EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04

K092913 · Ep Medsystems · JOQ · Oct 16, 2009 · Cardiovascular

Device Facts

• Record ID: K092913
• Device Name: EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04
• Applicant: Ep Medsystems
• Product Code: JOQ · Cardiovascular
• Decision Date: Oct 16, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1750
• Device Class: Class 2

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 Story

EP-4 Cardiac Stimulator is an external programmable pacemaker pulse generator used in clinical electrophysiology (EP) procedures. It accepts ECG input from the patient and provides electrical stimulation via catheters. The system comprises a touch-screen computer, keyboard, and a two- or four-channel AC-powered stimulation module. It operates as a standalone unit or integrated with the EP-WorkMate Recording System. Physicians use the device to perform refractory measurements, initiate/terminate tachyarrhythmias, and measure electrical conduction. It supports manual or pre-programmed pacing protocols (e.g., SNRTs, overdrive, arrhythmia induction). Up to 10 user-defined protocols can be stored. The device provides marker outputs for external recording systems, allowing clinicians to monitor stimulation effects in real-time to guide diagnostic decision-making.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

AC-powered stimulation module; touch-screen computer and keyboard interface; 2- or 4-channel output; standalone or integrated (EP-WorkMate) configuration; firmware-controlled stimulation protocols; marker outputs and external sync input.

Indications for Use

Indicated for use during clinical cardiac electrophysiology procedures for diagnostic electrical stimulation of the heart.

Predicate Devices

• EP-4™ Clinical Stimulator (K040207)

Submission Summary (Full Text)

{0}------------------------------------------------

Section 11

K092913

キリ/4

# Submitter's Name / Contact Person

Sushma Rao, MS, RAC Regulatory Affairs Specialist II [phone]

Alternative:

OCT 1 6 2009

Timothy J. Kappers, MBA, RAC Sr. Manager, Regulatory Affairs [phone]

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 / Usual<br>Name | 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 [phone] or [phone] 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