The Bard LabSystem III* 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.

The Bard STAMP Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the Bard LabSystem [III]* EP Laboratory) that can record and display the information.

Device Description

The LabSystem III 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 fluoro 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. Although Bard Electrophysiology manufactures and distributes ECG leadwires and catheters, these devices are not included with the LabSystem III.

The amplifier filters and transmits the data to the computer where it is stored on optical disks and displayed on video monitors. The Bard LabSystem III EP Laboratory is available with a dual screen to provide the user with a review screen to analyze data and generate reports at the same time real-time data is being acquired. The real-time screen displays and records real-time data. This system allows the user to perform signal measurements and to print out waveforms.

The system is a software driven tool that acquires and displays data, stores and reports data. The system can also acquire and display data from other sources such as an RF generator. It does not transmit alarms or arrhythmias, nor does it have arrhythmia detection capabilities.

AI/ML Overview

The provided text describes the Bard LabSystem III EP Laboratory, a data acquisition system for electrophysiology procedures. However, it does not contain a dedicated study proving device performance against specific acceptance criteria.

Instead, the document details the device's technical characteristics, its intended use, a comparison to a predicate device, and compliance with various national and international safety and software standards. The FDA's 510(k) clearance is based on a determination of substantial equivalence to existing legally marketed predicate devices, rather than a de novo clinical study with specific acceptance criteria.

Here's an analysis of the information that is available, addressing your questions to the best extent possible given the document limitations:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The document states: "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 III." However, the specific acceptance criteria and the numerical results are not reported. The focus is on compliance with standards and substantial equivalence, not a direct performance study.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. The document discusses "software qualification" and compliance with standards, but no details on specific test sets (sample size, country of origin, retrospective/prospective nature) are given.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. As no specific test set or clinical study is detailed, the method for establishing ground truth and the experts involved are not mentioned.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a MRMC comparative effectiveness study is not mentioned. The document focuses on the device's technical capabilities and its substantial equivalence to predicate devices, and that it facilitates physician analysis, but not how it improves human reader performance. In fact, it explicitly states: "The system does not... analyze data acquired during an EP procedure."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in essence, standalone testing of hardware and software was performed, though not in the context of an algorithm's diagnostic performance. The document states: "Software qualification is performed in-house on the system with results that meet acceptance criteria" and "All equipment pertaining to the LabSystem is tested and certified to meet the following national and international safety standards." These tests would be assessing the device's functionality and safety independently.

7. The Type of Ground Truth Used

The concept of a "ground truth" in the clinical diagnostic sense (e.g., pathology, outcomes data) is not applicable or mentioned in this submission. The "ground truth" here would relate to the correct functioning of the hardware and software according to design specifications and regulatory standards. For example, testing current leakage (EN60601-1:1990) would have a known "ground truth" value for acceptable leakage.

8. The Sample Size for the Training Set

This information is not provided. The device is a data acquisition and display system, not a machine learning model that would typically have a "training set" in the modern AI sense.

9. How the Ground Truth for the Training Set was Established

This information is not provided and is not applicable for this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The "study" described is primarily focused on compliance with established standards and internal "software qualification" processes, rather than a clinical performance study with defined acceptance criteria and a test set.

Non-Clinical Tests: The document lists several IEEE and EN standards related to electrical medical devices, software quality assurance, test documentation, verification & validation, and requirements specifications. It also mentions EN standards for EMC and patient leakage current.
Methodology: "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 III." This suggests internal testing against design specifications and regulatory requirements.
Basis for Approval: The FDA's 510(k) clearance is based on a determination of substantial equivalence to predicate devices. This means that the FDA found the LabSystem III to be as safe and effective as other similar devices already on the market, despite specific modifications made to the hardware and software. The argumentation is that "These modifications do not raise new issues of safety and effectiveness."

In conclusion, this 510(k) summary provides evidence of compliance with safety and software standards and a comparison to a predicate device to establish substantial equivalence for a data acquisition system. It does not detail a clinical performance study with specific acceptance criteria, test set sizes, expert ground truth, or adjudication methods in the way a diagnostic AI device submission might.

Summary

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

Bard Electrophysiology C.R. Bard, Inc. 55 Technology Drive Lowell, MA 01851 (978) 441-6202 www.BardEP.com

JUN - 3 2003

K031000
page 1 of 4

BARD

510(k) SUMMARY FOR THE LabSystem III EP Laboratory 6.

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990.

6.1 Submitter's Information

Name:	Bard Electrophysiology Division
	C.R. Bard, Inc.
Address:	55 Technology Drive
	Lowell, MA 01851
Phone:	(978) 323-2216 (Direct Line)
Fax:	(978) 323-2222
Contact Person:	Deborah L. Herrington
	Regulatory Affairs Manager
Date of Preparation:	March 28, 2003

6.2 Device Name:

Trade Name:	LabSystem III EP Laboratory
Common/Usual Name:	LabSystem
Classification Name:	Programmable Diagnostic Computer

6.3 Predicate Device Name(s):

The Coherent Systems, Inc.	- Coherent EP-STAT System*(K883152/October 13, 1988)
C.R. Bard, Inc.	- Bard BioPotential Amplifier(K874441/February 19, 1988)
C.R. Bard, Inc.	- Bard BioPotential Amplifier II -STAMP(K901358/November 27, 1991)
Bard ElectrophysiologyDivision of C.R. Bard, Inc.	- High Level Input Isolation Module(K953267/February 27, 1996)

*Acquired by Bard in March 1989 and renamed the Bard LabSystem EP Laboratory and Bard LabSystem DUO EP Laboratory

Image /page/0/Picture/13 description: The image shows the logo for Bard Electrophysiology. The logo consists of a stylized heart shape enclosed in a square on the left, followed by the word "Bard" in a larger, bolder font. Below "Bard" is the word "electrophysiology" in a smaller, italicized font. The logo is simple and professional, likely used for branding purposes.

{1}------------------------------------------------

6.4 Device Description

6.5 Intended Use of Device

* Please note that the name "LabSystem 111" is a working name used for in-house development purposes. Also, the in-house temporary working name for the software is "Windows EP System" or "WEPS". A final name will be chosen prior to release of the Windows EP Software Version 1.0.

{2}------------------------------------------------

K0310000
page 3 of 4

6.6 Summary of Technological Characteristics of the Bard LabSystem III EP Laboratory as Compared to the Predicate Device

Since 510(k) concurrence was received for the LabSystem and STAMP Amplifier, modifications have been made to the system. These modifications were made to enhance the amplifier module's manufacturability or user convenience and were deemed not to significantly alter the amplifier's overall safety and effectiveness and thus did not require new premarket notifications at the time the changes were made. Some of the changes were required for compliance with the ANSI/AAMI standard for Diagnostic Electrocardiographic Devices (EC11-1982, section 3.2.9).

the ECG/Pressure module as described in K913875 has been upgraded to allow channel selection capability and the addition of notch filters for noise rejection;
a 50/60 Hz notch filter was added to the module to filter the power line frequency and the input impedance of the module was increased from 1.6MegOhms to 10.6MegOhms;
V-Lead/Pressure Plus module was configured to provide 6-lead channels only with the addition of notch filters and 2 pressure channels and the input impedance of the module was increased from 1.6MegOhms to 10.6MegOhms;

1.5megOhms to 10.6megOhms,
the layout of the Intra-cardiac Pressure

the layout of the Intracardiac Pressure module was converted from through-hole components to surface mount components;
the Stimulator Switch Plus module was upgraded to make its input sensitive to the 1.5V trigger inputs found on cardiac stimulators marketed in Europe: and
various software enhancements for user interface ease of use.

These modifications are detailed in Section 2.2.

Like the LabSystem, various hardware and firmware upgrades have been made over the years to adapt to the ever-changing technology and to add user-preference features. Software changes have been implemented to address the changes in hardware/firmware. These modifications do not raise new issues of safety and effectiveness.

The technological characteristics of the LabSystem EP Laboratory and the LabSystem III EP Laboratory are essentially the same. Although changes to hardware/firmware and software have been made, the indications for use and the risks have not changed for this device. The system does not control the delivery of energy, it does not administer drugs, it does not perform any life-supporting or life-sustaining functions, it does not analyze data acquired during an EP procedure.

{3}------------------------------------------------

K031000
page 4 of 4

6.7 Discussion of Non-Clinical Tests and How the Results Support a Determination of Substantial Equivalence

The applicable standards pertaining to the software that drives the LabSystem III are listed below. These are the standards that were used for previous software versions and were used for Windows EP Software Version 1.0.

EN 60601-1-2: Ver 2:2001-9 IEEE Standard 730-1995 IEEE Standard 829-1983 (*1991) IEEE Standard 1012-1986 (*1992) IEEE Standard 830-1993 IEEE Standard 1008-1987 (*1993)

Electrical Medical Device Standards Software Quality Assurance Plans Software Test Documentation Software Verification & Validation Plans Software Requirement Specifications Software Unit testing

*Reaffirmed by IEEE in vear stated.

As previously stated, various modifications have been implemented with respect to the hardware, firmware and software that comprise the LabSystem. All equipment pertaining to the LabSystem is tested and certified to meet the following national and international safety standards.

EN60601-1-2: 2001-09 EMC, Radiated emissions & Conducted emissions requirements EN60601-1:1990 Patient leakage current (section 19, Table IV, Type CF, 50uA

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 III.

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 LabSvstem.

The "510(k) Substantial Equivalence Decision-Making Process (Detailed)" decision tree (CDRH 510(k) Manual 92-4158) was utilized to make a determination of substantial equivalence. This decision tree is depicted in Section 4 in Figure 4-1 with the decision points relevant to the LabSystem III highlighted in vellow. The answers to the following questions at the indicated decision points in Figure 4-1 lead to a determination of substantial equivalence.

Provided in Section 4 is a document titled "Comparison of LabSystem Duo Capabilities and WEPS Capabilities". This document provides a comparison of the capabilities of the predicate device to the LabSystem III, subject of this 510(k).

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 3 2003

Bard Electrophysiology Division of C.R. Bard, Inc. c/o Ms. Deborah L. Herrington Regulatory Affairs Manager 55 Technology Drive Lowell, MA 01851

Re: K031000

Trade Name: LabSystem III EP Laboratory with Windows Platform and EP Software Version 1.0 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II (two) Product Code: DQK Dated: March 28, 2003 Received: March 31, 2003

Dear Ms. Herrington:

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 such 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. Deborah L. Herrington

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

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

{6}------------------------------------------------

INDICATIONS FOR USE 1.5

Device Name:

The Bard electrophysiology LabSystem III* EP Laboratory

Indications for Use:

Contraindications:

None known.

Please note that the name "LabSystem III" is a working name used for in-house development purposes. The in-house temporary working name for the software is "Windows EP System" or "WEPS". A final name will be chosen prior to release of the LabSystem III with Windows EP Software.

N. On G. Th

510(k) Number K103602

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

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).