(211 days)
Not Found
No
The summary describes a standard ultrasound catheter with location tracking capabilities integrated with a navigation system. There is no mention of AI/ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a "Diagnostic Ultrasound Catheter" and its purpose is for "visualization of cardiac and great vessel anatomy and physiology" and to provide "location information." It does not mention treating or curing any conditions.
Yes.
The "Intended Use / Indications for Use" section explicitly states that "The Biosense Webster SOUNDSTAR™ 3D Diagnostic Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intra-luminal visualization..." where "diagnostic" clearly indicates its purpose. Additionally, the "Device Description" mentions that it has an "acoustic array identical to the ACUSON AcuNav" 10F Diagnostic Ultrasound Catheter."
No
The device description clearly details a physical catheter with embedded hardware components (location sensor, ultrasound transducer) and connections to external hardware systems (ultrasound system, CARTO® Navigation System). It is not solely software.
Based on the provided text, 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 (in vitro).
- Device Description: The description details an "IntraCardiac Echo (ICE) Catheter" with an ultrasound transducer and location sensor. This is consistent with an imaging and navigation device used internally.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples to diagnose a condition.
Therefore, the Biosense Webster SOUNDSTAR™ 3D Diagnostic Ultrasound Catheter is an in vivo diagnostic imaging and navigation device, not an in vitro diagnostic device.
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 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.
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 ACUSON AcuNav" 10F Diagnostic 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 Sequoia or the Cypress 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 intraluminal (cardiac and great vessel anatomy), heart
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 SOUNDSTAR™ 3D Ultrasound Catheter still applies to the modified device as there were no changes to the design, materials, manufacturing methods or performance of the device. Testing for compatibility with the CARTO® 3 EP Navigation Systems was submitted in the CARTO® 3 System 510(k). Therefore, no additional testing is submitted in this Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SOUNDSTAR™ 3D Ultrasound Catheter (K070242)
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).
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DEC - 4 zuug
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11 510(k) Summary
11.1 SPONSOR'S NAME & ADDRESS
Biosense Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765
11.2 Official Correspondent Balaka Das Senior Specialist, Regulatory Affairs Phone: 909-839-8599 Fax: 909-839-8804 Email: bdas2@its.jnj.com
- 11.3 SUBMISSION DATE May 6, 2009
11.4 TRADE NAME SOUNDSTAR™ 3D Ultrasound Catheter
11.5 COMMON NAME Electrophysiology Mapping/Ultrasound Catheter
- CLASSIFICATION NAME/PRODUCT CODE 11.6 Intravascular Ultrasound Catheter/OBJ
11.7 CLASSIFICATION Class II
- 11.8 PREDICATE DEVICE SOUNDSTAR™ 3D Ultrasound Catheter (K070242) cleared on May 15, 2007.
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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 ACUSON AcuNav" 10F Diagnostic 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 Sequoia or the Cypress Ultrasound Systems, will provide real-time integration of
ultrasound images with CARTO electromagnetic acquired maps.
11.10 INDICATIONS FOR USE
The Biosense Webster SOUNDSTARTM 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.
DESCRIPTION OF MODIFICATION 11.11
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.
SUMMARY OF NONCLINICAL TESTS 11.12
All testing previously submitted for the SOUNDSTAR™ 3D Ultrasound Catheter still applies to the modified device as there were no changes to the design, materials, manufacturing methods or performance of the
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K091352
pg 3 of 3
device. Testing for compatibility with the CARTO® 3 EP Navigation Systems was submitted in the CARTO® 3 System 510(k). Therefore, no additional testing is submitted in this Premarket Notification.
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.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines, representing the department's mission of promoting health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 0 4 2009
Biosense Webster, Inc. Balaka Das, Senior Specialist, Regulatory Affairs 3333 Diamond Canyon Rd. Diamond Bar, CA 91765
Re: K091352
Trade/Device Name: SoundStar 3D Ultrasound Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: November 3, 2009 Received: November 5, 2009
Dear Ms. Das:
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.
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
4
Page 2 - Ms. Balaka Das
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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K091352
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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRN Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Division of Cardiovascular Devices | Page 1 of 1 |
| 510(k) Number | K091352 |