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 Biosense Webster® CARTO™ 3 system, the Bard® LabSystem™ PRO EP Recording System is designed to: a) send patient demographics to Biosense Webster® CARTO™ 3, and b) acquire (from Biosense Webster® CARTO™ 3), store and display: i) synchronized 3D mapping events, ii) stimulation pacing data, and iii) images of completed 3D electro-anatomical maps of the human heart. The 3D mapping events and images are created by the Biosense Webster® CARTO™ 3 device and stored on the Bard® LabSystem™ PRO EP Recording System for review and insertion into the final clinical report. Integration also supports bidirectional communication of stimulation pacing channel selection and information sharing between the two systems.

Device Description

The V2.6 software for the LabSystem™ PRO EP Recording System is a bidirectional software interface that links the Bard LabSystem PRO EP Recording System with the Biosense-Webster CARTO 3 mapping/navigation system. The V2.6 software also incorporates the core recording system functionality of the released V2.4b software for the LabSystem PRO EP Recording System. The joint integrated solution provides a single repository for the resulting CARTO 3D electro-anatomical map and procedure information collected by LabSystem PRO EP Recording System. This interface will enhance the usability of the two systems when used in tandem. This will result in a workflow improvement, more streamlined data management, and simpler review of case details. The information will be shared via a network link using a BWI communication protocol.

The V2.6 software is intended for use with the LabSystem PRO EP Recording System (K031000). The LabSystem™ PRO 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 via ECG leadwires and catheters. It does not transmit alarms nor does it have arrhythmia detection capabilities.

AI/ML Overview

This document is a 510(k) summary for the V2.6 software for the Bard LabSystem PRO EP Recording System, which is a programmable diagnostic computer used in electrophysiology procedures. The submission focuses on demonstrating substantial equivalence to predicate devices and does not contain details about specific acceptance criteria or a clinical study in the format requested.

Therefore, much of the requested information cannot be extracted directly from this document.

Here's an attempt to answer the questions based on the provided text, highlighting what is not available:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document states that "Software qualification is performed in-house on the System with results that meet acceptance criteria, thus confirming the safety and effectiveness of each functional aspect of the LabSystem™ PRO EP Recording System." However, the specific acceptance criteria (e.g., performance metrics, thresholds) are not detailed in this summary.
- Reported Device Performance: No specific performance metrics or quantitative results are provided in this summary. The document focuses on demonstrating functional equivalence and adherence to standards.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not available in the provided 510(k) summary. It describes "Software qualification" being performed "in-house," but does not specify sample sizes for testing or 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)
- This information is not available. The document does not describe the establishment of ground truth by experts for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not available. No adjudication method is mentioned.
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
- This is not applicable/not available. The device (LabSystem™ PRO EP Recording System software) is not an AI-assisted diagnostic tool that would typically undergo an MRMC study comparing human readers with and without AI. It's a data acquisition, display, and integration system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly applicable in the context of an "algorithm-only" performance as one might see for an AI diagnostic tool. The "software qualification" mentioned is an in-house verification and validation process for the software's functionality and integration capabilities. The device itself is a system for acquiring and displaying data for physician analysis.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This information is not available. The concept of "ground truth" as used in clinical performance studies is not detailed for this type of software verification. The testing would likely focus on functional accuracy (e.g., data transfer integrity, correct display of information, proper integration).
The sample size for the training set
- This information is not available. This device's software (V2.6) for data acquisition and integration does not appear to involve a "training set" in the sense of machine learning algorithms. Its development and testing would involve traditional software engineering verification and validation.
How the ground truth for the training set was established
- This information is not available, as no training set (in the machine learning sense) is mentioned or implies.

Summary of what is available regarding "acceptance criteria" and "study":

Acceptance Criteria Mentioned: The document states that "Software qualification is performed in-house on the System with results that meet acceptance criteria, thus confirming the safety and effectiveness of each functional aspect of the LabSystem™ PRO EP Recording System."
Study Described: The core study mentioned is "Software qualification performed in-house." This is not a clinical study but rather a non-clinical verification and validation process.
Standards Referenced for Software Development/Testing:
- IEEE Standard 730-1995 Software Quality Assurance Plans
- IEEE Standard 829-1983 Software Test Documentation
- IEEE Standard 1012-1986 Software Verification and Validation Plans
- IEEE Standard 830-1993 Software Requirement Specifications
- IEEE Standard 1008-1987 Software Unit Testing
- EN 60601-1-2:2007 EMC, Radiated emissions and Conducted emissions requirements
- EN 60601-1:2005 Patient Leakage current (Section 19, Table IV, Type CF, 50uA)
Conclusion of Study: The non-clinical testing confirmed the safety and effectiveness of each functional aspect of the system, supporting the claim of substantial equivalence to predicate devices based on "same Indications for Use, principles of operation, and the technological characteristics."

This 510(k) submission is for a software update to an existing electrophysiology recording system, primarily focusing on integration capabilities. The "study" referenced is standard software verification and validation, not a clinical performance study with "ground truth" and "readers" in the context of diagnostic AI.

Summary

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という811 场

MAR 1 6 2012

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: ana.randall@crbard.com
Alternate Contact:	Julie Broderick
	Vice President, Regulatory Affairs
	PH: 978-323-2220
	FX: 978-323-2222
	Email address: julie.broderick@crbard.com
Date of Summary:	December 22, 2011
Device Trade Name:	LabSystem™ PRO EP Recording System
Device Common Name:	Programmable Diagnostic Computer
Classification Name:	Programmable Diagnostic Computer
Predicate Device(s):	Bard LabSystem PRO EP Recording System(K031000/June 3, 2003)

510(k) Submission for V2.6 software for the Bard

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K113811 2/5

V3.1 Software for the Bard LabSystem PRO EP Recording System (K101331/October 8, 2010)

GE Medical Systems Information Technologies, MAC-LAB/CARDIOLAB EP/COMBOLAB System (K032577/October 10, 2003)

Device Description:

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.

510(k) Submission for V2.6 software for the Bard LABSYSTEM™ PRO EP Recording System

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7/5 KII3811

Comparison to Predicate Devices:

The predicate devices for this 510(k) Premarket Notification are the LabSystem™ PRO EP Recording System (K031000), V3.1 Software for the LabSystem PRO EP Recording System (K101331) and the GE CARDIOLAB EP System (K032577). The Indications for Use for the LabSystem PRO EP Recording System V2.6 software and the CardioLab EP System (K032577) are essentially the same.

Both of these devices are electrophysiology recording systems that are used for the same intended purpose. Both systems are intended for use under the direct supervision of a licensed healthcare practitioner to acquire, filter, digitize, amplify, and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Both systems acquire signal types which include ECG signals, direct cardiac signals, and pressure recordings. Both systems obtain physiological parameters such as diastolic, systolic and mean blood pressure, heart rate and cycle length which are derived from the signal data, displayed and recorded. Both systems allow the user to monitor the acquisition of data, review the data, store the data, perform elementary caliper-type measurements of the data and generate reports on the data. Both systems acquire, amplify, display and record data received from other medical devices typically used during these procedures, such as imaging devices and RF generators. Both systems do not transmit alarms nor does not have arrhythmias detection capabilities.

510(k) Submission for V2.6 software for the Bard LABSYSTEM™ PRO EP Recording System

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Both Systems have the capability to integrate with the Biosense Webster®, CARTO™ 3 system, to send patient demographics to Biosense Webster® CARTO™ 3, and acquire (from Biosense Webster® CARTO™ 3), store and display: i) synchronized 3D mapping events, ii) stimulation pacing data, and iii) images of completed 3D electro-anatomical maps of the human heart. The 3D mapping events and images are created by the Biosense Webster® CARTO™ 3 device and stored on the Bard® LabSystem™ PRO EP Recording System for review and insertion into the final clinical report. Integration also supports bidirectional communication of stimulation pacing channel selection between the two systems.

The hardware, base software and firmware that are currently utilized in the LabSystem PRO EP Recording System (K031000 and K101331) are identical to the base software and firmware for the V2.6 software for the LabSystem PRO EP Recording System.

Summary of Non-Clinical Testing:

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

IEEE Standard 730-1995 IEEE Standard 829-1983 (*1991) IEEE Standard 1012-1986 (*1992) IEEE Standard 830-1993 IEEE Standard 1008-1987 (*1993) Software Quality Assurance Plans Software Test Documentation Software Verification and Validation Plans Software Requirement Specifications Software Unit Testing

*Reaffirmed by IEEE in year stated.

EN 60601-1-2:2007 EMC, Radiated emissions and Conducted emissions requirements

EN 60601-1:2005 Patient Leakage current (Section 19, Table IV, Type CF, 50uA)

510(k) Submission for V2.6 software for the Bard LABSYSTEM™ PRO EP Recording System

4/5

KII 30 11

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Image /page/4/Picture/0 description: The image shows handwritten text. The text on the left reads "K113811". To the right of that, the text reads "5/5".

Software qualification is performed in-house on the System with results that meet acceptance criteria, thus confirming the safety and effectiveness of each functional aspect of the LabSystem™ PRO EP Recording System.

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, and the technological characteristics support a determination of substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

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

Bard Electrophysiology Division of C.R. Bard, Inc. c/o Ms. Anastasia C. Randall Regulatory Affair Manager 55 Technology Dr. Lowell, Massachusetts 01851

APR 3 2012

Re: K113811

Trade/Device Name: LabSystem PRO EP Recording System V2.6 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: February 24, 2012 Received: February 27, 2012

Dear Ms. Randall:

This letter corrects our letter of March 16, 2012 regarding the incorrect software version identified on the clearance letter.

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 for about in 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 (OS) 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/Resourcesfor You/Industry/default.htm.

Sincerely yours

Bram D. Zuckerman, M.D.

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): K (13811

Device Name: LabSystem™ PRO EP Recording System

Indications for Use:

V2.6 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.

Contraindications: None

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

M.S. Hillben

(Division Sign-Old)
Division of Cardiovascular Devices

510(k) Number K113811

510(k) Submission for V2.6 software for the Bard LABSYSTEM™ PRO EP Recording System

Regulation Number and Section

§ 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).