was to confirm that the changes "met design requirements" and did not "adversely affect the safety or efficacy" when compared to the predicate. This is verified through a combination of standard engineering tests, electrical measurements, and functional checks.
-
The sample size for the training set
Not applicable. The device's software is menu-driven and firmware-based, controlling stimulation functions. It's not described as a machine learning system that requires a "training set" in the AI sense. The software's development followed "St. Jude Medical's Quality System requirements" and "design controls requirements documented in 21 CFR 820.30," which dictate rigorous testing and verification, but not "training data" in the AI context.
-
How the ground truth for the training set was established
Not applicable, as there is no "training set" for an AI algorithm.
{0}------------------------------------------------
Section 11
キリ/4
Submitter's Name / Contact Person
Sushma Rao, MS, RAC Regulatory Affairs Specialist II (856) 753-8533
Alternative:
OCT 1 6 2009
Timothy J. Kappers, MBA, RAC Sr. Manager, Regulatory Affairs (651) 756-2904
St. Jude Medical, Inc. Atrial Fibrillation Division Cooper Run Executive Park 575 Route 73 North, Building D West Berlin, NJ 08091-9293 (USA)
FDA Registration # 2248049
General Information
| Trade Name | EP-4™ Cardiac Stimulator |
|---|---|
| Common / UsualName | External Programmable Pacemaker Pulse Generator |
| Classification Name | JOQ, Class II, 21 CFR 870.1750 |
| Predicate Device | EP-4™ Clinical Stimulator (K040207) |
Device Description
The EP-4 Cardiac Stimulator consists of a touch-screen computer, an AC-powered stimulation module, which provides electrical stimulation to the heart during electrophysiology case studies. The EP-4 consists of a touch-screen computer that controls a two- or four-channel AC-powered stimulation module, and a keyboard. The stimulator is capable of performing single channel, simultaneous, or sequential stimulation at programmed output settings using existing/predicate programmed protocols.
The device is independent and self-contained, with the exception of marker outputs and an external sync input connector. It can be configured as a stand-alone system or in conjunction with the EP-WorkMate™ Recording System. It may also be used with other EP recording systems.
{1}------------------------------------------------
Key features of the EP-4 Cardiac Stimulator are:
- . Available in stand-alone configuration or integrated to the EP-WorkMate™ Recording System
- Compact and portable in stand alone configuration .
- . Touch screen display or color-coded keyboard user interface
- Initiate and terminate pacing manually or by a pre-programmed automatic mode .
- Available in two- or four-channel versions .
- . Pre-programmed protocols include SNRTs, overdrive and arrhythmia induction
- Up to 10 user-defined protocols can be stored in memorv .
- t Parameters can be changed with a single keystroke or touch screen button
Software Description
The EP-4 Cardiac Stimulator functions are controlled by the system software. The menudriven software is controlled through a user interface with a touch-screen computer or keyboard. The software architecture includes the system software and firmware in the mother, stimulator, and trigger boards.
Hardware Description
The EP-4 Cardiac Stimulator hardware consists of a touch-screen computer, an ACpowered stimulation module and a keyboard. The device may also be integrated into an EP-WorkMate recording system or used with other electrophysiology recording systems.
A graphical presentation of system interconnections is provided in Figure 2.
{2}------------------------------------------------
Image /page/2/Figure/2 description: The image shows a block diagram of the EP-4 Stimulation Module. The module has several inputs and outputs, including Stimulus Outputs, ECG Input, Pace/Sense Markers, and AUX. The Stimulus Outputs are connected to a Recording system or catheter, while the ECG Input is connected to the Patient. The Pace/Sense Markers and AUX are connected to a Chart Recorder and Recording/Reporting System.
Figure 2: EP-4 Cardiac Stimulator Interconnection Diagram
Indications for Use
The EP-4 Cardiac Stimulator is indicated for use during clinical cardiac electrophysiology procedures.
Intended Use
The EP-4 Cardiac Stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachyarrhythmias, and measurements of electrical conduction.
Device Comparison to the Cleared Device
The EP-4 Cardiac Stimulator has the same intended use and fundamental scientific technology as the predicate device. All technological characteristics of the EP-4 are substantially equivalent to the predicate device.
Summary of Non-Clinical Testing
Bench testing was performed to confirm that the changes met design requirements and did not adversely affect the safety or efficacy of the product.
{3}------------------------------------------------
092913 $4/4
Summary of Design Control Activities
The development of EP-4 design modifications was performed in accordance with St. Jude Medical's Quality System requirements, and in compliance with Quality System Regulation design controls requirements documented in 21 CFR 820.30.
Conclusion
The EP-4 Cardiac Stimulator has the same intended use and fundamental scientific technology as the predicate device. All technological characteristics of the EP-4 Cardiac Stimulator are substantially equivalent to the predicate device.
Where design 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-4 Cardiac Stimulator to be substantially equivalent to the predicate device.
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
St. Jude Medical c/o Ms. Sushma Rao Regulatory Specialist 575 Route 73 North Building D West Berlin, NJ 08091
OCT 1 6 2009
Re: K092913
Trade/Device Name: EP-4TM Cardiac Stimulator Regulatory Number: 21 CFR 870.1750 Regulation Name: Pulse Generator, Pacemaker, External Programmable Regulatory Class: II (two) Product Code: 74 JOQ Dated: September 18, 2009 Received: September 22, 2009
Dear Mr. Jung:
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.
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.
{5}------------------------------------------------
Page 2 - Ms. Sushma Rao
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/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.
http://www.fda.gov/MedicalDevices/ResourceforYou/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
{6}------------------------------------------------
K092913
INDICATIONS FOR USE STATEMENT
Section 6
INDICATIONS FOR USE
510(K) Number (if known):
Device Name: EP-4TM Cardiac Stimulator
Indications for Use
The EP-4 Cardiac Stimulator is indicated for use during clinical cardiac electrophysiology procedures.
Intended Use
The EP-4 Cardiac Stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachyarrhythmias, and measurements of electrical conduction.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mitchell R. Q-Tal B. Zuckerman
(Division Sign-Off) 10/01/01/07 Division of Cardiovascular Devices 510/k) Number
§ 870.1750 External programmable pacemaker pulse generator.
(a)
Identification. An external programmable pacemaker pulse generators is a device that can be programmed to produce one or more pulses at preselected intervals; this device is used in electrophysiological studies.(b)
Classification. Class II (performance standards).