(123 days)
No
The summary describes a standard ultrasound catheter with location tracking capabilities integrated with a navigation system. There is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
No
The device is indicated for "intra-cardiac and intra-luminal visualization" and "visualization of other devices in the heart," which are diagnostic purposes, not therapeutic.
Yes
The "Intended Use / Indications for Use" section states that the device is "indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology." Visualization of anatomy and physiology for clinical assessment is a diagnostic function.
No
The device description clearly details a physical catheter with embedded hardware components (magnetic location sensor and ultrasound transducer), making it a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart." This describes a device used within the body for imaging and navigation, not for testing samples outside the body.
- Device Description: The description details an "IntraCardiac Echo (ICE) Catheter" with an ultrasound transducer and magnetic location sensor. This is consistent with an invasive imaging and navigation device used during a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The focus is on real-time visualization and location within the body.
IVD devices are typically used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on in-vivo imaging and navigation.
N/A
Intended Use / Indications for Use
The Biosense Webster SOUNDSTAR® eco Diagnostic Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible CARTO® 3 EP Navigation Systems, the SOUNDSTAR® eco Catheter provides location information. Please refer to the Compatibility Matrix Insert for Compatible CARTO® 3 Systems as each catheter is compatible with a specific version of CARTO® 3 and is not backwards compatible with previous versions of CARTO® 3 EP Navigation Systems.
Product codes
OBJ
Device Description
The modified SOUNDSTAR eco10F and SOUNDSTAR eco10FG Catheters are both 90 cm 10F IntraCardiac Echo (ICE) Catheters with an acoustic array identical to the currently cleared SNDSTR10 and SNDSTR10G Catheters. The catheters have a magnetic location sensor (providing location information to the CARTO 3 Navigation System Version 2.2) and an ultrasound transducer (acquiring real time ultrasound images) embedded in the tip.
The modified SOUNDSTAR eco Catheters have a bifurcated 'tail' originating from their handle which is nearly identical to the bifurcated tail of the predicate devices. One leg terminates in the SOUNDSTAR Flex Tab connector, which connects via the appropriate SwiftLink cable to the corresponding Ultrasound system. For the SOUNDSTAR eco10F Catheter the SwiftLink cable connects to Acuson Cypress, Acuson Sequoia or Acuson X300 Ultrasound systems. For the SOUNDSTAR eco10FG Catheter the SwifLink cable connects to GE Vivid-i or Vivid-q Ultrasound systems.
Both versions of SOUNDSTAR eco10F and SOUNDSTAR eco10FG Catheters are based on the existing SOUNDSTAR 3D 10F (SNDSTR10) and SOUNDSTAR 3D 10FG (SNDSTR10G) catheters and have the same intended use and clinical applications. The predicate and modified catheters share the majority of components and manufacturing process as explained previously.
The modified SOUNDSTAR eco10F and SOUNDSTAR eco10FG Catheters, when connected to the corresponding Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO 3 Version 2.2 electromagnetic acquired maps.
Mentions image processing
Acquiring real time ultrasound images. Real-time integration of ultrasound images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The document does not describe the details of the performance studies conducted, only referring to "The SoundSTAR® eco Diagnostic Ultrasound Catheter has been validated for use with the Siemens ultrasound systems in conjunction with the CARTO® EP Navigation Systems listed in the following table" and "The SOUNDSTAR® eco Diagnostic Ultrasound Catheter has been validated for use with the GE utrasound systems in conjunction with the CARTO® EP Navigation Systems listed in the following table." Maximum surface temperature information is provided.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
K112050
15 510(K) SUMMARY
SPONSOR'S NAME & ADDRESS
Biosense Webster. Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765
OFFICIAL CORRESPONDENT
Marina Guevrekian Senior Specialist, Regulatory Affairs Phone: 909-839-8714 Fax: 909-839-8804 Email: mguevrek@its.jnj.com
SUBMISSION DATE
July 13, 2011
TRADE NAME
SOUNDSTAR® eco DIAGNOSTIC ULTRASOUND CATHETER
(Part Number: M-5723-15 / Catalogue Number: 10438577, Compatible with Siemens Ultrasound systems)
SOUNDSTAR® eco DIAGNOSTIC ULTRASOUND CATHETER
(Part Number: M-5723-16 / Catalogue Number: 10439072, Compatible with GE Ultrasound systems)
COMMON NAME
Electrophysiology Mapping/Ultrasound Catheter
CLASSIFICATION NAME/PRODUCT CODE
Intravascular Ultrasound Catheter/OBJ
CLASSIFICATION
Class II, 21 CFR 870.1200
PREDICATE DEVICE
The modified SOUNDSTAR eco10F and SOUNDSTAR eco10FG Catheters are substantially equivalent to the Biosense Webster SOUNDSTAR 3D Ultrasound Catheter (SNDSTR10) cleared on May 15, 2007 via 510(k) K070242 and also SOUNDSTAR 3D Ultrasound Catheter (SNDSTR10G) cleared on August 7, 2009 via 510(k) K092064 respectively.
1
DESCRIPTION OF MODIFIED DEVICE
The modified SOUNDSTAR eco10F and SOUNDSTAR eco10FG Catheters are both 90 cm 10F IntraCardiac Echo (ICE) Catheters with an acoustic arrav identical to the currently cleared SNDSTR10 and SNDSTR10G Catheters. The catheters have a magnetic location sensor (providing location information to the CARTO 3 Navigation System Version 2.2) and an ultrasound transducer (acquiring real time ultrasound images) embedded in the tip.
The modified SOUNDSTAR eco Catheters have a bifurcated 'tail' originating from their handle which is nearly identical to the bifurcated tail of the predicate devices. One leg terminates in the SOUNDSTAR Flex Tab connector, which connects via the appropriate SwiftLink cable to the corresponding Ultrasound system. For the SOUNDSTAR eco10F Catheter the SwiftLink cable connects to Acuson Cypress, Acuson Sequoia or Acuson X300 Ultrasound systems. For the SOUNDSTAR eco10FG Catheter the SwifLink cable connects to GE Vivid-i or Vivid-q Ultrasound systems.
Both versions of SOUNDSTAR eco10F and SOUNDSTAR eco10FG Catheters are based on the existing SOUNDSTAR 3D 10F (SNDSTR10) and SOUNDSTAR 3D 10FG (SNDSTR10G) catheters and have the same intended use and clinical applications. The predicate and modified catheters share the majority of components and manufacturing process as explained previously.
The modified SOUNDSTAR eco10F and SOUNDSTAR eco10FG Catheters, when connected to the corresponding Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO 3 Version 2.2 electromagnetic acquired maps.
INDICATIONS FOR USE
The Biosense Webster SOUNDSTAR® eco Diagnostic Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible CARTO® 3 EP Navigation Systems, the SOUNDSTAR® eco Catheter provides location information. Please refer to the Compatibility Matrix Insert for Compatible CARTO® 3 Systems as each catheter is compatible with a specific version of CARTO® 3 and is not backwards compatible with previous versions of CARTO® 3 EP Navigation Systems.
DESCRIPTION OF MODIFICATION
The modified SOUNDSTAR eco10F and SOUNDSTAR eco10FG Catheters are identical to the currently cleared SNDSTR10F and SNDSTR10FG Catheters in terms of: Indication for Use, Material, Manufacturing methods, Operating principles, Fundamental Scientific Technology, Performance, Array and Sensor specifications, Shelf Life and Sterilization methods. Modifications were only made in the handle of the catheter. Specifically, the catheter specific electronics (i.e. memory for sensor calibration data) were moved to the Hypertonics connector, and non catheter specific electronics (i.e. amplifiers) were moved to the Extension Cable.
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· SoundStar® eco ULTRASOUND CATHETER
COMPATIBILITY MATRIX
13 of 82
M-5276-702BC
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3
English
SoundStar®eco DIAGNOSTIC ULTRASOUND CATHETER COMPATIBILITY MATRIX INSERT
ADDENDUM TO SOUNDSTAR® eao DIAGNOSTIC ULTRASOUND CATHETER INSTRUCTIONS FOR USE (M-5276-701)
The SOUNDSTAR® eco Diagnostic Ultrasound Catheter has conjunction with the CARTO® EP Navigation Systems listed in the following table.
| Ultrasound Systems | CARTO® Systems |
|---|---|
| ACUSON Sequoia™ | CARTO® 3 version 2.2 * |
| ACUSON Cypress™ | CARTO® 3 version 2.2 * |
| ACUSON X300™ | CARTO® 3 version 2.2 * |
"The Soundstar® eco Diagnostic ULTrasound Catherer is not backwards compatible with previous versions of CARTO® 3 EP Navigation System,
TRANSDUCER SURFACE TEMPERATURE The following table provides the maximum surface temperature of the SoundSTAR® Catheter with the relevant ultrasound system. The tissue mirnicking material (TMM) temperature is displayed in accordance with IEC 60601-2-37 requirements.
| Ultrasound System | TMM (Max Temp) |
|---|---|
| ACUSON Sequoia* | 42.1°C |
| ACUSON Cypress* | 42.1°C |
| ACUSON X300* | 41.8°C |
DISCLAIMER OF WARRANTY AND LIMITATION OF LIABILITY
THERE IS NO EXPRESS OR IMPLIED WARRANTY.
INCLUDING WITHOUT LIMITATION ANY IMPLIED INARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE, ON THE PRODUCT(S) FARTHOBEAR FOR COLLERE NE CRORUMS AFFILIATED
SHALL BIOSENSE WEBSTER NO. CRORUMS AFFILIATED
COMPANIES, BE LIASTER ANC. CORUNC AFFULACED
COMPANIES, BEE LIASLE FOR ANY SECURAL C OTHER THAN AS EXPRESSLY PROVIDED BY SPECIFIC
LAW. WITHOUT LIMITING THE FOREGOING, BIOSENSE WEBSTER, INC. OR ITS AFFILIATED COMPANIES, SHALL
NOT BE LIABLE FOR ANY SPECIAL, DIRECT. INCIDENTAL, CONSEQUENTIAL, OR OTHER DAMAGES, LABELED FOR SINGLE USE OR WHERE REUSE ISS TROSENSE WEBSTER, INC. PRINTED MATTER. INCLUDING THIS PUBLICATION, ARE INFORMATIONAL
ONLY AND MEANT SOLELY TO GENERALLY DESCRIBE THE PRODUCT AT THE TIME OF MANUFACTURE AND ARE NOT MADE OR GIVEN AS A WARRANTY OF THE PRESCRIBED PRODUCT IN ANY WAY.
7n catheter M-5723-15
eco 10F
| 2
M-5276-702B C
4
Biosense Webster. 0086
SoundStar®eco
ULTRASOUND CATHETER
COMPATIBILITY MATRIX INSERT
Compatibility Matrix Inisert Engilish Page
M-5276-704XBXC
. . .
5
English
SOUNDSTAR® eco DIAGNOSTIC ULTRASOUND CATHETER COMPATIBILITY MATRIX INSERT
ADDENDUM TO SOUNDSTAR® eco DIAGNOSTIC ULTRASOUND CATHETER INSTRUCTIONS FOR USE (M-5276-703)
The SoundSTAR® eco Diagnostic Ultrasound Catheter has been validated for use with the GE utrasound systems In conjunction with the CARTO® EP Navigation Systems listed in the following table.
| Ultrasound Systems | CARTO® Systems |
|---|---|
| Vivid-I* | CARTO® 3 version 2.2 * |
| Vivid-q* | CARTO® 3 version 2.2 * |
*The SoundSTAR® eoo Diegnostic Us ITRASOUND versions of CARTO 3 EP Navigation System.
TRANSDUCER SURFACE TEMPERATURE The following table provides the maximum surface
temperature of the SOUNDSTAR® Catheter with the relevant ultrasound system. The tissue mimicking material (TMM) temperature Is displayed in accordance with IEC 60601-2-37 requirements.
| Ultrasound System | TMM (Max Temp) |
|---|---|
| Vivid-i* | 41.8°C |
| Vivid-q* | 41.8°C |
For catheter 175723-16
eco 10FG
| 2
LIABILITY
M-5276-704XBXC
DISCLAIMER OF WARRANTY AND LIMITATION OF
EADING IS NO EXPRESS OR IMPLIED WARRANTY,
INCLUDING WITHOUT LIMITATION ANY INPLIED
INCEDDING WITHOD COMPANIE ADA ANT INFORCED
PAARCAULA OF MERCEMANA ARTE OR FUTULOS FOR A
PARTACIAL OF MERCEMANA CARA AND CONSTITUTIOS FOR A
DESCRIBED HEBREWS UNDER INCOLORIES
INCIDENTAL, CONSEQUENTIAL, OR OTHER DAMAGES. LAW. WITHOUT LIMITING THE FOREGOING, BIOSENSE WEBSTER, INC. OR ITS AFFILIATED COMPANIES, SHALL NOT BE LIABLE FOR ANY SPECIAL, DREET, OR OTHER DAMAGES, ARISING OUT OF THE REUSE OF ANY PRODUCT(S) LABELED FOR SINGLE USE OR WHERE REUSE IS PROHIBITED BY APPLICABLE LAW.
DESCRIPTIONS AND SPECIFICATIONS APPEARING IN
BIOSENSE WEBSTER, INC. PRINTED MATTER, INCLUDING THIS PUBLICATION, ARE INFORMATIONAL
ONLY AND MEANT SOLELY TO GENERALLY DESCRIBE THE PRODUCT AT THE TIME OF MANUFACTURE AND
6
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 1 8 2011
Biosense Webster, Inc. c/o Marina Guevrekian, Ph.D. Senior Specialist, Regulatory Affairs 3333 Diamond Canyon Road Diamond Bar, CA 91765
Re: K112050
Trade/Device Name: SOUNDSTAR® eco 10F and SOUNDSTAR® eco 10FG catheters Regulatory Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (Two) Product Code: OBJ Dated: October 20, 2011 Received: October 21, 2011
Dear Dr. Guevrekian:
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.
7
Page 2 - Marina Guevrekian, Ph.D.
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/CDRH0ffices/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,
W
Bram D. Zuckerman, M.D. Directør Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
7 INDICATIONS FOR USE
510(k) No (if known): K112050
Device Name:
SOUNDSTAR® eco 10F CATHETER SOUNDSTAR® eco 10FG CATHETER
Indications for Use:
The Biosense Webster SOUNDSTAR® eco Diagnostic Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible CARTO® 3 EP Navigation Systems, the SOUNDSTAR® eco Catheter provides location information. Please refer to the Compatibility Matrix Insert for Compatible CARTO® 3 Systems as each catheter is compatible with a specific version of CARTO® 3 and is not backwards compatible with previous versions of CARTO® 3 EP Navigation Systems.
Prescription Use ----V — AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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| 100 | ------------- |
Division of Cardiovascular Devices 510(k) Number_K(2050
9
Image /page/9/Picture/5 description: The image shows the logo for Biosense Webster, a Johnson & Johnson company. The logo features the company name in a simple, sans-serif font, with the Johnson & Johnson tagline in a smaller font underneath. To the right of the company name is a stylized graphic that resembles a heart with a circle and lines inside.
ULTRASOUND CATHETER
ULTRASOUND CATHETER
COMPATIBILITY MATRIX
INSERT
Exclusi
Companeraty Matrix Insert
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M-5276-702BC
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SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER COMPATIBILITY MATRIX INSERT
ADDENDUM TO SOUNDSTAR® COO DIAGNOSTIC ULTRASOUND CATHETER INSTRUCTIONS FOR USE (M-5276-701)
The SoundSTAR® eoo Diagnostic Ultrasound Catheter has been validated for use with the Siemens ultrasound systems in conjunction with the CARTO® EP Navigation Systems listed in the following table.
| Ultrasound Systems | CARTO® Systems |
|---|---|
| ACUSON Sequola™ | CARTO® 3 version 2.2 * |
| ACUSON Cypress™ | CARTO® 3 version 2.2 * |
| ACUSON X300™ | CARTO® 3 version 2.2 * |
The SoundStar® eco Diagnostic Ul trasound Catherer is not backwards compatible with previous versions of CARTQ® 3 EP Navigation Syslem.
TRANSDUCER SURFACE TEMPERATURE The following table provides the maximum surface the relieving the SOUNDSTAR® Catheter with the relevant
ultrasound system. The tissue mimiciding material (TMM) temperature is displayed in accordance with IEC 60601-2-37 requirements.
| Ultrasound System | TMM (Max Temp) |
|---|---|
| ACUSON Sequoia* | 42.1°C |
| ACUSON Cypress* | 42.1°C |
| ACUSON X300* | 41.8°C |
DISCLAIMER OF WARRANTY AND LIMITATION OF
THERE IS NO EXPRESS OR IMPLIED WARRANTY, THEREAKTY WITHORCLIANTABLITY OR FITHESS FOR A
WARRANTT WITHORCHANTABLITY OR FITNESS FOR A
WARRANTT WITHOSE, ON THE PRODUCT ISSUESTISS
PARTICULAR PURPOSE, ON THE PRODUCTION IS SHALL BIOSENSE WEBSTER, INC., OR ITS AFFILIATED
COMPANIES, BE LIABLE FOR ANY SPECIAL, DIRECT, OUTHER THAN AS EXPRESSSLY PROVIDED BY SPECIAL SECURITIES OF SPEENSE
OTHER THAN AS EXEREESSLY PROVIDED BY SPECIAL BE SPECIALS SE WEBSTER, INC. OR IT'S AFFILIATED COMPANIES, SHALL NOT BE LIABLE FOR ANY SPECIAL, DIRECT, ARISING OUT OF THE REUSE OF ANY PRODUCT(S) LABELED FOR SINGLE USE OR WHERE REUSE IS PROHIBITED BY APPLICABLE LAW.
DESCRIPTIONS AND SPECIFICATIONS APPEARING IN BIOSENSE WEBSTER, INC. PRINTED MATTER,
INCLUDING THIS PUBLICATION, ARE INFORMATIONAL ONLY AND MEANT SOLELY TO GENERALLY DESCRIBE THE PRODUCT AT THE TIME OF MANUFACTURE AND ARE NOT MADE OR GIVEN AS A WARRANTY OF THE PRESCRIBED PRODUCT IN ANY WAY.
ta catheter 11-5723-15
eco. 10F
2/1
LIABILITY
-2 M-5276-702B_G
11
Biosense Webster.
a johnson johnson company
CE
0086
Sound SoundStak® eco
ULTRASOUND CATHETER
COMPATIBILITY MATRIX
INSERT
Compatibility Matrix Insert English Page
.
M-5276-704XBXC · . .
12
SOUNDSTAR® eco DIAGNOSTIC ULTRASOUND CATHETER COMPATIBILITY MATRIX INSERT
ADDENDUM TO SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER INSTRUCTIONS FOR USE (M-5276-703)
The SOUNDSTAR® eco Diagnostic Ultrasound Catheter has been validated for use with the GE ultrasound systems in
conjunction with the CARTO® EP Navigation Systems listed in the following table.
| Ultrasound Systems | CARTO® Systems |
|---|---|
| Vivid-i* | CARTO® 3 version 2.2 * |
| Vivid-q* | CARTO® 3 version 2.2 * |
· The SoundStar® eco Diagnostic ULTRasoung Catherer is not backwards compatible with previous versions of CARTO
3 EP Navigation System.
TRANSDUCER SURFACE TEMPERATURE The following table provides the maximum surface
temperature of the SOUNDSTAR® Catheter with the relevant
ultrasound system. The tissue mimicking material (TMM) temperature is displayed in accordance with IEC 60601-2-37 requirements.
| Ultrasound System | TMM (Max Temp) |
|---|---|
| Vivid-1* | 41.8°C |
| Vivid-g* | 41.8°C |
For catheter M5723-16
eco 10FG
DISCLAIMER OF WARRANTY AND LIKITATION OF LIABILITY
THERE IS NO EXPRESS OR IMPLIED WARRANTY, INPLIED WARRANTY OF MERCHANTABILITY OF ARRETHS
PARTICULAR PURPOSE, ON THE PRODUCTS OR FUTUS
PARTICULAR PURPOSE, ON THE PRODUCTS OF CORPORATIONS ANDER SHALL BIOSENSE WEBSTER, INC., OR ITS AFFILLATED
COMPANIES, BE LIABLE FOR ANY SPECIAL, DIRECT, OTHER THAN AS EXPRESSLY PROVIDED BY SPECIFIC WEBSTER INC. OR ITS AFFILIATED COMPANIES, SHALL NEBOTEN, IROFOR ANY SPECIAL, DIRECT,
INCIDENTAL, CONSEQUENTIAL, OR OTHER DAMAGES, ARISING OUT OF THE REUSE OF ANY PRODUCT(S) LABELED FOR SINGLE USE OR WHERE REUSE IS PROHIBITED BY APPLICABLE LAW. DESCRIPTIONS AND SPECIFICATIONS APPEARING IN BIOSENSE WEBSTER AND SPECIFICATION, ARE INFORMATIONS IN
INCLUDING THIS PUBLICATION, AREE MEDIRER
INCLUDING THIS PUBLICATION, AREE MEDIRER
INCLUDING THIS PUBLICATION, AREE MED ONLY AND MEANT SOLELY TO GENERALLY DESCRIBE THE PRODUCT AT THE TIME OF MANUFACTURE AND
| 2
M-5276-704XBXC