(156 days)
No
The summary describes a standard ultrasound catheter for visualization and navigation, with no mention of AI or ML capabilities in image processing, analysis, or any other function.
No.
The device is described as an ultrasound catheter for visualization and navigation, not for treating any medical condition.
Yes
Explanation: The device is indicated for "intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology," which directly involves the process of identifying and assessing internal body structures or functions to aid in diagnosis.
No
The device description explicitly states it is a catheter, which is a physical hardware component. The summary also details performance studies related to physical properties like acoustic output, biocompatibility, sterilization, and mechanical safety, further indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The SOUNDSTAR CRYSTAL Ultrasound Catheter is used for intra-cardiac and intra-luminal visualization of anatomy and physiology within the body. It provides real-time imaging and location information.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly interacts with and images structures inside the body.
Therefore, the SOUNDSTAR CRYSTAL Ultrasound Catheter falls under the category of an in vivo diagnostic or therapeutic device (specifically, an imaging device used for diagnosis and potentially guiding procedures), rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
OBJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac and great vessel anatomy, heart.
Indicated Patient Age Range
Adult
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)
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
- ISO 11135, Sterilization of health-care products - Ethylene oxide
- ISO 11607-1 and ISO 11607-2, Packaging for terminally sterilized medical devices
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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"
1
(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
2
Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
SOUNDSTAR™ CRYSTAL Ultrasound Catheter
Indications for Use (Describe)
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.
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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4
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 200 | |
| Irvine, CA 92618 | |
| Establishment Registration Number: 9044811 | |
| Official Correspondent | Sheba Chacko |
| Senior Regulatory Affairs Program Lead | |
| Telephone: (949) 450-6058 | |
| Fax: (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 |
| SOUNDSTAR | |||
| eco 10F/10FG | |||
| Ultrasound | |||
| Catheter | Biosense Webster, Inc. | K112050 | Nov 11, 2011 |
| Reference Device Information | |||
| AcuNav Crystal | |||
| Ultrasound | |||
| Catheter | Siemens Medical | ||
| Solutions USA, Inc. | K233270 | Oct 28, 2023 |
Table 2: Predicate and Reference Device Information
5
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/10FG
Ultrasound Catheter] | Reference Device
[K233270]
AcuNav Crystal
Ultrasound Catheter |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | SOUNDSTAR™ CRYSTAL
Ultrasound Catheters | SoundStar eco 10F
Ultrasound Catheter | AcuNav Crystal Ultrasound
Catheter |
| 510(k) | Subject Device | K112050 | K233270 |
| Manufacturer | Biosense Webster, Inc. | Biosense Webster, Inc. | Siemens Medical Solutions
USA, Inc. |
| Indications for 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 | 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 | The catheter is intended for
intracardiac and intra-
luminal visualization of
cardiac and great vessel
anatomy and physiology as
well as visualization of other
devices in the heart of adult
and pediatric patients. The
catheter is intended for
imaging guidance only, not
treatment delivery, during
cardiac interventional
percutaneous procedures. |
Summary of Substantial Equivalence [21 CFR 807.92 (a) (6)] 1.5
6
| 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 ●
7
- 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.