BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO
Device Facts
| Record ID | K050006 |
|---|---|
| Device Name | BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO |
| Applicant | C.R. Bard, Inc. |
| Product Code | DRQ · Cardiovascular |
| Decision Date | May 27, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2060 |
| Device Class | Class 2 |
Indications for Use
The Bard Borealis Ampifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transmitting this information to a host computer (the Bard LabSystem [III] EP Laboratory) that can record and display the information. 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, and storage of cardiac electrophysiologic
Device Story
Borealis Amplifier collects, amplifies, filters, and formats physiological signals (ECG, intracardiac pressure) from EP catheters, surface ECG electrodes, and pressure transducers. Device acts as an interface, transmitting conditioned signals to host Bard LabSystem III EP Laboratory for physician-led recording and display. Used in clinical EP labs; operated by trained medical staff. System does not control therapy, administer drugs, perform life support, or perform automated data analysis. Hardware updates include notch filters for noise rejection, increased input impedance (1.6MΩ to 10.6MΩ), and surface-mount component conversion. Benefits include improved manufacturability, user convenience, and signal quality via enhanced noise rejection.
Clinical Evidence
Bench testing only. No clinical data. Testing included electrical safety (EN 60601-1, EN 60601-2-27, EN 60601-2-34), electromagnetic compatibility (IEC 61000 series), and software verification and validation (IEEE 730, 829, 1012, 830, 1008).
Technological Characteristics
Real-time embedded amplifier system. Features notch filters (50/60 Hz), 10.6MΩ input impedance. Hardware includes ECG/Pressure modules and Intracardiac Pressure modules (surface-mount components). Connectivity: wired interface to host LabSystem III. Standards: EN 60601-1, EN 60601-1-2, EN 60601-1-4, EN 60601-2-27, EN 60601-2-34, IEC 61000 series. Software: firmware/software upgrades for user interface and signal processing.
Indications for Use
Indicated for the amplification and conditioning of electrocardiographic signals of biologic origin and pressure transducer input for recording and display by the Bard LabSystem III EP Laboratory during cardiac electrophysiologic procedures.
Regulatory Classification
Identification
A transducer signal amplifier and conditioner is a device used to provide the excitation energy for the transducer and to amplify or condition the signal emitted by the transducer.
Predicate Devices
- Bard Biopotential Amplifier II (K913875)
Submission Summary (Full Text)
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050006
Image /page/0/Picture/1 description: The image shows the logo for Bard Electrophysiology. The logo features a stylized heart symbol to the left of the word "Bard" in bold, followed by the word "electrophysiology" in a smaller, non-bold font. The text is aligned to the right of the heart symbol.
MAY 2 7 2005
## Borealis Amplifier
Project 3261 Section 6 510(k) Summary for the Borealis Amplifier
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### 6.0 510(k) Summary for the Borealls Amplifier
This 510(k) Summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990.
## 6.1 Submitter's Information
| Name: | Bard Electrophysiology Division of C.R. Bard, Inc. |
|-----------------------------------|-----------------------------------------------------|
| Address: | 55 Technology Drive<br>Lowell, MA 01851 |
| Phone: | (978) 323 2216 (Direct Line) |
| Fax: | (978) 323-2222 |
| Establishment Registration Number | 1222791 |
| Contact Person: | Deborah L. Herrington<br>Regulatory Affairs Manager |
| Date of Preparation: | December 20, 2004 |
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## 6.2 Device Name
| Trade Name: |
|----------------------|
| Common/Usual Name: |
| Classification Name: |
CLEARSIGN Amplifier Borealis Amplifier Programmable Amplifier
#### 6.3 Predicate Device Name(s)
C.R. Bard, Inc.: Bard Biopotential Amplifier II, K913875, November 27, 1991
#### 6.4 Device Description
The Borealis Amplifier is a medical device intended to collect, amplify, filter and format physiological signals for transfer to a host computer system (Bard Electrophysiologic LabSystem III Laboratory) capable of recording and display of such information. The physiologic signal information is acquired from diagnostic and therapeutic electrophysiology (EP) catheters, surface electrocardiographic (ECG) electrodes, intravascular pressure transducers, intracardiac stimulators and RF ablation generators.
### 6.5 Intended use of the Device
The Bard Borealis Ampifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transmitting this information to a host computer (the Bard LabSystem [III] EP Laboratory) that can record and display the information.
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, and storage of cardiac electrophysiologic
#### 6.6 Summary of the technological characteristics of the Borealis Amplifier 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).
Confidential: This document contains information that is the confidential and proprietary property of C.R.Bard, inc. Netther this document nor the information therein may be reproduced, used or distributed to or for the benefit of any third party without the prior written consent of Bard Page 1 of 5
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Image /page/1/Picture/1 description: The image contains the logo for Bard Electrophysiology. The logo features a stylized heart shape to the left of the text "Bard electrophysiology". The word "Bard" is in a larger, bolder font than "electrophysiology", which is placed below it.
Project 3261 Section 6 510(k) Summary for the Borealis Amplifier
- The ECG/Pressure module as described in K913875 has been upgraded to allow 1. 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 2. the input impedance of the module was increased from 1.6MegOhms to 10.6MegOhms;
- The V-Lead/Pressure Plus module was configured to provide 6-lead channels only with ന് the addition of notch filters and 2 pressure channels and the input impedance of the module was increased from 1.6MegOhms to 10.6MegOhms;
- The layout of the Intracardiac Pressure module was converted from through-hole 4. components to surface mount components;
- The Stimulator Switch Plus module was upgraded to make its input sensitive to the ક. 1.5V trigger inputs found on cardiac stimulators marketed in Europe; and
- Various software enhancements were made for user interface ease of use. 6.
These modifications are detailed in Section 2.2.
Various hardware and firmware upgrades have been the STAMP Amplifier 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 Borealis Amplifier and the STAMP Amplifier 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 therapy, it does not administer drugs, it does not perform any lifesupporting or life-sustaining functions, and it does not analyze data acquired during an EP procedure.
## 6.7 Discussion of non-clinical tests and how the results support a determination of substantial equivalence
The applicable standards pertaining to the Borealis Amplifier are listed below. These are the standards that were for previous software versions of the STAMP Amplifier.
| EN 60601-1-2: Ver 2:2001-9 | Electrical Medical Device Standards |
|---------------------------------|------------------------------------------|
| IEEE Standard 730-1995 | Software Quality Assurance Plans |
| IEEE Standard 829-1983 (*1991) | Software Test Documentation |
| IEEE Standard 1012-1986 (*1992) | Software Verification & Validation Plans |
| IEEE Standard 830-1993 | Software Requirement Specifications |
| IEEE Standard 1008-1987 (*1993) | Software Unit testing |
Various modifications have been implemented with respect to the hardware and firmware that comprise the Borealis Amplifier has been tested to the following international standards:
EN 60601-1 Electrical Safety EN 60601-1-1 Electrical Safety System Standard EN 60601-1-2 Electromagnetic Compatibility EN 60601-1-4 Programmable Electrical Medical Systems EN 60601-2-27 Electrocardiograph Equipment EN 60601-2-34 Safety Requirements for Blood Pressure Monitoring Equipment
This document contains information that is the confidential and proprietary property of C.R.Bard, inc. Nelther this 0 0 Confidential: document nor the information therein may be reproduced, used or or for the benefit of any third part without the prior written consent of Bard Page 2 of 5
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Image /page/2/Picture/1 description: The image shows the logo for Bard Electrophysiology. The logo features a stylized heart graphic to the left of the word "Bard" in bold font. Below "Bard" is the word "electrophysiology" in a smaller, non-bold font.
Project 3261 Section 6 510(k) Summary for the Borealis Amplifier
IEC 61000-3-2 Current Harmonics IEC 61000-3-3 Voltage Fluctuations IEC 61000-4-2 Electromagnetic Compatibility (EMC) Part 4 Testing & Measurement Techniques, Section 2 Electrostatic Discharge Immunity Test IEC 61000-4-3 Electromagnetic Compatibility (EMC) Part 4 Testing & Measurement Techniques, Section 3 Radiated, Radio Frequency, Electromagnetic Field Immunity Test IEC 61000-4-4 Electromagnetic Compatibility (EMC) Part 4 Testing & Measurement Techniques, Section 4 Electrical Fast Transient/Burst Immunity Test IEC 61000-4-5 Electromagnetic Compatibility (EMC) Part 4 Testing & Measurement Techniques, Section 5 Surge Immunity Test IEC 61000-4-6 Electromagnetic Compatibility (EMC) Part 4 Testing & Measurement Techniques, Section 6 Immunity to Conducted Disturbances Induced by Radio Frequency Fields IEC 61000-4-8 First Edition Magnetic Field Immunity IEC 61000-4-11 First Edition Power Dips and Interruption Immunity IEC Publication 529 Degrees of Protection Provided by Enclosures (IP Codes) Software qualification is performed on the system according to specific acceptance criteria, thus
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 yellow. The answers to the following questions at the indicated decision points in Figure 4-1 lead to a determination of substantial equivalence.
confirming the safety and effectiveness of each functional aspect of the Borealis Ampifier.
Provided in Section 4 is a document titled "Comparison of the Borealis Amplifier Capabilities and STAMP Amplifier Capabilities. This document provides a comparison of the capabilities of the predicate device to the Borealis Amplifier, subject of this 510(k).
This comparison document was developed to assist in demonstrating the similarities with respect to the capabilities of the two systems. The document contains a tabular comparison of the two systems with the STAMP Amplifier capabilities in the second column. The first column indicates whether or not the corresponding capability exists in the Borealis Amplifier system.
#### New device is compared to a marketed device
Response: Yes. The Borealis Amplifier, subject of this submission, is compared to the STAMP Amplifier currently marketed by Bard.
#### Does the new device have the same indication statements?
Response: Yes. The indications for the Borealis Amplifier covered under this Premarket Notification are the same as those of its predicate device. The indications for use for the Bard Electrophysiology LabSysem III Laboratory covered under this Premarket Notification are the same as it's predicate device. Refer to Section 7 for copies of the predicate device labeling.
The Borealis 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 Electrophysiology LabSystem III Laboratory) that can record and display the information.
This document contains information that is the confidential and proprietary property of C.R.Bard, Inc. Neither this Confidential: document nor the Information therein may be reproduced, used or distributed to or for the benefit of any third party without the prior written consent of Bard Page 3 of 5
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Image /page/3/Picture/1 description: The image shows the logo for Bard Electrophysiology. The logo features a stylized heart shape with a square around it, followed by the word "Bard" in a bold, sans-serif font. Below "Bard" is the word "electrophysiology" in a smaller, italicized font. The logo is simple and professional, and it is likely used to represent a medical device company or a medical practice specializing in electrophysiology.
Project 3261 Section 6 510(k) Summary for the Borealis Amplifier
The Bard Electrophysiology LabSystem III Laboratory is a computer and software driven data acquisition and analysis tool designed to facilitate the gathering, display, and analysis by a physician, and storage of cardiac electrophysiologic data.
The new device has the same intended use and may be "Substantially Equivalent".
Response: Yes. The Borealis Amplifier, like it's predicate device the STAMP Amplifier, is a real time embedded system designed to amplify and condition electrocardiographic and blood pressure signals of biologic origin for transfer to a host computer (the Bard Electrophysiology LabSystem III Laboratory) that can record and display information.
## Does the new device have the same technological characteristics, e.g., design, materials, etc.?
Response: Yes. One of the main reasons for the Premarket Notification Submission of the Borealis Amplifier is due to the near term component obsolescence of many of the components of the predicate device, the STAMP Amplifier. The Borealis Amplifier design is an update of the STAMP Amplifier design that employs available technology that has exactly the same technological characteristics.
## Are the descriptive characteristics precise enough to ensure equivalence?
Response: Yes. The Borealis Amplifier uses the same principles for data acquisition and signal conditioning as the STAMP Amplifier using available technology. Methods of communication signal processing represent the current state of the art in keeping with exactly the same indications for use.
The LabSystem III consists of the same basic hardware components and device components. Although there have been upgrades to the various components such as the monitor, keyboard, trackball/mouse, etc. the intended use of the system has not changed.
Please refer to the document titled "Comparison of the Borealis Ampifier Capabilities and the STAMP Amplifier Capabilities" in Section 4. As stated above, this document provides a comparison of the capabilities of the predicate device to the Borealis Amplifier, subject of this 510(k).
Although Bard believes that the descriptive characteristics are precise enough to ensure equivalence, test data is provided to demonstrate that the system meets the specified performance requirements.
Section 3 contains a summary of all testing conducted in support of the Borealis Amplifier. The individual reports are provided in the Appendices in Volume II.
As mentioned above. Volume II contains the Performance Specification Requirement along with the individual reports including Electrical Safety, EMC Emissions Test, the EMC Immunity Test, the System Stress Test Protocol and Report, and the Software Verification and Validation Test Plan and Report.
The testing demonstrates that the Borealis Ampifier meets the established performance requirements.
Based on the comparison document in Section 4 and the testing summarized in Section 3 (reports in Volume II, Appendices) Substantial Equivalence to the predicate device, STAMP Amplifier, has been demonstrated.
Confidential: This document contains intornation that is the confidential and proprietary property of C.R.Bard, Inc. Neither this document nor the information therein may be reproduced to or for the benefit of any third party without the prior written consent of Bard
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Image /page/4/Picture/1 description: The image shows the logo for Bard Electrophysiology. The logo features a stylized heart shape enclosed in a square on the left. To the right of the heart is the word "Bard" in bold, followed by "electrophysiology" in a smaller font size below it. The logo is simple and professional, likely representing a medical or healthcare-related company.
Project 3261 Section 6 510(k) Summary for the Borealis Amplifier
Following the decision making process outlined above leads to a "Substantially Equivalent" determination.
Revision History
| Revision | Date | Author | Description |
|----------|----------|------------|--------------------------|
| 1 | 12/01/04 | W. Griffin | Est. Reg. No. |
| 2 | 12/16/04 | W. Griffin | Add EN 60601-1-1 & edits |
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MAY 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
C.R. Bard, Inc. c/o Ms. Deborah L. Herrington Manager, Regulatory Affairs Bard Electrophysiology 55 Technology Drive Lowell, MA 01851
K050006 Re:
Trade Name: Bard Borealis (CLEARSIGN) Amplifier Regulation Number: 21 CFR 870.2060 Regulation Name: Transducer Signal Amplifier and Conditioner Regulatory Class: Class II (two) Product Code: 74 DRQ Dated: May 12, 2005 Received: May 13, 2005
Dear Ms. Herrington:
We have reviewed your Section 510(k) premarket notification of intent to market the indicati We have reviewed your Section > ro(x) premained is substantially equivalent (for the indications for used above and nave decembined the acted predicate devices marketed in interstate for use stated in the enclosule) to regars manated to the Medical Device Amendments, or to commerce prior to May 26, 1776, the enazence with the provisions of the Federal Food, Drug, devices that have been recassince in accordance what a premarket approval application (PMA).).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act, and Cosmetic Act (Act) that do not require approvine speral controls provisions of the Act. The
You may, therefore, market the device, subject to the general magistration, You may, therefore, market the device, see, course in the more of the manual registration, listing of general controls provisions of the net networks of the more of the masanst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) nike existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA may be subject to such additional controlis. Existing may on 898. In addition, FDA may be found in the Code of Peach. Regaring your device in the Federal Register.
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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 (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. 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 (240) 276-0120. 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 may be obtained 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,
Bhimmar for
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
Carlos Corporation
510(k) Number (if known): K05000 6
Device Name: Bard Borealis (CLEARSIGN) Amplifier
Indications For Use:
The Bard Borealis (CLEARSIGN) 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Klammpson
Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K05000(a
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