(61 days)
Not Found
No
The summary describes a diagnostic ultrasound catheter and its integration with a navigation system. There is no mention of AI, ML, or any advanced image processing techniques that would suggest the use of these technologies. The focus is on real-time ultrasound imaging and location information.
No.
The device is indicated for intra-cardiac and intra-luminal visualization and providing location information, which are diagnostic purposes, not therapeutic (treatment) purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "visualization of cardiac and great vessel anatomy and physiology" and "visualization of other devices in the heart," which are diagnostic purposes. In addition, the device name itself includes "Diagnostic Ultrasound Catheter".
No
The device description clearly details a physical catheter with embedded hardware components (location sensor, ultrasound transducer) and physical connectors, indicating it is 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 a catheter with an ultrasound transducer and location sensor for real-time imaging and navigation within the heart. This aligns with an in-vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The device provides visual and location information directly from within the body.
IVD devices are designed to perform tests on specimens derived from the human body to provide information for diagnostic purposes. This device is an imaging and navigation tool used directly within the body.
N/A
Intended Use / Indications for Use
The Biosense Webster SOUNDSTAR 3D Diagnostic Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible CARTO® EP Navigation Systems, the SOUNDSTAR 3D Catheter provides location information.
Product codes
OBJ
Device Description
The Biosense Webster SOUNDSTAR 3D Ultrasound Catheter is a 90 cm 10F IntraCardiac Echo (ICE) Catheter with an acoustic array identical to the Biosense Webster SOUNDSTAR 3D Ultrasound Catheter, model M-5723-12, Ultrasound Catheter. The catheter has a location sensor (providing location information to CARTO® EP Navigation Systems with ultrasound capability) and an ultrasound transducer (acquiring real time ultrasound images) embedded in the tip.
The SOUNDSTAR 3D Ultrasound Catheter has a bifurcated 'tail' originating from its handle. One leg terminates in the SOUNDSTAR tab connector, which connects via a Swiftlink cable to an ultrasound system. The other leg terminates in the CARTO® Hypertronic connector, which connects via a Patient Interface Unit (PIU) extension cable to the CARTO® Navigation System.
The SOUNDSTAR 3D Ultrasound Catheter, when connected to a CARTO® EP Navigation System with ultrasound capability, and the GE Vivid-i or Vivid-q Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO® 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
All testing previously submitted for the predicate SOUNDSTAR 3D Ultrasound Catheter, model number M-5723-12, still applies to the modified device as there were no changes to the design, materials, manufacturing methods or performance of the device. In addition, various functionality testing was performed on the SOUNDSTAR Catheter, model number M-5723-05, with GE Vivid-i/q Ultrasound System and CARTO® 3 System functionality. Testing verified that the three components, when connected simultaneously, functioned appropriately as designed. This additional functionality testing which was performed on the SOUNDSTAR Catheter, model number M-5723-05, demonstrates equivalence to the modified device (model number M-5723-12), as SOUNDSTAR Catheter, model number M-5723-05 is nearly identical to the predicate SOUNDSTAR Catheter, model number M-5723-12, with the exception that the identification codes in the catheter connectors are different. The predicate device, the SOUNDSTAR Catheter, model number M-5723-12, is physically identical to the modified device (model number M-5723-12), which is the subject of this submission. The only modification to model number M-5723-12 is to the labeling of the device to allow compatibility with multiple CARTO® EP Navigation Systems with ultrasound capability. Testing for compatibility with the CARTO 3 EP Navigation Systems is referenced in the Compatibility Summary Report found in Appendix 3.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
K101138 pg 1 of 3
Special 510(k) for SoundStar 3D Ultrasound Catheter: IEU change.to add CARTO 3 Compatibility
11 510(k) Summary
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11.1 SPONSOR'S NAME & ADDRESS Biosense Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765
JUN 2 2 2010 -
11.2 OFFICIAL CORRESPONDENT Melissa C. Schultz Project Manager, Regulatory Affairs Phone: 909-839-8787 Fax: 909-839-8804 Email: MSchult1@its.jnj.com
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11.3 SUBMISSION DATE April 21, 2010
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11.4 TRADE NAME SOUNDSTAR 3D Ultrasound Catheter
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11.5 COMMON NAME Electrophysiology Mapping/Ultrasound Catheter
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CLASSIFICATION NAME/PRODUCT CODE 11.6 Intravascular Ultrasound Catheter/OBJ
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11.7 CLASSIFICATION Class II
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11.8 PREDICATE DEVICE SOUNDSTAR 3D Ultrasound Catheter, model M-5723-12 (K092064) cleared on August 7, 2009.
BIOSENSE WEBSTER INC.
1
11.9 DESCRIPTION OF DEVICE
The Biosense Webster SOUNDSTAR 3D Ultrasound Catheter is a 90 cm 10F IntraCardiac Echo (ICE) Catheter with an acoustic array identical to the Biosense Webster SOUNDSTAR 3D Ultrasound Catheter, model M-5723-12, Ultrasound Catheter. The catheter has a location sensor (providing location information to CARTO® EP Navigation Systems with ultrasound capability) and an ultrasound transducer (acquiring real time ultrasound images) embedded in the tip.
pg 20f3
11 101138
The SOUNDSTAR 3D Ultrasound Catheter has a bifurcated 'tail' originating from its handle. One leg terminates in the SOUNDSTAR tab connector, which connects via a Swiftlink cable to an ultrasound system. The other leg terminates in the CARTO® Hypertronic connector, which connects via a Patient Interface Unit (PIU) extension cable to the CARTO® Navigation System.
The SOUNDSTAR 3D Ultrasound Catheter, when connected to a CARTO® EP Navigation System with ultrasound capability, and the GE Vivid-i or Vivid-q Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO® electromagnetic acquired maps.
11.10 INDICATIONS FOR USE
The Biosense Webster SOUNDSTAR 3D Diagnostic Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible CARTO® EP Navigation Systems, the SOUNDSTAR 3D Catheter provides location information.
11.11 DESCRIPTION OF MODIFICATION
The modified SOUNDSTAR 3D Ultrasound Catheter is physically identical to the predicate device in terms of design, manufacturing methods, materials and performance. There are absolutely no changes to the device whatsoever. The only modification is to the labeling for the device to allow compatibility with multiple CARTO® EP Navigation Systems with ultrasound capability.
11.12 SUMMARY OF NONCLINICAL TESTS
All testing previously submitted for the predicate SOUNDSTAR 3D Ultrasound Catheter, model number M-5723-12, still applies to the modified device as there were no changes to the design, materials,
BIOSENSE WEBSTER. INC.
2
manufacturing methods or performance of the device. In addition, various functionality testing was performed on the SOUNDSTAR Catheter, model number M-5723-05, with GE Vivid-i/q Ultrasound System and CARTO® 3 System functionality. Testing verified that the three components, when connected simultaneously, functioned appropriately as designed. This additional functionality testing which was performed on the SOUNDSTAR Catheter, model number M-5723-05, demonstrates equivalence to the modified device (model number M-5723-12), as SOUNDSTAR Catheter, model number M-5723-05 is nearly identical to the predicate SOUNDSTAR Catheter, model number M-5723-12, with the exception that the identification codes in the catheter connectors are different. The predicate device, the SOUNDSTAR Catheter, model number M-5723-12, is physically identical to the modified device (model number M-5723-12), which is the subject of this submission. The only modification to model number M-5723-12 is to the labeling of the device to allow compatibility with multiple CARTO® EP Navigation Systems with ultrasound capability. Testing for compatibility with the CARTO 3 EP Navigation Systems is referenced in the Compatibility Summary Report found in Appendix 3.
11.13 SUBSTANTIAL EQUIVALENCE
The modified SOUNDSTAR 3D Ultrasound Catheter is identical to the previously cleared SOUNDSTAR 3D Ultrasound Catheter in that the devices:
- have the same intended use,
- use the same operating principle,
- use the same fundamental scientific technology, .
- incorporate the same design, .
- incorporate the same materials and construction, .
- have the same shelf life, and .
- are packaged using the same materials and processes. .
In summary, the SOUNDSTAR 3D Ultrasound Catheter described in this submission is substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, rendered in black lines. The bird is oriented towards the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biosense Webster, Inc c/o Ms. Melissa Schultz Project Manager, Regulatory Affairs 3333 Diamond Canyon Rd Diamond Bar, CA 91765
JUN 2 2 2010
Re: K101138
Trade/Device Name: Soundstar 3D Ultrasound Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II (two) Product Code: OBJ Dated: May 25, 2010 Received: May 26, 2010
Dear Ms. Schultz:
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
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Page 2 - Ms. Melissa Schultz
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm fou 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" (21CFF) Patt 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 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 no mber (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
M. A. Hillemann
Bram D. Zuckerman, M.D. for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use ব
510(k) No (if known): __ K |0 || 38
Device Name: SOUNDSTAR 3D Ultrasound Catheter
Indications for Use:
The Biosense Webster SOUNDSTAR 3D 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® EP Navigation Systems, the SOUNDSTAR 3D Catheter provides location information.
Over-The-Counter Prescription Use Use N -- 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
M. A. Hillemeier
Division Sign-Off) Jivision of Cardiovascular Devices
510(k) Number_K101) 38