The SOUNDSTAR™ CRYSTAL 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 catheter provides location information. Refer to the Compatibility Matrix Insert for compatible CARTO™ 3 Systems as each catheter is compatible with a specific version of the CARTO™ 3 System and is not backward compatible with previous versions of the CARTO™ 3 EP Navigation System.

Device Description

The SOUNDSTAR CRYSTAL Ultrasound catheter is disposable and licensed for single use only. The catheter is optimized for intracardiac scanning. With the catheter, the physician can maneuver the imaging plane located inside the catheter tip to see the region of interest. The physician can steer the catheter to optimize tissue visualization. The catheter is to be used only on systems with which they have been tested and found compatible. The proposed device, when connected to the corresponding Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO® 3 EP Navigation System.

AI/ML Overview

The provided text is a 510(k) premarket notification for the SOUNDSTAR™ CRYSTAL Ultrasound Catheter. It does not describe a study involving acceptance criteria and device performance in the context of AI/algorithm performance.

The document states: "The SOUNDSTAR™ CRYSTAL Ultrasound catheter in this submission uses the same intended use, technology and principles as the predicate device and hence clinical data is not required to establish substantial equivalence." This indicates that the regulatory submission primarily relies on demonstrating equivalence to a previously cleared device through non-clinical testing, rather than presenting a study proving performance against specific acceptance criteria with human or AI assessment.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria, as such a study (especially a clinical or AI-centric one) is not included in this submission. The "Performance Testing" section lists various engineering and safety standards (e.g., ISO, ANSI/AAMI, IEC) that the device complies with, but these are not presented as acceptance criteria for performance in the way described in your prompt (e.g., sensitivity, specificity, or human reader improvement with AI).

If you have a different document that details a clinical study or AI algorithm performance, I would be happy to analyze that.

Summary

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June 12, 2024

Biosense Webster, Inc. Sheba Chacko Senior Regulatory Affairs Program Lead 31 Technology Drive, Suite 200 Irvine, California 92618

Re: K240050

Trade/Device Name: SOUNDSTAR™ CRYSTAL Ultrasound Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: May 31, 2024 Received: May 31, 2024

Dear Sheba Chacko:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Aneesh S. Deoras -S

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality

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Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K240050

Device Name

SOUNDSTAR™ CRYSTAL Ultrasound Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

1.1 Submitter [ 21 CFR 807.92(a) (1)] and Device Information [21 CFR 807.92 (a) (2)]

Date Summary Prepared	May 30, 2024
Applicant	Biosense Webster, Inc.31 Technology Drive, Suite 200Irvine, CA 92618Establishment Registration Number: 9044811
Official Correspondent	Sheba ChackoSenior Regulatory Affairs Program LeadTelephone: (949) 450-6058Fax: (949) 450-6886
Trade Name	SOUNDSTAR™ Crystal Ultrasound Catheter
Common Name	Intracardiac Echocardiography Catheter
Classification Name	Diagnostic Intravascular Catheters
Device Classification	Class II, 21 CFR 870.1200
FDA Product Code	OBJ
Predicate device(s)	SOUNDSTAR eco 10F/10FG Ultrasound Catheter (K112050)AcuNav Crystal Ultrasound Catheter (K233270)

Table 1: Submitter Information

1.2 Predicate Device and Reference Device Information [21 CFR 807.92(a) (3)]

Predicate Device Information
Predicate Device Name	Manufacturer	510(k) #	Decision Date
SOUNDSTAReco 10F/10FGUltrasoundCatheter	Biosense Webster, Inc.	K112050	Nov 11, 2011
Reference Device Information
AcuNav CrystalUltrasoundCatheter	Siemens MedicalSolutions USA, Inc.	K233270	Oct 28, 2023

Table 2: Predicate and Reference Device Information

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1.3 Description of the Device Subject to Premarket Notification [21 CFR 807.92(a) (4)] The SOUNDSTAR CRYSTAL Ultrasound catheter is disposable and licensed for single use only. The catheter is optimized for intracardiac scanning. With the catheter, the physician can maneuver the imaging plane located inside the catheter tip to see the region of interest. The physician can steer the catheter to optimize tissue visualization. The catheter is to be used only on systems with which they have been tested and found compatible. The proposed device, when connected to the corresponding Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO® 3 EP Navigation System.

1.4 Intended Use [21 CFR 807.92(a) (5)]

Indications of Use: The SOUNDSTAR™ CRYSTAL 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 catheter provides location information. Refer to the Compatibility Matrix Insert for compatible CARTO™ 3 Systems as each catheter is compatible with a specific version of the CARTO™ 3 System and is not backward compatible with previous versions of the CARTO™ 3 EP Navigation System.

Element of Comparison	Proposed/Subject Device	Predicate Device[K112050][SoundStar eco 10F/10FGUltrasound Catheter]	Reference Device[K233270]AcuNav CrystalUltrasound Catheter
Device Name	SOUNDSTAR™ CRYSTALUltrasound Catheters	SoundStar eco 10FUltrasound Catheter	AcuNav Crystal UltrasoundCatheter
510(k)	Subject Device	K112050	K233270
Manufacturer	Biosense Webster, Inc.	Biosense Webster, Inc.	Siemens Medical SolutionsUSA, Inc.
Indications for Use	The SOUNDSTAR™CRYSTAL UltrasoundCatheter and relatedaccessory devices areindicated for intra-cardiacand intra-luminalvisualization of cardiac andgreat vessel anatomy andphysiology as well asvisualization of other devicesin the heart. When used withcompatible CARTO™ 3 EPNavigation Systems, thecatheter provides locationinformation. Refer to theCompatibility Matrix Insertfor compatible CARTO™ 3Systems as each catheter iscompatible with a specificversion of the CARTO™ 3System and is not backwardcompatible with previous	The Biosense WebsterSOUNDSTAR® ecoDiagnostic UltrasoundCatheter and relatedaccessory devices areindicated for intra-cardiacand intra-luminalvisualization of cardiac andgreat vessel anatomy andphysiology as well asvisualization of other devicesin the heart. When used withcompatible CARTO® 3 EPNavigation Systems, theSOUNDSTAR® ecoCatheter provides locationinformation. Please refer tothe Compatibility MatrixInsert for CompatibleCARTO® 3 Systems as eachcatheter is compatible with aspecific version of CARTO 3and is not backwards	The catheter is intended forintracardiac and intra-luminal visualization ofcardiac and great vesselanatomy and physiology aswell as visualization of otherdevices in the heart of adultand pediatric patients. Thecatheter is intended forimaging guidance only, nottreatment delivery, duringcardiac interventionalpercutaneous procedures.

Summary of Substantial Equivalence [21 CFR 807.92 (a) (6)] 1.5

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versions of the CARTOTм 3	compatible with previous
EP Navigation System.	versions of CARTO® 3 EP
	Navigation Systems.
Adult	Adult	Adult & Pediatric
Manual Control knobs on the	Manual Control knobs on the	Manual Control knobs on the
handle provide bidirectional	handle provide bidirectional	handle provide bidirectional
steering capabilities in 2	steering capabilities in 2	steering capabilities in 2
planes, left/right and	planes, left/right and	planes, left/right and
posterior /anterior.	posterior /anterior.	posterior
Mode of Operation
X	X	X
X	X	X
X	X	X
X	X	X
MECHANICAL DESIGN CHARACTERISTICS
9F	10 F	9F
90 cm	90 cm	90 cm
The handle houses the	The handle houses the	The handle houses the
steering mechanism that	steering mechanism that	steering mechanism that
enables deflection of the	enables deflection of the	enables deflection of the
distal tip	distal tip	distal tip
OTHER DESIGN CHARACTERISTICS
Yes	Yes	Yes
Compliant to ISO 10993-1	Compliant to ISO 10993-1	Compliant to ISO 10993-1
EtO	EtO	EtO
Twist and lock mechanism	Lever Mechanism	Twist and lock mechanism
Plastic tray,	Paper board tray,	Plastic tray,
One Pouch,	Double Pouch,	One Pouch,
Non-Telescoping one-piece	Telescoping two-piece	Non-Telescoping one-piece
CCSBS unit	CCSBS unit	CCSBS unit

Table 3: Summary of Substantial Equivalence

Other changes include update in the acoustic array where the number and length of active element array are changed with respect to the predicate device. Also, the raw materials included addition of Mobilize Pebax Compounding Solutions from that of the predicate device. These changes have been verified by well-established protocols. Preclinical testing has been conducted to confirm that the acoustic array has equivalent acoustic property for imaging performance and Biocompatibility test under ISO 10993-1 has been conducted to confirm that there is no impact on the results from the change of catheter materials.

1.6 Performance Testing: [21 CFR 807.92(b)(1)]

The device has been evaluated for acoustic output, biocompatibility, sterilization, packaging, shelf life as well as thermal, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The device complies with the following voluntary standards:

ISO 14971 risk management to medical devices ●
ANSI/AAMI ES 60601-1 Safety Requirements for Medical Equipment
IEC 60601-1-2 EMC requirements for Medical Equipment ●
IEC 60601-2-37 Diagnostic Ultrasound Safety Standards ●
ISO 10993-1 Biocompatibility ●

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ISO 11135, Sterilization of health-care products - Ethylene oxide
ISO 11607-1 and ISO 11607-2, Packaging for terminally sterilized medical devices

Summary of Clinical Tests 1.6.1

The SOUNDSTAR™ CRSTAL Ultrasound catheter in this submission uses the same intended use, technology and principles as the predicate device and hence clinical data is not required to establish substantial equivalence.

Conclusion on Safety and Effectiveness [21 CFR 807.92(b) (3)] 1.7

The SOUNDSTAR™ CRYSTAL Ultrasound Catheter is substantially equivalent to its currently cleared predicate devices based on the successful completion of nonclinical bench testing and pre-clinical studies, as well as the technological comparison exhibiting similar principles of design, operation, and indications for use.

Regulation Number and Section

§ 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).