LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE

K101331 · C.R. Bard Inc., Bard Electrophysiology Division · DQK · Oct 8, 2010 · Cardiovascular

Device Facts

• Record ID: K101331
• Device Name: LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE
• Applicant: C.R. Bard Inc., Bard Electrophysiology Division
• Product Code: DQK · Cardiovascular
• Decision Date: Oct 8, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The Bard LabSystem™ EP Laboratory is a computer and software driven data acquisition and analysis tool designed to facilitate the gathering, display, analysis by a physician, pace mapping and storage of cardiac electrophysiologic data. When integrated with the Philips EP navigator system, the BARD® LabSystem™ PRO EP Recording System is designed to acquire, analyze, and display 3D electroanatomical maps of the human heart. The maps are constructed using intracardiac electrograms with their respective cardiac locations taken from live x-ray overlay on a patient's 3D cardiac anatomy. Maps may be displayed as electrical activation maps, voltage maps, dominant frequency maps and location maps with user defined measurement values.

Device Story

Microprocessor-based data acquisition system used during electrophysiology procedures. Inputs include ECG, intracardiac, and pressure signals via patient-connected amplifiers, plus digital data from fluoroscopic systems and RF generators. Software (V3.1) processes these inputs to facilitate physician-led analysis, pace mapping, and storage of cardiac data. When integrated with Philips EP navigator, it constructs 3D electroanatomical maps by overlaying intracardiac electrograms onto live x-ray images of the patient's 3D cardiac anatomy. Outputs include electrical activation, voltage, dominant frequency, and location maps with user-defined measurements, displayed on-screen for clinical review. Used in clinical settings by physicians to guide cardiac procedures and inform clinical decision-making regarding cardiac electrophysiology.

Clinical Evidence

Bench testing only. No clinical data provided. The system was developed and tested in accordance with 21 CFR 820.30 Quality System Regulations and relevant IEEE standards.

Technological Characteristics

Microprocessor-based data acquisition system. Components include patient-connected amplifiers for ECG, intracardiac, and pressure signals. Connectivity includes integration with external fluoroscopic systems and RF generators. Software-driven analysis and 3D mapping. Developed under 21 CFR 820.30.

Indications for Use

Indicated for use by physicians to acquire, display, analyze, pace map, and store cardiac electrophysiologic data. When integrated with the Philips EP navigator system, it is indicated for the acquisition, analysis, and display of 3D electroanatomical maps of the human heart. No contraindications reported.

Regulatory Classification

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.

Predicate Devices

• Bard LabSystem PRO EP Recording System (K031000)
• CartoMerge Module of the Carto™ XP V8 EP Navigation System (K042999)

Submission Summary (Full Text)

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# OCT 0 8 2010

# 510(k) Summary

# 510(k) SUMMARY

This 510(k) Summary is provided per the requirements of section 807.92(c).

| Owner Name: | Bard Electrophysiology Division of C.R. Bard, Inc |
|----------------------|------------------------------------------------------------------|
| Address: | 55 Technology Drive |
| | Lowell, MA 01851 |
| Phone Number: | 978-323-2348 |
| Fax Number: | 978-323-2222 |
| Contact Person: | Anastasia C. Randall |
| | Manager, Regulatory Affairs |
| | Email address: [e-mail] |
| Alternate Contact: | Julie Broderick |
| | Director, Regulatory Affairs |
| | PH: 978-323-2220 |
| | FX: 978-323-2222 |
| | Email address: [e-mail] |
| Date of Summary: | May 10, 2010 |
| Device Trade Name: | LabSystemTM PRO EP Recording System |
| Device Common Name: | Programmable Diagnostic Computer |
| Classification Name: | Programmable Diagnostic Computer |
| Predicate Device(s): | Bard LabSystem PRO EP Recording System<br>(K031000/June 3, 2003) |

510(k) Submission for V3.1 software for the Bard

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Biosense Webster, Inc. CartoMerge Module of the Carto™ XP V8 EP Navigation System (K042999/March 21, 2005)

## Device Description:

The LabSystem EP Recording System is a microprocessor based data acquisition system that is used during electrophysiology procedures to acquire ECG, intracardiac, pressure and digital data from other devices like fluoroscopic systems and RF generators. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient.

#### Indications for Use:

The Bard LabSystem EP Laboratory is a computer and software driven data acquisition and analysis tool designed to facilitate the gathering, display, analysis by a physician, pace mapping and storage of cardiac electrophysiologic data. When integrated with the Philips EP navigator system, the BARD® LabSystem™ PRO EP Recording System is designed to acquire, analyze, and display 3D electroanatomical maps of the human heart. The maps are constructed using intracardiac electrograms with their respective cardiac locations taken from live x-ray overlay on a patient's 3D cardiac anatomy. Maps may be displayed as electrical activation maps, voltage maps, dominant frequency maps and location maps with user defined measurement values.

#### Comparison to Predicate Devices:

The predicate devices for this 510(k) Premarket Notification are the LabSystem™ PRO EP Recording System (K031000) and the CartoMerge Module of the Carto™ XP V8 Navigation System (K042999).

The Indications for Use for both the LabSystem PRO EP Recording System V3.1 software and the CartoMerge Module of the CartoXP V8 EP Navigation System are

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substantially equivalent as the CartoMerge Module of the CartoXP V8 Navigation System measurements are obtained in the same way as with the Bard LabSystem PRO EP Recording System V3.1 software. The two systems support activation timing, voltage amplitude, frequency measurements and location maps displayed on a segmented cardiac anatomy. Both Systems can acquire, analyze, and display 3D electroanatomical maps, construct maps using intracardiac electrograms with 3D cardiac positions, display color maps registered over patient's 3D cardiac anatomy, display electrical activation maps, display voltage maps, display dominant frequency maps, display location maps, and display user-defined measurement values. The generated electro-anatomical maps may be viewed in 3D on screen.

The hardware, base software and firmware that are currently utilized in the commercialized LabSystem PRO EP Recording System are identical to the LabSystem PRO EP Recording System with V3.1 software.

# Summary of Non-Clinical Testing:

The LabSystem™ PRO EP Recording System is developed and produced in accordance with 21 CFR 820.30 Quality System Regulations. The software product is developed and tested in accordance with the following industry standards. Use of the IEEE standards is voluntary.

## Substantial Equivalence:

The LabSystem™ PRO EP Recording System, subject of this 510(k), is substantially equivalent to the predicate devices. They have the same Indications for Use, principles of operation, materials of construction and the technological characteristics support a determination of substantial equivalence.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 0 8 2010

C.R. Bard, Inc. Bard Electrophysiology Division c/o Ms. Anastasia C. Randall Regulatory Affairs Manager 55 Technology Drive Lowell, MA 01851

Re: K101331

Trade/Device Name: LabSystem PRO EP Recording System V3.1 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: September 27, 2010 Received: September 28, 2010

# Dear Ms. Randall:

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.

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Page 2 - Ms. Anastasia C. Randall

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Dana R. Ulmer

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 Statement

#### Indications for Use

510(k) Number (if known):

Device Name: LabSystem™ PRO EP Recording System

#### Indications for Use:

V3.1 software for the LabSystem™ PRO EP Recording System Indication: The Bard LabSystem™ EP Laboratory is a computer and software driven data acquisition and analysis tool designed to facilitate the gathering, display, analysis by a physician, pace mapping and storage of cardiac electrophysiologic data.

When integrated with the Philips EP navigator system, the BARD® LabSystem™ PRO EP Recording System is designed to acquire, analyze, and display 3D electroanatomical maps of the human heart. The maps are constructed using intracardiac electrograms with their respective cardiac locations taken from live x-ray overlay on a patient's 3D cardiac anatomy. Maps may be displayed as electrical activation maps, voltage maps, dominant frequency maps and location maps with user defined measurement values.

#### Contraindications: None

× Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Division of Cardiovascular Devices

510(k) Number_K10) 331

510(k) Submission for V3.1 software for the Bard LABSYSTEM™ PRO EP Recording System

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