(30 days)
Not Found
Not Found
No
The summary describes a diagnostic ultrasound catheter and its integration with a navigation system. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on real-time ultrasound imaging and location information.
No
The device is described as a "Diagnostic Ultrasound Catheter" and its intended use is for "intra-cardiac and intra-luminal visualization" and "acquiring real time ultrasound images," indicating it is used for diagnosis, not treatment.
Yes
The device's intended use is for "intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology," which is a diagnostic purpose to assess the state of the patient's anatomy and physiology.
No
The device description clearly states it is a physical catheter with embedded hardware components (acoustic array, magnetic location sensor, ultrasound transducer) and connects to external ultrasound systems. It is not solely software.
Based on the provided information, the Biosense Webster SOUNDSTAR® eco Diagnostic Ultrasound Catheter is not an In Vitro Diagnostic (IVD) device.
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 embedded in the tip. This is consistent with an invasive medical device used for real-time imaging and navigation within the heart.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body, which are hallmarks of IVD devices.
Therefore, the device is an in vivo diagnostic device, specifically an ultrasound catheter used for imaging and navigation within the body.
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 eco 8F and SOUNDSTAR eco 8F G Catheters are both 90 cm long and 8F in diameter. They are IntraCardiac Echo (ICE) Catheters with acoustic array and magnetic location sensor equivalent to the currently cleared SQUNDSTAR eco 10F and SOUNDSTAR eco 10FG Catheters. The magnetic location sensor (providing location information to the CARTO 3 EP Navigation System Version 2.3 and 3.2) and an ultrasound transducer (acquiring real time ultrasound images) are embedded in the catheter tip.
The modified SOUNDSTAR eco 8F and SOUNDSTAR eco 8F G Catheters have a bifurcated 'tail' originating from the catheter handle which is identical to the bifurcated tail of the predicate device; the SOUNDSTAR eco 10F. One leg terminates in the SOUNDSTAR Flex Tab connector, which connects via the appropriate SWIFTLINK cable, to the appropriate Ultrasound system. Specifically, for the SOUNDSTAR eco Catheter 8F. the SWIFTLINK cable connects to the Acuson Cypress™, the Acuson Sequoia™ or the Acuson X300™ and Acuson SC2000™ and Acuson SC2000™ Ultrasound systems. For the SOUNDSTAR eco 8F G Catheter, the SWIFTLINK cable connects to Vivid i and Vivid q Ultrasound systems.
Both versions of SOUNDSTAR eco 8F and SOUNDSTAR eco 8F G Catheters are based on the existing SOUNDSTAR eco 10F and SOUNDSTAR eco 10FG 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 eco 8F and SOUNDSTAR eco 8F G Catheters, when connected to the corresponding Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO 3 Version 2.3 and Version 3.2 electromagnetic acquired maps.
Mentions image processing
Not Found
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
To support the design change of the catheter, Design Verification Testing was performed on the modified SOUNDSTAR eco8F and SOUNDSTAR eco 8F G Catheters.
Safety and Electromagnetic Compliance testing was also performed to support the design changes on the predicate device. The Safety and Electromagnetic compliance testing validates the use of the modified devices; the SOUNDSTAR eco 8F and SOUNDSTAR eco 8F G Catheters with all the validated Siemens and GE Ultrasound systems.
Key Metrics
Not Found
Predicate Device(s)
SOUNDSTAR eco 10F P/N:M-5276-17 / Catalogue number 10439011 and SOUNDSTAR . eco 10FG P/N:M-5276-17 / Catalogue number 10439011.
Reference Device(s)
AcuNav 8F P/N M-5723-09 / Catalogue number 10135936 and AcuNav 8FG P/N M-5723-07 / Catalogue number 10135910.
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
K140318 page 1 of 5
Special 510K for SOUNDSTAR® eco 8F and SOUNDSTAR® eco 8F G Catheters
14 510(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
February 6, 2014
TRADE NAME
SOUNDSTAR® eco DIAGNOSTIC ULTRASOUND CATHETER
(Part Number: M-5723-17 / Catalogue Number: 10439011, Compatible with Siemens Ultrasound systems)
SOUNDSTAR® eco DIAGNOSTIC ULTRASOUND CATHETER
(Part Number: M-5723-18 / Catalogue Number: 10439236, 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 eco8F and SOUNDSTAR ecoF G Catheters are substantially equivalent to:
- SOUNDSTAR eco 10F P/N:M-5276-17 / Catalogue number 10439011 and SOUNDSTAR . eco 10FG P/N:M-5276-17 / Catalogue number 10439011.
page 79
1
Special 510K for SOUNDSTAR® eco 8F and SOUNDSTAR® eco 8F G Catheters
- · AcuNav 8F P/N M-5723-09 / Catalogue number 10135936 and AcuNav 8FG P/N M-5723-07 / Catalogue number 10135910.
DESCRIPTION OF MODIFIED DEVICE
The modified SOUNDSTAR eco 8F and SOUNDSTAR eco 8F G Catheters are both 90 cm long and 8F in diameter. They are IntraCardiac Echo (ICE) Catheters with acoustic array and magnetic location sensor equivalent to the currently cleared SQUNDSTAR eco 10F and SOUNDSTAR eco 10FG Catheters. The magnetic location sensor (providing location information to the CARTO 3 EP Navigation System Version 2.3 and 3.2) and an ultrasound transducer (acquiring real time ultrasound images) are embedded in the catheter tip.
The modified SOUNDSTAR eco 8F and SOUNDSTAR eco 8F G Catheters have a bifurcated 'tail' originating from the catheter handle which is identical to the bifurcated tail of the predicate device; the SOUNDSTAR eco 10F. One leg terminates in the SOUNDSTAR Flex Tab connector, which connects via the appropriate SWIFTLINK cable, to the appropriate Ultrasound system. Specifically, for the SOUNDSTAR eco Catheter 8F. the SWIFTLINK cable connects to the Acuson Cypress™, the Acuson Sequoia™ or the Acuson X300™ and Acuson SC2000™ Ultrasound systems. For the SOUNDSTAR eco 8F G Catheter, the SWIFTLINK cable connects to Vivid i and Vivid q Ultrasound systems.
Both versions of SOUNDSTAR eco 8F and SOUNDSTAR eco 8F G Catheters are based on the existing SOUNDSTAR eco 10F and SOUNDSTAR eco 10FG 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 eco 8F and SOUNDSTAR eco 8F G Catheters, when connected to the corresponding Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO 3 Version 2.3 and Version 3.2 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.
2
DESCRIPTION OF MODIFICATION
The modifications to the predicate devices are:
] . A smaller diameter for the catheter body shaft. Consequently a smaller French size. Therefore change from 10 French to 8 French.
- Change in the sensor design
The magnetic sensor in the predicate devices; SOUNDSTAR® eco 10F, SOUNDSTAR® eco 10FG catheters had a diameter of 1.3mm. The sensor used in the modified devices is a smaller sensor; magnetic sensor of 1.0mm, to allow the new sensor to fit in the smaller catheter body. In both catheters the Electromagnetic (EM) sensor enables accurate magnetic navigation for electro-anatomical mapping.
SOUNDSTAR eco 10F and SOUNDSTAR eco 10F G catheters sensor contains 3 coils in three X, Y, and Z axis. The coils have Ferrite core inside them and are assembled orthogonally with each other.
The coils have been repositioned for SOUNDSTAR® eco 8F catheter in comparison to the SOUNDSTAR® eco 10F catheters. Basically, the ferrites inside the coils of the SOUNDSTAR eco 8F and SOUNDSTAR eco 8F G catheters sensor have been replaced by air cores and assembled orthogonally.
The replacement of the ferrites by air cores in the sensor will allow the catheters to be used in the Stereotaxis Niobe® environment.
The main differences between the sensors are in the design and manufacturing process, while the end product is equivalent in functionality and performance
- The SOUNDSTAR® eco 8F Catheters will be able to generate ultrasound images within the Stereotaxis NIOBE® Remote Magnetic System without impacting the location or image quality. For the catheter functionality, as mentioned above, the coils located inside of the sensor have been repositioned and the existing ferrites have been removed and replaced by air cores to allow the catheter to be used in the Sterotaxis Niobe® environment. The sensor material remains the same.
SUMMARY OF NONCLINICAL TESTS
To support the design change of the catheter, Design Verification Testing was performed on the modified SOUNDSTAR eco8F and SOUNDSTAR eco 8F G Catheters.
Safety and Electromagnetic Compliance testing was also performed to support the design changes on the predicate device. The Safety and Electromagnetic compliance testing validates the use of the modified devices; the SOUNDSTAR eco 8F and SOUNDSTAR eco 8F G Catheters with all the validated Siemens and GE Ultrasound systems.
Image /page/2/Picture/14 description: This image shows the text 'page 81' vertically oriented. The word 'page' is stacked on top of the number '81'. The text is in a simple, sans-serif font and appears to be part of a page number within a larger document.
3
Special 510K for SOUNDSTAR® eco 8F and SOUNDSTAR® eco 8F G Catheters
The modified catheters are compatible with SOUNDSTAR eco Extension Cable and the CARTO 3 version 2.3 and 3.2 EP Navigation system. This compatibility has been documented by a Letter to file, filed on December 10, 2013.
SUBSTANTIAL EQUIVALENCE CONCLUSION
SIMILARITIES TO THE PREDICATE DEVICES .
a) The modified SOUNDSTAR eco 8F and SOUNDSTAR eco8F G Catheters are identical to the currently cleared SOUNDSTAR eco 10F and SOUNDSTAR eco 10FG Catheters in the following aspects:
- Have the same intended use .
- . Use the same operating principle
- Are manufactured in the same manufacturing facility .
- Use the same fundamental scientific technology .
- Incorporate the same materials and construction .
- Have the same deflection mechanism .
- The magnetic sensor has the same material and location .
- Have the same Ultrasound connections (to both Siemens and GE . Ultrasound systems)
- Catheter body & strain relief have identical assembly process .
- Have the same 64-channel acoustic phased array .
- Have the same acoustic array location and connection .
- Have the same packaging and are packaged using the same materials and . processes
- Have the same Electronics; the PCB is inside the Hypertronic connector . and Extension Cable
- Identical magnetic sensor location (not connected to the Printed Circuit . Board (PCB))
- Identical handle, magnetic location sensor wires and connections .
- Have the same handle material .
- Have the same Steering mechanism .
- Have identical Hypertronic connector .
- Most of the manufacturing processes are identical .
- Have the same shelf life .
- Use the same sterilization method (EtO sterilization) .
- . Are single use devices
b) The modified SOUNDSTAR eco 8F and SOUNDSTAR eco 8F G Catheters are identical to the currently cleared AcuNav 8F and AcuNav 8FG catheters in the following aspects
- . Have the same shaft material, color and process with a 90cm useable length
4
- . The product functional specification (hi pot, acoustic, articulation) and the DVT criteria is identical
- . Have the same strain relief material. composition and mechanical design
DIFFERENCES FROM THE PREDICATE DEVICES
a) The modified SOUNDSTAR eco8F and SOUNDSTAR eco8FG Catheters are different from the currently cleared SNDSTR10 and SNDSTR10G Catheters in the following aspects:
- · Have different Tip dimensions
- · Have a smaller French size for the catheter body shaft. Change from 10French to 8French diameter
- · A smaller sensor to fit in a smaller diameter of shaft.
- · The SOUNDSTAR eco 8F catheters will be able to generate ultrasound images within the Stereotaxis NIOBE® Remote Magnetic System, without impacting the location or image quality.
- The labels, IFUs and Matrices are slightly modified .
- The handle color is blue .
c) The modified SOUNDSTAR eco 8F and SOUNDSTAR eco 8F G Catheters are different to the currently cleared AcuNav 8F and AcuNav 8FG catheters in the following aspects
- . The last .5 cm of the shaft distal end out of 90 cm of the entire shaft length has additional internal grove to accommodate the sensor. The product functional specifications ( hi pot, acoustic, articulation, length, OD, ID, Shaft Material) and the DVT criteria do not change despite of this change.
- 트 The strain relief color is black
- . Has the new Heat Shrink Tube shown at figure 5 on page 19 as the item F.
page
83
5
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60S Silver Spring, MD 20993-0002
Image /page/5/Picture/3 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized symbol that resembles an abstract human figure or a caduceus-like design.
March 12, 2014
Biosense Webster Marina Guevrekian Senior Specialist Regulatory Affairs 3333 Diamond Canyon Rd. Diamond Bar, CA 91765 US
K140318 Re:
Trade/Device Name: Soundstar ECO 8FG Ultrasound Catheter, Soundstar ECO 8F Ultrasound Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Intravascular Ultrasound Catheter Regulatory Class: II Product Code: OBJ Dated: February 6, 2014 Received: February 10, 2014
Dear Marina 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems
6
Page 2 - Marina Guevrekian
(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 contact 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 CDR/'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/MedicalDeviccs/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Linda J. Ricci - S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
K140318 Special 510K for SOUNDSTAR® eco 8F and SOUNDSTAR® eco 8F G Catheters
6 INDICATIONS FOR USE
510(k) No (if known): TBI)
Device Name:
SOUNDSTAR eco 8F Catheter SOUNDSTAR eco 8F G 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 ---------イ — AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
の日、2008年には、2005年には、2007年には、2006年には、2006年には、2008年の100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Concurrence of CDRH, Office of Device Evaluation (ODE)
Linda J. Ricci - S
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BIOSENSE WEBSTER, INC.